Conditions: Respiratory Syncytial Virus Infection
Keywords: Respiratory Syncytial Virus (RSV) Antiviral Hematopoietic Cell Transplant (HCT) Lower respiratory tract infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).

Detailed description:

Arms:
arm 1: Participants will receive presatovir on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56. arm 2: Participants will receive placebo to match presatovir on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56.

Interventions: intervention 1: Presatovir intervention 2: Placebo
Intervention descriptions: intervention 1: Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube intervention 2: Placebo to match presatovir administered orally or via nasogastric tube

Protocol document:
Prot_009.pdf: 
Study Title: 
Sponsor: 
IND Number: 
EudraCT Number: 
Clinical Trials.gov 
Identifier: 
Indication: 
Protocol ID: 
Clinical Program 
Manager: 
Gilead Medical Monitor: 
Protocol Version/Date: 
(rJ GILEAU 
CLINICAL STUDY PROTOCOL 
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled 
Multi-Center Study Evaluating Antiviral Effects, 
Phrumacokinetics, Safety, and Tolerability ofGS-5806 in 
Hematopoietic Cell Transplant (HCT) Recipients with Respirat01y 
Syncytial Vims (RSV) Infection of the Lower Respirat01y Tract 
Gilead Sciences, Inc. 
199 E Blaine St. 
Seattle, W A 98102 
114498 
2014-002475-29 
TBD 
Respirat01y Syncytial Vims (RSV) 
GS-US-218-1502 
Name: 
Telephone: 
Fax: 
Name: 
Telephone: 
Fax: 
Mobile: 
PD 
PPD 
PPD 
Seth Toback, MD 
PPD 
PPD 
PPD 
Original 
09 Jlme 2014 
Amendment 1 31 July 2014 
CONFIDENTIALITY STATEMENT 
The inf01mation contained in this document, pruiiculru·ly unpublished data, is the propeliy or 
under conu·ol of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable Institutional 
Review Board or Independent Ethics Committee. The infonnation is only to be used by you in 
connection with authorized clinical studies of the investigational dmg described in the protocol. 
You will not disclose any of the inf01mation to others without written authorization from 
Gilead Sciences, Inc., except to the extent necessruy to obtain infonned consent from those 
persons to whom the dmg may be administered. 


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TABLE OF CONTENTS
TABLE OF CONTENTS .......................................................................................................................................2
LIST OF IN-TEXT TABLES.................................................................................................................................4
PROTOCOL SYNOPSIS .......................................................................................................................................5
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS.............................................................17
1.
INTRODUCTION .......................................................................................................................................21
1.1.
Background .....................................................................................................................................21
1.2.
GS-5806 ..........................................................................................................................................22
1.2.1.
General Information ......................................................................................................22
1.2.2.
Nonclinical Pharmacokinetics.......................................................................................23
1.2.3.
Nonclinical Pharmacology and Toxicology ..................................................................23
1.2.4.
Clinical Trials of GS-5806 ............................................................................................25
1.3.
Rationale for This Study .................................................................................................................28
1.4.
Dose Rationale ................................................................................................................................29
1.5.
Compliance .....................................................................................................................................29
2.
OBJECTIVES..............................................................................................................................................30
3.
STUDY DESIGN.........................................................................................................................................31
3.1.
Endpoints ........................................................................................................................................31
3.2.
Study Design...................................................................................................................................32
3.3.
Study Treatments ............................................................................................................................32
3.4.
Duration of Treatment.....................................................................................................................33
3.5.
Discontinuation Criteria..................................................................................................................33
3.6.
Source Data.....................................................................................................................................33
4.
SUBJECT POPULATION...........................................................................................................................35
4.1.
Number of Subjects and Subject Selection .....................................................................................35
4.2.
Inclusion Criteria.............................................................................................................................35
4.3.
Exclusion Criteria............................................................................................................................36
5.
INVESTIGATIONAL MEDICINAL PRODUCTS ....................................................................................38
5.1.
Randomization, Blinding and Treatment Codes .............................................................................38
5.1.1.
Procedures for Breaking Treatment Codes....................................................................38
5.2.
Description and Handling of GS-5806............................................................................................39
5.2.1.
Formulation...................................................................................................................39
5.2.2.
Packaging and Labeling ................................................................................................39
5.2.3.
Storage and Handling....................................................................................................39
5.3.
Dosage and Administration of GS-5806 .........................................................................................39
5.4.
Prior and Concomitant Medications................................................................................................40
5.5.
Accountability for GS-5806............................................................................................................40
5.5.1.
Investigational Medicinal Product Return or Disposal..................................................41
6.
STUDY PROCEDURES .............................................................................................................................42
6.1.
Subject Enrollment and Treatment Assignment..............................................................................42
6.1.1.
Visit 1: Screening Visit (Days -2 to -1).........................................................................42
6.1.2.
Visit 2: Baseline Assessments, Randomization, and Treatment 
Assessments (Day 1) .....................................................................................................43
6.2.
Visit 3: Day 3 (± 24 hours)..............................................................................................................45
6.3.
Visit 4: Day 5 (± 24 hours)..............................................................................................................45


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6.4.
Visit 5: Day 7 (± 24 hours)..............................................................................................................46
6.5.
Visits 6-8: Days 9, 13, and 17 (± 24 hours).....................................................................................46
6.6.
Visit 9: Day 22 (± 24 hours)............................................................................................................47
6.7.
Visit 10: End of Study/Day 28 (+ 3 days).......................................................................................48
6.8.
Visits 11 – 14*: Day 35, 42, 49, and 56 (± 48 hours)......................................................................48
6.9.
Assessments for Premature Discontinuation from IMP dosing and Early Withdrawal...................48
6.9.1.
Assessments for Premature Discontinuation from IMP Administration .......................49
6.9.2.
Assessments for Early Termination/Withdrawal...........................................................49
6.10.
Assessments for Unscheduled Visits...............................................................................................49
6.11.
Study Assessments..........................................................................................................................50
6.11.1.
Nasal Samples, Virology, and Antibody Titer ..............................................................50
6.11.2.
Virology and Resistance Monitoring.............................................................................50
6.11.3.
Vital Signs.....................................................................................................................51
6.11.4.
Oxygen Saturation.........................................................................................................51
6.11.5.
Plasma PK .....................................................................................................................51
6.11.6.
Safety Labs....................................................................................................................52
6.11.7.
Chest X-ray ...................................................................................................................52
6.11.8.
Optional Extended Viral Monitoring.............................................................................52
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT........................................................................53
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events..........................53
7.1.1.
Adverse Events..............................................................................................................53
7.1.2.
Serious Adverse Events.................................................................................................53
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events ..................................................................54
7.2.
Assessment of Adverse Events and Serious Adverse Events..........................................................55
7.2.1.
Assessment of Causality for IMP and Procedures.........................................................55
7.2.2.
Assessment of Severity .................................................................................................55
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events and Serious 
Adverse Events to Gilead................................................................................................................55
7.4.
Gilead Reporting Requirements......................................................................................................57
7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events...................................................................................................................58
7.6.
Toxicity Management .....................................................................................................................58
7.7.
Special Situations Reports...............................................................................................................58
7.7.1.
Definitions of Special Situations...................................................................................58
7.7.2.
Instructions for Reporting Special Situations................................................................59
8.
STATISTICAL CONSIDERATIONS.........................................................................................................61
8.1.
Analysis Objectives and Endpoints.................................................................................................61
8.1.1.
Analysis Objectives.......................................................................................................61
8.1.2.
Primary Endpoint ..........................................................................................................61
8.1.3.
Secondary Endpoint ......................................................................................................61
8.1.4.
Other Endpoints of Interest ...........................................................................................61
8.2.
Analysis Conventions......................................................................................................................62
8.2.1.
Analysis Sets .................................................................................................................62
8.3.
Data Handling Conventions ............................................................................................................63
8.4.
Demographic Data and Baseline Characteristics ............................................................................63
8.5.
Efficacy Analysis ............................................................................................................................63
8.5.1.
Primary Analysis...........................................................................................................63
8.5.2.
Secondary Analyses ......................................................................................................64
8.5.3.
Exploratory Analyses ....................................................................................................64
8.6.
Safety Analysis................................................................................................................................65
8.7.
Extent of Exposure..........................................................................................................................65


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8.7.1.
Adverse Events..............................................................................................................65
8.7.2.
Laboratory Evaluations .................................................................................................65
8.7.3.
Other Safety Evaluations...............................................................................................66
8.8.
Pharmacokinetic Analysis...............................................................................................................66
8.9.
Sample Size.....................................................................................................................................66
8.10.
Data Monitoring Committee ...........................................................................................................66
9.
RESPONSIBILITIES...................................................................................................................................67
9.1.
Investigator Responsibilities ...........................................................................................................67
9.1.1.
Good Clinical Practice...................................................................................................67
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval....................................................................................................67
9.1.3.
Informed Consent..........................................................................................................67
9.1.4.
Confidentiality...............................................................................................................68
9.1.5.
Study Files and Retention of Records ...........................................................................68
9.1.6.
Case Report Forms........................................................................................................69
9.1.7.
Data Quality Control and Quality Assurance................................................................70
9.1.8.
Investigational Medicinal Product Accountability and Return......................................70
9.1.9.
Inspections.....................................................................................................................71
9.1.10.
Protocol Compliance.....................................................................................................71
9.2.
Sponsor Responsibilities .................................................................................................................71
9.2.1.
Protocol Modifications..................................................................................................71
9.2.2.
Study Report and Publications ......................................................................................71
9.3.
Joint Investigator/Sponsor Responsibilities ....................................................................................72
9.3.1.
Payment Reporting........................................................................................................72
9.3.2.
Access to Information for Monitoring...........................................................................72
9.3.3.
Access to Information for Auditing or Inspections .......................................................72
9.3.4.
Study Discontinuation...................................................................................................72
10.
REFERENCES ............................................................................................................................................73
11.
APPENDICES .............................................................................................................................................76
Appendix 1.
Investigator Signature Page...........................................................................................77
Appendix 2.
Study Procedures Table.................................................................................................78
Appendix 3.
Management of Clinical and Laboratory Adverse Events.............................................81
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities................................................................................................................82
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements.................................................................105
LIST OF IN-TEXT TABLES
Table 6-1.
PK Timepoints...............................................................................................................52


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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
199 E Blaine St.
Seattle, WA 98102
Study Title: 
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled 
Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, 
Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant 
(HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection 
of the Lower Respiratory Tract
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
114498
2014-002475-29
TBD
Study Centers 
Planned:
Approximately 30 centers in Asia Pacific, Australia, Canada, Europe, 
South America, and the United States
Objectives:
The primary objective of this study is as follows:

To evaluate the effect of GS-5806 on RSV viral load in 
autologous or allogeneic HCT recipients with an acute RSV lower 
respiratory tract infection (LRTI)
The secondary objectives of this study are as follows: 

To evaluate the effect of GS-5806 on rates of respiratory failure
and all-cause mortality

To evaluate the pharmacokinetics (PK), safety, and tolerability of 
GS-5806
Study Design:
Randomized, double-blind, placebo-controlled study evaluating the 
effect of GS-5806 on efficacy, PK, safety, and tolerability in HCT 
recipients with RSV LRTI.  
All subjects will be permitted to receive the standard of care therapy 
for RSV infection per their local medical practices, in addition to the
investigational medicinal product (IMP).


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Subjects will be randomized in a 1:1 ratio to receive IMP 
(GS-5806 or placebo) and will be stratified by 2 criteria: 
1)
Supplemental O2 requirement (≤ 2 L/min or > 2 L/min) at the 
time of randomization
2)
Treatment of current RSV infection (yes or no) with ribavirin 
(oral, intravenous, or aerosolized)
Number of Subjects 
Planned:
Approximately 60 RSV-positive subjects
Target Population:
Males and females 18 to 75 years of age who have had an allogeneic 
or autologous HCT and have documented RSV LRTI 
Duration of 
Treatment:
5 doses over 17 days
Diagnosis and
Eligibility Criteria:
For a complete list of study inclusion and exclusion criteria, please 
refer to Section 4.2.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria at the time 
of randomization to be eligible for participation in this study:
1. Received an autologous or allogeneic HCT using any 
conditioning regimen
2. Evidence of new abnormalities on chest X-ray obtained 
< 48 hours prior to Screening, determined to be consistent with 
LRTI by the local radiologist, relative to the most recent previous 
chest X-ray.  If chest X-ray is not available, a chest X-ray must be 
obtained for Screening
3. Documented RSV in both the upper (eg, nasal swab, 
nasopharyngeal swab, nasal wash) and lower (eg, induced 
sputum, bronchoalveolar lavage [BAL], lung biopsy) respiratory 
tract as determined by local testing (eg, polymerase chain reaction 
[PCR], direct fluorescence antibody [DFA], respiratory viral 
panel [RVP] assay, or culture).  All samples must have been 
collected ≤6 days prior to Day 1
4. An informed consent document signed and dated by the subject or 
a legal guardian of the subject and investigator or his/her designee


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5. A negative urine or serum pregnancy test is required for female 
subjects (unless surgically sterile or greater than two years 
post-menopausal)
6. Male and female subjects of childbearing potential who engage in
heterosexual intercourse must agree to use protocol specified 
method(s) of contraception as described in Appendix 5
7. Willingness to complete necessary study procedures and have 
available a working telephone or email
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to 
be enrolled in this study.
Related to concomitant or previous medication use:
1. Use of non-marketed (according to region) investigational agents 
within 30 days, OR use of any monoclonal anti-RSV antibodies 
within 4 months or 5 half-lives of screening, whichever is longer, 
OR use of any investigational RSV vaccines after HCT
2. Use of a strong cytochrome P450 enzyme (CYP) inducer 
including but not limited to rifampin, St. John’s Wort, 
carbamazepine, and phenytoin, within 1 week prior to the 
first dose of IMP
Related to medical history:
3. Pregnant, breastfeeding, or lactating females 
4. Unable to tolerate nasal sampling required for this study, as 
determined by the investigator
5. Known history of HIV/AIDS with a CD4 count <200 cells/μL
within the last month
6. History of drug and/or alcohol abuse that, in the opinion of the 
investigator, may prevent adherence to study activities
Related to medical conditions:
7. Requiring invasive mechanical ventilation at the time of 
randomization
8. A relapse (including molecular relapse) of their underlying 
disease for which they received a transplant at Screening


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9. Documented to be positive for other respiratory viruses (limited to 
influenza, parainfluenza, human rhinovirus, adenovirus, or human 
metapneumovirus), from the lower respiratory tract sample as 
determined by local testing  
10. Clinically significant bacteremia or fungemia within 7 days prior 
to Screening that has not been adequately treated, as determined 
by the investigator
11. Clinically significant bacterial, fungal, or viral pneumonia within 
2 weeks prior to Screening that has not been adequately treated, as 
determined by the investigator
12. Excessive nausea/vomiting at screening, as determined by the 
investigator, or an inability to swallow pills that precludes oral 
administration of the IMP
13. Any condition which, in the opinion of the investigator, would 
prevent full participation in this trial or would interfere with the 
evaluation of the trial endpoints
Related to allergies:
14. Known hypersensitivity or allergy to the IMP, its metabolites, or 
formulation excipients (microcrystalline cellulose, mannitol, 
croscarmellose sodium, magnesium stearate, polyvinyl alcohol, 
titanium dioxide, polyethylene glycol and talc)
15. Allergy to sulfa drugs 
Related to laboratory results:
16. Creatinine clearance < 30 mL/min (calculated using the 
Cockcroft-Gault method)
17. AST/ALT > 3x ULN
18. Total bilirubin > 3x ULN
Study Procedures/
Frequency:
For a complete overview of study procedures and visits, please refer 
to Section 6 and Appendix 2.
Study Procedures
Vital signs (VS): Vital signs will be measured at Visits 1, 2, 4, 6, 7, 
8, 9, and 10 (Days -2 to -1, 1, 5, 9, 13, 17, 22, and 28), and will
include body temperature, heart rate, respiratory rate, and blood 
pressure. 
O2 saturation: O2 saturation will be recorded at Visits 1, 2, 4, 6, 7, 8, 
9, and 10 (Days -2 to -1, 1, 5, 9, 13, 17, 22, and 28), while breathing 
room air, even if the subject is dependent on supplemental O2. Refer 
to Section 6.11.4 for procedure instructions.


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Laboratory tests: When available, existing laborat01y values 
:::; 6 days prior to Screening (Visit 1) may be used for eligibility 
assessment. Study staff will perfonn urine or senun pregnancy tests 
on site at Screening (as necessruy). Blood specimens for safety at 
Visits 2, 4, 6, 7, 8, 9, and 10 (Days 1, 5, 9, 13, 17, 22, and 28), RSV 
viremia evaluation (using quantitative real time polymerase chain 
reaction [RT-qPCR]) at Visits 2, 4, 6, 7, 8, 9, and 10 (Days 1, 5, 9, 13, 
17, 22, and 28), and senun antibody titers to RSV at Visits 2 and 
10 (Days 1 and 28) will be collected prior to dosing. A blood 
specimen for senun creatinine will be collected 4 hours post-dose at 
Visit 2 (Day 1). For hospitalized subjects only, additional blood 
specimens for sennn creatinine will be collected on Days 2, 3, and 
4 (24, 48, and 72 hours [±3 hours] post-first GS-5806 dose). 
PK blood draws: PK samples will be collected from all subjects at 
the following time points: 4 hours post-dose at Visit 2 (Day 1), 
pre-dose at Visits 4, 6, 7 and 8 (Days 5, 9, 13, and 17), and anytime at 
Visit 9 (Day 22). For hospitalized subjects only, an additional PK 
sample will be collected from hospitalized subjects at Visit 3 (Day 3, 
48 hours [±3 hours] post-first GS-5806 dose) . 
.............. ,_-"'--li_.ng: Nasal sampling will be j)erfonned at all study visits 
with the exception of the Screening 
~~~~~,-~~--~-~~·--~-·~ 
visit (Visit 1 ), and stored and shipped to a central laborat01y for 
testing according to specifications in the study procedures manual. 
All samples must be collected prior to dosing. Two nasal samples will 
be obtained, 1 from each nosu·il, each time nasal sampling is 
perf01med. Nasal samples will be used for RSV sequencing to 
evaluate development of resistance and a multiplex assay to identify 
co-infections. 
Induced sputum: If an induced sputum was not used to demonsu·ate 
RSV in the lower respirat01y u·act at Screening (ie, another lower 
respirat01y u·act sample such as BAL was used), an induced sputum 
will be obtained on Day 1 prior to dosing. This sample will be 
analyzed at a cenu·allaboratory using RT-qPCR to dete1mine RSV 
viral load and a multiplex assay to identify any viral co-infections. 
RSV testing: RSV present in both the upper and lower respirat01y 
u·act samples as detennined by local testing (eg, PCR, DFA, RVP 
assay, or culture) must be documented prior to Screening. All RSV 
samples (from upper and lower respirat01y u·act) used for Screening 
must have been collected :::; 6 days prior to Day 1. For all study 
related nasal samples, one of the nasal samples collected at each study 
visit will be analyzed at a centi·al laboratOiy using RT -qPCR to 
dete1mine RSV viral load. 
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0 tional Extended Viral Monitoring: 
PO 
~--------------------------~ 
). 
Study Visits 
Visit 1: Screening (Day -2 to -1) 
This visit must be perf01m ed in the hospital or clinic. The following 
Screening procedures/labs are required: 
• 
Obtain written inf01m ed consent 
• 
Collection of medical hist01y and demographics 
• 
Review of concomitant medications 
• 
VS, including 0 2 saturation 
• 
Height and weight 
• 
Chest X-ray (chest X-rays obtained < 48 hours prior to Screening 
may be used) 
• 
Blood draw for Screening labs for locallaborat01y analyses, 
unless existing laborat01y values collected ::; 6 days prior to 
Screening can be obtained for review 
• 
Urine or senun pregnancy test in women unable to confi1m 
menopause, hysterectomy, and/or bilateral oophorectomy 
• 
Review of any adverse events (AEs) occmTing after signing of the 
consent fonn 
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Visit 2: Baseline Assessments, Randomization, and IMP 
Administration (Day 1) 
If the subject meets all eligibility criteria, Visits 1 and 2 may occur on 
the same day. The IMP must be administered under supervision by 
the study staff. Visit 2 must occur in the hospital or clinic.  Visit 2 
assessments should be performed in the following order:

VS, including O2 saturation

Weight

Blood draw (for safety labs, serum antibody titer to RSV, and 
RSV viremia)

Obtain 2 nasal samples 

Obtain induced sputum (unless induced sputum was used to 
demonstrate the presence of RSV ≤6 days prior to Day 1).  

Randomization via IXRS

IMP administration 

Blood draw at 4 hours post-dose for PK and serum creatinine

Assessment of AEs and concomitant medications

For hospitalized subjects only: blood draw at 24 (Day 2) and 
72 (Day 4) hours (±3 hours) post-first GS-5806 dose for serum 
creatinine
Visit 3: Day 3 (± 24 hours)
This visit may be performed in the hospital, clinic, or at home.

For all subjects: obtain 2 nasal samples

For hospitalized subjects only: blood draw at 48 hours (±3 hours) 
post-first GS-5806 dose for PK and serum creatinine
Visit 4:  Day 5 (± 24 hours) 
This visit must be performed in the hospital or clinic, and should be 
performed in the following order :

VS, including O2 saturation

Weight

PK blood draw: pre-dose

Blood draw (for safety labs and RSV viremia)

Obtain 2 nasal samples 


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
IMP administration

Assessment of AEs, concomitant medications, re-hospitalizations, 
admission to intensive care unit (ICU) or utilization of ICU care, 
mechanical ventilation (invasive and non-invasive of any 
duration), and supplemental O2 use ( ≥ 2 L/min)
Visit 5: Day 7 (± 24 hours)
This visit may be performed in the hospital, clinic, or at home.

Obtain 2 nasal samples 
Visits 6 – 8:  Days 9, 13, and 17 (± 24 hours)
These visits must be performed in the hospital or clinic. Visits 6-8 
assessments should be performed in the following order:

VS, including O2 saturation

Weight

PK blood draw: pre-dose 

Blood draw (for safety labs and RSV viremia)

Obtain 2 nasal samples 

IMP administration 

Assessment of AEs, concomitant medications, re-hospitalizations,
admission to ICU or utilization of ICU care, mechanical 
ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use ( ≥2 L/min)
Visit 9 and 10: Day 22 (± 24 hours) and End of Study/Day 28
(+ 3 days)
These visits must be performed in the hospital or clinic. Visit 10 may 
occur no earlier than Day 28 and no later than Day 31. Visit 9 and 
10 assessments should be performed in the following order:

VS, including O2 saturation 

Weight

PK blood draw (Day 22 only)

Blood draw for safety labs, for serum antibody titer to RSV 
(Day 28 only), and for RSV viremia

Obtain 2 nasal samples 


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Gilead Sciences, Inc. 
Amendment 1 
Test Product, Dose, 
and Mode of 
Administration: 
Reference Therapy, 
Dose, and Mode of 
Administration: 
CONFIDENTIAL 
• 
Obtain sample for local RSV testing* (Day 22 only) (refer to 
Section 6.11.8) 
• 
Assessment of AEs and concomitant medications, 
re-hospitalizations, admission to ICU or utilization of ICU care, 
mechanical ventilation (invasive and non-invasive of any 
duration), and supplemental 0 2 use (:::: 2 Llmin) 
* PPD 
Visits 11-14*: Day 35, 42, 49, and 56 (± 48 hours) 
Visits 11- 14 assessments may be perf01med in the hospital, clinic, 
or at home. 
• 
Obtain 2 nasal samples 
• 
Assessment of procedure-related AEs 
PD 
200 mg GS-5806 (four 50 mg tablets) administered orally on Study 
Days 1, 5, 9, 13, and 17 
The IMP must be administered after the subject has been fasting 
(with exception of clear liquids and medications) for at least 2 hours. 
The subject will remain in a fasting condition for approximately 
1 hour after dosing. The entire dose must be taken within 1 hour. 
Tablets are not to be cmshed, split, dissolved, or chewed. The subject 
should be observed for 30 minutes after IMP adminisu·ation. If 
vomiting occurs within the 30 minutes observation period and 
undissolved tablets are present in the vomitus, the subject may 
receive a second dose. If a second dose is given, the subject should be 
observed for an additional 30 minutes. Subjects should avoid direct 
ulu·aviolet (UV) exposure for 8 days after receiving IMP. 
Placebo to Match tablets administered orally. 
Adminisu·ation is the same as for GS-5806. 
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GS-5806 
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Criteria for 
Evaluation: 
Safety: 
Efficacy: 
CONFIDENTIAL 
Final 
Amendment 1 
Safety will be assessed by the reporting of AEs and serious adverse 
events (SAEs) throughout the study, clinicallaborat01y tests, and VS 
at various time points during the study. 
The primmy endpoint is the time-weighted average change in nasal 
RSV viral load (log10 copies/mL) from Baseline (Day 1) to Day 9 as 
measured by R T -qPCR. 
The key secondmy endpoints are: 
• 
Prop01tion of subjects developing respirat01y failure (of any 
cause) requiring mechanical ventilation (invasive or noninvasive) 
through Day 28 
• 
Prop01tion of all-cause m01tality among subjects through Day 28 
The explorat01y endpoints are: 
IT 
I 
I 
I 
I 
I 
I 
I 
I 
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GS-5806 
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Statistical Methods: 
CONFIDENTIAL 
IT 
I 
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Final 
Amendment 1 
The full analysis set (F AS) will include subjects who have an RSV 
log10 viral load greater than or equal to the LLOQ of the RT-qPCR 
assay in the pre-dose Day 1 nasal sample, as detennined by R T -qPCR 
at the central lab, and have received at least 1 full dose ofiMP. 
The primruy efficacy analysis of time-weighted average change in 
RSV log10 viral load from Day 1 through Day 9 will be perfonned on 
subjects included in the FAS. To test the null hypothesis that there is 
no difference between the GS-5806 and placebo u·eatment groups in 
the time-weighted average change in RSV viral load, a parameu·ic 
analysis of covru·iance (ANCOV A) model with conesponding 
Baseline RSV viral load as a covru·iate will be used, with a 2-sided 
0.05 level. Adjusted means and 95% confidence intervals (Cis) will 
also be presented. 
The F AS analysis set will be used for all smnmru·ies and analyses of 
secondruy endpoints. All secondruy and other endpoints will be 
analyzed using 2-sided tests for u·eatment differences. The prop01iion 
of subjects who develop respirat01y failure requiring mechanical 
ventilation and the prop01iion of subjects with all-cause m01iality will 
be analyzed using Fisher's exact tests. 
PD 
All endpoints will be sUIIllnru·ized using descriptive statistics 
(sample size, mean, standard deviation [SD], median, Q1, Q3, 
minimum, and maximum) for continuous data and by the number and 
percent of subjects for categorical data. 
Safety analyses will be perf01med on all subjects who received at 
least one dose of IMP. Safety data will be collected and smnmarized 
from screening through Day 28. Safety data will be listed by subject 
and smnmarized by u·eatment (active or placebo) using the number 
(percent) of subjects with events/abnonnalities for categorical data 
and using descriptive statistics for continuous data. 
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Concentrations of GS-5806 in plasma will be determined using a 
validated bioanalytical assay(s). Individual subject GS-5806 
concentration-time data will be displayed using scheduled sampling 
times. Descriptive statistics (eg, n, mean, standard deviation, %CV, 
median, and range) will be calculated for each sampling time. 
Pharmacokinetic/pharmacodynamic (PK/PD) relationship may be 
explored as appropriate.
Sample size calculations are based on results observed in a study that 
evaluated the efficacy of oral and aerosolized ribavirin treatment for 
preventing progression from upper to lower respiratory tract infection 
in hematopoietic cell transplant recipients with RSV infections
(unpublished data from Dr. 
).  The sample size 
calculation assumes the time-weighted average change in RSV log10
viral load from Day 1 to Day 9 in the placebo group will 
be -1.5 log10 copies/mL with a corresponding standard deviation (SD) 
of 1.75 and that 85% of the subjects will be evaluable.  Based on 
these assumptions, with 25 subjects per group there is approximately
85% power to detect a 1.5 log difference in time-weighted average
change in log10 viral load treatment groups using a 2-sided 0.05-level 
test.  Given an evaluable rate of 85%, a total of 60 subjects will need 
to be randomized into the study.
All safety data will be monitored by a Data Monitoring Committee 
(DMC). 
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) 
including archiving of essential documents.
PPD


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
C 
degrees Celsius
F
degrees Fahrenheit
AE
adverse event
AhR
aryl hydrocarbon
AIDS
auto-immune deficiency syndrome
ALT
alanine aminotransferase
ANC
absolute neutrophil count
ANCOVA
analysis of covariance
ANOVA
analysis of variance
AST
aspartate aminotransferase
AUC
area under the plasma/serum/peripheral blood mononuclear cell concentration 
versus time curve
BAL
bronchoalveolar lavage
BCRP
breast cancer resistance protein
BID
twice a day 
BMI
body mass index
BUN
blood urea nitrogen
CBC
complete blood count
CCM
cell culture medium
CI
confidence interval
Cmax
the maximum observed serum/plasma/peripheral blood mononuclear (PBMC) 
concentration of drug
CRF
case report form(s)
CRO
contract (or clinical) research organization 
CSR
clinical study report
CT
computerized tomography
CYPxx
cytochrome P450 enzyme xx
DAVG
time-weighted average change
DDI
drug-drug interactions
DFA
direct fluorescence antibody
DMC
Data Monitoring Committee
DSPH
Drug Safety and Public Health
EC
ethics committee
EC50
concentration of drug to reach 50% inhibition of virus replication
ECG
electrocardiogram
eCRF
electronic case report form(s)
EDC
electronic data capture
ELF
epithelial lining fluid
EMR
electronic medical records


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
EudraCT
European clinical trials database
FAS
full analysis set
FIH
First in human
FDA
(United States) Food and Drug Administration
GCP
Good Clinical Practice (Guidelines)
GD 
gestational day
GI
gastrointestinal
GLP
good laboratory practice
GSI
Gilead Sciences, Inc.
hr
hour
HCT
Hematopoietic Cell Transplant
HDPE
high-density polyethylene
hERG
human ether-à-go-go-related gene
HIV
human immunodeficiency virus
HLGT
high level group term
HLT
high level term 
HSP
hysterosalpingogram
IB
investigator’s brochure
IC50
concentration of drug to reach 50% inhibition
ICH
International Conference on Harmonisation
ICU
Intensive Care Unit
IEC
independent ethics committee
IMP
Investigational Medicinal Product
IND
Investigational New Drug (Application)
IRB
institutional review board
IUD
intrauterine device
IVIG
Intravenous Immunoglobulin
IXRS
interactive voice/web response system
kg
kilogram
LLN
lower limit of the normal range
LLOQ
lower limit of quantification
LLT
lower level term
LRTI
lower respiratory tract infection
MedDRA
Medical Dictionary for Regulatory Activities
mg
milligram
min
minute
mL
milliliter
mmHg
millimeters mercury
MMRM
mixed-effect model repeated measures
NA
not applicable
ND
not detectable


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
nM
nanomolar
NOAEL
no-observed-adverse-effect level
NOEL
no-observed-effect level
O2
oxygen
OATP
organic anion transporter proteins
PD
Pharmacodynamic
PFUe
plaque forming unit equivalents
Pgp
P glycoprotein
PK
pharmacokinetic
PO
oral administration (per os, by mouth)
PR
the interval between the beginning of the P wave and the beginning of the QRS 
complex on ECG
PT
preferred term
PXR
pregnane x receptor
Q1
first quartile
Q3
third quartile
QA
quality assurance
QRS
part of electrocardiographic wave representing ventricular depolarization
QT
interval between the start of the Q wave and the end of the T wave on ECG
QTc
corrected QT
QTcF
QT interval corrected for heart rate using the Fridericia formula
RNA
ribonucleic acid
ROW
rest of world
RSV
respiratory syncytial virus
RT-qPCR
quantitative real time polymerase chain reaction
SAE
serious adverse event
SAP
Statistical Analysis Plan
SD
standard deviation
SOC
system organ class
SOP
standard operating procedure
SpO2
oxygen saturation
SUSAR
Suspected Unexpected Serious Adverse Reaction
TBD
to be determined
tmax
the time (observed time point) of Cmax
t½
an estimate of the terminal elimination half-life of the drug in 
serum/plasma/PBMC, calculated by dividing the natural log of 2 by the terminal 
elimination rate constant (λz)
UV
ultraviolet
µL
microliter
ULN
upper limit of the normal range
URTI
upper respiratory tract infection


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
US
United States
RVP
respiratory viral panel
VS
vital signs
Vss
apparent volume of distribution at steady state
v/v
volume/volume
WBC
white blood cell count


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1.
INTRODUCTION
1.1.
Background
Respiratory syncytial virus (RSV), a member of the family Paramyxoviridae, is an enveloped 
virus with a negative single-strand ribonucleic acid (RNA) genome. The RSV genome encodes 
for 11 proteins, including 3 surface glycoproteins (F, G, and SH) and several proteins that 
comprise the viral RNA polymerase complex (N, P, L, and M2-1). Two major antigenic 
subgroups of RSV are known, RSV A and RSV B, that differ primarily in the genetic sequence 
of the G glycoprotein while maintaining a higher degree of homology across other parts of the 
genome. Both subgroups show comparable pathogenicity and can co-circulate in the same 
community during a seasonal epidemic, but their individual prevalence usually varies from 
season to season.
RSV infection is the most common cause of admissions to pediatric general inpatient units in the 
United States (US) and Western Europe {20222}. Unfortunately, the rate of hospitalization 
among RSV-infected children has remained unchanged in the US over the last decade. From 
1997 to 2006, RSV-coded hospitalizations accounted for 24% of an estimated 5.5 million lower 
respiratory tract infection (LRTI) hospitalizations among children < 5 years of age. During this 
period, it was estimated that approximately 172,000 hospitalizations each year were caused by 
RSV infection among children < 5 years of age; approximately 73% of these hospitalizations 
occur among children < 12 months of age {20227}.
RSV infection is also a cause of respiratory disease in the adult population.  Adult recipients of 
autologous or allogeneic hematopoietic cell transplants (HCT) are at high risk for RSV infection 
related morbidity and mortality.  Based upon retrospective epidemiologic data, 2-17% of HCT 
recipients will develop RSV infection of the respiratory tract {28652} {26908} {28657} {28645}
{28650} {28653} {20233}.  Progression from upper respiratory tract infection (URTI) to LRTI 
may occur in 17-84% of these RSV-infected patients {28641} {26937} {28657} {28650} {28653}
{20233} {28646} {28724} {28654} {28648}. Once RSV progresses from URTI to LRTI, the 
morbidity and mortality is high.  Progression to LRTI often requires hospitalization and at times, 
intensive care unit admission for supportive care (eg oxygenation, mechanical ventilation, 
intravenous fluids, vasopressors).  LRTI is associated with high mortality rates, ranging from 
6.5-26.7%. {28647} {28646} {28656} {28641} {28725} {28643} {28644} {28652} {28650}.  A long 
term sequelae seen among survivors of RSV LRTI is airflow decline documented at 1 year after 
the initial infection {28643}.
Currently there are no effective vaccines or approved prophylactic treatment options for RSV 
infection in the HCT population.  Once hospitalized, treatment for RSV infection in HCT 
patients is supportive, with intravenous hydration, supplemental oxygen, and mechanical 
ventilation.   Although treatment options such as antiviral agents, corticosteroids, and 
immunoglobulin are frequently used, there is no definitive treatment for RSV infection in the 
HCT population.  Synagis® (palivizumab), a monoclonal antibody against RSV approved for 
prophylaxis against RSV infection among high risk infants, has never been evaluated in a 
randomized controlled study for treatment of RSV infection in the HCT population.  A recent 


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retrospective analysis suggests that palivizumab is not effective for treatment of RSV LRTI in 
the HCT population {28654}.  Virazole® (ribavirin), an inhaled antiviral agent, is approved for 
treatment of RSV infection in the pediatric population but is not used in general pediatric 
practice because of concerns regarding its efficacy and tolerability, as well as the complexity of 
the specialized aerosol delivery system that is required {19902}.  A randomized study of inhaled 
ribavirin has been attempted in the HCT population; however, due to the aforementioned
concerns, only 14 subjects were recruited over a 5-year period {28640}. A recent review of 
published epidemiologic studies suggests that ribavirin-based therapy, oral or aerosolized, had 
variable success rates for preventing RSV-associated morbidity or mortality in high risk HCT 
patients {28655}.  A single center retrospective analysis also suggested that ribavirin treatment, 
when administered during the URTI phase, resulted in lower rates of progression to LRTI in 
treated versus untreated patients (16% versus 45%) and mortality (35% versus 70%) {26937}.  
Taking into account the limited available efficacy data from controlled clinical trials, the current 
guidelines for diagnosis and treatment of RSV infection do not provide recommendations 
regarding whether patients should be treated with any treatments other than supportive care at the 
LRTI versus URTI phase {28723}.  Therefore, variability in standard practices for treatment of 
RSV infection in HCT patients exists around the world.
1.2.
GS-5806
1.2.1.
General Information
GS-5806 is an oral RSV fusion inhibitor with potent and selective anti-RSV activity in vitro. 
When tested in vitro against 75 diverse clinical isolates of RSV type A and B, the EC50 values 
(concentration of drug to reach 50% inhibition of virus replication) ranged from 0.15 to 1.09 nM, 
with a mean EC50 value of 0.43 0.22 nM. In vivo efficacy data from cotton rats infected with 
human RSV demonstrated that administration of GS-5806 at 0.3 to 30 mg/kg resulted in a 
dose-dependent reduction in viral load in both the upper respiratory tract and lungs. The 
steady-state pharmacokinetic (PK) volume of distribution (Vss) in all nonclinical species tested 
was 2- to10-fold higher than the volume of total body water and the oral bioavailability was 
moderate to high. The exposure to GS-5806 in the lung and lung epithelial lining fluid (ELF) 
was also assessed in Sprague-Dawley rats and yielded lung tissue/plasma and ELF/plasma ratios 
of approximately 30 and 9, respectively. Concentrations in lung tissue and ELF declined 
approximately in parallel to those in plasma indicating rapid equilibration between the lung and 
plasma compartments. GS-5806 exhibited low cytotoxicity in cell culture and did not interact 
with pharmacologically relevant receptors that are predictive of off-target toxicity.  Based on in 
vitro and nonclinical pharmacokinetic studies, GS-5806 did not demonstrate the potential for 
significant drug-drug interactions (DDI).
Additional details regarding nonclinical pharmacokinetics, pharmacology, and toxicology can be 
found in the current GS-5806 Investigator’s Brochure (IB).


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1.2.2.
Nonclinical Pharmacokinetics
Consistent with the high, concentration-independent forward permeability across 
Caco-2 monolayers and low, concentration-independent efflux, GS-5806 exhibited moderate to 
high bioavailability in nonclinical species. Systemic clearance of GS-5806 in nonclinical species 
is well predicted from the rates of metabolism by hepatic microsomal fractions and primary 
hepatocytes.  Biliary excretion is likely to be the major route of elimination of GS-5806 and its 
metabolites as < 2% of radiolabeled GS-5806 dosed orally to rats was recovered in urine.  The 
major routes of metabolism of GS-5806 are oxidative deamination and N-acetylation. In humans, 
the deamination pathway is likely catalyzed by multiple CYP enzymes such as CYP1A2, 
CYP2B6, and CYP2C19.  GS-5806 shows weak inhibition of OATP1B1, OATP1B3, Pgp 
(IC50 values of 98, 100, and 92 μM, respectively). GS-5806 is a weak inhibitor of OCT1, OCT2, 
and BSEP with IC50 values of 40.2, 16.7, and 29.3 μM, respectively. No inhibition of OAT1 or 
OAT3 was observed for GS-5806 at concentrations up to 80 μM. Therefore, drug interactions of 
GS-5806 with substrates of these transporters are unlikely in the expected clinically relevant 
concentration range.
Additional details regarding nonclinical pharmacokinetics can be found in the GS-5806 IB. 
1.2.3.
Nonclinical Pharmacology and Toxicology
The IC50 for the inhibitory effect of GS-5806 on hERG potassium current was 7.8 µM. 
Cardiovascular effects of GS-5806 were evaluated in dogs at doses up to 75 mg/kg. The principal 
hemodynamic findings were lower heart rate values, and higher arterial pulse and systolic 
pressure values. All hemodynamic effects dissipated by 22 hours post-dose. All 
electrocardiograms (ECGs) were qualitatively within normal limits, and no GS-5806-related 
arrhythmias or abnormal waveforms were detected. Slight GS-5806-related higher PR and QTc 
interval values were expected physiological responses secondary to concomitant 
GS-5806-related lower heart rate values. These changes were not considered physiologically 
important in the context of this study. 
In a repeat dose study, GS-5806 was administered by oral gavage for 4 weeks to young adult rats 
once daily at doses up to100 mg/kg/day. Two animals administered 100 mg/kg/day were found 
dead during the dosing phase. Although the cause of death for these 2 animals was 
undetermined, an association with GS-5806 cannot be excluded. Based on the results of this 
study, the NOAEL for GS-5806 is 70 mg/kg/day, which corresponded to mean AUC0-t and 
Cmax values on Day 23 of the dosing phase of 96, 316 ng·h/mL, and 6028 ng/mL, respectively. In 
a repeat-dose study conducted in young adult dogs, GS-5806 was administered by oral gavage 
for 4 weeks at doses up to 20 mg/kg/day. The NOAEL for this study is 20 mg/kg/day, which 
corresponded to mean AUC0-t and Cmax values on Day 27 of the dosing phase of 
129,831 ng·h/mL and 8081 ng/mL, respectively.
GS-5806 was negative in the rat micronucleus study and did not cause mutations in the Ames 
assay or induce chromosomal damage in vitro with or without S9 metabolic activation. Thus, the 
potential for genetic toxicity is considered low.


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In an oral gavage dose range-finding developmental toxicity study in rats, females were 
administered GS-5806 at doses up to 100 mg/kg/day from gestational day (GD) 6 through 
GD 17 (12-day period), with scheduled necropsy occurring on GD 21. GS-5806 treatment 
resulted in significant reductions in maternal body weight, and the NOAEL for maternal toxicity 
was 30 mg/kg/day. There were no effects on embryo-fetal viability and growth and no fetal 
anomalies, and the NOEL for developmental toxicity was 100 mg/kg/day. 
In an oral gavage dose range-finding developmental toxicity study in rabbits, females were 
administered GS-5806 at dose levels up to50 mg/kg/day from GD 7 through GD 19 
(13-day period), with scheduled necropsy occurring on GD 29. GS-5806 treatment resulted in 
lower maternal body weight at doses ≥30 mg/kg/day. The early termination (moribund sacrifice) 
of 1 female in the 50 mg/kg/day group on GD 20 was attributed to GS-5806 administration, due 
to significant reductions in body weight and food consumption, and the NOEL for maternal 
toxicity was 10 mg/kg/day. There were no effects on embryo-fetal viability and growth and no 
treatment-related fetal anomalies. The NOEL for developmental toxicity was 50 mg/kg/day.
In a dose range-finding study in juvenile rats, GS-5806 was administered at doses up to 
100 mg/kg/day on postnatal day (PND) 7 through PND 14.  Noteworthy effects were limited to 
decreased body weight gain at doses ≥ 70 mg/kg/day and a mild to moderate (1.5- to 2.5-fold), 
dose-dependent increase in total bilirubin at doses ≥ 30 mg/kg/day.  The NOAEL was considered 
to be 30 mg/kg/day, corresponding to respective mean Cmax and AUC0-t values on PND 14 of 
2415 ng/mL and 44,179 ngh/mL. In a definitive juvenile rat study, GS-5806 was administered 
beginning on PND 4 through PND 21 at doses up to 100 mg/kg/day.  An increase in mortality 
was seen at doses ≥70 mg/kg/day.  Reflux-related inflammation and epithelial 
degeneration/erosion/ulcer in the upper respiratory tract occurred at doses ≥70 mg/kg/day, and 
the mortality was likely related to decreased milk intake secondary to the reflux-related 
inflammation in the upper respiratory tract. This is consistent with the observation that neither
clinical pathology data nor anatomic pathology data indicated  specific target organ toxicity as 
the cause of death for the pups that had treatment-related mortalities.  Surviving pups had no 
indications of systemic toxicity.  Based on the above results, the NOEL was considered to be 
30 mg/kg/day, which  corresponded to respective mean Cmax and AUC0-t on PND 21 of 
1430 ng/mL and 19,300 ng·h/mL, respectively.
In a 4-week juvenile dog study, GS-5806 was orally administered once daily on PND 11 through 
PND 38 at doses up to 20 mg/kg/day, with only minimal, transient effects on neonatal/juvenile 
development and no adverse target organ toxicity. The NOAEL was 20 mg/kg/day, 
corresponding to PND 38 Cmax and AUC0-t values of 7180 ng/mL and 139,000 ng·h/mL, 
respectively.
Additional details regarding nonclinical pharmacology and toxicology can be found in the 
GS-5806 IB. 


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1.2.4.
Clinical Trials of GS-5806
1.2.4.1.
GS-US-218-0101
This Phase 1, placebo-controlled, single- and multiple-dose ranging, first-in-human (FIH) study 
was conducted to evaluate safety, tolerability, and PK following oral administration of GS-5806 
to up to 70 unique subjects.  The study included 3 stages (Parts A, B, and C) with 8 total 
staggered cohorts (7 pre-specified, 1 adaptive). Within each cohort of Parts A and B, 8 unique 
subjects were randomized to receive blinded investigational medicinal product (IMP), either 
GS-5806 (n = 6) or placebo (n = 2). Within each cohort of Part C, 10 unique subjects were 
randomized to receive blinded IMP, either GS-5806 (n = 8) or placebo (n = 2). A maximum 
single dose of 300mg and multiple dose regimen of 75mg once daily for 7 days was achieved.  
GS-5806 PK was evaluated under fasting and fed states.
No deaths or serious adverse events (SAEs) were reported, and there were no dose-limiting 
toxicities. In the GS-5806-treated subjects, there were no discontinuations due to AEs. Among 
the 23 subjects who received single doses of GS-5806, 5 subjects (21.7%) experienced a total of 
11 AEs, with the most common AEs being presyncope and dermatitis (reported by 2 subjects 
each). Both incidents of presyncope, and 1 of the 2 events of dermatitis, were judged by the 
investigator to be related to study procedures; 1 event of dermatitis was inflammation of the skin 
of the right antecubital and 1 event was nonspecific dermatitis on the chest. Among the 
52 subjects receiving multiple doses of GS-5806, 20 subjects (38.4%) experienced a total of 
45 AEs, with diarrhea and nausea reported by 4 subjects and headache and contact dermatitis 
reported by 3 subjects. All other AEs experienced by subjects receiving multiple doses of 
GS-5806 were reported by ≤2 subjects each.
Twelve-lead ECGs were obtained at Baseline and Days 1, 15, and 21. Analysis of these ECGs 
demonstrated no clinically significant increase in the PR, QRS, QT, and QTcF intervals, and no 
clinically significant arrhythmias associated with administration of GS-5806.
GS-5806 exposures increased in an approximately dose-proportional manner over the dose range 
tested following single and multiple oral administrations under fasted conditions. GS-5806 
terminal half-lives ranged from 30 to 33 hours following single oral administration and 
approximately 36 hours following multiple oral administrations. Overall, the variability of the 
PK parameters was relatively low, with the majority of the PK parameters displaying CV% of 
30% or lower. In addition, the food effect on GS-5806 PK following single or multiple oral 
administration has been evaluated. Following single administration of GS-5806 at 25, 50, or 
75 mg, Cmax under fed conditions decreased approximately 20% to 40% compared to fasted 
conditions, but this effect was less pronounced following once daily dosing at the higher dose 
(75 mg) around steady-state.
1.2.4.2.
Study GS-US-218-0109
This Phase 1 mass-balance study was conducted to evaluate the PK, metabolism, and excretion 
of GS-5806. The primary objective of this study was to determine the mass balance of GS-5806 
following administration of a single, oral dose of radiolabeled [14C]-GS-5806.  The secondary 


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objectives of this study were to evaluate the PK of GS-5806 and metabolites, where possible and 
to determine the metabolite profile of GS-5806 in humans following administration of a single, 
oral dose of radiolabeled [14C]-GS-5806.
Eight subjects were enrolled and assessed for a period of a minimum of 10 days and a maximum 
of 21 days with a 7-day follow-up period. Following a single oral radiolabeled dose of GS-5806
(50 mg), the maximum mean concentrations of drug-derived radioactivity in blood and plasma 
were observed at 2 hours post-dose for both matrices.  The overall recovery of radioactivity was 
89.9%, with recovery primarily in feces (72.3%) versus urine (17.6%).  Mean blood to plasma 
concentration ratios ranged from 0.450 to 0.591 through 120 hours post-dose, indicating that 
radioactivity was primarily in the plasma, relative to the cellular components of the blood.
The circulating radioactivity consisted mainly of GS-5806 (88%) and low levels of minor 
metabolites 5-chloro-2-amino (N-methanesulfonyl) benzamide (M58; 7%), 
oxy-GS-5806-glucuronide (M47; 3%), and GS-557855 (M30B; 1%)). 
The major component excreted in feces was unchanged parent GS-5806 (18.5% of the dose; 
coeluted with dioxy-GS-5806-2 [M63]), along with other minor metabolites 
(dioxy-GS-5806-3 [M64; 5.42% of the dose] and dioxy-GS-557855-2 [M70; 3.51% of the 
dose]). The remaining identified 8 metabolites detected in feces each accounted for less than a 
mean of 2.5% of the dose. In urine, unchanged parent GS-5806 was the main species 
(~10.0% of the dose), and metabolite M47 represented ~3.59% of the dose. 
In summary, [14C]GS-5806 was primarily eliminated in the feces after oral administration to 
healthy subjects. Low levels of various metabolites were observed indicating the likely absence 
of a single dominant pathway. Radioactivity was eliminated as a combination of metabolites and 
unchanged parent drug. Overall, the pharmacokinetics of GS-5806 is not expected to be 
meaningfully altered in the setting of renal impairment (eg, mild to moderate).
1.2.4.3.
Study GS-US-218-0103
This Phase 2a, randomized, double-blind, placebo-controlled study was conducted to evaluate 
the safety, tolerability, and efficacy of GS-5806 in healthy adult volunteers infected with an RSV 
challenge virus (RSV-A Memphis 37b strain). The study included 7 quarantines, each 
comprising approximately 20 subjects. Each subject was admitted to the Quarantine Unit and 
inoculated with RSV on Study Day 0. Subjects were randomized and treated with GS-5806 or 
placebo when infection was documented in the nasal wash, or by the fifth day after inoculation, 
whichever occurred first.
For Quarantines 1 through 4 (pre-specified quarantines), subjects were randomized 1:1 to receive 
GS-5806 or placebo, administered as a 50 mg single dose on Dose Day 1, followed by 25 mg 
once daily on Dose Days 2 through 5.
For Quarantines 5 through 7 (adaptive quarantines), subjects were randomized 4:1 to receive 
GS-5806 or placebo. Subjects in Quarantine 5 were administered a 50 mg single dose on Dose 
Day 1, followed by 25 mg once daily on Dose Days 2 and 3. Subjects in Quarantine 6 were 
administered a 100 mg single dose. Subjects in Quarantine 7 were administered a 10 mg 
single dose on Dose Day 1, followed by 5 mg once daily on Dose Days 2 through 5.


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A total of 140 subjects were randomized into this study.  All subjects completed study drug and 
1 placebo subject discontinued the study due to investigator’s discretion.  Baseline demographics 
and characteristics were similar between treatment groups across all dose cohorts.  
Seventy-eight (78) subjects received the pre-specified dose in quarantines 1-4 (GS-5806 n=39, 
placebo n=39).  Of these, 54 subjects (69%) were documented to be RSV positive prior to 
randomization and were included in the primary and secondary analyses (GS-5806 n=27, 
placebo n=27).  A total of 87 subjects received GS-5806 across all quarantines. 
Treatment with GS-5806 resulted in the following:
Primary Endpoint:

Treatment with GS-5806 resulted in lower mean AUC viral load from initial dose through 
end of quarantine.  Viral load was assessed twice daily using nasal washes.  The mean AUC 
of viral load as measured by the RT-qPCR assay from first viral load measurement post 
initial dose of study drug through Day 12 was significantly lower in GS-5806 subjects 
compared to placebo subjects (Δ= 506.9 log10 PFUe*hour/mL, p<0.001).
Secondary Endpoints:

Treatment with GS-5806 resulted in lower mean AUC viral load during the entire quarantine 
period. The mean AUC of viral load post challenge through Study Day 12 as measured by 
the RT-qPCR assay was significantly lower in GS-5806 subjects compared to placebo 
subjects (Δ= 531.0 log10 PFUe*hour/mL, p=<0.001). 

Treatment with GS-5806 resulted in lower mean total mucus weight during dosing. The 
average weight of each unused tissue was determined prior to start of study. The daily mucus 
weight was calculated by first counting the number of tissues used each day, then subtracting 
the total weight of these tissues, unused, from the daily total weight of used tissues.  The 
mean total weight of mucus produced post-initial dose of study drug through the dose was 
significantly lower in the GS-5806 subjects compared to placebo subjects (Δ= 8.2 g, 
p=0.028). 

Treatment with GS-5806 resulted in a lower mean AUC of change from Baseline in total 
symptom score during the entire quarantine period. Ten symptoms (runny nose, stuffy nose, 
sneezing, sore throat, earache, malaise [tiredness], cough, shortness of breath, headache, and 
muscle and/or joint ache) were each scored from 0 (no symptoms) to 3 (quite bothersome 
most/all of the time). Total symptom scores (0-30) were the average score of questions 
answered by each subject, multiplied by 10.  The mean AUC of change from Baseline in total 
symptom score post initial dose of study drug through Study Day 12 was significantly lower 
in the GS-5806 subjects compared to placebo subjects (Δ= 225.1 score*hour, p=0.005).  The 
total symptoms score AUC was also significantly lower for GS-5806 treated subjects.


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In each of the adaptive quarantines statistically significant results were also achieved in the 
primary endpoint and each of the secondary endpoints described above with the exception of a 
reduction in mean total mucus weight in Quarantine 7. In addition, an exposure response effect 
was noted.
No subject experienced a serious AE. All AEs were mild or moderate (Grade 1 or 2) in severity, 
except for three Grade 3 AEs experienced by 1 placebo-treated subject (increased blood lactate 
dehydrogenase, alanine aminotransferase [ALT], and aspartate aminotransferase [AST]). 
Grade 1 pulmonary function decrease (<10% change) was the only treatment-related AE 
experienced by >2 subjects in either treatment group (GS-5806: 4.6%, n=4/87; placebo: 3.8%, 
n=2/53).  Changes in clinical laboratory values were Grade 1 or 2 in severity, except for one 
Grade 4 value (increased AST; reported for placebo-treated subject described above). Elevated 
ALT was more commonly reported among GS-5806-treated subjects (GS-5806: 14.9%; placebo: 
9.4%), but elevated AST was less commonly reported (GS-5806: 5.7%; placebo: 15.1%). Low 
neutrophil count was reported as Grade 1 in 11 subjects (2 received placebo) and Grade 2 in 
2 subjects (1 received placebo). Among the 9 subjects who experienced a Grade 1 low neutrophil 
count and received GS-5806, 2 had a Grade 1 low neutrophil count at Screening. Clinically 
relevant changes in vital signs or ECGs were not observed.
1.3.
Rationale for This Study
There is a significant unmet medical need for a safe, convenient, and effective treatment for RSV 
infection.  The only approved antiviral therapy for RSV, ribavarin, is approved for use in 
pediatric populations only, but is rarely used in clinical practice due to its limited efficacy and 
concerning safety profile. There is no approved antiviral therapy for RSV infection among HCT 
recipients, where the current standard of care is supportive or off-label use of ribavirin.
This study follows a Phase 1 FIH study (GS-US-218-0101) and a Phase 2a RSV challenge study 
(GS-US-218-0103), which evaluated the safety, tolerability, and PK of single and multiple doses 
of GS-5806 in 140 healthy adult volunteers.  In Study GS-US-218-0103, GS-5806 was shown to 
be efficacious in reducing RSV viral load and clinical symptoms in healthy adult subjects 
experimentally infected with RSV.  
Given these results from healthy adult volunteers studied in a controlled setting, 2 studies are 
being conducted to evaluate the efficacy, safety, and tolerability of GS-5806 in the HCT 
population. Study GS-US-218-0108 is being conducted in HCT patients with an RSV-related 
URTI. This study, which will be run concurrently, will enroll HCT patients with an RSV-related 
LRTI. Safety and efficacy data generated from these studies, together with currently available 
data, will be used to support further clinical development of GS-5806 in pediatric and adult 
patients infected with RSV.


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1.4.
Dose Rationale
The dose and administration schedule selected for this study is a single dose of 200 mg GS-5806 
administered orally in the fasted state on Days 1, 5, 9, 13, and 17. This regimen was selected 
based upon the PK characteristics of GS-5806 and the pharmacokinetic/pharmacodynamic 
(PK/PD) relationship established in the antiviral effect study with different doses/regimens in 
Study GS-US-218-0103. 
In Study GS-US-218-0103, a 5-day treatment regimen of GS-5806 (50 mg single dose on Dose 
Day 1, followed by 25 mg once daily on Dose Days 2 through 5) resulted in a significant 
reduction in RSV viral load. The mean AUC of RSV viral load as measured by the RT-qPCR
assay from first viral load measurement post initial dose of study drug through end of quarantine 
(Day 12) was significantly lower in GS-5806 subjects compared to placebo subjects 
(Δ= 506.9 log10 PFUe*hour/mL, p<0.001). This 5-day regimen was able to achieve GS-5806 
trough concentrations ~4-5 fold of paEC95 (52 ng/mL) for up to 120 hours following dose
initiation for the virus used in the challenge study, the M37 strain of RSV. 
In selecting the dose for the current study, the goal was to achieve GS-5806 trough 
concentrations above 4-fold of paEC95 for most of the clinical RSV isolates for the duration of 
RSV shedding in HCT patients. Longitudinal viral dynamics data from investigators at an 
academic HCT center also indicate that the majority of HCT patients shed RSV for 15 days, but 
some may shed for as long as 21 days (unpublished). Therefore, a total of 5 doses of GS-5806 
(200 mg each dose, every 4 days) is expected to provide > 4-fold paEC95 coverage for ~95% of 
75 wild-type clinical RSV isolates through Day 22, which is expected to result in significant 
durable antiviral effect. 
1.5.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.


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2.
OBJECTIVES
The primary objective of this study is:

To evaluate the effect of GS-5806 on RSV viral load in autologous or allogeneic HCT 
recipients with an acute RSV LRTI 
The secondary objectives of this study are:

To evaluate the effect of GS-5806 on rates of respiratory failure and all-cause mortality

To evaluate the PK, safety, and tolerability of GS-5806


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Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
3. 
STUDY DESIGN 
3.1. 
Endpoints 
The prima1y endpoint of this study is: 
Final 
Amendment 1 
• 
Time-weighted average change in nasal RSV viral load (log10 copies/mL) from Baseline 
(Day 1) to Day 9 as measmed by RT-qPCR 
The key secondruy endpoints of this study ru·e: 
• 
Prop01tion of subjects developing respirat01y fail me (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28 
• 
Proportion of all-cause m01tality among subjects through Day 28 
The explorat01y endpoints ru·e: 
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GS-5806 
Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
(]' 
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3.2. 
Study Design 
Final 
Amendment 1 
This is a randomized, double-blind, placebo-controlled study evaluating the effect of GS-5806 on 
efficacy, PK, safety, and tolerability in HCT recipients with RSV IRTI. This study will emoll 
approximately 60 subjects from approximately 30 intemational HCT centers. RSV positive 
subjects with evidence oflRTI will be randomized 1:1 to receive GS -5806 or placebo given as 
200mg eve1y 4 days for a total of 5 doses. Subjects will be followed for a total of 28 days, 
during which a total of 10 Study visits will be 
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3.3. 
Study Treatments 
Approximately 60 subjects will be randomized 1:1 to receive 200 mg (four 50 mg tablets) of 
IMP (GS-5806 or placebo) as a single dose on Days 1, 5, 9, 13, and 17. The IMP will be 
administered after the subject has fasted (with exception of clear liquids and medications) for at 
least 2 hours. The entire dose must be taken within 1 hour. Subjects will remain fasting for 
approximately 1 hour after dosing. Tablets are not to be cmshed, split, dissolved, or chewed. 
IMP should be dispensed with gloves. Subjects should avoid direct UV exposure for 8 days after 
receiving IMP. 
Subjects will remain in the clinic for 30 minutes post-dose for observation. If vomiting occurs 
within 30 minutes after IMP administration and undissolved tablets are present in the vomitus, 
the subject should receive another dose. If another dose is administered, the subject should 
remain in the clinic for an additional30 minutes post-dose for observation. 
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GS-5806 will be provided as white, plain-faced, film-coated, round tablets containing 50 mg 
GS-5806 (61 mg GS-5806-02, bis-hydrochloride salt dihydrate form of GS-5806). Placebo to 
Match will be provided as white, plain-faced, film-coated, round tablets containing no GS-5806.
The expected duration of subject participation is approximately 1 month, to include Screening 
through the final visit on Day 28.  
3.4.
Duration of Treatment
The treatment portion of the study is 17 days (a total of 5 doses administered as single doses on 
Days 1, 5, 9, 13, and 17).
3.5.
Discontinuation Criteria
Reasons for potential premature discontinuation from IMP dosing include:

Any Grade 3 or 4 AE or SAE

Intercurrent illness that would, in the judgment of the investigator, affect the subject’s ability 
to receive IMP (eg, unable to ingest oral dose). 
In the event any of the above criteria are met, the Principal Investigator (PI) will review the case 
in detail and discuss with the Gilead Medical Monitor whether the subject should be 
discontinued from IMP.
Reasons for premature discontinuation from the Study include:

Subject request to discontinue for any reason

Subject noncompliance

Pregnancy during the study; refer to Section 7.7.2

Discontinuation of the study at the request of Gilead, a regulatory agency or an institutional 
review board or independent ethics committee (IRB/IEC)
If a subject prematurely discontinues from IMP dosing, he/she will remain on study and will 
continue with all subsequent Study Visits and assessments, with the exception of IMP dosing.  
If a subject prematurely discontinues from the Study, every attempt should be made to bring the 
subject back for the Early Termination procedures.  See Section 6.9 for more information.
3.6.
Source Data
For the purposes of this study, study specific questionnaires (ie, respiratory symptom 
assessments) are considered source documents and are to be filed with the subject’s medical or 
study records.  Electronic data (ie, diagnostic machines that transcribe data directly to a database, 


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or data entered directly into an Electronic Medical Record system) is considered source data, 
provided the data is not recorded directly on the CRF/eCRF, and provided there is a clear audit 
trail in the electronic record(s).  Template source document worksheets will be prepared by 
Gilead and provided to sites to use at their discretion.  If source document worksheets are used, 
they are to be kept with the subject’s medical or study records as original source documents.  No 
data will be recorded directly on the CRF/eCRF, and any data recorded directly on the 
CRF/eCRF will not be considered source data.


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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
The subject population will consist of approximately 60 RSV-positive males and females 18 to 
75 years of age who have had an allogeneic or autologous HCT and have documented acute RSV 
related LRTI symptoms, recruited from approximately 30 centers in Asia Pacific, Australia, 
Canada, Europe, South America, and the United States.
4.2.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this 
study.
1. Received an autologous or allogeneic HCT using any conditioning regimen
2. Evidence of new abnormalities on chest X-ray obtained < 48 hours prior to Screening, 
determined to be consistent with LRTI by the local radiologist, relative to the most recent 
previous chest X-ray.  If chest X-ray is not available, a chest X-ray must be obtained for 
Screening.
3. Documented RSV in both the upper (eg, nasal swab, nasopharyngeal swab, nasal wash) and 
lower (eg, induced sputum, BAL, lung biopsy) respiratory tract as determined by local testing 
(eg, PCR, DFA, RVP assay, or culture).  All samples must have been collected ≤6 days prior 
to Day 1.
4. An informed consent document signed and dated by the subject or a legal guardian of the 
subject and investigator or his/her designee
5. A negative urine or serum pregnancy test is required for female subjects (unless surgically 
sterile or greater than two years post-menopausal)
6. Male and female subjects of childbearing potential who engage in heterosexual intercourse 
must agree to use protocol specified method(s) of contraception as described in Appendix 5
7. Willingness to complete necessary study procedures and have available a working telephone 
or email


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4.3.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
Related to concomitant or previous medication use:
1. Use of non-marketed (according to region) investigational agents within 30 days, OR use of 
any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of screening, whichever 
is longer, OR use of any investigational RSV vaccines after HCT
2. Use of a strong cytochrome P450 enzyme (CYP) inducer including but not limited to 
rifampin, St. John’s Wort, carbamazepine, and phenytoin, within 1 week prior to the 
first dose of IMP
Related to medical history:
3. Pregnant, breastfeeding, or lactating females 
4. Unable to tolerate nasal sampling required for this study, as determined by the investigator
5. Known history of HIV/AIDS with a CD4 count <200 cells/μL within the last month
6. History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent
adherence to study activities
Related to medical conditions:
7. Requiring invasive mechanical ventilation at the time of randomization 
8. A relapse (including molecular relapse) of their underlying disease for which they received a 
transplant at Screening
9. Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, 
human rhinovirus, adenovirus, or human metapneumovirus), from the lower respiratory tract 
sample as determined by local testing
10. Clinically significant bacteremia or fungemia within 7 days prior to Screening that has not 
been adequately treated, as determined by the investigator
11. Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening 
that has not been adequately treated, as determined by the investigator
12. Excessive nausea/vomiting at screening, as determined by the investigator, or an inability to 
swallow pills that precludes oral administration of the IMP
13. Any condition which, in the opinion of the investigator, would prevent full participation in 
this trial or would interfere with the evaluation of the trial endpoints


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Related to allergies:
14. Known hypersensitivity or allergy to the IMP, its metabolites, or formulation excipients 
(microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl 
alcohol, titanium dioxide, polyethylene glycol and talc)
15. Allergy to sulfa drugs 
Related to laboratory results:
16. Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)
17. AST/ALT > 3x ULN
18. Total bilirubin > 3x ULN


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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Randomization, Blinding and Treatment Codes
This is a randomized, double-blind, placebo-controlled multi-center study. Eligible subjects will 
be stratified by the following factors:

Supplemental O2 requirement (≤2 L/min or > 2 L/min) at the time of randomization

Treatment of current RSV infection (yes or no) with ribavirin (oral, intravenous, or 
aerosolized)
Treatment of current RSV infection with ribavirin will be defined as ≥1 dose of ribavirin 
(oral, intravenous, or aerosolized) prior to randomization or with written orders for the initiation 
of therapy at the time of randomization.  Subjects will be randomized in a 1:1 ratio to receive 
IMP (GS-5806 or matching placebo).
Assignment to study treatment will be blinded to the study subjects, investigational site 
personnel, study vendors, and the Sponsor, except for the delegated personnel who will review 
and check the randomization and drug allocation for accuracy.
5.1.1.
Procedures for Breaking Treatment Codes
In the event of a medical emergency where breaking the blind is required to provide medical care 
to the subject, the investigator may obtain treatment assignment directly from the IXRS system 
for that subject. In the event of technology failure, the PI may call the IXRS help line to access 
treatment codes. Gilead recommends but does not require that the investigator contact the Gilead
medical monitor before breaking the blind. Treatment assignment should remain blinded unless 
that knowledge is necessary to determine subject emergency medical care. The rationale for 
unblinding must be clearly explained in source documentation and on the case report 
form/ electronic case report form (CRF/eCRF), along with the date on which the treatment 
assignment was obtained. The investigator is requested to contact the Gilead medical monitor 
promptly in case of any treatment unblinding. Details of unblinding will be provided in the 
study-specific Unblinding Plan.
Blinding of study treatment is critical to the integrity of this clinical trial and therefore, if a 
subject’s treatment assignment is disclosed to the investigator, the subject will have study 
treatment discontinued. All subjects will be followed until study completion unless consent to do 
so is specifically withdrawn by the subject.
Gilead Drug Safety and Public Health (DSPH) may independently unblind cases for expedited 
reporting of suspected unexpected serious adverse reactions (SUSARs).


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5.2.
Description and Handling of GS-5806
5.2.1.
Formulation
GS-5806 will be supplied as white, plain-faced, film-coated, round tablets containing 50 mg 
GS-5806 (61 mg GS-5806-02, bis-hydrochloride salt dihydrate form of GS-5806). In addition to 
the active ingredient, GS-5806 tablets contain the following inactive ingredients: 
microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl 
alcohol, titanium dioxide, polyethylene glycol, and talc, all of which are common pharmaceutical 
excipients.
The supplied matching placebo tablets are identical in physical appearance to the 50 mg
GS-5806 tablets and contain the same inactive ingredients.
5.2.2.
Packaging and Labeling
GS-5806 tablets and matching placebo are packaged in white, high density polyethylene (HDPE) 
bottles with desiccant and polyester fiber coil. Each bottle contains 4 tablets and is capped with a 
white, continuous thread, child-resistant polypropylene screw cap fitted with an induction-sealed, 
aluminum-faced liner.
All labels for IMP distributed to investigative sites in the US and the rest of world (ROW) will 
meet all applicable requirements of the US Food and Drug Administration (FDA), the EU 
Annex 13 of Good Manufacturing Practices: Manufacture of investigational medicinal products 
(July 2010), and/or other local regulations, as applicable.
5.2.3.
Storage and Handling
Sufficient quantities of GS-5806 tablets and matching placebo will be shipped to the investigator 
or qualified designee from Gilead Sciences Materials & Logistics (or its designee).
GS-5806 tablets should be stored at controlled room temperature of 25°C (77°F); excursions are 
permitted between 15°C and 30°C (59°F and 86°F). Storage conditions are specified on the label.  
Until dispensed to the subjects, all bottles of IMP should be stored in a securely locked area, 
accessible only to authorized site personnel. The study center will be required to maintain a log 
of daily temperature readings in the storage area for the duration of the study. To ensure the 
stability and proper identification, the drug products will be stored in the containers in which 
they were supplied until units are dispensed to individual subjects at the site.
5.3.
Dosage and Administration of GS-5806
Eligible subjects will receive 200 mg GS-5806 or placebo on Days 1, 5, 9, 13, and 17. Doses will 
be administered with water, after the subject has fasted for at least 2 hours (with exception of 
clear liquids and medications). The entire dose must be taken within 1 hour.  Subjects will 
remain in a fasting condition for at least 1 hour after dosing. IMP is to be dispensed with gloves. 
Tablets are not to be crushed, split, dissolved, or chewed. Subjects will remain in the clinic for 


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30 minutes post-dose for observation.  If vomiting occurs within 30 minutes after IMP 
administration and undissolved tablets are present in the vomitus, the subject should receive 
another dose.  If another dose is administered, the subject should remain in the clinic for an 
additional 30 minutes post-dose for observation. Subjects should avoid direct UV exposure for 
8 days after receiving IMP.
5.4.
Prior and Concomitant Medications
GS-5806 has a low systemic clearance in humans, so significant drug-drug interactions, in which 
concomitantly administered drugs inhibit the metabolic clearance of GS-5806 by CYP enzymes, 
are unlikely. Low levels of minor metabolites were observed in the human mass balance study 
(GS-US-218-0109) indicating that metabolism of GS-5806 is mediated by multiple minor 
metabolic pathways with the likely absence of a single dominant pathway. As such, the net effect 
of strong induction of 1 or 2 pathways by a potent CYP inducer is unclear. Therefore, 
concomitant administration of strong CYP inducers (including but not limited to rifampin, 
St John’s Wort, carbamazepine, and phenytoin) is excluded to avoid potential drug resistance.
In vitro, GS-5806 is a substrate of the efflux transporters P glycoprotein (P-gp) and breast cancer 
resistance protein (BCRP). However, GS-5806 exhibits moderate to high bioavailability in 
nonclinical species and approximately dose-proportional increase in exposures following single 
(75 mg to 300 mg) or multiple (10 to 75 mg once daily) oral administrations in healthy adults, 
consistent with its high solubility and high membrane permeability. Therefore, the bioavailability 
of GS-5806 is not expected to be limited by P-gp and BCRP activities, and clinically relevant 
interactions with P-gp and BCRP inhibitors are not expected.
In vitro, GS-5806 is a substrate of the hepatic uptake organic anion transporter proteins (OATP) 
OATP1B1 and OATP1B3. Clinically, single doses of GS-5806 have been well tolerated up to 
800 mg (Cmax and AUC ~3.6-and ~5-fold of 200 mg, respectively) in healthy volunteers. 
GS-5806 exposures may be increased upon coadministration with OATP inhibitors (eg, rifampin,
cyclosporine, and gemfibrozil).
GS-5806 may cause concentration-dependent inhibition of multidrug and toxin extrusion via 
transporters MATE1 and MATE2-K with IC50 values of 0.50 and 3.8 μM, respectively. When 
co-administered with renally eliminated concomitant medications (ie, filtration plus secretion), 
GS-5806 may increase the exposures of substrates secreted by the MATEs transporters, such as 
ganciclovir, acyclovir, levofloxacin, metformin, captopril, procainamide, fexofenadine, 
cimetidine, cephradine, and cephalexin. Dosing and safety monitoring should be consistent with 
prescribing information, in particular for agents which require dose reductions in the setting of 
renal impairment.
5.5.
Accountability for GS-5806
The investigator is responsible for ensuring adequate accountability of all used and unused IMP 
bottles. This includes acknowledgement of receipt of each shipment of IMP (quantity and 
condition). 


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GS-5806 accountability records will be provided to each study site to:

Record the date and quantity of IMP bottles received

Record the date, subject number, subject initials, the IMP bottle number dispensed

Record the date, quantity of used and unused IMP bottles returned, along with the initials of 
the person recording the information.
5.5.1.
Investigational Medicinal Product Return or Disposal
At the site initiation visit or first monitoring visit, the study monitor will evaluate each study 
center’s IMP disposal procedures and provide appropriate instruction for return or destruction of 
unused IMP supplies. If the site has an appropriate Standard Operating Procedure (SOP) for drug 
destruction (as reviewed and approved by Gilead Sciences, Inc [GSI]), the site may destroy used 
and unused IMP supplies performed in accordance with the site’s (hospital/pharmacy) SOP after 
reconciliation has been completed by the site monitor. If the site does not have acceptable 
procedures in place for drug destruction, arrangements will be made between the site and GSI
(or GSI representative) for return of unused IMP supplies. A copy of the site’s SOP will be 
obtained for central files. Where possible, IMP will be destroyed at the site. 
Upon study completion, a copy of the Investigational Drug Accountability records must be filed 
at the site. Another copy will be returned to GSI. If drug is destroyed on site, the investigator 
must maintain accurate records for all IMP destroyed. Records must show the identification and 
quantity of each unit destroyed, the method of destruction, and person who disposed of the drug. 
All IMP records must be maintained at the site and copies must be submitted to GSI at the end of 
the study.


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6.
STUDY PROCEDURES
The study procedures to be conducted for each subject enrolled in the study are presented in 
tabular form in Appendix 2 and described in the text that follows. Additional information is 
provided in the study procedures manual.
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol. Investigators must document any deviation 
or departure from protocol procedures, regardless of causality, and notify the sponsor or contract 
research organization (CRO).
6.1.
Subject Enrollment and Treatment Assignment
6.1.1.
Visit 1: Screening Visit (Days -2 to -1)
Visit 1 must be performed in the hospital or clinic.  Potential subjects will have a documented
positive test for RSV from the upper and lower respiratory tract and be approached for informed 
consent.  The Principal Investigator or a medically qualified Sub-Investigator (eg, MD, DO, or 
nurse practitioner) must review and discuss the study with each subject prior to consent. All 
screening assessments must be performed after obtaining written consent. All screening labs and 
procedures will be performed locally and results will be reviewed by the investigator prior to 
IMP administration at Visit 2. 
The following procedures will be completed at Screening:

Obtain written informed consent

Collection of medical history and demographics

Review of concomitant medications

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

Height and Weight

O2 saturation (on room air)

Chest X-ray (chest X-rays obtained < 48 hours prior to Screening may be used)

Blood draw for screening labs for local laboratory analyses (labs obtained ≤6 days prior to 
Screening may be used)
Serum creatinine clearance
AST/ALT
Total bilirubin


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
Urine or serum pregnancy test (for women unable to confirm menopause, hysterectomy 
and/or bilateral oophorectomy)

Record any SAEs and all AEs related to protocol-mandated procedures occurring after 
signing of the consent form
Subjects meeting all of the inclusion criteria and none of the exclusion criteria will be 
randomized into the study.  Subjects must continue to meet all inclusion criteria and none of the 
exclusion criteria at the time of randomization.  If all lab results and procedures are available and 
satisfy the inclusion/exclusion criteria, Screening and Visit 2 (Day 1) may occur on the same 
day.  From the time of obtaining informed consent through the first administration of IMP, 
record all SAEs, as well as any AEs related to protocol-mandated procedures on the AE case 
report form (eCRF).  All other untoward medical occurrences observed during the Screening 
period, including exacerbation or changes in medical history are to be captured on the medical 
history eCRF.  See Section 7 Adverse Events and Toxicity Management for additional details.
6.1.2.
Visit 2: Baseline Assessments, Randomization, and Treatment Assessments 
(Day 1)
6.1.2.1.
Baseline Assessments
Visit 2 must be performed in the hospital or clinic and should occur within 24 hours of 
confirmation of the subject’s eligibility. Samples and assessments performed at Screening 
(Visit 1) may not be used as Visit 2 Baseline assessments.  Baseline (Visit 2) assessments should 
be performed in the following order and documented on Day 1 prior to IMP administration:

Review of concomitant medications, mechanical ventilation (invasive and non-invasive of 
any duration), and supplemental O2 use

Weight

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure) O2 saturation 
(on room air)

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include WBC with differential, Hgb, 
platelets, BUN, creatinine, serum albumin, AST, ALT, and total bilirubin)
Serum antibody titer to RSV
RSV viremia


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
Nasal samples (2 total, 1 from each nostril)

Obtain induced sputum for central laboratory analysis (unless induced sputum was used to 
demonstrate the presence of RSV in the lower respiratory tract ≤6 days prior to Day 1)
6.1.2.2.
Randomization and Treatment Assessments (Day 1)
After all Baseline assessments are complete, eligible subjects will be randomized via Interactive 
Voice/Web Response System (IXRS) and IMP will be administered.  
Randomization to GS-5806 or placebo will be based on a randomization schedule prepared by 
Gilead and/or designee before the start of the study. Subjects must continue to satisfy all 
inclusion/exclusion criteria at the time of randomization. At randomization, eligible subjects will 
be stratified by the following:

Supplemental O2 requirement (≤2 L/min or > 2 L/min) at the time of randomization

Treatment of current RSV infection (yes or no) with ribavirin (oral, intravenous, or 
aerosolized)
Treatment of current RSV infection with ribavirin will be defined as ≥1 dose of ribavirin 
(oral, intravenous, or aerosolized) prior to randomization or with written orders for the initiation 
of therapy at the time of randomization.  Subjects will be randomized in a 1:1 ratio to receive 
IMP (GS-5806 or matching placebo).
Subjects will receive 200 mg (four 50 mg tablets) of GS-5806 or matching placebo at Day 1. All 
IMP will be administered with water, after the subject has been fasting (with exception of clear 
liquids and medications) for a minimum of 2 hours. The entire dose must be taken within 1 hour.  
Subjects will remain in a fasting condition for 1 hour post-dose. Tablets are not to be crushed, 
chewed, split, or dissolved, and should always be dispensed with gloves.  Non-hospitalized 
subjects will remain in the clinic for 30 minutes post-dose for observation.  If vomiting occurs 
within 30 minutes after IMP administration and undissolved tablets are present in the vomitus, 
the subject should receive another dose.  If another dose is administered, the subject should 
remain in the clinic for an additional 30 minutes post-dose for observation.  Subjects should 
avoid direct UV exposure for 8 days after receiving IMP.
The following procedure will be performed and documented on Day 1 after IMP dosing:

Blood draw for central laboratory analysis:
Serum creatinine 4 hours post-dose
PK sampling 4 hours post-dose

Review of AEs


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6.1.2.3.
Post-dose Follow-up for Hospitalized Subjects 
For hospitalized subjects, a blood draw for central laboratory analysis of serum creatinine will be 
collected at 24 and 72 hours (±3 hours) post-first GS-5806 dose.  Subjects who are not 
hospitalized during this time will not return to the hospital or clinic for these blood draws.  
6.2.
Visit 3: Day 3 (± 24 hours)
Visit 3 assessments may be performed in the hospital, clinic, or at the subject’s home by the 
study coordinator or designee.  

For all subjects: nasal samples (2 total, 1 from each nostril)

For hospitalized subjects, a blood draw for central laboratory analysis at 48 hours (±3 hours) 
post-first GS-5806 dose:
Serum creatinine
PK sampling
6.3.
Visit 4: Day 5 (± 24 hours)
Visit 4 assessments must be performed in clinic or in hospital and should be performed in the 
following order and documented (also refer to Appendix 2 Study Procedures Table):

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure) 

O2 saturation (on room air)

Weight

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include to include WBC with 
differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total 
bilirubin)  
PK sampling: pre-dose
RSV viremia 

Nasal samples (2 total, 1 from each nostril)

IMP administration* 

Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use (≥2 L/min)


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Amendment 1
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* Subjects will receive 200 mg (four 50 mg tablets) of GS-5806 or matching placebo at Day 5. 
IMP will be administered with water, after the subject has been fasting for a minimum of 2 hours 
(with exception of clear liquids and medications). The entire dose must be taken within 1 hour.  
Subjects will remain in a fasting condition for 1 hour post-dose. Tablets are not to be crushed, 
chewed, split, or dissolved, and should always be dispensed with gloves. Subjects will remain in 
the clinic for 30 minutes post-dose for observation.  If vomiting occurs within 30 minutes after 
IMP administration and undissolved tablets are present in the vomitus, the subject should receive 
another dose.  If another dose is administered, the subject should remain in the clinic for an 
additional 30 minutes post-dose for observation.  Subjects should avoid direct UV exposure for 
8 days after receiving IMP.
6.4.
Visit 5: Day 7 (± 24 hours)
Visit 5 assessments may be performed in the hospital, clinic, or at the subject’s home by the 
study coordinator or designee.  

Nasal samples (2 total, 1 from each nostril)
6.5.
Visits 6-8: Days 9, 13, and 17 (± 24 hours)
Visits 6-8 assessments must be performed in clinic or in hospital and should be performed in the 
following order and documented at these visits (also refer to Appendix 2, Study Procedures 
Table):

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

O2 saturation (on room air)

Weight

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include to include WBC with 
differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total 
bilirubin)  
PK sampling: pre-dose 
RSV viremia 

Nasal samples (2 total, 1 from each nostril)

IMP administration* 

Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use ( ≥2 L/min)


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Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
Final 
Amendment 1 
* Subjects will receive 200 mg (fom 50 mg tablets) of GS-5806 or matching placebo at Days 9, 
13, and 17. All IMP will be administered with water, after the subject has been fasting for a 
minimum of2 homs (with exception of clear liquids and medications). The entire dose must be 
taken within 1 hom . Subjects will remain in a fasting condition for 1 hom post-dose. Tablets are 
not to be cmshed, chewed, split, or dissolved, and should always be dispensed with gloves. 
Subjects will remain in the clinic for 30 minutes post-dose for observation. If vomiting occms 
within 30 minutes after IMP administration and lmdissolved tablets are present in the vomitus, 
the subject should receive another dose. If another dose is administered, the subject should 
remain in the clinic for an additional 30 minutes post-dose for observation. Subjects should 
avoid direct UV exposme for 8 days after receiving IMP. 
6.6. 
Visit 9: Day 22 (::1:: 24 hours) 
Visit 9 assessments must be perf01med in clinic or in hospital and should be perfonned in the 
following order and documented (also refer to Appendix 2, Study Procedmes Table): 
• 
Vital Signs (body temperatme, heart rate, respirat01y rate, and blood pressme) 
• 
0 2 satmation (on room air) 
• 
Weight 
• 
Blood draw for central laborat01y analysis: 
-
Safety Labs (hematology and sennn chemistiy to include WBC with differential, Hgb, 
platelets, BUN, creatinine, sennn albumin, AST, ALT, and total bilimbin) 
-
PK sampling 
-
RSV viremia 
• 
Nasal samples (2 total, 1 from each nostril) 
• 
Obtain sample for local RSV testing* (refer to Section 6.11.8) 
• 
Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms ), mechanical ventilation (invasive and non-invasive of any dmation), and 
supplemental 0 2 use ( ~ 2 Umin) 
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Gilead Sciences, Inc. 
6.7. 
Visit 10: End of Study/Day 28 (+ 3 days) 
Final 
Amendment 1 
Visit 10 assessments must be perf01med in clinic or in hospital. The visit will occur no earlier 
than Day 28 and no later than Day 31. Visit 10 assessments should be perf01med in the following 
order and documented (also refer to Appendix 2, Study Procedures Table): 
• 
Vital Signs (body temperature, heart rate, respirat01y rate, and blood pressure) 
• 
0 2 saturation (on room air) 
• 
Weight 
• 
Blood draw for central laborat01y analysis: 
-
Safety Labs (hematology and semm chemistiy to include WBC with differential, Hgb, 
platelets, BUN, creatinine, sennn albumin, AST, ALT, and total bilimbin) 
-
Sennn antibody titer to RSV 
-
RSV viremia 
• 
Nasal samples (2 total, 1 from each nostril) 
• 
Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms ), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental 0 2 use ( ~ 2 Llmin) 
6.8. 
Visits 11-14*: Day 35, 42, 49, and 56 (± 48 hours) 
Visits 11 - 14 assessments may be perfonned in the hospital, clinic, or at home. 
• 
Obtain nasal samples (2 total, 1 from each nosu·il) 
• 
Assessment of procedure-related AEs 
6.9. 
Assessments for Premature Discontinuation from IMP dosing and Early 
Withdrawal 
Reasons for premature discontinuation from IMP dosing or the study are outlined in Section 3.5. 
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6.9.1.
Assessments for Premature Discontinuation from IMP Administration
If a subject prematurely discontinues IMP dosing, the subject will remain on study and will
continue with all subsequent study visits and assessments through Visit 10, Day 28 (End of 
Study), with the exception of IMP administration.
6.9.2.
Assessments for Early Termination/Withdrawal
Every attempt should be made to keep subjects in the study and to perform the required 
study-related and follow-up procedures (see Sections 6.2 through 6.7). If this is not possible or 
acceptable to the subject or investigator, the subject may be withdrawn from the study. 
If a subject withdraws early from the study for any reason, every attempt should be made to 
bring the subject back to the clinic or hospital for the following early termination assessments:

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

O2 saturation (on room air)

Weight

Blood sample collection for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include to include WBC with 
differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total 
bilirubin) (only if the subject withdraws prior to Visit 9 [Day 22])
Serum antibody titer to RSV
RSV viremia

Nasal samples (2 total, 1 from each nostril)

Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use ( ≥ 2 L/min)
6.10.
Assessments for Unscheduled Visits
Assessments performed between scheduled study visits for hospitalized subjects do not have to 
be entered as an unscheduled visit.  If non-hospitalized subjects return to the hospital or clinic 
between scheduled study visits, an unscheduled visit should be performed and recorded. The 
following procedures will be performed and documented at these visits:

Vital signs, including O2 saturation (on room air)


GS-5806 
Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
• 
Collection of nasal samples for analysis at the central lab 
Final 
Amendment 1 
• 
Assessment of AEs, concomitant medications, re-hospitalizations, ICU admissions or 
utilization ofiCU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms ), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental 0 2 use ( ~ 2 Llmin) 
6.11. 
Study Assessments 
6.11.1. 
Nasal Samples, Virology, and Antibody Titer 
At Screening (Visit 1 ), all subjects should be RSV positive in both the upper ( eg, nasal swab, 
nasopharyngeal swab, nasal wash) and lower (eg, induced sputum, BAL, lung biopsy) respirat01y 
tract, as detennined by locallaborat01y test methods (eg, PCR, DFA, RVP assay, or culture) 
:S6 days prior to Day 1. If the subject meets eligibility criteria based on results of tests completed 
as pmi of standard of cm·e, Visit 1 and 2 procedures, including randomization and IMP 
administration, may occur on the same day provided the subject continues to satisfy all 
inclusion/ exclusion criteria. 
Nasal samples will be obtained at each study visit, with the exception of Screening (Visit 1 ), for 
analysis at the centmllaborat01y. Two samples will be collected at each time point, 1 from each 
naris. Nasal samples will be analyzed using RT-qPCR to detennine RSV viral load, RSV 
sequencing to evaluate develOJ.)lnent of resistance (see Section 6.11.2), and a multij.)lex assay to 
identi 
co-infections. PD 
The procedure for collecting, storing and shipping induced sputum samples will be outlined in 
the Laborat01y Manual. 
Blood samples will be collected for RSV viremia evaluation (RT-qPCR) at Visits 2, 4, 6, 7, 8, 9, 
and 10 (Days 1, 5, 9, 13, 17, 22 and 28) prior to dosing, and RSV antibody titers at Visits 2 and 
10 (Days 1 and 28). Samples will be processed, stored and shipped to the centmllaborat01y as 
per instmctions outlined in the Laborat01y Manual. 
6.11.2. 
Virology and Resistance Monitoring 
To assess the potential for emergence of resistance to GS-5806, population sequencing of the 
RSV F gene will be conducted on evaluable nasal swab samples collected from GS-5806 and 
j.)lacebo-u·eated RSV-infected subjects according to the Resistance Analysis Plan. PPD 
Population sequencmg of tlie RSV F gene will oe conauctea on eval.Ua:ole nasa swab 
-~.-
samples from all GS-5806-u·eated RSV-infected subjects in this group. Any mutation in the 
F gene identified by population sequencing in GS-5806-u·eated subjects relative to the 
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pretreatment baseline sequence will be characterized phenotypically following their introduction 
into wild-type RSV using an established reverse genetics system. The susceptibility of the 
F mutant recombinants to GS-5806 will be assessed in cell-based antiviral susceptibility assays 
to determine whether each treatment-emergent mutation (TEM) confers reduced susceptibility to 
the compound.
6.11.3.
Vital Signs
This assessment will include body temperature, heart rate, respiratory rate, and blood pressure.  
The subject is required to sit quietly for approximately 2 minutes prior to obtaining VS. Vital 
signs will be collected at all study visits performed in the hospital or clinic, with the exception of 
the optional extended viral monitoring visits.
6.11.4.
Oxygen Saturation
O2 saturation assessment will begin by first asking the subject to sit quietly for 1 minute.  
O2 saturation will be recorded while breathing room air, even if the subject is dependent on 
O2 supplementation. If the subject is receiving supplemental O2, the O2 source will be removed 
for a period of 30 seconds prior to this assessment. The O2 saturation will be documented in the 
source at regular intervals (approximately every 15 seconds) during the 2-minute testing period.  
O2 saturation evaluation will be considered complete when the 2-minute period has elapsed, or 
when the subject achieves a saturation of 87%, whichever is achieved first.  The lowest 
O2 saturation recorded over the 2-minute interval will be captured in the eCRF. O2 saturation will 
be collected at all study visits performed in the hospital or clinic.  Subjects undergoing invasive 
mechanical ventilation will not have the oxygen removed and “< 87%” should be recorded in the 
source documentation and the reason should be documented. If it is determined by the 
investigator that it is unsafe to remove the subject’s supplemental O2 for assessment of 
O2 saturation (eg, subject is on high-flow mask), then this should be recorded in the source 
documentation as “< 87%” and the reason should be documented.
6.11.5.
Plasma PK
PK blood sampling will be performed using the site’s local procedures and analyzed at a central 
laboratory.  PK blood samples will be processed, placed in individual tubes, and stored/shipped 
to the central laboratory as per instructions outlined in the Laboratory Manual.  PK samples will 
be obtained for all subjects at Visits 2, 4, 6, 7, 8 and 9.  For hospitalized subjects, an additional 
PK sample will be obtained at Visit 3 (48 hours [±3 hours] post-first GS-5806 dose) as outlined 
in Table 6-1.  Subjects who are not hospitalized Visit 3 will not return to the hospital or clinic for 
this blood draw.  These plasma PK samples may also be used to evaluate the plasma PK of 
co-administered agents (eg, ganciclovir, acyclovir).


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Gilead Sciences, Inc. 
Amendment 1 
Table 6-1. 
PK Timepoints 
Visit 2 
Visit 3 
Visit 4 
Visit 6 
Visit 7 
Visit 8 
Visit 9 
(Day 1) 
(Day 3) 
(Day 5) 
(Day 9) 
(Day 13) 
(Day 17) 
(Day 22) 
4hrs post-dose 
anytime 
pre-dose 
pre-dose 
pre-dose 
pre-dose 
anytime 
X (for 
PK samples 
X 
hospitalized 
X 
X 
X 
X 
X 
subjects only) 
6.11.6. 
Safety Labs 
When available, the most recent laborat01y values (obtained within 7 days prior to Screening 
[Visit 1]) may be used for eligibility assessment, with the exception of RSV results and 
pregnancy testing. If an existing laboratory value is not available for eligibility assessment, the 
test will be perf01m ed using the local laborat01y. All testing of samples obtained after the 
screening assessments will be perfonned at a central laborat01y selected by GSI. 
Testing of blood specimens will include WBC with differential, Hgb, platelets, BUN, creatinine, 
semm albumin, AST, ALT, and total bilimbin at Visits 2, 4, 6, 7, 8, 9, and 10 (Days 1, 5, 9, 13, 
17, 22, and 28). Blood samples will be collected pre-dose at all visits where IMP is 
administered. 
A blood specimen for senun creatinine will be collected 4 homs post-dose at Visit 2 (Day 1). 
For hospitalized subjects, blood specimens for sennn creatinine will be collected on Days 2, 3, 
and 4 (24, 48, and 72 homs [±3 homs] post-fu·st GS-5806 dose). Subjects who are not 
hospitalized dming this time will not retmn to the hospital or clinic for these blood draws. 
Urine or senun pregnancy tests will occm for all females of child-bearing potential at Screening. 
6.11.7. 
Chest X-ray 
Results from chest X-rays and CT scans used for screening and eligibility, including the 
comparison chest radiograph, will be collected and stored electronically for a possible central 
read. 
6.11.8. 
Optional Extended Viral Monitoring 
PD 
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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse 
Events
7.1.1.
Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical study subject 
administered a medicinal product, which does not necessarily have a causal relationship with the
treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease 
temporally associated with the use of a medicinal product, whether or not considered related to 
the medicinal product. AEs may also include pre- or post-treatment complications that occur as a 
result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or 
occupational exposure. Preexisting events that increase in severity or change in nature during or 
as a consequence of participation in the clinical study will also be considered AEs.
An AE does not include the following:

Medical or surgical procedures such as surgery, endoscopy, tooth extraction, and transfusion.
The condition that led to the procedure may be an adverse event and must be reported.

Pre-existing diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen

Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions)

Overdose without clinical sequelae 

Any medical condition or clinically significant laboratory abnormality with an onset date 
before the consent form is signed and not related to a protocol-associated procedure is not an 
AE. It is considered to be pre-existing and should be documented on the medical history 
CRF.
7.1.2.
Serious Adverse Events
A serious adverse event (SAE) is defined as an event that, at any dose, results in the following:

Death

Life-threatening (Note: The term “life-threatening” in the definition of “serious” refers to an 
event in which the subject was at risk of death at the time of the event; it does not refer to an 
event that hypothetically might have caused death if it were more severe.)

In-patient hospitalization or prolongation of existing hospitalization


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
Persistent or significant disability/incapacity

A congenital anomaly/birth defect

A medically important event or reaction: such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the subject or may 
require intervention to prevent one of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is a reportable 
under expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse. For the avoidance of doubt, infections resulting from contaminated medicinal 
product will be considered a medically important event and subject to expedited reporting 
requirements.
7.1.2.1.
Protocol-Specific Serious Adverse Event Instructions
Protocol-specific SAE reporting exemptions: In this study, death related to clinical progression
of underlying disease requiring HCT, or graft failure will not need to be reported as an SAE.
Death related to clinical progression of underlying disease requiring HCT, or graft failure should 
only be reported as SAEs on the eCRF, unless there is evidence suggesting a causal relationship 
between the IMP or study procedure and the event.  In that case, the investigator must 
immediately report the event as an SAE in accordance with the procedure in Section 7.3 below.  
Such clinical progression or graft failure which are assessed as not related to IMP/procedure) 
will be exempt from global expedited reporting requirements for the duration of the study.  The 
events will be collected and evaluated by Gilead and reported as appropriate in any relevant 
aggregate safety report, as well as the final clinical study report.
To minimize the possibility of exposing study subjects to unusual risk, the safety information 
from the study will also be reviewed by an independent DMC on an ongoing basis.   The DMC
may have access to partially blinded or unblinded data and will determine if it is safe to continue 
the study according to the protocol.
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not recorded as AEs or SAEs. 
However, laboratory abnormalities (eg, clinical chemistry, hematology, and urinalysis) that 
require medical or surgical intervention or lead to IMP interruption, modification, or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, electrocardiogram, X-rays, vital signs) that are 
associated with signs and/or symptoms must be recorded as an AE or SAE if they meet the 
definition of an AE or SAE as described in Sections 7.1.1 and 7.1.2. If the laboratory 
abnormality is part of a syndrome, record the syndrome or diagnosis (eg, anemia), not the 
laboratory result (ie, decreased hemoglobin).


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For specific information on handling of clinical laboratory abnormalities in this study, please 
refer to Section 7.5.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or a designated qualified subinvestigator is responsible for assessing AEs and 
SAEs for causality and severity, and for final review and confirmation of accuracy of event
information and assessments.
7.2.1.
Assessment of Causality for IMP and Procedures
The investigator or a designated qualified subinvestigator is responsible for assessing the 
relationship to IMP therapy using clinical judgment and the following considerations:

No: Evidence exists that the adverse event has an etiology other than the IMP. For SAEs, an 
alternative causality must be provided (eg, pre-existing condition, underlying disease, 
intercurrent illness, or concomitant medication).

Yes: There is reasonable possibility that the event may have been caused by the 
investigational medicinal product.
It should be emphasized that ineffective treatment should not be considered as causally related in
the context of adverse event reporting. 
The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations:

No: Evidence exists that the adverse event has an etiology other than the study procedure.

Yes: The adverse event occurred as a result of protocol procedures (eg, venipuncture)
7.2.2.
Assessment of Severity
Severity should be recorded and graded according to the GSI Grading Scale for Severity of 
Adverse Events and Laboratory Abnormalities For AEs or SAEs associated with laboratory 
abnormalities, the event should be graded on the basis of the clinical severity in the context of 
the underlying conditions; this may or may not be in agreement with the grading of the 
laboratory abnormality.
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events 
and Serious Adverse Events to Gilead
Requirements for collection prior to IMP initiation:
After informed consent, but prior to initiation of study medication, the following types of events 
should be reported on the case report form (eCRF): all SAEs and adverse events related to 
protocol-mandated procedures.


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Adverse Events:
Following initiation of study medication, all AEs, regardless of cause or relationship, through the 
Day 28 End of Study visit must be reported to the eCRF database as instructed. All AEs should 
be followed up until resolution or until the adverse event is stable, if possible. Gilead Sciences 
may request that certain AEs be followed beyond the protocol defined follow up period, as 
determined by the Medical Monitor.
Serious Adverse Events:
All SAEs, regardless of cause or relationship, that occurs after the subject first consents to 
participate in the study (ie, signing the informed consent) and throughout the duration of the 
study, including the protocol-required post treatment follow-up period, must be reported to the 
eCRF database and Gilead Drug Safety and Public Health (DSPH) as instructed. This also 
includes any SAEs resulting from protocol-associated procedures performed after informed 
consent is signed.
Any SAEs and deaths that occur after the post treatment follow-up visit but within 30 days or 
4-weeks of the last dose of study IMP, regardless of causality, should also be reported. 
Investigators are not obligated to actively seek SAEs after the protocol defined follow up period
(the Day 28 End of Study visit), however, if the investigator learns of any SAEs that occur after 
study participation has concluded and the event is deemed relevant to the use of IMP, he/she 
should promptly document and report the event to Gilead DSPH.
During the optional extended viral monitoring period (through Day 56), AEs related to 
protocol-mandated procedures must be collected and reported to Gilead DSPH.
All AEs and SAEs will be recorded in the eCRF database within the timelines outlined in the 
eCRF completion guideline. 
Electronic Serious Adverse Event (eSAE) Reporting Process:

Site personnel record all SAE data in the eCRF database and from there transmit the SAE 
information to Gilead DSPH within 24 hours of the investigator’s knowledge of the event. 
Detailed instructions can be found in the eCRF completion guidelines.

If for any reason it is not possible to record the SAE information electronically (ie, the eCRF 
database is not functioning), record the SAE on the paper serious adverse event reporting 
form and submit within 24 hours to:
Gilead DSPH:
Fax:
+1-650-522-5477
E-mail:
Safety_fc@gilead.com


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
As soon as it is possible to do so, any SAE reported via paper must be transcribed into the 
eCRF Database according to instructions in the eCRF completion guidelines.

If an SAE has been reported via a paper form because the eCRF database has been locked, no 
further action is necessary.

For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be submitted by e-mail or fax when requested and applicable. 
Transmission of such documents should occur without personal subject identification, 
maintaining the traceability of a document to the subject identifiers.

Additional information may be requested to ensure the timely completion of accurate safety 
reports.

Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the subject’s CRF/eCRF and the event description section of the SAE 
form.

Site personnel should record all SAE data in the eCRF database for those protocol-specific 
SAEs which are exempted from expedited reporting requirements (Section 7.1.2.1).  They 
should also transmit the SAE information to Gilead DSPH if the SAEs are assessed by the 
investigator as related to the IMP or study procedure.
7.4.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA Code of 
Federal Regulations, the EU Clinical Trials Directive (2001/20/EC) and relevant updates, and 
other country-specific legislation or regulations, Gilead may be required to expedite to 
worldwide regulatory agencies reports of SAEs, serious adverse drug reactions (SADRs), or 
suspected unexpected serious adverse reactions (SUSARs). In accordance with the EU Clinical 
Trials Directive (2001/20/EC), Gilead or a specified designee will notify worldwide regulatory 
agencies and the relevant Independent Ethics Committee (IEC) in concerned Member States of 
applicable SUSARs as outlined in current regulations.
Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the current GS-5806 IB or relevant local label as applicable. 
All investigators will receive a safety letter notifying them of relevant SUSAR reports associated 
with any study IMP. The investigator should notify the IRB or IEC of SUSAR reports as soon as 
is practical, where this is required by local regulatory agencies, and in accordance with the local 
institutional policy. 


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7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities are usually not recorded as AEs or SAEs. However, laboratory 
abnormalities (eg, clinical chemistry, hematology) independent of the underlying medical 
condition that require medical or surgical intervention or lead to IMP interruption or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, vital signs) that are associated with signs and/or 
symptoms must be recorded as an AE or SAE if they meet the definition of an AE or SAE, 
respectively, as described in Section 7.1. If the laboratory abnormality is part of a syndrome, 
record the syndrome or diagnosis (ie, anemia) not the laboratory result (ie, decreased 
hemoglobin).
Severity should be recorded and graded according to the GSI Grading Scale for Severity of 
Adverse Events and Laboratory Abnormalities Appendix 4. For AEs or SAEs associated with 
laboratory abnormalities, the event should be graded on the basis of the clinical severity in the 
context of the underlying conditions; this may or may not be in agreement with the grading of 
the laboratory abnormality.
7.6.
Toxicity Management 
All clinical and clinically significant laboratory toxicities will be managed according to uniform 
guidelines detailed in Appendix 3.
Any questions regarding toxicity management should be directed to the Gilead Sciences Medical 
Monitor.
7.7.
Special Situations Reports
7.7.1.
Definitions of Special Situations
Special situation reports include all reports of medication error, abuse, misuse, overdose, reports 
of adverse events associated with product complaints, and pregnancy reports regardless of an 
associated AE.  
Medication error is any unintentional error in the prescribing, dispensing, or administration of a 
medicinal product while in the control of the health care provider, subject, or consumer.
Abuse is defined as persistent or sporadic intentional excessive use of a medicinal product by a 
subject.
Misuse is defined as any intentional and inappropriate use of a medicinal product that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a medicinal 
product given per administration or cumulatively which is above the maximum recommended 
dose as per protocol or in the product labelling (as it applies to the daily dose of the subject in 


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question). In cases of a discrepancy in drug accountability, overdose will be established only 
when it is clear that the subject has taken the excess dose(s). Overdose cannot be established 
when the subject cannot account for the discrepancy except in cases in which the investigator has 
reason to suspect that the subject has taken the additional dose(s).
Product complaint is defined as complaints arising from potential deviations in the manufacture, 
packaging, or distribution of the medicinal product.  
7.7.2.
Instructions for Reporting Special Situations
7.7.2.1.
Instructions for Reporting Pregnancies
The investigator should report pregnancies in female study subjects that are identified after 
initiation of study medication and throughout the study, including the post IMP follow-up period, 
to Gilead DSPH using the pregnancy report form within 24 hours of becoming aware of the 
pregnancy.
Refer to Section 7.3 and the eCRF completion guidelines for full instructions on the mechanism 
of pregnancy reporting.
The pregnancy itself is not considered an AE nor is an induced elective abortion to terminate a 
pregnancy without medical reasons.
Any premature termination of pregnancy (eg, a spontaneous abortion, an induced therapeutic 
abortion due to complications or other medical reasons) must be reported within 24 hours as an 
SAE. The underlying medical reason for this procedure should be recorded as the AE term.
A spontaneous abortion is always considered to be an SAE and will be reported as described in 
Section 7.3. Furthermore, any SAE occurring as an adverse pregnancy outcome post study must 
be reported to Gilead DSPH.
The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome should be reported to Gilead DSPH using the pregnancy outcome report 
form. If the end of the pregnancy occurs after the study has been completed, the outcome should 
be reported directly to Gilead DSPH. Gilead DSPH contact information is provided in 
Section 7.3.
Pregnancies of female partners of male study subjects exposed to Gilead or other investigational 
agents must also be reported and relevant information should be submitted Gilead DSPH using 
the pregnancy and pregnancy outcome forms within 24 hours. Monitoring of the subject should 
continue until the conclusion of the pregnancy. If the end of the pregnancy occurs after the study 
has been completed, the outcome should be reported directly to Gilead DSPH.
Refer to Appendix 5 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Requirements.


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7.7.2.2.
Reporting Other Special Situations
All other special situation reports must be reported on the special situations report form and 
forwarded to Gilead DSPH within 24 hours of the investigator becoming aware of the situation. 
These reports must consist of situations that involve study IMP and/or Gilead concomitant 
medications, but do not apply to non-Gilead concomitant medications. 
Special situations involving non-Gilead concomitant medications does not need to be reported on 
the special situations report form; however, for special situations that result in AEs due to a 
non-Gilead concomitant medication, the AE should be reported in the eCRFs. 
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
Refer to section 7.3 and the CRF/eCRF completion guidelines for full instructions on the 
mechanism of special situations reporting.
All clinical sequelae in relation to these special situation reports will be reported as AEs or SAEs 
at the same time using the AE CRF/eCRF and/or the SAE report form. Details of the symptoms 
and signs, clinical management, and outcome will be reported, when available.


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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
The primary objective of this study is as follows:

To evaluate the effect of GS-5806 on RSV viral load in autologous or allogeneic HCT 
recipients with an acute RSV LRTI
The secondary objectives of this study are as follows: 

To evaluate the effect of GS-5806 on rates of respiratory failure and all-cause mortality

To evaluate the PK, safety and tolerability of GS-5806
8.1.2.
Primary Endpoint
The primary endpoint is the time-weighted average change in nasal RSV viral load (log10
copies/mL) from Baseline (Day 1) to Day 9 as measured by RT-qPCR. The time-weighted 
average change in nasal RSV viral load from Baseline to Day 9 is defined as:
∑
  {0.5 × (. +
) × (
−
)} 
(
−
)
where Yi is the change from Baseline in RSV log10 viral load at Visit i, t is the time at the 
specified timepoint, a is the Baseline assessment at Day 1 and b is the last assessment at or prior 
to Day 9. The time-weighted average change, often referred to as the DAVG, provides the 
average viral burden in change from baseline during the time period of interest.
8.1.3.
Secondary Endpoint
Secondary endpoints are:

Proportion of subjects developing respiratory failure (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28

Proportion of all-cause mortality among subjects through Day 28
8.1.4.
Other Endpoints of Interest
Other endpoints of interest are:

RSV log10 viral load and change from baseline in RSV log10 viral load in the nasal samples  

Time-weighted average RSV log10 viral load and time-weighted average change from 
baseline in RSV log10 viral load in the nasal samples 


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
Proportion of subjects with detectable RSV in the nasal samples

Proportion of subjects requiring supplemental O2 (≥ 2 L/min) 

RSV log10 viral load and change from baseline in RSV log10 viral load in the blood 

Time-weighted average RSV log10 viral load and time-weighted average change from 
baseline in RSV log10 viral load in the blood

Proportion of subjects who have detectable RSV in the blood 

Proportion of subjects whose O2 saturation drops below 88% by Day 28

O2 saturation and change from baseline in O2 saturation

Time-weighted average O2 saturation and time-weighted average change from baseline in O2
saturation 

Proportion of subjects requiring ICU admission or equivalent ICU care (due to any cause) 
through Day 28 

Total number of ICU admissions or equivalent ICU care hours (for subjects receiving ICU 
care) through Day 28

Total number of mechanical ventilation (invasive or non-invasive) hours through Day 28

Duration of hospitalization through Day 28
8.2.
Analysis Conventions
8.2.1.
Analysis Sets
8.2.1.1.
Efficacy
The full analysis set (FAS) will include subjects who have an RSV log10 viral load greater than 
or equal to the LLOQ of the RT-qPCR assay in the pre-dose Day 1 nasal sample, as determined 
by RT-qPCR at the central lab, and have received at least 1 full dose of IMP.
8.2.1.2.
Safety
The primary analysis set for safety analyses is defined as all subjects who received at least a full 
dose of IMP.
All data collected during treatment will be included in the safety summaries.
8.2.1.3.
Pharmacokinetics 
The PK analysis set will include all subjects in the safety analysis set who have evaluable 
on-study PK measurements.


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8.3.
Data Handling Conventions
Missing data can have an impact upon the interpretation of the trial data. As this study is of short 
duration, it is anticipated that missing data will be minimal. In general, values for missing data 
will not be imputed. For laboratory data, a missing Baseline value will be replaced with a 
screening value, if available; otherwise it will be treated as normal (ie, Grade 0; no toxicity 
grade) for the summary of graded laboratory abnormalities. A retest value may be used if the 
first test is invalidated (eg, specimen hemolyzed).
Values will not be imputed for missing vital sign and other safety data; however, a missing 
Baseline value will be replaced with a Screening value, if available. 
Details for the handling of missing data due to subject discontinuation or other reasons, including 
unusable and spurious data, and rules for determining major and minor protocol deviations will 
be described in the SAP.
All available data for subjects that do not complete the study will be included in the data listings. 
Tables that include both individual subject PK data and summary statistics will present all 
available data, but only subjects in the PK analysis will be included in the summary statistics.
Viral load data will be log transformed prior to analyses.
8.4.
Demographic Data and Baseline Characteristics
Demographic and Baseline measurements will be summarized using standard descriptive 
methods.
Demographic summaries will include sex, race/ethnicity, randomization stratification group, and 
age.
Baseline data will include a summary of body weight, height, and BMI.
For categorical demographic and Baseline characteristics, a Fisher’s exact test will be used to 
compare treatment groups. For continuous demographic and Baseline characteristics, a Wilcoxon 
rank sum test will be used to compare treatment groups.
8.5.
Efficacy Analysis
8.5.1.
Primary Analysis
The primary endpoint is the time-weighted average change in nasal RSV viral load
(log10 copies/mL) from Day 1 to Day 9. The primary analysis will be performed on subjects 
included in the FAS population. To test the null hypothesis that there is no difference between 
the GS-5806 and placebo treatment groups in the time-weighted average change in viral load, a 
parametric analysis of covariance (ANCOVA) model with corresponding Baseline viral load as a 
covariate will be used, with a 2-sided 0.05 level. Adjusted means and 95% confidence intervals 
(CIs) will also be presented. 


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8.5.2. 
Secondary Analyses 
Final 
Amendment 1 
The F AS will be used for all summaries and analyses of secondmy endpoints. All secondaiy 
endpoints will be analyzed using 2-sided tests to compare treatment differences. 
The proportion of subjects who develop respirat01y failure requiring mechanical ventilation and 
the proportion of subjects with all-cause mortality will be analyzed using Fisher's exact tests. 
In order to accmmt for multiple hypothesis testing of endpoints, a fainily alpha spending mle will 
be used to control the Type 1 en or rate of 0.05 across the primmy and secondaiy endpoints, 
testing for differences between u·eatment groups. The primmy endpoint analysis will serve as 
the gatekeeper for the seconda1y analyses. If the primmy null hypothesis is rejected, then the 
following secondmy endpoints will be tested sequentially at a = 0.05 based upon the closed 
testing procedure { 11631}. 
• 
Prop01tion of subjects developing respirat01y failure (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28 
• 
Proportion of all-cause m01tality among all subjects through Day 28 
8.5.3. 
Exploratory Analyses 
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8.6. 
Safety Analysis 
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All safety data collected on or after the date that IMP was first dispensed up to the date of last 
dose of IMP through Day 28 will be summarized by u·eatment group (according to the IMP 
received). Data for the preu·eatment and u·eahnent-free follow-up periods will be included in data 
listings only. Data for the u·eatment period will be summarized by u·eahnent (active or placebo) 
using the number of subjects (n and percent) with events/abnonnalities for categorical data and 
using descriptive statistics for continuous data. 
8.7. 
Extent of Exposure 
A subject's extent of exposure to IMP data will be generated from the IMP adminisu·ation data. 
Exposure data will be summarized by u·eahnent group. 
8.7.1. 
Adverse Events 
Clinical and laborat01y adverse events will be coded using the Medical Dictiomuy for 
Regulat01y Activities (MedDRA). System Organ Class (SOC), High-Level Group Te1m 
(HLGT), High-Level Te1m (HLT), Prefen ed Te1m (PT), and Lower-Level Te1m (LLT) will be 
attached to the clinical database. 
Events will be summarized on the basis of the date of onset for the event. A u·eatment-emergent 
adverse event will be defined as any adverse event that begins on or after the date of first dose of 
IMP up to the date oflast dose of IMP tluough Day 28. 
Summaries (number and percentage of subjects) ofu·eatment-emergent adverse events (by SOC, 
and PT) will be provided by u·eahnent group. 
8.7.2. 
Laboratory Evaluations 
Selected laborat01y data will be summarized using only observed data. Data and change from 
Baseline at all scheduled time points will be summarized. 
Graded laborat01y abn01malities will be defmed using the grading scheme in Appendix 4. 
Grading of laborat01y abn01malities for analysis purposes will be perfonned by GSI. 
Incidence ofu·eatment-emergent laborat01y abnonnalities, defined as values that increase at least 
1 toxicity grade from Baseline at any time post Baseline up to and including Day 28 will be 
summarized by u·eatment group. If Baseline data are missing, then any graded abn01mality 
(ie, at least a Grade 1) will be considered u·eahnent emergent. 
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Laboratory abnormalities that occur before the first dose of IMP or after the subject has been 
discontinued from treatment for at least 28 days will be included in a data listing.
8.7.3.
Other Safety Evaluations
Vital signs data will be summarized using descriptive statistics by the observed data and by the 
change from Baseline at each time point.
8.8.
Pharmacokinetic Analysis
Individual subject GS-5806 concentration-time data will be displayed using scheduled sampling 
times. Descriptive statistics (eg, n, mean, standard deviation, %CV, median, and range) will be 
calculated for each sampling time. PK/PD relationship may be explored as appropriate.
8.9.
Sample Size
Sample size calculations are based on results observed in a study that evaluated the efficacy of 
oral and aerosolized ribavirin treatment for preventing progression from upper to lower 
respiratory tract infection in hematopoietic cell transplant recipients with RSV infections
(unpublished data from Dr. 
).  The sample size calculation assumes the 
time-weighted average change in RSV log10 viral load from Day 1 to Day 9 in the placebo group 
will be -1.5 log10 copies/mL with a corresponding standard deviation (SD) of 1.75 and that 85% 
of the subjects will be evaluable.  Based on these assumptions, with 25 subjects per group there 
is approximately 85% power to detect a 1.5 log difference in time-weighted average change in 
log10 viral load between treatment groups using a 2-sided 0.05-level test.  Given an evaluable 
rate of 85%, a total of 60 subjects will need to be randomized into the study.
8.10.
Data Monitoring Committee
An external multidisciplinary data monitoring committee (DMC) will review the progress of the 
study and perform interim reviews of safety  data as specified in the DMC charter and provide 
recommendation to Gilead whether the nature, frequency, and severity of adverse effects 
associated with study treatment warrant the early termination of the study in the best interests of
the participants, whether the study should continue as planned, or the study should continue with 
modifications.   
The DMC’s specific activities will be defined by a mutually agreed charter, which will define the 
DMC’s membership, conduct and meeting schedule.
While the DMC will be asked to advise Gilead regarding future conduct of the study, including 
possible early study termination, Gilead retains final decision-making authority on all aspects of 
the study.
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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and 
South Africa), International Conference on Harmonisation (ICH) guidelines, or with the laws and 
regulations of the country in which the research is conducted, whichever affords the greater 
protection to the study subject. These standards are consistent with the European Union Clinical 
Trials Directive 2001/20/EC and Good Clinical Practice Directive 2005/28/EC.
The investigator will ensure adherence to the basic principles of Good Clinical Practice, as 
outlined in 21 CFR 312, subpart D, “Responsibilities of Sponsors and Investigators,” 21 CFR, 
part 50, 1998, and 21 CFR, part 56, 1998.
The investigator and all applicable subinvestigators will comply with 21 CFR, Part 54, 1998, 
providing documentation of their financial interest or arrangements with Gilead, or proprietary 
interests in the investigational drug under study. This documentation must be provided prior to 
the investigator’s (and any subinvestigator’s) participation in the study. The investigator and 
subinvestigator agree to notify Gilead of any change in reportable interests during the study and 
for 1 year following completion of the study. Study completion is defined as the date when the 
last subject completes the protocol-defined activities.
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval
The investigator (or sponsor as appropriate according to local regulations) will submit this 
protocol, informed consent form, and any accompanying material to be provided to the subject 
(such as advertisements, subject information sheets, or descriptions of the study used to obtain 
informed consent) to an IRB/IEC, depending on region. The investigator will not begin any study 
subject activities until approval from the IRB/IEC has been documented and provided as a letter 
to the investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC for any modifications made to the protocol or any accompanying material to be 
provided to the subject after initial approval, with the exception of those necessary to reduce 
immediate risk to study subjects.
9.1.3.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study and before undertaking any study-related procedures. The 


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investigator must use the most current IRB or IEC-approved consent form for documenting 
written informed consent. Each informed consent (or assent as applicable) will be appropriately 
signed and dated by the subject or the subject’s legally authorized representative and the person 
conducting the consent discussion, and also by an impartial witness if required by IRB/IEC or
local requirements.
9.1.4.
Confidentiality
The investigator must assure that subjects’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only subject initials, date of birth, another 
unique identifier (as allowed by local law) and an identification code will be recorded on any 
form or biological sample submitted to the Sponsor, IRB/IEC, or laboratory. Laboratory 
specimens must be labeled in such a manner as to protect subject identity while allowing the 
results to be recorded to the proper subject. Refer to specific laboratory instructions.  NOTE: The 
investigator must keep a screening log showing codes, names, and addresses for all subjects 
screened and for all subjects enrolled in the trial. Subject data will be processed in accordance 
with all applicable regulations.
The investigator agrees that all information received from Gilead, including but not limited to the 
investigator brochure, this protocol, CRF/eCRF, the IMP, and any other study information, 
remain the sole and exclusive property of Gilead during the conduct of the study and thereafter. 
This information is not to be disclosed to any third party (except employees or agents directly 
involved in the conduct of the study or as required by law) without prior written consent from 
Gilead. The investigator further agrees to take all reasonable precautions to prevent the 
disclosure by any employee or agent of the study site to any third party or otherwise into the 
public domain.
9.1.5.
Study Files and Retention of Records
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following two categories: (1) investigator’s study file, and 
(2) subject clinical source documents.
The investigator’s study file will contain the protocol/amendments, CRF and query forms,
IRB/IEC and governmental approval with correspondence, informed consent, drug records, staff 
curriculum vitae and authorization forms, and other appropriate documents and correspondence.
The required source data should include sequential notes containing at least the following 
information for each subject:

Subject identification (name, date of birth, gender);

Documentation that subject meets eligibility criteria, ie, history, physical examination, and 
confirmation of diagnosis (to support inclusion and exclusion criteria);


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
Documentation of the reason(s) a consented subject is not enrolled

Participation in study (including study number);

Study discussed and date of informed consent;

Dates of all visits;

Documentation that protocol specific procedures were performed;

Results of efficacy parameters, as required by the protocol;

Start and end date (including dose regimen) of IMP, including dates of dispensing and return;

Record of all adverse events and other safety parameters (start and end date, and including 
causality and severity);

Concomitant medication (including start and end date, dose if relevant; dose changes);

Date of study completion and reason for early discontinuation, if it occurs.
All clinical study documents must be retained by the investigator until at least 2 years or 
according to local laws, whichever is longer, after the last approval of a marketing application in 
an ICH region (ie, United States, Europe, or Japan) and until there are no pending or planned 
marketing applications in an ICH region; or, if no application is filed or if the application is not 
approved for such indication, until 2 years after the investigation is discontinued and regulatory 
authorities have been notified. Investigators may be required to retain documents longer if 
specified by regulatory requirements, by local regulations, or by an agreement with Gilead. The 
investigator must notify Gilead before destroying any clinical study records.
Should the investigator wish to assign the study records to another party or move them to another 
location, Gilead must be notified in advance.
If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and Gilead to store 
these records securely away from the site so that they can be returned sealed to the investigator 
in case of an inspection. When source documents are required for the continued care of the 
subject, appropriate copies should be made for storage away from the site.
9.1.6.
Case Report Forms
For each subject consented, an eCRF will be completed by an authorized study staff member 
whose training for this function is documented according to study procedures. eCRF should be 
completed on the day of the subject visit to enable the sponsor to perform central monitoring of 
safety data.  Subsequent to data entry, a study monitor will perform source data verification 
within the EDC system. Original entries as well as any changes to data fields will be stored in 


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the audit trail of the system.  Prior to database lock (or any interim time points as described in the 
clinical data management plan), the investigator will use his/her log in credentials to confirm that 
the forms have been reviewed, and that the entries accurately reflect the information in the 
source documents. The eCRF capture the data required per the protocol schedule of events and 
procedures. System-generated or manual queries will be issued to the investigative site staff as 
data discrepancies are identified by the monitor or internal Gilead staff, who routinely review the 
data for completeness, correctness, and consistency. The site coordinator is responsible for 
responding to the queries in a timely manner, within the system, either by confirming the data as 
correct or updating the original entry, and providing the reason for the update (eg, data entry 
error). At the conclusion of the trial, Gilead will provide the site with a read-only archive copy 
of the data entered by that site. This archive must be stored in accordance with the records 
retention requirements outlined in Section 9.1.5.
9.1.7.
Data Quality Control and Quality Assurance
To insure accurate, complete, and reliable data, the Sponsor or its representatives will do the 
following:

Provide instructional material to the study sites, as appropriate.

Instruct the investigators and study personnel on the protocol, the completion of the CRFs, 
and study procedures.

Make periodic visits to the study site.

Be available to consultation and stay in contact with the study site personnel by mail, email, 
telephone, and/or fax.

Monitor the subject data recorded in the CRFs against source documents at the study site.

Review and evaluate CRF data and use standard computer edits to detect errors in data 
collection.
9.1.8.
Investigational Medicinal Product Accountability and Return
Gilead recommends that used and unused IMP supplies be destroyed on site if possible.  The 
study monitor will evaluate each study center’s IMP disposal procedures and provide appropriate 
instruction for destruction of unused IMP supplies. If the site has an appropriate standard 
operating procedure (SOP) for drug destruction as determined by Gilead QA, the site may 
destroy used (empty or partially empty) and unused IMP supplies in accordance with that site’s 
approved SOP. A copy of the site’s approved SOP will be obtained for central files. If IMP 
cannot be destroyed on site, the study monitor will provide instructions for return to Gilead or
the shipping facility from which it came for eventual destruction.


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If IMP is destroyed on site, the investigator must maintain accurate records for all IMP
destroyed. Records must show the identification and quantity of each unit destroyed, the method 
of destruction, and the person who disposed of the IMP. Upon study completion, copies of the 
IMP accountability records must be filed at the site. Another copy will be returned to Gilead.
The study monitor will review IMP supplies and associated records at periodic intervals.
9.1.9.
Inspections
The investigator will make available all source documents and other records for this trial to 
Gilead’s appointed study monitors, to IRB/IECs, or to regulatory authority or health authority 
inspectors.
9.1.10.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.
9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications, except those intended to reduce immediate risk to study subjects, may be 
made only by Gilead. The investigator must submit all protocol modifications to the IRB/IEC in 
accordance with local requirements and receive documented IRB/IEC approval before 
modifications can be implemented.
9.2.2.
Study Report and Publications
A clinical study report (CSR) will be prepared and provided to the applicable regulatory 
agencies. Gilead will ensure that the report meets the standards set out in the ICH Guideline for 
Structure and Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may 
be prepared in certain cases.
Investigators in this study may communicate, orally present, or publish in scientific journals or 
other scholarly media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent 
of Gilead in an abstract, manuscript, or presentation form or the study has been completed at 
all study sites for at least 2 years.

The investigator will submit to Gilead any proposed publication or presentation along with 
the respective scientific journal or presentation forum at least 30 days before submission of 
the publication or presentation. 

No such communication, presentation, or publication will include Gilead’s confidential 
information (see Section 9.1.4).


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Amendment 1
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
The investigator will comply with Gilead’s request to delete references to its confidential 
information (other than the study results) in any paper or presentation and agrees to withhold 
publication or presentation for an additional 60 days in order to obtain patent protection if 
deemed necessary.
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol (eg, attendance at Investigator's Meetings).  If required under the applicable statutory 
and regulatory requirements, Gilead will capture and disclose to Federal and State agencies any 
expenses paid or reimbursed for such services, including any clinical trial payments, meal, travel 
expenses or reimbursements, consulting fees, and any other transfer of value.
9.3.2.
Access to Information for Monitoring
In accordance with regulations and guidelines, the study monitor must have direct access to the 
investigator’s source documentation in order to verify the accuracy of the data recorded in the 
CRF/eCRF.
The monitor is responsible for routine review of the CRF/eCRF at regular intervals throughout 
the study to verify adherence to the protocol and the completeness, consistency, and accuracy of 
the data being entered on them. The monitor should have access to any subject records needed to 
verify the entries on the CRF/eCRF. The investigator agrees to cooperate with the monitor to 
ensure that any problems detected through any type of monitoring (central, on site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or of Gilead may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority the 
investigator agrees to notify the Gilead medical monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
Study Discontinuation
Both the sponsor and the investigator reserve the right to terminate the study at any time. Should 
this be necessary, both parties will arrange discontinuation procedures and notify the appropriate 
regulatory authority(ies), IRBs, and IECs. In terminating the study, Gilead and the investigator 
will assure that adequate consideration is given to the protection of the subjects’ interests.


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Gilead Sciences, Inc.
Amendment 1
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10.
REFERENCES
11631
Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that 
do not require all primary effects to be significant. Statist Med 2003;22 (15):2387-400.
19902
American Academy of Pediatrics Committee on Infectious Diseases: Use of ribavirin 
in the treatment of respiratory syncytial virus infection. Pediatrics 1993;92 (3):501-4.
20222
Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, et al. Global 
burden of acute lower respiratory infections due to respiratory syncytial virus in young 
children: a systematic review and meta-analysis. Lancet 2010;375 (9725):1545-55.
20227
Stockman LJ, Curns AT, Anderson LJ, Fischer-Langley G. Respiratory Syncytial 
Virus-associated Hospitalizations Among Infants and Young Children in the United 
States, 1997-2006. Pediatr Infect Dis J 2012;31 (1):5-9.
20233
Nichols WG, Gooley T, Boeckh M. Community-acquired respiratory syncytial virus 
and parainfluenza virus infections after hematopoietic stem cell transplantation: the 
Fred Hutchinson Cancer Research Center experience. Biol Blood Marrow Transplant 
2001;7 Suppl:11S-5S.
26908
Shah JN, Chemaly RF. Management of RSV infections in adult recipients of 
hematopoietic stem cell transplantation. Blood 2011;117 (10):2755-63.
26937
Shah DP, Ghantoji SS, Shah JN, El Taoum KK, Jiang Y, Popat U, et al. Impact of 
aerosolized ribavirin on mortality in 280 allogeneic haematopoietic stem cell 
transplant recipients with respiratory syncytial virus infections. J Antimicrob 
Chemother 2013;68 (8):1872-80.
28640
Boeckh M, Englund J, Li Y, Miller C, Cross A, Fernandez H, et al. Randomized 
controlled multicenter trial of aerosolized ribavirin for respiratory syncytial virus 
upper respiratory tract infection in hematopoietic cell transplant recipients. Clin Infect 
Dis 2007;44 (2):245-9.
28641
Chemaly RF, Ghosh S, Bodey GP, Rohatgi N, Safdar A, Keating MJ, et al. 
Respiratory viral infections in adults with hematologic malignancies and human stem 
cell transplantation recipients: a retrospective study at a major cancer center. Medicine 
(Baltimore) 2006;85 (5):278-87.
28643
Erard V, Chien JW, Kim HW, Nichols WG, Flowers ME, Martin PJ, et al. Airflow 
decline after myeloablative allogeneic hematopoietic cell transplantation: the role of 
community respiratory viruses. J Infect Dis 2006;193 (12):1619-25.


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Gilead Sciences, Inc.
Amendment 1
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28644
Harrington RD, Hooton TM, Hackman RC, Storch GA, Osborne B, Gleaves CA, et al. 
An outbreak of respiratory syncytial virus in a bone marrow transplant center. J Infect 
Dis 1992;165 (6):987-93.
28645
Khanna N, Widmer AF, Decker M, Steffen I, Halter J, Heim D, et al. Respiratory 
syncytial virus infection in patients with hematological diseases: single-center study 
and review of the literature. Clin Infect Dis 2008;46 (3):402-12.
28646
Avetisyan G, Mattsson J, Sparrelid E, Ljungman P. Respiratory syncytial virus 
infection in recipients of allogeneic stem-cell transplantation: a retrospective study of 
the incidence, clinical features, and outcome. Transplantation 2009;88 (10):1222-6.
28647
Kim YJ, Boeckh M, Englund JA. Community respiratory virus infections in 
immunocompromised patients: hematopoietic stem cell and solid organ transplant 
recipients, and individuals with human immunodeficiency virus infection. Seminars in 
respiratory and critical care medicine 2007;28 (2):222-42.
28648
Kim YJ, Guthrie KA, Waghmare A, Walsh EE, Falsey AR, Kuypers J, et al. 
Respiratory syncytial virus in hematopoietic cell transplant recipients: factors 
determining progression to lower respiratory tract disease. J Infect Dis 2014:1-10.
28650
Martino R, Porras RP, Rabella N, Williams JV, Ramila E, Margall N, et al. 
Prospective study of the incidence, clinical features, and outcome of symptomatic 
upper and lower respiratory tract infections by respiratory viruses in adult recipients of 
hematopoietic stem cell transplants for hematologic malignancies. Biol Blood Marrow 
Transplant 2005;11 (10):781-96.
28652
Raboni SM, Nogueira MB, Tsuchiya LR, Takahashi GA, Pereira LA, Pasquini R, et al. 
Respiratory tract viral infections in bone marrow transplant patients. Transplantation 
2003;76 (1):142-6.
28653
Schiffer JT, Kirby K, Sandmaier B, Storb R, Corey L, Boeckh M. Timing and severity 
of community acquired respiratory virus infections after myeloablative versus non-
myeloablative hematopoietic stem cell transplantation. Haematologica 2009;94 
(8):1101-8.
28654
Seo S, Campbell AP, Xie H, Chien JW, Leisenring WM, Englund JA, et al. Outcome 
of respiratory syncytial virus lower respiratory tract disease in hematopoietic cell 
transplant recipients receiving aerosolized ribavirin: significance of stem cell source 
and oxygen requirement. Biol Blood Marrow Transplant 2013;19 (4):589-96.
28655
Shah DP, Ghantoji SS, Mulanovich VE, Ariza-Heredia EJ, Chemaly RF. Management 
of respiratory viral infections in hematopoietic cell transplant recipients. American 
journal of blood research 2012;2 (4):203-18.


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Gilead Sciences, Inc.
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28656
Small TN, Casson A, Malak SF, Boulad F, Kiehn TE, Stiles J, et al. Respiratory 
syncytial virus infection following hematopoietic stem cell transplantation. Bone 
Marrow Transplant 2002;29 (4):321-7.
28657
Whimbey E, Champlin RE, Couch RB, Englund JA, Goodrich JM, Raad I, et al. 
Community respiratory virus infections among hospitalized adult bone marrow 
transplant recipients. Clin Infect Dis 1996;22 (5):778-82.
28723
Hirsch HH, Martino R, Ward KN, Boeckh M, Einsele H, Ljungman P. Fourth 
European Conference on Infections in Leukaemia (ECIL-4): guidelines for diagnosis 
and treatment of human respiratory syncytial virus, parainfluenza virus, 
metapneumovirus, rhinovirus, and coronavirus. Clin Infect Dis 2013;56 (2):258-66.
28724
Ghosh S, Champlin RE, Englund J, Giralt SA, Rolston K, Raad I, et al. Respiratory 
syncytial virus upper respiratory tract illnesses in adult blood and marrow transplant 
recipients: combination therapy with aerosolized ribavirin and intravenous 
immunoglobulin. Bone Marrow Transplant 2000;25 (7):751-5.
28725
Whimbey E, Couch RB, Englund JA, Andreeff M, Goodrich JM, Raad, II, et al. 
Respiratory syncytial virus pneumonia in hospitalized adult patients with leukemia. 
Clin Infect Dis 1995;21 (2):376-9.


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Gilead Sciences, Inc.
Amendment 1
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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Study Procedures Table
Appendix 3.
Management of Clinical and Laboratory Adverse Events
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory 
Abnormalities
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements


GS-SR06 
Protocol GS-US-218-1 502 
Final 
Gilead Sciences, Inc. 
Amendmt.:nt 1 
Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC. 
199 E BLAINE ST 
SEATTLE, WA 98102 
STUDY ACKNOWLEDGEMENT 
A Phase 2b, Randomized, Double-BJind, Placebo-Controlled Multi-Center Study 
Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in 
Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) 
Infection of the Lower Respiratory Tract 
GS-US-218-1502, Protocol Amendment 1, 31 July 2014 
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval. 
p p D 
,~~[Lien 
Name (Printed) 
Signature [PPD I 
Author 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices, and 1 agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated. 
I will provide all sludy personnel under my supervision copies of the protocol and access to all 
infom1ation provided by Gilead Sciences, lnc. 1 will discuss this material with them to ensure 
that they are fully informed about the drugs and the study. 
Principal investigator Name (Printed) 
Signature 
Date 
Site Number 
CONFIDENTIAL 
Page 77 
31 July 2014 


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Appendix 2.
Study Procedures Table
Visit 1: 
Screening
(Day -2 to 
-1)
Visit 2: Baseline 
Assessments,
Randomization, 
and Treatment 
Assessments
(Day 1)
Visit 
3: Day 
3
(±24 
hours)
Visit 
4: Day 
5
(±24 
hours)
Visit 
5: Day 
7
(±24 
hours)
Visit 
6: Day 
9
(±24 
hours)
Visit 
7: Day 
13
(±24 
hours)
Visit 
8: Day 
17
(±24 
hours)
Visit 
9:  
Day 
22
(±24 
hours)
Visit 10:   
End of 
study/Day 
28
(+3 days)
Optional Extended Viral 
Monitoringl
Visit 
11:   
Day 
35
(±48
hours)
Visit 
12:   
Day 
42
(±48
hours)
Visit 
13:   
Day 
49
(±48
hours)
Visit 
14:   
Day 
56
(±48 
hours)
Must complete 
visit in the 
hospital or clinic
X
X
X
X
X
X
X
X
Written Informed 
Consent
X
Medical History
and 
Demographics
X
Chest X-ray
Xa
Screening Labs
Xb
Urine or Serum 
Pregnancy Test
Xc
Vital Signs (inc. 
O2 Saturation d)
X
X
X
X
X
X
X
X
Height
X
Weight
X
X
X
X
X
X
X
X
Safety Labs e
X
X
X
X
X
X
X
RSV antibody 
titer
X
X
RSV Viremia
X
X
X
X
X
X
X


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Gilead Sciences, Inc.
Amendment 1
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Visit 1: 
Screening
(Day -2 to 
-1)
Visit 2: Baseline 
Assessments,
Randomization, 
and Treatment 
Assessments
(Day 1)
Visit 
3: Day 
3
(±24 
hours)
Visit 
4: Day 
5
(±24 
hours)
Visit 
5: Day 
7
(±24 
hours)
Visit 
6: Day 
9
(±24 
hours)
Visit 
7: Day 
13
(±24 
hours)
Visit 
8: Day 
17
(±24 
hours)
Visit 
9:  
Day 
22
(±24 
hours)
Visit 10:   
End of 
study/Day 
28
(+3 days)
Optional Extended Viral 
Monitoringl
Visit 
11:   
Day 
35
(±48
hours)
Visit 
12:   
Day 
42
(±48
hours)
Visit 
13:   
Day 
49
(±48
hours)
Visit 
14:   
Day 
56
(±48 
hours)
Nasal Samples f
X
X
X
X
X
X
X
X
X
X
X
X
X
Local RSV 
Testing
Xk
Induced Sputum g
X
Randomization
X
IMP
Administration
X
X
X
X
X
PK Sample
Xh
Xj
Xh
Xh
Xh
Xh
Xh
Serum creatinine
Xi
Xi
Adverse Events
X
X
X
X
X
X
X
X
Xm
Xm
Xm
Xm
ICU admissions, 
re-
hospitalizations,  
standard of care 
test results, 
mechanical 
ventilation, and 
supplemental O2
X
X
X
X
X
X
Concomitant 
Medications
X
X
X
X
X
X
X
X
a
Chest X-ray obtained < 48 hours prior to Screening may be used
b
Existing values collected ≤ 6 days prior to Screening may be used
c
Required for women unable to confirm menopause, hysterectomy and/or bilateral oophorectomy


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Gilead Sciences, Inc.
Amendment 1
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d
On room air
e
Hematology and serum chemistry to include WBC with differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total bilirubin
f
2 samples total, 1 from each nostril – collected prior to dosing on dosing days
g
Collected pre-dose if induced sputum was not used to demonstrate the presence of RSV in the lower respiratory tract ≤6 days prior to Day 1
h
PK samples collected for all subjects 4 hours post-dose Day 1; pre-dose on Days 5, 9, 13, and 17; and anytime on Day 22
i
For hospitalized subjects only: blood will be drawn for serum creatinine at 4 hours post-dose at Visit 2 (Day 1) and on Days 2, 3 and 4 (24, 48 and 72 hours [±3hours]
post-first GS-5806 dose if they remain hospitalized at those times. 
j
For hospitalized subjects only: PK sample collected at Visit 3 (48 hours [±3 hours] post-first GS-5806 dose)
k
Only for subjects who agree to the Optional Extended Viral Monitoring at the time of consent
l
Only for subjects who agree to the Optional Extended Viral Monitoring at the time of consent and test positive (or inconclusive) for RSV at Visit 9 (Day 22)
m
Assessment of procedure-related AEs only


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Gilead Sciences, Inc.
Amendment 1
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Appendix 3.
Management of Clinical and Laboratory Adverse Events
Grade 1
Grade 4
Grade 3
Grade 2
May continue 
dosing at the 
discretion of the 
investigator
Repeat lab to 
confirm toxicity 
grade
Repeat lab to 
confirm toxicity 
grade
If confirmed and possibly and/or probably related to 
investigational medicinal products:
1.
Withhold investigational medicinal products until Grade 2
2.
Restart all investigational medicinal products at full dose
If confirmed and unrelated to 
investigational medicinal products, 
dosing may continue at the 
discretion of the investigator
If confirmed and 
possibly or probably 
related to 
investigational 
medicinal products, 
discontinue 
investigational 
medicinal products
dosing permanently 
and follow at periodic 
intervals at least 
weekly until a return 
to Baseline or is 
otherwise explained
If Grade 3 or 4 recurrence that is confirmed and possibly or 
probably related to investigational medicinal products, discontinue 
all investigational medicinal products dosing permanently
If Grade 3 or 4 recurrence that is considered unrelated to 
investigational medicinal products, continue all investigational 
medicinal products at the same dose at the discretion of the 
investigator


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Gilead Sciences, Inc.
Amendment 1
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Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
Version: 18Junel2012
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Hemoglobin
HIV POSITIVE
Adult and Pediatric 57 Days
8.5 to 10.0 g/dL 
85 to 100 g/L
7.5 to 8.5 g/dL 
75 to 85 g/L
6.5 to 7.5 g/dL 
65 to 75 g/L
6.5 g/dL
65 g/L
HIV NEGATIVE
Adult and Pediatric 57 Days 
10.0 to 10.9 g/dL
100 to 109 g/L
OR
Any decrease from Baseline
2.5 to 3.5 g/dL
25 to 35 g/L
9.0 to 10.0 g/dL
90 to 100 g/L
OR
Any decrease from Baseline
3.5 to 4.5 g/dL
35 to 45 g/L
7.0 to 9.0 g/dL
70 to 90 g/L
OR
Any decrease from Baseline
4.5 g/dL
45 g/L
7.0 g/dL
70 g/L
Infant, 36–56 Days
(HIV POSITIVE OR
NEGATIVE)
8.5 to 9.4 g/dL
85 to 94 g/L
7.0 to 8.5 g/dL
70 to 85 g/L
6.0 to 7.0 g/dL
60 to < 70 g/L
6.0 g/dL
< 60 g/L
Infant, 22–35 Days
(HIV POSITIVE OR
NEGATIVE)
9.5 to 10.5 g/dL
95 to 105 g/L
8.0 to 9.5 g/dL
80 to 95 g/L
7.0 to 8.0 g/dL
70 to 80 g/L
7.0 g/dL
70 g/L
Infant, 1–21 Days
(HIV POSITIVE OR
NEGATIVE)
12.0 to 13.0 g/dL
120 to 130 g/L
10.0 to 12.0 g/dL
100 to 120 g/L
9.0 to 10.0 g/dL
90 to 100 g/L
9.0 g/dL
90 g/L


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Protocol GS-US-218-1502
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Gilead Sciences, Inc.
Amendment 1
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HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Absolute Neutrophil Count 
(ANC)
Adult and Pediatric, 7 Days
1000 to 1300/mm3
750 to 1000/mm3
500 to 750/mm3
500/mm3
1.00 to 1.30 GI/L
0.75 to 1.00 GI/L
0.50 to 0.75 GI/L
0.50 GI/L
Infant, 2 – 7 Days
1250 to 1500/mm3
1.25 to 1.50 GI/L
1000 to 1250/mm3
1.00 to < 1.25 GI/L
750 to 1000/mm3
0.75 to < 1.00 GI/L
750/mm3
< 0.75 GI/L
Infant, 1 Day
4000 to 5000/mm3
4.00 to 5.00 GI/L
3000 to 4000/mm3
3.00 to < 4.00 GI/L
1500 to 3000/mm3
1.50 to < 3.00 GI/L
1500/mm3
< 1.50 GI/L
Absolute CD4+ Count
HIV NEGATIVE ONLY
Adult and Pediatric 
> 13 Years
300 to 400/mm3
300 to 400/μL
200 to 300/mm3
200 to 300/μL
100 to 200/mm3
100 to 200/μL
100/mm3
100/μL
Absolute Lymphocyte Count
HIV NEGATIVE ONLY
Adult and Pediatric 
13 Years
600 to 650/mm3
0.60 to 0.65 GI/L
500 to 600/mm3
0.50 to 0.60 GI/L
350 to 500/mm3
0.35 to 0.50 GI/L
350/mm3
0.35 GI/L
Platelets 
100,000 to < 125,000/mm3
100 to 125 GI/L
50,000 to 100,000/mm3
50 to 100 GI/L
25,000 to 50,000/mm3
25 to 50 GI/L
25,000/mm3
25 GI/L
WBCs 
2000/mm3 to 2500/mm3
1,500 to 2,000/mm3
1000 to 1,500/mm3
1000/mm3
2.00 GI/L to 2.50 GI/L
1.50 to 2.00 GI/L
1.00 to 1.50 GI/L
1.00 GI/L
Hypofibrinogenemia
100 to 200 mg/dL
75 to 100 mg/dL
50 to 75 mg/dL
50 mg/dL
1.00 to 2.00 g/L
0.75 to 1.00 g/L
0.50 to 0.75 g/L
0.50 g/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 84
31 July 2014
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Hyperfibrinogenemia
ULN to 600 mg/dL
600 mg/dL
—
—
ULN  to 6.0 g/L
6.0 g/L
—
—
Fibrin Split Product 
20 to 40 μg/mL
40 to 50 μg/mL
50 to 60 μg/mL
60 μg/mL
20 to 40 mg/L
40 to 50 mg/L
50 to 60 mg/L
60 mg/L
Prothrombin Time (PT)
1.00 to 1.25 ULN
1.25 to 1.50 ULN 
1.50 to 3.00 ULN 
3.00 ULN 
International Normalized Ratio 
of prothrombin time (INR)
1.1 to 1.5 x ULN
>1.5 to 2.0 x ULN
>2.0 to 3.0 x ULN
>3.0 x ULN
Activated Partial
Thromboplastin Time (APTT)
1.00 to 1.66 ULN
1.66 to 2.33 ULN
2.33 to 3.00 ULN
3.00 ULN
Methemoglobin 
5.0 to 10.0%
10.0 to 15.0%
15.0 to 20.0%
20.0% 


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 85
31 July 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hyponatremia 
130 to <LLN mEq/L
125 to 130 mEq/L
121 to 125 mEq/L
121 mEq/L
130 to <LLN mmol/L
125 to 130 mmol/L
121 to 125 mmol/L
121 mmol/L
Hypernatremia 
146  to 150 mEq/L
150 to 154 mEq/L
154 to 159 mEq/L
159 mEq/L
146  to 150 mmol/L
150 to 154 mmol/L
154 to 159 mmol/L
159 mmol/L
Hypokalemia 
3.0 to 3.4 mEq/L
2.5 to 3.0 mEq/L
2.0 to 2.5 mEq/L
2.0 mEq/L
3.0 to 3.4 mmol/L
2.5 to 3.0 mmol/L
2.0 to 2.5 mmol/L
2.0 mmol/L
Hyperkalemia 
5.6 to 6.0 mEq/L
6.0 to 6.5 mEq/L
6.5 to 7.0 mEq/L
7.0 mEq/L
5.6 to 6.0 mmol/L
6.0 to 6.5 mmol/L
6.5 to 7.0 mmol/L
7.0 mmol/L
Hypoglycemia
Adult and Pediatric
1 Month
55 to 64 mg/dL
40 to 55 mg/dL
30 to 40 mg/dL
30 mg/dL
3.03 to 3.58 mmol/L
2.20 to 3.03 mmol/L
1.64 to 2.20 mmol/L
1.64 mmol/L
Infant, 1 Month
50 to 54 mg/dL
2.8 to 3.0 mmol/L
40 to 50 mg/dL
2.2 to 2.8 mmol/L
30 to 40 mg/dL
1.7 to 2.2 mmol/L
30 mg/dL
1.7 mmol/L
Hyperglycemia, Nonfasting 
116 to 160 mg/dL
160 to 250 mg/dL
250 to 500 mg/dL
500 mg/dL
6.42 to 8.91 mmol/L
8.91 to 13.90 mmol/L
13.90 to 27.79 mmol/L
27.79 mmol/L
Hyperglycemia, Fasting
110 to 125 mg/dL
6.08 to 6.96 mmol/L
>125 to 250 mg/dL
>6.96 to 13.90 mmol/L
>250 to 500 mg/dL
>13.90 to 27.79 mmol/L
>500 mg/dL
>27.79 mmol/L
Hypocalcemia 
(corrected for albumin if 
appropriate*)
Adult and Pediatric
7 Days
7.8 to 8.4  mg/dL
7.0 to 7.8 mg/dL
6.1 to 7.0 mg/dL
6.1 mg/dL
1.94 to 2.10 mmol/L
1.74 to 1.94 mmol/L
1.51 to 1.74 mmol/L
1.51 mmol/L
Infant, 7 Days
6.5 to 7.5 mg/dL
1.61 to 1.88  mmol/L
6.0 to 6.5 mg/dL
1.49 to < 1.61 mmol/L
5.5 to 6.0 mg/dL
1.36 to < 1.49 mmol/L 
5.5 mg/dL
< 1.36 mmol/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 86
31 July 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hypercalcemia (corrected 
for albumin if appropriate*)
Adult and Pediatric 
7 Days
>ULN to 11.5 mg/dL
11.5 to 12.5 mg/dL
12.5 to 13.5 mg/dL
13.5 mg/dL
>ULN to 2.88 mmol/L
2.88 to 3.13 mmol/L
3.13 to 3.38 mmol/L
3.38 mmol/L
Infant, 7 Days
11.5 to 12.4 mg/dL
2.86 to 3.10  mmol/L
12.4 to 12.9 mg/dL
> 3.10 to 3.23  mmol/L
12.9 to 13.5 mg/dL
> 3.23 to 3.38  mmol/L
13.5 mg/dL
> 3.38 mmol/L
Hypocalcemia (ionized)
3.0 mg/dL to LLN
2.5 to < 3.0 mg/dL
2.0 to 2.5 mg/dL
2.0 mg/dL
0.74 mmol/L to LLN
0.62 to 0.74 mmol/L
0.49 to 0.62 mmol/L
0.49 mmol/L
Hypercalcemia (ionized)
ULN to 6.0 mg/dL
6.0 to 6.5 mg/dL
6.5 to 7.0 mg/dL
7.0 mg/dL
ULN to 1.50 mmol/L
1.50 to 1.63 mmol/L
1.63 to 1.75 mmol/L
1.75 mmol/L
Hypomagnesemia
1.40 to  <LLN mg/dL
1.2 to <LLN mEq/L
1.04 to 1.40 mg/dL
0.9 to 1.2 mEq/L
0.67 to 1.04 mg/dL
0.6 to 0.9 mEq/L
0.67 mg/dL
0.6 mEq/L
0.58 to <LLN mmol/L
0.43 to 0.58 mmol/L
0.28 to 0.43 mmol/L
0.28 mmol/L
Hypophosphatemia
Adult and Pediatric
14 Years
2.0 to < LLN mg/dL
1.5 to 2.0 mg/dL
1.0 to 1.5 mg/dL
1.0 mg/dL
0.63  to LLN mmol/L
0.47 to 0.63 mmol/L
0.31 to 0.47 mmol/L
0.31 mmol/L
Pediatric 1 Year–14 Years 
3.0 to 3.5 mg/dL
0.96 to 1.12 mmol/L
2.5 to 3.0 mg/dL
0.80 to < 0.96 mmol/L
1.5 to 2.5 mg/dL
0.47 to < 0.80 mmol/L
1.5 mg/dL
< 0.47 mmol/L
Pediatric 1 Year
3.5 to 4.5 mg/dL
1.12 to 1.46 mmol/L
2.5 to 3.5 mg/dL
0.80 to < 1.12 mmol/L
1.5 to 2.5 mg/dL
0.47 to < 0.80 mmol/L
1.5 mg/dL
< 0.47 mmol/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 87
31 July 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hyperbilirubinemia 
Adult and Pediatric 
> 14 Days
1.0 to 1.5 ULN 
1.5 to 2.5 ULN
2.5 to 5.0 ULN 
5.0 ULN 
Infant, 14 Days
(non-hemolytic)
NA
20.0 to 25.0 mg/dL
342 to 428 μmol/L
25.0 to 30.0 mg/dL
> 428 to 513 μmol/L
30.0 mg/dL
> 513 μmol/L
Infant, 14 Days
(hemolytic)
NA
NA
20.0 to 25.0 mg/dL
342 to 428 μmol/L
25.0 mg/dL
> 428 μmol/L
Blood Urea Nitrogen
1.25 to 2.50 ULN 
2.50 to 5.00 ULN 
5.00 to 10.00 ULN 
10.00 ULN
Hyperuricemia
>ULN to 10.0 mg/dL 
10.0 to 12.0 mg/dL 
12.0 to 15.0 mg/dL 
15.0 mg/dL
>ULN to 597 μmol/L
597 to 716 μmol/L
716 to 895 μmol/L
895 μmol/L
Hypouricemia
1.5 mg/dL to LLN
1.0 to 1.5 mg/dL
0.5 to 1.0 mg/dL
0.5 mg/dL
87 μmol/L to LLN
57 to 87 μmol/L
27 to 57 μmol/L
27 μmol/L
Creatinine 
1.50 to 2.00 mg/dL
2.00 to 3.00 mg/dL
3.00 to 6.00 mg/dL 
6.00 mg/dL
133 to 177 μmol/L
177 to 265 μmol/L
265 to 530 μmol/L
530 μmol/L
Bicarbonate
16.0 mEq/L to LLN 
11.0 to 16.0 mEq/L
8.0 to 11.0 mEq/L
8.0 mEq/L
16.0 mmol/L to LLN
11.0 to 16.0 mmol/L
8.0 to 11.0 mmol/L
8.0 mmol/L
Triglycerides
(Fasting)
NA
500 to 750 mg/dL
750 to 1200 mg/dL
1200 mg/dL
5.64–8.47 mmol/L
8.47–13.55 mmol/L
13.55 mmol/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 88
31 July 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
LDL
(Fasting)
130 to 160 mg/dL
>160 to 190 mg/dL
> 190 mg/dL
NA
3.35 to 4.15 mmol/L
>4.15 to 4.92 mmol/L
>4.92 mmol/L
Pediatric >2 to <18 years
110 to 130 mg/dL
>130 to 190 mg/dL
> 190 mg/dL
NA
2.84 to 3.37 mmol/L
>3.37 to  4.92 mmol/L
>4.92 mmol/L
Hypercholesterolemia
(Fasting)
200 to 239 mg/dL
239 to 300 mg/dL
300 mg/dL
NA
5.16 to 6.19 mmol/L
6.19 to 7.77 mmol/L
7.77 mmol/L
Pediatric 18 Years
170 to 199 mg/dL
4.39 to 5.15 mmol/L
199 to 300 mg/dL
5.15 to 7.77 mmol/L
300 mg/dL
7.77 mmol/L
NA
Creatine Kinase
3.0 to 6.0 ULN
6.0 to 10.0 ULN
10.0 to 20.0 ULN
20.0 ULN
*Calcium should be corrected for albumin if albumin is < 4.0 g/dL


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 89
31 July 2014
ENZYMES
Grade 1
Grade 2
Grade 3
Grade 4
AST (SGOT) 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
ALT (SGPT) 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
GGT
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
Alkaline Phosphatase 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
Total Amylase
1.0 to 1.5 ULN
1.5 to 2.0 ULN
2.0 to 5.0 ULN
5.0 ULN
Pancreatic Amylase
1.0 to 1.5 ULN
1.5 to 2.0 ULN
2.0 to 5.0 ULN
5.0 ULN
Lipase 
1.0 to 1.5 ULN
1.5 to 3.0 ULN
3.0 to 5.0 ULN
5.0 ULN
Albumin
3.0 g/dL to LLN
30 g/L to LLN
2.0 to 3.0 g/dL
20 to 30 g/L
2.0 g/dL
20 g/L
NA


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 90
31 July 2014
URINALYSIS
Grade 1
Grade 2
Grade 3
Grade 4
Hematuria (Dipstick) 
1
2
3-4+
NA
Hematuria (Quantitative) 
See Note below
                              Females
>ULN - 10 RBC/HPF
10-75 RBC/HPF
> 75 RBC/HPF
NA
                              Males
6-10 RBC/HPF
10-75 RBC/HPF
> 75 RBC/HPF
NA
Proteinuria (Dipstick)
1
2–3
4
NA
Proteinuria, 24 Hour Collection
Adult and Pediatric 
10 Years
200 to 999 mg/24 h
>999 to 1999 mg/24 h
>1999 to 3500 mg/24 h
3500 mg/24 h
Pediatric 3 Mo to 
< 10 Years
201 to 499 mg/m2/24 h
>499 to 799 mg/m2/24 h
>799 to 1000 mg/m2/24 h
1000 mg/ m2/24 h
Glycosuria (Dipstick)
1+
2-3
4
NA
Notes: 

Toxicity grades for Quantitative and Dipstick Hematuria will be assigned by Covance Laboratory, however for other laboratories, toxicity grades will only be assigned to 
Dipstick Hematuria.

With the exception of lipid tests, any graded laboratory test with a result that is between the LLN and ULN should be assigned Grade 0.

If the severity of a clinical AE could fall under either one of two grades (eg, the severity of an AE could be either Grade 2 or Grade 3), select the higher of the two grades 
for the AE.


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 91
31 July 2014
CARDIOVASCULAR
Grade 1
Grade 2
Grade 3
Grade 4
Cardiac Arrhythmia (general)
(By ECG or physical exam)
Asymptomatic AND No 
intervention indicated
Asymptomatic AND Non-
urgent medical intervention 
indicated
Symptomatic, non-life-
threatening AND Non-
urgent medical intervention 
indicated 
Life-threatening arrhythmia 
OR Urgent intervention 
indicated
Cardiac-ischemia/Infarction
NA
NA
Symptomatic ischemia 
(stable angina) OR Testing 
consistent with ischemia 
Unstable angina OR Acute 
myocardial infarction
Hemorrhage (significant acute 
blood loss)
NA
Symptomatic AND No 
transfusion indicated
Symptomatic AND 
Transfusion of 2 units 
packed RBCs (for children 
10 cc/kg) indicated 
Life-threatening hypotension 
OR Transfusion of 2 units 
packed RBCs indicated (for 
children 10 cc/kg) indicated
Hypertension (with repeat 
testing at same visit)
140–159 mmHg systolic 
OR 
90–99 mmHg diastolic
159–179 mmHg systolic 
OR 
99–109 mmHg diastolic
179 mmHg systolic 
OR 
109 mmHg diastolic
Life-threatening consequences 
(eg, malignant hypertension) 
OR Hospitalization (other than 
ER visit) indicated
Pediatric 17 Years (with 
repeat testing at same visit)
NA
91st–94th percentile adjusted 
for age, height, and gender 
(systolic and/or diastolic)
≥95th percentile adjusted 
for age, height, and gender 
(systolic and/or diastolic)
Life-threatening consequences 
(eg, malignant hypertension) 
OR Hospitalization indicated 
(other than emergency room 
visit)
Hypotension
NA
Symptomatic, corrected with 
oral fluid replacement
Symptomatic, IV fluids 
indicated
Shock requiring use of 
vasopressors or mechanical 
assistance to maintain blood 
pressure
Pericardial Effusion
Asymptomatic, small 
effusion requiring no 
intervention
Asymptomatic, moderate or 
larger effusion requiring no 
intervention
Effusion with non-life-
threatening physiologic 
consequences OR Effusion 
with nonurgent intervention 
indicated
Life-threatening consequences 
(eg, tamponade) OR Urgent 
intervention indicated


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 92
31 July 2014
CARDIOVASCULAR
Grade 1
Grade 2
Grade 3
Grade 4
Prolonged PR Interval
PR interval 
0.21 to 0.25 sec
PR interval
0.25 sec
Type II 2nd degree AV 
block OR Ventricular pause 
3.0 sec
Complete AV block 
Pediatric 16 Years
1st degree AV block
(PR > normal for age and 
rate)
Type I 2nd degree AV block 
Type II 2nd degree AV 
block 
Complete AV block
Prolonged QTc
Asymptomatic, QTc interval 
0.45 to 0.47 sec OR Increase 
interval 0.03 sec above 
baseline
Asymptomatic, QTc interval 
0.48 to 0.49 sec OR Increase 
in interval 0.03 to 0.05 sec 
above baseline
Asymptomatic, QTc interval 
0.50 sec OR Increase in 
interval 0.06 sec above 
baseline
Life-threatening 
consequences, eg, Torsade de 
pointes or other associated 
serious ventricular 
dysrhythmia
Pediatric 16 Years
Asymptomatic, QTc interval 
0.450 to 0.464 sec 
Asymptomatic, QTc interval 
0.465 to 0.479 sec 
Asymptomatic, QTc interval 
0.480 sec 
Life-threatening 
consequences, eg, Torsade de 
pointes or other associated 
serious ventricular 
dysrhythmia
Thrombosis/Embolism
NA
Deep vein thrombosis AND 
No intervention indicated (eg, 
anticoagulation, lysis filter, 
invasive procedure) 
Deep vein thrombosis AND 
Intervention indicated (eg, 
anticoagulation, lysis filter, 
invasive procedure) 
Embolic event (eg, pulmonary 
embolism, life-threatening 
thrombus) 
Vasovagal Episode (associated 
with a procedure of any kind)
Present without loss of 
consciousness 
Present with transient loss of 
consciousness
NA 
NA
Ventricular Dysfunction 
(congestive heart failure, 
CHF)
NA
Asymptomatic diagnostic 
finding AND intervention 
indicated
New onset with symptoms 
OR Worsening symptomatic 
CHF
Life-threatening CHF


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 93
31 July 2014
RESPIRATORY
Grade 1
Grade 2
Grade 3
Grade 4
Bronchospasm (acute)
FEV1 or peak flow reduced to 
70% to 80%
FEV1 or peak flow 50% to 69%
FEV1 or peak flow 25% to 
49% 
Cyanosis OR FEV1 or peak flow 
25% OR Intubation
Dyspnea or Respiratory 
Distress
Dyspnea on exertion with no 
or minimal interference with 
usual social & functional 
activities 
Dyspnea on exertion causing 
greater than minimal interference 
with usual social & functional 
activities 
Dyspnea at rest causing 
inability to perform usual 
social & functional activities 
Respiratory failure with 
ventilatory support indicated
Pediatric 14 Years
Wheezing OR minimal 
increase in respiratory rate for 
age
Nasal flaring OR Intercostal 
retractions OR Pulse oximetry 
90% to 95%
Dyspnea at rest causing 
inability to perform usual 
social & functional activities 
OR Pulse oximetry 90%
Respiratory failure with 
ventilatory support indicated
OCULAR/VISUAL
Grade 1
Grade 2
Grade 3
Grade 4
Uveitis
Asymptomatic but detectable 
on exam
Symptomatic anterior uveitis OR 
Medical intervention indicated
Posterior or pan-uveitis OR 
Operative intervention 
indicated
Disabling visual loss in affected 
eye(s) 
Visual Changes (from 
Baseline)
Visual changes causing no or 
minimal interference with 
usual social & functional 
activities
Visual changes causing greater 
than minimal interference with 
usual social & functional 
activities
Visual changes causing 
inability to perform usual 
social & functional activities
Disabling visual loss in affected 
eye(s)


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 94
31 July 2014
SKIN
Grade 1
Grade 2
Grade 3
Grade 4
Alopecia
Thinning detectable by 
study participant or  
caregiver (for disabled 
adults)
Thinning or patchy hair loss 
detectable by health care 
provider
Complete hair loss
NA
Cutaneous Reaction – Rash
Localized macular rash 
Diffuse macular, 
maculopapular, or 
morbilliform rash OR Target 
lesions 
Diffuse macular, 
maculopapular, or morbilliform 
rash with vesicles or limited 
number of bullae OR 
Superficial ulcerations of 
mucous membrane limited to 
one site
Extensive or generalized 
bullous lesions OR 
Stevens-Johnson syndrome 
OR Ulceration of mucous 
membrane involving two 
or more distinct mucosal 
sites OR Toxic epidermal 
necrolysis (TEN)
Hyperpigmentation
Slight or localized
Marked or generalized
NA
NA
Hypopigmentation
Slight or localized 
Marked or generalized
NA
NA
Pruritis (itching – no skin 
lesions) 
(See also Injection Site 
Reactions: Pruritis associated 
with injection)
Itching causing no or 
minimal interference with 
usual social & functional 
activities
Itching causing greater than 
minimal interference with 
usual social & functional 
activities
Itching causing inability to 
perform usual social & 
functional activities 
NA


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 95
31 July 2014
GASTROINTESTINAL
Grade 1
Grade 2
Grade 3
Grade 4
Anorexia
Loss of appetite without 
decreased oral intake
Loss of appetite associated with 
decreased oral intake without 
significant weight loss 
Loss of appetite associated 
with significant weight loss 
Life-threatening consequences 
OR Aggressive intervention 
indicated [eg, tube feeding or 
total parenteral nutrition]
Ascites
Asymptomatic
Symptomatic AND Intervention 
indicated (eg, diuretics or 
therapeutic paracentesis)
Symptomatic despite 
intervention
Life-threatening consequences
Cholecystitis
NA
Symptomatic AND Medical 
intervention indicated
Radiologic, endoscopic, or 
operative intervention 
indicated
Life-threatening consequences 
(eg, sepsis or perforation) 
Constipation 
NA
Persistent constipation requiring 
regular use of dietary 
modifications, laxatives, or 
enemas 
Obstipation with manual 
evacuation indicated
Life-threatening consequences 
(eg, obstruction)
Diarrhea 
Adult and Pediatric 
1 Year
Transient or intermittent 
episodes of unformed stools 
OR Increase of 3 stools 
over baseline/24 hr
Persistent episodes of unformed 
to watery stools OR Increase of 
4–6 stools over baseline per 
24 hrs. 
Bloody diarrhea OR Increase 
of 7 stools per 24-hour 
period OR IV fluid 
replacement indicated
Life-threatening consequences 
(eg, hypotensive shock)
Pediatric 1 Year
Liquid stools (more 
unformed than usual) but 
usual number of stools
Liquid stools with increased 
number of stools OR Mild 
dehydration
Liquid stools with moderate 
dehydration
Liquid stools resulting in 
severe dehydration with 
aggressive rehydration 
indicated OR Hypotensive 
shock
Dysphagia-Odynophagia 
Symptomatic but able to eat 
usual diet
Symptoms causing altered 
dietary intake without medical 
intervention indicated
Symptoms causing severely 
altered dietary intake with 
medical intervention indicated
Life-threatening reduction in 
oral intake


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Amendment 1
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GASTROINTESTINAL
Grade 1
Grade 2
Grade 3
Grade 4
Mucositis/Stomatitis 
(clinical exam)
See also Proctitis, 
Dysphagia-Odynophagia
Erythema of the mucosa
Patchy pseudomembranes or 
ulcerations 
Confluent pseudomembranes 
or ulcerations OR Mucosal 
bleeding with minor trauma
Tissue necrosis OR Diffuse 
spontaneous mucosal bleeding 
OR Life-threatening 
consequences (eg, aspiration, 
choking)
Nausea 
Transient (24 hours) or 
intermittent nausea with no 
or minimal interference with 
oral intake
Persistent nausea resulting in 
decreased oral intake for 24–48 
hours
Persistent nausea resulting in 
minimal oral intake for 48 
hours OR Aggressive 
rehydration indicated (eg, 
IV fluids)
Life-threatening consequences 
(eg, hypotensive shock)
Pancreatitis
NA
Symptomatic AND 
Hospitalization not indicated 
(other than ER visit)
Symptomatic AND 
Hospitalization indicated 
(other than ER visit)
Life-threatening consequences 
(eg, sepsis, circulatory failure, 
hemorrhage)
Proctitis (functional-
symptomatic)
Also see Mucositis/ 
Stomatitis for Clinical 
Exam
Rectal discomfort AND No 
intervention indicated
Symptoms causing greater than 
minimal interference with usual 
social & functional activities OR 
Medical intervention indicated 
Symptoms causing inability to 
perform usual social/ 
functional activities OR 
Operative intervention 
indicated 
Life-threatening consequences 
(eg, perforation)
Vomiting
Transient or intermittent 
vomiting with no or 
minimal interference with 
oral intake
Frequent episodes of vomiting 
with no or mild dehydration
Persistent vomiting resulting 
in orthostatic hypotension OR 
Aggressive rehydration 
indicated
Life-threatening consequences 
(eg, hypotensive shock)


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Protocol GS-US-218-1502
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Amendment 1
CONFIDENTIAL
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31 July 2014
NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Alteration in Personality-
Behavior or in Mood (eg, 
agitation, anxiety, 
depression, mania, 
psychosis)
Alteration causing no or 
minimal interference with 
usual social & functional 
activities 
Alteration causing greater than 
minimal interference with 
usual social & functional 
activities 
Alteration causing inability to 
perform usual social & 
functional activities 
Behavior potentially harmful 
to self or others (eg, 
suicidal/homicidal ideation or 
attempt, acute psychosis) OR 
Causing inability to perform 
basic self-care functions
Altered Mental Status 
For Dementia, see Cognitive 
and Behavioral/Attentional 
Disturbance (including 
dementia and ADD)
Changes causing no or 
minimal interference with 
usual social & functional 
activities
Mild lethargy or somnolence 
causing greater than minimal 
interference with usual social 
& functional activities
Confusion, memory 
impairment, lethargy, or 
somnolence causing inability 
to perform usual social & 
functional activities
Delirium OR obtundation, OR 
coma
Ataxia 
Asymptomatic ataxia 
detectable on exam OR 
Minimal ataxia causing no 
or minimal interference with 
usual social & functional 
activities
Symptomatic ataxia causing 
greater than minimal 
interference with usual social 
& functional activities
Symptomatic ataxia causing 
inability to perform usual 
social & functional activities 
Disabling ataxia causing 
inability to perform basic self-
care functions
Cognitive and 
Behavioral/Attentional 
Disturbance (including 
dementia and Attention 
Deficit Disorder) 
Disability causing no or 
minimal interference with 
usual social & functional 
activities OR Specialized 
resources not indicated
Disability causing greater than 
minimal interference with 
usual social & functional 
activities OR Specialized 
resources on part-time basis 
indicated
Disability causing inability to 
perform usual social & 
functional activities OR 
Specialized resources on a 
full-time basis indicated
Disability causing inability to 
perform basic self-care 
functions OR 
Institutionalization indicated
CNS Ischemia
(acute)
NA
NA
Transient ischemic attack
Cerebral vascular accident 
(CVA, stroke) with 
neurological deficit 


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 98
31 July 2014
NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Developmental delay –
Pediatric 16 Years
Mild developmental delay, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate 
for the setting 
Moderate developmental 
delay, either motor or 
cognitive, as determined by 
comparison with a 
developmental screening tool 
appropriate for the setting 
Severe developmental delay, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate for 
the setting 
Developmental regression, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate for 
the setting
Headache 
Symptoms causing no or 
minimal interference with 
usual social & functional 
activities
Symptoms causing greater 
than minimal interference with 
usual social & functional 
activities
Symptoms causing inability to 
perform usual social & 
functional activities
Symptoms causing inability to 
perform basic self-care 
functions OR Hospitalization 
indicated (other than ER visit) 
OR Headache with significant 
impairment of alertness or
other neurologic function 
Insomnia
NA
Difficulty sleeping causing 
greater than minimal 
interference with usual 
social/functional activities
Difficulty sleeping causing 
inability to perform usual 
social & functional activities
Disabling insomnia causing 
inability to perform basic self-
care functions
Neuromuscular Weakness 
(including myopathy & 
neuropathy) 
Asymptomatic with 
decreased strength on exam 
OR Minimal muscle weak-
ness causing no or minimal 
interference with usual 
social & functional activities
Muscle weakness causing 
greater than minimal 
interference with usual social 
& functional activities
Muscle weakness causing 
inability to perform usual 
social & functional activities 
Disabling muscle weakness 
causing inability to perform 
basic self-care functions OR 
Respiratory muscle weakness 
impairing ventilation
Neurosensory Alteration 
(including paresthesia and 
painful neuropathy)
Asymptomatic with sensory 
alteration on exam or 
minimal paresthesia causing 
no or minimal interference 
with usual social &
functional activities 
Sensory alteration or 
paresthesia causing greater 
than minimal interference with 
usual social & functional 
activities 
Sensory alteration or 
paresthesia causing inability to 
perform usual social & 
functional activities
Disabling sensory alteration or 
paresthesia causing inability to 
perform basic self-care 
functions


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Amendment 1
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NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Seizure: (new onset) 
NA
1 seizure 
2–4 seizures 
Seizures of any kind that are 
prolonged, repetitive (eg, 
status epilepticus), or difficult 
to control (eg, refractory 
epilepsy)
Seizure: (pre-existing) 
For Worsening of Existing 
Epilepsy the Grades Should 
Be Based on an Increase 
from Previous Level of 
Control to Any of These 
Levels
NA
Increased frequency of pre-
existing seizures (non-
repetitive) without change in 
seizure character OR 
infrequent breakthrough 
seizures while on stable meds 
in a previously controlled 
seizure disorder
Change in seizure character 
from baseline either in 
duration or quality (eg, 
severity or focality) 
Seizures of any kind that are 
prolonged, repetitive (eg, 
status epilepticus), or difficult 
to control (eg, refractory 
epilepsy)
Seizure 
– Pediatric 18 Years
Seizure, generalized onset 
with or without secondary 
generalization, lasting 
< 5 minutes with < 24 hours 
post ictal state
Seizure, generalized onset 
with or without secondary 
generalization, lasting 5–20 
minutes with 
< 24 hours post ictal state
Seizure, generalized onset 
with or without secondary 
generalization, lasting 
> 20 minutes 
Seizure, generalized onset 
with or without secondary 
generalization, requiring 
intubation and sedation
Syncope (not associated 
with a procedure)
NA
Present
NA
NA
Vertigo
Vertigo causing no or 
minimal interference with 
usual social & functional 
activities
Vertigo causing greater than 
minimal interference with 
usual social & functional 
activities 
Vertigo causing inability to 
perform usual social & 
functional activities
Disabling vertigo causing 
inability to perform basic self-
care functions


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Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 100
31 July 2014
MUSCULOSKELETAL
Grade 1
Grade 2
Grade 3
Grade 4
Arthralgia
See also Arthritis
Joint pain causing no or 
minimal interference with 
usual social & functional 
activities
Joint pain causing greater than 
minimal interference with usual 
social & functional activities
Joint pain causing inability 
to perform usual social & 
functional activities
Disabling joint pain causing 
inability to perform basic self-
care functions
Arthritis
See also Arthralgia
Stiffness or joint swelling 
causing no or minimal 
interference with usual 
social & functional activities
Stiffness or joint swelling causing 
greater than minimal interference 
with usual social & functional 
activities
Stiffness or joint swelling 
causing inability to perform 
usual social & functional 
activities
Disabling joint stiffness or 
swelling causing inability to 
perform basic self-care 
functions
Bone Mineral Loss
BMD t-score or z-score
–2.5 to –1.0 
BMD t-score or z-score –2.5
Pathological fracture 
(including loss of vertebral 
height)
Pathologic fracture causing 
life-threatening consequences 
Pediatric 21 Years
BMD z-score 
–2.5 to –1.0
BMD z-score < –2.5
Pathological fracture 
(including loss of vertebral 
height)
Pathologic fracture causing 
life-threatening consequences 
Myalgia
(non-injection site)
Muscle pain causing no or 
minimal interference with 
usual social & functional 
activities
Muscle pain causing greater than 
minimal interference with usual 
social & functional activities
Muscle pain causing 
inability to perform usual 
social & functional activities
Disabling muscle pain causing 
inability to perform basic self-
care functions
Osteonecrosis
NA
Asymptomatic with radiographic 
findings AND No operative 
intervention indicated
Symptomatic bone pain with 
radiographic findings OR 
Operative intervention 
indicated
Disabling bone pain with 
radiographic findings causing 
inability to perform basic self-
care functions


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Amendment 1
CONFIDENTIAL
Page 101
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SYSTEMIC
Grade 1
Grade 2
Grade 3
Grade 4
Acute Systemic Allergic 
Reaction 
Localized urticaria 
(wheals) with no medical 
intervention indicated
Localized urticaria with medical 
intervention indicated OR Mild 
angioedema with no medical 
intervention indicated
Generalized urticaria OR 
Angioedema with medical 
intervention indicated OR 
Symptomatic mild 
bronchospasm
Acute anaphylaxis OR Life-
threatening bronchospasm OR 
laryngeal edema
Chills
Symptoms causing no or 
minimal interference with 
usual social & functional 
activities
Symptoms causing greater than 
minimal interference with usual 
social & functional activities 
Symptoms causing inability to 
perform usual social & 
functional activities
NA
Fatigue
Malaise
Symptoms causing no or 
minimal interference with 
usual social & functional 
activities
Symptoms causing greater than 
minimal interference with usual 
social & functional activities
Symptoms causing inability to 
perform usual social & 
functional activities
Incapacitating fatigue/malaise 
symptoms causing inability to 
perform basic self-care 
functions
Fever (nonaxillary)
37.7C to 38.6C
99.8F to 101.5F
38.7C to 39.3C
101.6F to 102.8F
39.4C to 40.5C
102.9F to 104.9F
40.5C 
104.9F
Pain- Indicate Body Site
See also Injection Site 
Pain, Headache, 
Arthralgia, and Myalgia
Pain causing no or 
minimal interference with 
usual social & functional 
activities
Pain causing greater than minimal 
interference with usual social & 
functional activities
Pain causing inability to 
perform usual social & 
functional activities
Disabling pain causing 
inability to perform basic self-
care functions OR 
Hospitalization (other than ER 
visit) indicated
Unintentional Weight 
Loss
NA
5% to 9% loss in body weight from 
baseline
10% to 19% loss in body 
weight from baseline
20% loss in body weight 
from baseline OR  Aggressive 
intervention indicated [eg, 
tube feeding or total parenteral 
nutrition]


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Amendment 1
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INJECTION SITE REACTION
Grade 1
Grade 2
Grade 3
Grade 4
Injection Site Pain (pain 
without touching)
Or Tenderness (pain when 
area is touched) 
Pain/tenderness causing no 
or minimal limitation of use 
of limb
Pain/tenderness limiting use of 
limb OR Pain/tenderness 
causing greater than minimal 
interference with usual social 
& functional activities
Pain/tenderness causing 
inability to perform usual 
social & functional activities
Pain/tenderness causing inability 
to perform basic self-care 
function OR Hospitalization 
(other than ER visit) indicated 
for management of 
pain/tenderness
Injection Site Reaction 
(Localized), 15 Years
Erythema OR Induration
of 5 5 cm to 9 9 cm (or 
2581 cm2)
Erythema OR Induration OR 
Edema 9 cm any diameter 
(or 81 cm2)
Ulceration OR Secondary 
infection OR Phlebitis OR 
Sterile abscess OR Drainage
Necrosis (involving dermis and 
deeper tissue)
Pediatric 15 Years
Erythema OR Induration 
OR Edema present but 
2.5 cm diameter
Erythema OR Induration 
OR Edema > 2.5 cm 
diameter but < 50% surface 
area of the extremity 
segment (eg, upper 
arm/thigh)
Erythema OR Induration 
OR Edema involving 
50% surface area of the 
extremity segment (eg, 
upper arm/thigh) OR 
Ulceration OR Secondary 
infection OR Phlebitis OR 
Sterile abscess OR 
Drainage
Necrosis (involving dermis and 
deeper tissue)
Pruritis Associated with 
Injection 
See also Skin: Pruritis 
(itching—no skin lesions)
Itching localized to injection 
site AND Relieved 
spontaneously or with 
48 h treatment 
Itching beyond the injection 
site but not generalized OR 
Itching localized to injection 
site requiring 48 h treatment 
Generalized itching causing 
inability to perform usual 
social & functional activities
NA


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
Page 103
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ENDOCRINE/METABOLIC
Grade 1
Grade 2
Grade 3
Grade 4
Lipodystrophy (eg, back 
of neck, breasts, 
abdomen)
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious 
changes on casual visual 
inspection
NA
Diabetes Mellitus
NA
New onset without need to initiate 
medication OR Modification of 
current meds to regain glucose 
control
New onset with initiation of 
indicated med OR Diabetes 
uncontrolled despite treatment 
modification
Life-threatening consequences 
(eg, ketoacidosis, 
hyperosmolar non-ketotic 
coma) 
Gynecomastia
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious on 
casual visual inspection
NA
Hyperthyroidism 
Asymptomatic
Symptomatic causing greater than 
minimal interference with usual 
social & functional activities OR 
Thyroid suppression therapy 
indicated
Symptoms causing inability to 
perform usual social & 
functional activities OR 
Uncontrolled despite treatment 
modification 
Life-threatening consequences 
(eg, thyroid storm)
Hypothyroidism
Asymptomatic
Symptomatic causing greater than 
minimal interference with usual 
social & functional activities OR 
Thyroid replacement therapy 
indicated
Symptoms causing inability to 
perform usual social & 
functional activities OR 
Uncontrolled despite treatment 
modification 
Life-threatening consequences 
(eg, myxedema coma)
Lipoatrophy (eg, fat loss 
from the face, extremities, 
buttocks)
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious on 
casual visual inspection
NA


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Gilead Sciences, Inc.
Amendment 1
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Page 104
31 July 2014
GENITOURINARY
Grade 1
Grade 2
Grade 3
Grade 4
Intermenstrual Bleeding 
(IMB)
Spotting observed by participant 
OR Minimal blood observed 
during clinical or colposcopic 
exam
Intermenstrual bleeding not 
greater in duration or amount 
than usual menstrual cycle
Intermenstrual bleeding greater 
in duration or amount than usual 
menstrual cycle
Hemorrhage with life-
threatening hypotension OR 
Operative intervention 
indicated
Urinary Tract 
obstruction (eg, stone)
NA
Signs or symptoms of urinary 
tract obstruction without 
hydronephrosis or renal 
dysfunction
Signs or symptoms of urinary 
tract obstruction with 
hydronephrosis or renal 
dysfunction
Obstruction causing life-
threatening consequences
INFECTION
Grade 1
Grade 2
Grade 3
Grade 4
Infection (any other 
than HIV infection)
Localized, no systemic antiμbial 
treatment indicated AND 
Symptoms causing no or 
minimal interference with usual 
social & functional activities
Systemic antiμbial treatment 
indicated OR Symptoms 
causing greater than minimal 
interference with usual social 
& functional activities
Systemic antiμbial treatment 
indicated AND Symptoms 
causing inability to perform 
usual social & functional 
activities OR Operative 
intervention (other than simple 
incision and drainage) indicated
Life-threatening 
consequences (eg, septic 
shock)
Basic Self-care Functions: Activities such as bathing, dressing, toileting, transfer/movement, continence, and feeding.
Usual Social & Functional Activities: Adaptive tasks and desirable activities, such as going to work, shopping, cooking, use of transportation, pursuing a hobby, etc.


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Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
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31 July 2014
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1) Pregnancy and Contraception Requirements for Males and Females of Childbearing 
Potential 
Pregnancy must be excluded before the start of treatment with study drug and prevented 
thereafter by reliable contraceptive methods. A urine or serum pregnancy test will be performed 
at the screening visit to ensure pregnant women are not included in the trial. Please refer to the 
latest version of the investigator’s brochure for additional information about the effects of 
GS 5806. 
2) Definition of Female of Childbearing Potential
For the purposes of this study, a female subject of childbearing potential is a nonmenopausal 
female who has not had a hysterectomy, bilateral oophorectomy, or medically documented 
ovarian failure. This definition includes a pubertal female who has not yet started menstruating. 
A woman who has had a tubal sterilization is considered to be of childbearing potential.
A female subject may be considered menopausal in either of the following conditions:

Surgical menopause: Appropriate medical documentation of prior complete bilateral 
oophorectomy (ie, surgical removal of the ovaries and occurring at the age at which the 
procedure was performed)

Spontaneous menopause: Permanent cessation of previously occurring menses as a result of 
ovarian failure with documentation of hormonal deficiency by a certified health care 
provider. The worldwide mean age of spontaneous menopause is 49.24 (SD 1.73) years

A hormonal deficiency should be properly documented in the case of suspected spontaneous 
menopause as follows:
— If age 54 years and with the absence of normal menses: serum follicle stimulating 
hormone (FSH) level elevated to within the postmenopausal range based on the 
laboratory reference range where the hormonal assay is performed
— If age <54 years and with the absence of normal menses: negative serum or urine human 
chorionic gonadotropin (hCG) with concurrently elevated serum FSH level in the 
postmenopausal range, depressed estradiol (E2) level in the postmenopausal range, and 
absent serum progesterone level, based on the laboratory reference ranges where the 
hormonal assays are performed
3) Contraceptive Requirements 
Female subjects of childbearing potential and male subjects who engage in intercourse must 
agree to utilize protocol specified methods of contraception from the screening/enrollment visit 
throughout the study period and for 30 days following the last dose of study drug. Female study 
subjects who are not heterosexually active must provide periodic confirmation of continued 


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Protocol GS-US-218-1502
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Gilead Sciences, Inc.
Amendment 1
CONFIDENTIAL
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31 July 2014
abstinence from heterosexual intercourse and regular pregnancy testing while taking GS-5806. 
The investigator will counsel subjects on the protocol specified method(s) for avoiding 
pregnancy in case the subject chooses to engage in heterosexual intercourse.
Protocol specified contraceptive methods are as follows: (1) a combination of one hormonal 
method and one barrier method; (2) two barrier methods where one method is the male condom; 
or (3) use of an intrauterine device (IUD) or tubal sterilization; see Appendix Table 1 below. 
Acceptable hormonal methods include injectable progesterone, progesterone implants, 
combination oral contraceptives, transdermal contraceptive patch, and vaginal ring. Acceptable 
barrier methods include diaphragm with spermicide, cervical cap with spermicide, and the male 
condom with spermicide. Female subjects must use either a hormonal method or a barrier 
method if the partner has a vasectomy and the male partner should be the sole partner for that 
subject. For a vasectomy, appropriate post-vasectomy documentation of the absence of sperm in 
the ejaculate must be available. If a subject has undergone tubal sterilization or has had a Copper 
T 380A IUD or LNg 20 IUD inserted, no other contraception is needed.  
If tubal sterilization is via the Essure procedure, verification of tubal blockage by 
hysterosalpingogram (HSP) must be performed approximately 3 months after microinsertion. 
Prior to verification, Essure is not considered a reliable form of contraception and the 
contraception methods described below must be used. Female subjects who utilize hormonal 
contraceptives as one of their birth control methods must have used the same method for at least 
3 months before study dosing.
Female subjects of childbearing potential must have a negative urine or serum pregnancy test at 
screening prior to receiving the first dose of study drug.
Appendix Table 1.
Protocol Specified Contraceptive Methods
Methods to Use by Themselves
Combination Methods
Hormone Methods
(choose one and use with a barrier 
method)
Barrier Methods
(use both OR choose one and use with 
a hormone method)
Intrauterine Devices (IUDs)

Copper T 380A IUD

LNg 20 IUD
Tubal Sterilization
Estrogen and Progesterone

Oral contraceptives

Transdermal patch

Vaginal ring
Progesterone

Injection

Implant

Diaphragm with spermicide
OR

Cervical cap with spermicide

Male condom (with spermicide)
Partner’s vasectomy must be used with a hormone or barrier method and the 
male partner should be the sole partner for that subject. For a vasectomy, 
appropriate post-vasectomy documentation of the absence of sperm in the 
ejaculate must be available.


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Amendment 1
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The investigator will counsel all subjects on the most effective method(s) for avoiding pregnancy 
during the study.
4) Additional Requirements for Male Subjects
Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm 
donation while enrolled in the study and for at least 30 days after administration of the last dose 
of study medication
Use of condoms, with spermicide, has been proven to decrease the risk of transmission of HIV 
and other sexually transmitted diseases. The use of spermicide is not recommended if the subject 
or subject’s partner is infected with HIV.
5) Procedures to be Followed in the Event of Pregnancy
Subjects will be instructed to notify the investigator if they become pregnant at any time during 
the study, or if they become pregnant within 30 days or 4 weeks of last study drug dose. Subjects 
who become pregnant or who suspect that they are pregnant during the study must report the 
information to the investigator and discontinue study drug immediately. Subjects whose partner 
has become pregnant or suspects she is pregnant during the study must report the information to 
the investigator. 
Instructions for reporting pregnancy, partner pregnancy, and pregnancy outcome are outlined in 
Section 7.7.2.1.

Prot_010.pdf: 
Study Title: 
Sponsor: 
IND Number: 
EudraCT Number: 
Clinical Trials.gov 
Identifier: 
Indication: 
Protocol ID: 
Clinical Program 
Manager: 
Gilead Medical Monitor: 
Protocol Version/Date: 
(rJ GILEAU 
CLINICAL STUDY PROTOCOL 
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled 
Multi-Center Study Evaluating Antiviral Effects, 
Phrumacokinetics, Safety, and Tolerability ofGS-5806 in 
Hematopoietic Cell Transplant (HCT) Recipients with Respirat01y 
Syncytial Vims (RSV) Infection of the Lower Respirat01y Tract 
Gilead Sciences, Inc. 
199 E Blaine St. 
Seattle, W A 98102 
114498 
2014-002475-29 
TBD 
Respirat01y Syncytial Vims (RSV) 
GS-US-218-1502 
Name: 
Telephone: 
Fax: 
Name: 
Telephone: 
Fax: 
Mobile: 
Original 
Amendment 1 
Amendment2 
PPD 
PPD 
PPD 
Seth Toback, MD 
PPD 
PPD 
PPD 
09 Jlme 2014 
31 July 2014 
22 September 2014 
CONFIDENTIALITY STATEMENT 
The inf01mation contained in this document, pruiiculru·ly unpublished data, is the prope1iy or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable Institutional 
Review Board or Independent Ethics Committee. The infonnation is only to be used by you in 
connection with authorized clinical studies of the investigational dmg described in the protocol. 
You will not disclose any of the infonnation to others without written authorization from 
Gilead Sciences, Inc., except to the extent necessruy to obtain infonned consent from those 
persons to whom the dmg may be administered. 


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TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................................................2
LIST OF IN-TEXT TABLES........................................................................................................................................4
PROTOCOL SYNOPSIS ..............................................................................................................................................5
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS....................................................................17
1.
INTRODUCTION ..............................................................................................................................................21
1.1.
Background ............................................................................................................................................21
1.2.
GS-5806 .................................................................................................................................................22
1.2.1.
General Information .............................................................................................................22
1.2.2.
Nonclinical Pharmacokinetics..............................................................................................23
1.2.3.
Nonclinical Pharmacology and Toxicology .........................................................................23
1.2.4.
Clinical Trials of GS-5806 ...................................................................................................25
1.3.
Rationale for This Study ........................................................................................................................28
1.4.
Dose Rationale .......................................................................................................................................29
1.5.
Compliance ............................................................................................................................................29
2.
OBJECTIVES.....................................................................................................................................................30
3.
STUDY DESIGN................................................................................................................................................31
3.1.
Endpoints ...............................................................................................................................................31
3.2.
Study Design..........................................................................................................................................32
3.3.
Study Treatments ...................................................................................................................................32
3.4.
Duration of Treatment............................................................................................................................33
3.5.
Discontinuation Criteria.........................................................................................................................33
3.6.
Source Data............................................................................................................................................33
4.
SUBJECT POPULATION..................................................................................................................................35
4.1.
Number of Subjects and Subject Selection ............................................................................................35
4.2.
Inclusion Criteria....................................................................................................................................35
4.3.
Exclusion Criteria...................................................................................................................................36
5.
INVESTIGATIONAL MEDICINAL PRODUCTS ...........................................................................................38
5.1.
Randomization, Blinding and Treatment Codes ....................................................................................38
5.1.1.
Procedures for Breaking Treatment Codes...........................................................................38
5.2.
Description and Handling of GS-5806...................................................................................................39
5.2.1.
Formulation..........................................................................................................................39
5.2.2.
Packaging and Labeling .......................................................................................................39
5.2.3.
Storage and Handling...........................................................................................................39
5.3.
Dosage and Administration of GS-5806 ................................................................................................39
5.4.
Prior and Concomitant Medications.......................................................................................................40
5.5.
Accountability for GS-5806...................................................................................................................41
5.5.1.
Investigational Medicinal Product Return or Disposal.........................................................41
6.
STUDY PROCEDURES ....................................................................................................................................42
6.1.
Subject Enrollment and Treatment Assignment.....................................................................................42
6.1.1.
Visit 1: Screening Visit (Days -2 to -1)................................................................................42
6.1.2.
Visit 2: Baseline Assessments, Randomization, and Treatment 
Assessments (Day 1)............................................................................................................43
6.2.
Visit 3: Day 3 (± 24 hours).....................................................................................................................45
6.3.
Visit 4: Day 5 (± 24 hours).....................................................................................................................45


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6.4.
Visit 5: Day 7 (± 24 hours).....................................................................................................................46
6.5.
Visits 6-8: Days 9, 13, and 17 (± 24 hours)............................................................................................46
6.6.
Visit 9: Day 22 (± 24 hours)...................................................................................................................47
6.7.
Visit 10: End of Study/Day 28 (+ 3 days)..............................................................................................48
6.8.
Visits 11 – 14*: Day 35, 42, 49, and 56 (± 48 hours).............................................................................48
6.9.
Assessments for Premature Discontinuation from IMP dosing and Early Withdrawal..........................49
6.9.1.
Assessments for Premature Discontinuation from IMP Administration ..............................49
6.9.2.
Assessments for Early Termination/Withdrawal..................................................................49
6.10.
Assessments for Unscheduled Visits......................................................................................................49
6.11.
Study Assessments.................................................................................................................................50
6.11.1.
Nasal Samples, Virology, and Antibody Titer .....................................................................50
6.11.2.
Virology and Resistance Monitoring....................................................................................50
6.11.3.
Vital Signs............................................................................................................................51
6.11.4.
Oxygen Saturation................................................................................................................51
6.11.5.
Plasma PK ............................................................................................................................51
6.11.6.
Safety Labs...........................................................................................................................52
6.11.7.
Chest X-ray ..........................................................................................................................52
6.11.8.
Optional Extended Viral Monitoring....................................................................................52
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT...............................................................................53
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events.................................53
7.1.1.
Adverse Events.....................................................................................................................53
7.1.2.
Serious Adverse Events........................................................................................................53
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events .........................................................................54
7.2.
Assessment of Adverse Events and Serious Adverse Events.................................................................55
7.2.1.
Assessment of Causality for IMP and Procedures................................................................55
7.2.2.
Assessment of Severity ........................................................................................................55
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events and Serious 
Adverse Events to Gilead.......................................................................................................................55
7.4.
Gilead Reporting Requirements.............................................................................................................57
7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events..........................................................................................................................58
7.6.
Toxicity Management ............................................................................................................................58
7.7.
Special Situations Reports......................................................................................................................58
7.7.1.
Definitions of Special Situations..........................................................................................58
7.7.2.
Instructions for Reporting Special Situations.......................................................................59
8.
STATISTICAL CONSIDERATIONS................................................................................................................61
8.1.
Analysis Objectives and Endpoints........................................................................................................61
8.1.1.
Analysis Objectives..............................................................................................................61
8.1.2.
Primary Endpoint .................................................................................................................61
8.1.3.
Secondary Endpoint .............................................................................................................61
8.1.4.
Other Endpoints of Interest ..................................................................................................61
8.2.
Analysis Conventions.............................................................................................................................62
8.2.1.
Analysis Sets ........................................................................................................................62
8.3.
Data Handling Conventions ...................................................................................................................63
8.4.
Demographic Data and Baseline Characteristics ...................................................................................63
8.5.
Efficacy Analysis ...................................................................................................................................63
8.5.1.
Primary Analysis..................................................................................................................63
8.5.2.
Secondary Analyses .............................................................................................................64
8.5.3.
Exploratory Analyses ...........................................................................................................64
8.6.
Safety Analysis.......................................................................................................................................65
8.7.
Extent of Exposure.................................................................................................................................65


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8.7.1.
Adverse Events.....................................................................................................................65
8.7.2.
Laboratory Evaluations ........................................................................................................65
8.7.3.
Other Safety Evaluations......................................................................................................66
8.8.
Pharmacokinetic Analysis......................................................................................................................66
8.9.
Sample Size............................................................................................................................................66
8.10.
Data Monitoring Committee ..................................................................................................................66
9.
RESPONSIBILITIES..........................................................................................................................................67
9.1.
Investigator Responsibilities ..................................................................................................................67
9.1.1.
Good Clinical Practice..........................................................................................................67
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval...........................................................................................................67
9.1.3.
Informed Consent.................................................................................................................67
9.1.4.
Confidentiality......................................................................................................................68
9.1.5.
Study Files and Retention of Records ..................................................................................68
9.1.6.
Case Report Forms...............................................................................................................69
9.1.7.
Data Quality Control and Quality Assurance.......................................................................70
9.1.8.
Investigational Medicinal Product Accountability and Return.............................................70
9.1.9.
Inspections............................................................................................................................71
9.1.10.
Protocol Compliance............................................................................................................71
9.2.
Sponsor Responsibilities ........................................................................................................................71
9.2.1.
Protocol Modifications.........................................................................................................71
9.2.2.
Study Report and Publications .............................................................................................71
9.3.
Joint Investigator/Sponsor Responsibilities ...........................................................................................72
9.3.1.
Payment Reporting...............................................................................................................72
9.3.2.
Access to Information for Monitoring..................................................................................72
9.3.3.
Access to Information for Auditing or Inspections ..............................................................72
9.3.4.
Study Discontinuation..........................................................................................................72
10.
REFERENCES ...................................................................................................................................................73
11.
APPENDICES ....................................................................................................................................................76
Appendix 1.
Investigator Signature Page....................................................................................................77
Appendix 2.
Study Procedures Table..........................................................................................................78
Appendix 3.
Management of Clinical and Laboratory Adverse Events......................................................81
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities...............82
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements.................................................................................................105
LIST OF IN-TEXT TABLES
Table 6-1.
PK Timepoints........................................................................................................................52


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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
199 E Blaine St.
Seattle, WA 98102
Study Title: 
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled 
Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, 
Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant 
(HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection 
of the Lower Respiratory Tract
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
114498
2014-002475-29
TBD
Study Centers 
Planned:
Approximately 30 centers in Asia Pacific, Australia, Canada, Europe, 
South America, and the United States
Objectives:
The primary objective of this study is as follows:

To evaluate the effect of GS-5806 on RSV viral load in 
autologous or allogeneic HCT recipients with an acute RSV lower 
respiratory tract infection (LRTI)
The secondary objectives of this study are as follows: 

To evaluate the effect of GS-5806 on rates of respiratory failure
and all-cause mortality

To evaluate the pharmacokinetics (PK), safety, and tolerability of 
GS-5806
Study Design:
Randomized, double-blind, placebo-controlled study evaluating the 
effect of GS-5806 on efficacy, PK, safety, and tolerability in HCT 
recipients with RSV LRTI.  
All subjects will be permitted to receive the standard of care therapy 
for RSV infection per their local medical practices, in addition to the
investigational medicinal product (IMP).


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Subjects will be randomized in a 1:1 ratio to receive IMP 
(GS-5806 or placebo) and will be stratified by 2 criteria: 
1. Supplemental O2 requirement (≤ 2 L/min or > 2 L/min) at the time 
of randomization
2. Treatment of current RSV infection (yes or no) with ribavirin 
(oral, intravenous, or aerosolized)
Number of Subjects 
Planned:
Approximately 60 RSV-positive subjects
Target Population:
Males and females 18 to 75 years of age who have had an allogeneic 
or autologous HCT and have documented RSV LRTI 
Duration of 
Treatment:
5 doses over 17 days
Diagnosis and
Eligibility Criteria:
For a complete list of study inclusion and exclusion criteria, please 
refer to Section 4.2.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria at the time 
of randomization to be eligible for participation in this study:
1. Received an autologous or allogeneic HCT using any 
conditioning regimen
2. Evidence of new abnormalities on chest X-ray obtained 
< 48 hours prior to Screening, determined to be consistent with 
LRTI by the local radiologist, relative to the most recent previous 
chest X-ray.  If chest X-ray is not available, a chest X-ray must be 
obtained for Screening
3. Documented RSV in both the upper (eg, nasal swab, 
nasopharyngeal swab, nasal wash) and lower (eg, induced 
sputum, bronchoalveolar lavage [BAL], lung biopsy) respiratory 
tract as determined by local testing (eg, polymerase chain reaction 
[PCR], direct fluorescence antibody [DFA], respiratory viral 
panel [RVP] assay, or culture).  All samples must have been 
collected ≤6 days prior to Day 1
4. An informed consent document signed and dated by the subject or 
a legal guardian of the subject and investigator or his/her designee


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5. A negative urine or serum pregnancy test is required for female 
subjects (unless surgically sterile or greater than two years 
post-menopausal)
6. Male and female subjects of childbearing potential must agree to
contraceptive requirements as described in Appendix 5
7. Willingness to complete necessary study procedures and have 
available a working telephone or email
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to 
be enrolled in this study.
Related to concomitant or previous medication use:
1. Use of non-marketed (according to region) investigational agents 
within 30 days, OR use of any monoclonal anti-RSV antibodies 
within 4 months or 5 half-lives of screening, whichever is longer, 
OR use of any investigational RSV vaccines after HCT
2. Use of a strong cytochrome P450 enzyme (CYP) inducer 
including but not limited to rifampin, St. John’s Wort, 
carbamazepine, and phenytoin, within 2 weeks prior to the 
first dose of IMP
Related to medical history:
1. Pregnant, breastfeeding, or lactating females 
2. Unable to tolerate nasal sampling required for this study, as 
determined by the investigator
3. Known history of HIV/AIDS with a CD4 count < 200 cells/μL
within the last month
4. History of drug and/or alcohol abuse that, in the opinion of the 
investigator, may prevent adherence to study activities
Related to medical conditions:
1. Requiring invasive mechanical ventilation at the time of 
randomization
2. A relapse (including molecular relapse) of their underlying 
disease for which they received a transplant at Screening


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3. Documented to be positive for other respiratory viruses (limited to 
influenza, parainfluenza, human rhinovirus, adenovirus, or human 
metapneumovirus), from the lower respiratory tract sample as 
determined by local testing  
4. Clinically significant bacteremia or fungemia within 7 days prior 
to Screening that has not been adequately treated, as determined 
by the investigator
5. Clinically significant bacterial, fungal, or viral pneumonia within 
2 weeks prior to Screening that has not been adequately treated, as 
determined by the investigator
6. Excessive nausea/vomiting at screening, as determined by the 
investigator, or an inability to swallow pills that precludes oral 
administration of the IMP
7. Any condition which, in the opinion of the investigator, would 
prevent full participation in this trial or would interfere with the 
evaluation of the trial endpoints
Related to allergies:
1. Known hypersensitivity or allergy to the IMP, its metabolites, or 
formulation excipients (microcrystalline cellulose, mannitol, 
croscarmellose sodium, magnesium stearate, polyvinyl alcohol, 
titanium dioxide, polyethylene glycol and talc)
2. Allergy to sulfa drugs 
Related to laboratory results:
1. Creatinine clearance < 30 mL/min (calculated using the 
Cockcroft-Gault method)
2. AST/ALT > 3x ULN
3. Total bilirubin > 3x ULN
Study Procedures/
Frequency:
For a complete overview of study procedures and visits, please refer 
to Section 6 and Appendix 2.
Study Procedures
Vital signs (VS): Vital signs will be measured at Visits 1, 2, 4, 6, 7, 
8, 9, and 10 (Days -2 to -1, 1, 5, 9, 13, 17, 22, and 28), and will
include body temperature, heart rate, respiratory rate, and blood 
pressure. 
O2 saturation: O2 saturation will be recorded at Visits 1, 2, 4, 6, 7, 8, 
9, and 10 (Days -2 to -1, 1, 5, 9, 13, 17, 22, and 28), while breathing 
room air, even if the subject is dependent on supplemental O2. Refer 
to Section 6.11.4 for procedure instructions.


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Laboratory tests: When available, existing laborat01y values 
:::; 6 days prior to Screening (Visit 1) may be used for eligibility 
assessment. Study staff will perfonn urine or senun pregnancy tests 
on site at Screening and at each dosing visit (Visits 2, 4, 6, 7, and 8) 
prior to administration of IMP (as necessaty). Blood specimens for 
safety at Visits 2, 4, 6, 7, 8, 9, and 10 (Days 1, 5, 9, 13, 17, 22, 
and 28), RSV vireinia evaluation (using quantitative real time 
polymerase chain reaction [RT-qPCR]) at Visits 2, 4, 6, 7, 8, 9, and 
10 (Days 1, 5, 9, 13, 17, 22, and 28), and sennn antibody titers to 
RSV at Visits 2 and 10 (Days 1 and 28) will be collected prior to 
dosing. A blood specimen for senun creatinine will be collected 
4 hours post-dose at Visit 2 (Day 1). For hospitalized subjects only, 
additional blood specimens for senun creatinine will be collected on 
Days 2, 3, and 4 (24, 48, and 72 hours [±3 hours] post-fu·st GS-5806 
dose). 
PK blood draws: PK samples will be collected from all subjects at 
the following time points: 4 hours post-dose at Visit 2 (Day 1), 
pre-dose at Visits 4, 6, 7 and 8 (Days 5, 9, 13, and 17), and anytime at 
Visit 9 (Day 22). For hospitalized subjects only, an additional PK 
sample will be collected from hospitalized subjects at Visit 3 (Day 3, 
48 hours [±3 hours] post-first GS-5806 dose) . 
....G.~=~;;.;;
li~
ng: Nasal sampling will be j)erfonned at all study visits 
wttli tlie exception of tlie Screening 
~~~~~--~---~·--~~~ 
visit (Visit 1 ), and stored and shipped to a centrallaborat01y for 
testing according to specifications in the study procedures manual. 
All samples must be collected prior to dosing. Two nasal samples will 
be obtained, 1 from each nostril, each time nasal sampling is 
perf01med. Nasal samples will be used for RSV sequencing to 
evaluate development of resistance and a multiplex assay to identify 
co-infections. 
Induced sputum: If an induced sputum was not used to demonstrate 
RSV in the lower respirat01y tract at Screening (ie, another lower 
respirat01y tract sample such as BAL was used), an induced sputum 
will be obtained on Day 1 prior to dosing. This sample will be 
analyzed at a centrallaborat01y using RT-qPCR to detetmine RSV 
viral load and a multiplex assay to identify any viral co-infections. 
RSV testing: RSV present in both the upper and lower respirat01y 
tract samples as detennined by local testing (eg, PCR, DFA, RVP 
assay, or culture) must be documented prior to Screening. All RSV 
samples (from upper and lower respirat01y tract) used for Screening 
Page9 
22 September 2014 


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CONFIDENTIAL 
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Amendment2 
must have been collected :::; 6 days prior to Day 1. For all study 
related nasal samples, one of the nasal samples collected at each study 
visit will be analyzed at a central laborat01y using RT -qPCR to 
detennine RSV viral load. 
0 tional Extended Viral Monitoring: 
PO 
Study Visits 
Visit 1: Screening (Day -2 to -1) 
This visit must be perf01med in the hospital or clinic. The following 
Screening procedures/labs are required: 
• 
Obtain written inf01med consent 
• 
Collection of medical hist01y and demographics 
• 
Review of concomitant medications 
• 
VS, including 0 2 saturation 
• 
Height and weight 
• 
Chest X-ray (chest X-rays obtained < 48 hours prior to Screening 
maybe used) 
• 
Blood draw for Screening labs for locallaborat01y analyses, 
unless existing laborat01y values collected :::; 6 days prior to 
Screening can be obtained for review 
• 
Urine or senun pregnancy test in women unable to confi1m 
menopause, hysterectomy, and/or bilateral oophorectomy 
• 
Review of any adverse events (AEs) occmTing after signing of the 
consent fonn 
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22 September 2014 


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Visit 2: Baseline Assessments, Randomization, and IMP 
Administration (Day 1) 
If the subject meets all eligibility criteria, Visits 1 and 2 may occur on 
the same day. The IMP must be administered under supervision by 
the study staff. Visit 2 must occur in the hospital or clinic.  Visit 2 
assessments should be performed in the following order:

VS, including O2 saturation

Weight

Blood draw (for safety labs, serum antibody titer to RSV, and 
RSV viremia)

Obtain 2 nasal samples 

Urine or serum pregnancy test in women unable to confirm 
menopause, hysterectomy, and/or bilateral oophorectomy

Obtain induced sputum (unless induced sputum was used to 
demonstrate the presence of RSV ≤6 days prior to Day 1).  

Randomization via IXRS

IMP administration 

Blood draw at 4 hours post-dose for PK and serum creatinine

Assessment of AEs and concomitant medications

For hospitalized subjects only: blood draw at 24 (Day 2) and 
72 (Day 4) hours (±3 hours) post-first GS-5806 dose for serum 
creatinine
Visit 3: Day 3 (± 24 hours)
This visit may be performed in the hospital, clinic, or at home.

For all subjects: obtain 2 nasal samples

For hospitalized subjects only: blood draw at 48 hours (±3 hours) 
post-first GS-5806 dose for PK and serum creatinine
Visit 4:  Day 5 (± 24 hours) 
This visit must be performed in the hospital or clinic, and should be 
performed in the following order :

VS, including O2 saturation

Weight

PK blood draw: pre-dose


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
Blood draw (for safety labs and RSV viremia)

Obtain 2 nasal samples 

Urine or serum pregnancy test in women unable to confirm 
menopause, hysterectomy, and/or bilateral oophorectomy

IMP administration

Assessment of AEs, concomitant medications, re-hospitalizations, 
admission to intensive care unit (ICU) or utilization of ICU care, 
mechanical ventilation (invasive and non-invasive of any 
duration), and supplemental O2 use ( ≥ 2 L/min)
Visit 5: Day 7 (± 24 hours)
This visit may be performed in the hospital, clinic, or at home.

Obtain 2 nasal samples 
Visits 6 – 8:  Days 9, 13, and 17 (± 24 hours)
These visits must be performed in the hospital or clinic. Visits 6-8 
assessments should be performed in the following order:

VS, including O2 saturation

Weight

PK blood draw: pre-dose 

Blood draw (for safety labs and RSV viremia)

Obtain 2 nasal samples 

Urine or serum pregnancy test in women unable to confirm 
menopause, hysterectomy, and/or bilateral oophorectomy

IMP administration 

Assessment of AEs, concomitant medications, re-hospitalizations,
admission to ICU or utilization of ICU care, mechanical 
ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use ( ≥2 L/min)
Visit 9 and 10: Day 22 (± 24 hours) and End of Study/Day 28
(+ 3 days)
These visits must be performed in the hospital or clinic. Visit 10 may 
occur no earlier than Day 28 and no later than Day 31. Visit 9 and 
10 assessments should be performed in the following order:

VS, including O2 saturation 

Weight


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Protocol GS-US-218-1502 
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Gilead Sciences, Inc. 
Amendment 2 
Test Product, Dose, 
and Mode of 
Administration: 
Reference Therapy, 
Dose, and Mode of 
Administration: 
CONFIDENTIAL 
• 
PK blood draw (Day 22 only) 
• 
Blood draw for safety labs, for senun antibody titer to RSV 
(Day 28 only), and for RSV viremia 
• 
Obtain 2 nasal samples 
• 
Obtain sample for local RSV testing* (Day 22 only) (refer to 
Section 6.11.8) 
• 
Assessment of AEs and concomitant medications, 
re-hospitalizations, admission to ICU or utilization of ICU care, 
mechanical ventilation (invasive and non-invasive of any 
duration), and supplemental 0 2 use (:::: 2 Llmin) 
* PPD 
Visits 11-14*: Day 35, 42, 49, and 56(± 48 hours) 
Visits 11- 14 assessments may be perf01med in the hospital, clinic, 
or at home. 
• 
Obtain 2 nasal samples 
• 
Assessment of procedure-related AEs 
PPD 
200 mg GS-5806 (four 50 mg tablets) administered orally on Study 
Days 1, 5, 9, 13, and 17 
The IMP must be administered after the subject has been fasting 
(with exception of clear liquids and medications) for at least 2 hours. 
The subject will remain in a fasting condition for approximately 
1 hour after dosing. The entire dose must be taken within 1 hour. 
Tablets are not to be cmshed, split, dissolved, or chewed. The subject 
should be observed for 30 minutes after IMP adminisu·ation. If 
vomiting occurs within the 30 minutes observation period and 
undissolved tablets are present in the vomitus, the subject may 
receive a second dose. If a second dose is given, the subject should be 
observed for an additional 30 minutes. Subjects should avoid direct 
ulu·aviolet (UV) exposure for 8 days after receiving IMP. 
Placebo to Match tablets administered orally. Adminisu·ation is the 
same as for GS-5806. 
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Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
Criteria for 
Evaluation: 
Safety: 
Efficacy: 
CONFIDENTIAL 
Final 
Amendment2 
Safety will be assessed by the reporting of AEs and serious adverse 
events (SAEs) throughout the study, clinicallaborat01y tests, and VS 
at various time points during the study. 
The primmy endpoint is the time-weighted average change in nasal 
RSV viral load (log10 copies/mL) from Baseline (Day 1) to Day 9 as 
measured by R T -qPCR. 
The key secondmy endpoints are: 
• 
Prop01tion of subjects developing respirat01y failure (of any 
cause) requiring mechanical ventilation (invasive or noninvasive) 
through Day 28 
• 
Prop01tion of all-cause m01tality among subjects through Day 28 
The explorat01y endpoints are: 
IT 
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 
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Statistical Methods: 
CONFIDENTIAL 
IT 
I 
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Final 
Amendment2 
The full analysis set (F AS) will include subjects who have an RSV 
log10 viral load greater than or equal to the LLOQ of the RT-qPCR 
assay in the pre-dose Day 1 nasal sample, as detennined by R T -qPCR 
at the central lab, and have received at least 1 full dose ofiMP. 
The primruy efficacy analysis of time-weighted average change in 
RSV log10 viral load from Day 1 through Day 9 will be perfonned on 
subjects included in the FAS. To test the null hypothesis that there is 
no difference between the GS-5806 and placebo u·eatment groups in 
the time-weighted average change in RSV viral load, a parameu·ic 
analysis of covru·iance (ANCOV A) model with conesponding 
Baseline RSV viral load as a covru·iate will be used, with a 2-sided 
0.05 level. Adjusted means and 95% confidence intervals (Cis) will 
also be presented. 
The F AS analysis set will be used for all smnmru·ies and analyses of 
secondruy endpoints. All secondruy and other endpoints will be 
analyzed using 2-sided tests for u·eatment differences. The prop01iion 
of subjects who develop respirat01y failure requiring mechanical 
ventilation and the prop01iion of subjects with all-cause m01iality will 
be analyzed using Fisher's exact tests. 
PD 
All endpoints will be sUIIllnru·ized using descriptive statistics 
(sample size, mean, standard deviation [SD], median, Q1, Q3, 
minimum, and maximum) for continuous data and by the number and 
percent of subjects for categorical data. 
Safety analyses will be perf01med on all subjects who received at 
least one dose of IMP. Safety data will be collected and smnmarized 
from screening through Day 28. Safety data will be listed by subject 
and smnmarized by u·eatment (active or placebo) using the number 
(percent) of subjects with events/abnonnalities for categorical data 
and using descriptive statistics for continuous data. 
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Concentrations of GS-5806 in plasma will be determined using a 
validated bioanalytical assay(s). Individual subject GS-5806 
concentration-time data will be displayed using scheduled sampling 
times. Descriptive statistics (eg, n, mean, standard deviation, %CV, 
median, and range) will be calculated for each sampling time. 
Pharmacokinetic/pharmacodynamic (PK/PD) relationship may be 
explored as appropriate.
Sample size calculations are based on results observed in a study that 
evaluated the efficacy of oral and aerosolized ribavirin treatment for 
preventing progression from upper to lower respiratory tract infection 
in hematopoietic cell transplant recipients with RSV infections
(unpublished data from Dr. 
).  The sample size 
calculation assumes the time-weighted average change in RSV log10
viral load from Day 1 to Day 9 in the placebo group will 
be -1.5 log10 copies/mL with a corresponding standard deviation (SD) 
of 1.75 and that 85% of the subjects will be evaluable.  Based on 
these assumptions, with 25 subjects per group there is approximately
85% power to detect a 1.5 log difference in time-weighted average
change in log10 viral load treatment groups using a 2-sided 0.05-level 
test.  Given an evaluable rate of 85%, a total of 60 subjects will need 
to be randomized into the study.
All safety data will be monitored by a Data Monitoring Committee 
(DMC). 
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) 
including archiving of essential documents.
PPD


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
C 
degrees Celsius
F
degrees Fahrenheit
AE
adverse event
AhR
aryl hydrocarbon
AIDS
auto-immune deficiency syndrome
ALT
alanine aminotransferase
ANC
absolute neutrophil count
ANCOVA
analysis of covariance
ANOVA
analysis of variance
AST
aspartate aminotransferase
AUC
area under the plasma/serum/peripheral blood mononuclear cell concentration 
versus time curve
BAL
bronchoalveolar lavage
BCRP
breast cancer resistance protein
BID
twice a day 
BMI
body mass index
BUN
blood urea nitrogen
CBC
complete blood count
CCM
cell culture medium
CI
confidence interval
Cmax
the maximum observed serum/plasma/peripheral blood mononuclear (PBMC) 
concentration of drug
CRF
case report form(s)
CRO
contract (or clinical) research organization 
CSR
clinical study report
CT
computerized tomography
CYPxx
cytochrome P450 enzyme xx
DAVG
time-weighted average change
DDI
drug-drug interactions
DFA
direct fluorescence antibody
DMC
Data Monitoring Committee
DSPH
Drug Safety and Public Health
EC
ethics committee
EC50
concentration of drug to reach 50% inhibition of virus replication
ECG
electrocardiogram
eCRF
electronic case report form(s)
EDC
electronic data capture
ELF
epithelial lining fluid
EMR
electronic medical records


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
EudraCT
European clinical trials database
FAS
full analysis set
FIH
First in human
FDA
(United States) Food and Drug Administration
GCP
Good Clinical Practice (Guidelines)
GD 
gestational day
GI
gastrointestinal
GLP
good laboratory practice
GSI
Gilead Sciences, Inc.
hr
hour
HCT
Hematopoietic Cell Transplant
HDPE
high-density polyethylene
hERG
human ether-à-go-go-related gene
HIV
human immunodeficiency virus
HLGT
high level group term
HLT
high level term 
HSP
hysterosalpingogram
IB
investigator’s brochure
IC50
concentration of drug to reach 50% inhibition
ICH
International Conference on Harmonisation
ICU
Intensive Care Unit
IEC
independent ethics committee
IMP
Investigational Medicinal Product
IND
Investigational New Drug (Application)
IRB
institutional review board
IUD
intrauterine device
IVIG
Intravenous Immunoglobulin
IXRS
interactive voice/web response system
kg
kilogram
LLN
lower limit of the normal range
LLOQ
lower limit of quantification
LLT
lower level term
LRTI
lower respiratory tract infection
MedDRA
Medical Dictionary for Regulatory Activities
mg
milligram
min
minute
mL
milliliter
mmHg
millimeters mercury
MMRM
mixed-effect model repeated measures
NA
not applicable
ND
not detectable


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
nM
nanomolar
NOAEL
no-observed-adverse-effect level
NOEL
no-observed-effect level
O2
oxygen
OATP
organic anion transporter proteins
PD
Pharmacodynamic
PFUe
plaque forming unit equivalents
Pgp
P glycoprotein
PK
pharmacokinetic
PO
oral administration (per os, by mouth)
PR
the interval between the beginning of the P wave and the beginning of the QRS 
complex on ECG
PT
preferred term
PXR
pregnane x receptor
Q1
first quartile
Q3
third quartile
QA
quality assurance
QRS
part of electrocardiographic wave representing ventricular depolarization
QT
interval between the start of the Q wave and the end of the T wave on ECG
QTc
corrected QT
QTcF
QT interval corrected for heart rate using the Fridericia formula
RNA
ribonucleic acid
ROW
rest of world
RSV
respiratory syncytial virus
RT-qPCR
quantitative real time polymerase chain reaction
SAE
serious adverse event
SAP
Statistical Analysis Plan
SD
standard deviation
SOC
system organ class
SOP
standard operating procedure
SpO2
oxygen saturation
SUSAR
Suspected Unexpected Serious Adverse Reaction
TBD
to be determined
tmax
the time (observed time point) of Cmax
t½
an estimate of the terminal elimination half-life of the drug in 
serum/plasma/PBMC, calculated by dividing the natural log of 2 by the terminal 
elimination rate constant (λz)
UV
ultraviolet
µL
microliter
ULN
upper limit of the normal range
URTI
upper respiratory tract infection


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
US
United States
RVP
respiratory viral panel
VS
vital signs
Vss
apparent volume of distribution at steady state
v/v
volume/volume
WBC
white blood cell count


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1.
INTRODUCTION
1.1.
Background
Respiratory syncytial virus (RSV), a member of the family Paramyxoviridae, is an enveloped 
virus with a negative single-strand ribonucleic acid (RNA) genome. The RSV genome encodes 
for 11 proteins, including 3 surface glycoproteins (F, G, and SH) and several proteins that 
comprise the viral RNA polymerase complex (N, P, L, and M2-1). Two major antigenic 
subgroups of RSV are known, RSV A and RSV B, that differ primarily in the genetic sequence 
of the G glycoprotein while maintaining a higher degree of homology across other parts of the 
genome. Both subgroups show comparable pathogenicity and can co-circulate in the same 
community during a seasonal epidemic, but their individual prevalence usually varies from 
season to season.
RSV infection is the most common cause of admissions to pediatric general inpatient units in the 
United States (US) and Western Europe {20222}. Unfortunately, the rate of hospitalization 
among RSV-infected children has remained unchanged in the US over the last decade. From 
1997 to 2006, RSV-coded hospitalizations accounted for 24% of an estimated 5.5 million lower 
respiratory tract infection (LRTI) hospitalizations among children < 5 years of age. During this 
period, it was estimated that approximately 172,000 hospitalizations each year were caused by 
RSV infection among children < 5 years of age; approximately 73% of these hospitalizations 
occur among children < 12 months of age {20227}.
RSV infection is also a cause of respiratory disease in the adult population.  Adult recipients of 
autologous or allogeneic hematopoietic cell transplants (HCT) are at high risk for RSV infection 
related morbidity and mortality.  Based upon retrospective epidemiologic data, 2-17% of HCT 
recipients will develop RSV infection of the respiratory tract {28652} {26908} {28657} {28645}
{28650} {28653} {20233}.  Progression from upper respiratory tract infection (URTI) to LRTI 
may occur in 17-84% of these RSV-infected patients {28641} {26937} {28657} {28650} {28653}
{20233} {28646} {28724} {28654} {28648}. Once RSV progresses from URTI to LRTI, the 
morbidity and mortality is high.  Progression to LRTI often requires hospitalization and at times, 
intensive care unit admission for supportive care (eg oxygenation, mechanical ventilation, 
intravenous fluids, vasopressors).  LRTI is associated with high mortality rates, ranging from 
6.5-26.7%. {28647} {28646} {28656} {28641} {28725} {28643} {28644} {28652} {28650}.  A long 
term sequelae seen among survivors of RSV LRTI is airflow decline documented at 1 year after 
the initial infection {28643}.
Currently there are no effective vaccines or approved prophylactic treatment options for RSV 
infection in the HCT population.  Once hospitalized, treatment for RSV infection in HCT 
patients is supportive, with intravenous hydration, supplemental oxygen, and mechanical 
ventilation.   Although treatment options such as antiviral agents, corticosteroids, and 
immunoglobulin are frequently used, there is no definitive treatment for RSV infection in the 
HCT population.  Synagis® (palivizumab), a monoclonal antibody against RSV approved for 
prophylaxis against RSV infection among high risk infants, has never been evaluated in a 
randomized controlled study for treatment of RSV infection in the HCT population.  A recent 


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retrospective analysis suggests that palivizumab is not effective for treatment of RSV LRTI in 
the HCT population {28654}.  Virazole® (ribavirin), an inhaled antiviral agent, is approved for 
treatment of RSV infection in the pediatric population but is not used in general pediatric 
practice because of concerns regarding its efficacy and tolerability, as well as the complexity of 
the specialized aerosol delivery system that is required {19902}.  A randomized study of inhaled 
ribavirin has been attempted in the HCT population; however, due to the aforementioned
concerns, only 14 subjects were recruited over a 5-year period {28640}. A recent review of 
published epidemiologic studies suggests that ribavirin-based therapy, oral or aerosolized, had 
variable success rates for preventing RSV-associated morbidity or mortality in high risk HCT 
patients {28655}.  A single center retrospective analysis also suggested that ribavirin treatment, 
when administered during the URTI phase, resulted in lower rates of progression to LRTI in 
treated versus untreated patients (16% versus 45%) and mortality (35% versus 70%) {26937}.  
Taking into account the limited available efficacy data from controlled clinical trials, the current 
guidelines for diagnosis and treatment of RSV infection do not provide recommendations 
regarding whether patients should be treated with any treatments other than supportive care at the 
LRTI versus URTI phase {28723}.  Therefore, variability in standard practices for treatment of 
RSV infection in HCT patients exists around the world.
1.2.
GS-5806
1.2.1.
General Information
GS-5806 is an oral RSV fusion inhibitor with potent and selective anti-RSV activity in vitro. 
When tested in vitro against 75 diverse clinical isolates of RSV type A and B, the EC50 values 
(concentration of drug to reach 50% inhibition of virus replication) ranged from 0.15 to 1.09 nM, 
with a mean EC50 value of 0.43 0.22 nM. In vivo efficacy data from cotton rats infected with 
human RSV demonstrated that administration of GS-5806 at 0.3 to 30 mg/kg resulted in a 
dose-dependent reduction in viral load in both the upper respiratory tract and lungs. The 
steady-state pharmacokinetic (PK) volume of distribution (Vss) in all nonclinical species tested 
was 2- to10-fold higher than the volume of total body water and the oral bioavailability was 
moderate to high. The exposure to GS-5806 in the lung and lung epithelial lining fluid (ELF) 
was also assessed in Sprague-Dawley rats and yielded lung tissue/plasma and ELF/plasma ratios 
of approximately 30 and 9, respectively. Concentrations in lung tissue and ELF declined 
approximately in parallel to those in plasma indicating rapid equilibration between the lung and 
plasma compartments. GS-5806 exhibited low cytotoxicity in cell culture and did not interact 
with pharmacologically relevant receptors that are predictive of off-target toxicity.  Based on in 
vitro and nonclinical pharmacokinetic studies, GS-5806 did not demonstrate the potential for 
significant drug-drug interactions (DDI).
Additional details regarding nonclinical pharmacokinetics, pharmacology, and toxicology can be 
found in the current GS-5806 Investigator’s Brochure (IB).


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1.2.2.
Nonclinical Pharmacokinetics
Consistent with the high, concentration-independent forward permeability across 
Caco-2 monolayers and low, concentration-independent efflux, GS-5806 exhibited moderate to 
high bioavailability in nonclinical species. Systemic clearance of GS-5806 in nonclinical species 
is well predicted from the rates of metabolism by hepatic microsomal fractions and primary 
hepatocytes.  Biliary excretion is likely to be the major route of elimination of GS-5806 and its 
metabolites as < 2% of radiolabeled GS-5806 dosed orally to rats was recovered in urine.  The 
major routes of metabolism of GS-5806 are oxidative deamination and N-acetylation. In humans, 
the deamination pathway is likely catalyzed by multiple CYP enzymes such as CYP1A2, 
CYP2B6, and CYP2C19.  GS-5806 shows weak inhibition of OATP1B1, OATP1B3, Pgp 
(IC50 values of 98, 100, and 92 μM, respectively). GS-5806 is a weak inhibitor of OCT1, OCT2, 
and BSEP with IC50 values of 40.2, 16.7, and 29.3 μM, respectively. No inhibition of OAT1 or 
OAT3 was observed for GS-5806 at concentrations up to 80 μM. Therefore, drug interactions of 
GS-5806 with substrates of these transporters are unlikely in the expected clinically relevant 
concentration range.
Additional details regarding nonclinical pharmacokinetics can be found in the GS-5806 IB. 
1.2.3.
Nonclinical Pharmacology and Toxicology
The IC50 for the inhibitory effect of GS-5806 on hERG potassium current was 7.8 µM. 
Cardiovascular effects of GS-5806 were evaluated in dogs at doses up to 75 mg/kg. The principal 
hemodynamic findings were lower heart rate values, and higher arterial pulse and systolic 
pressure values. All hemodynamic effects dissipated by 22 hours post-dose. All 
electrocardiograms (ECGs) were qualitatively within normal limits, and no GS-5806-related 
arrhythmias or abnormal waveforms were detected. Slight GS-5806-related higher PR and QTc 
interval values were expected physiological responses secondary to concomitant 
GS-5806-related lower heart rate values. These changes were not considered physiologically 
important in the context of this study. 
In a repeat dose study, GS-5806 was administered by oral gavage for 4 weeks to young adult rats 
once daily at doses up to100 mg/kg/day. Two animals administered 100 mg/kg/day were found 
dead during the dosing phase. Although the cause of death for these 2 animals was 
undetermined, an association with GS-5806 cannot be excluded. Based on the results of this 
study, the NOAEL for GS-5806 is 70 mg/kg/day, which corresponded to mean AUC0-t and 
Cmax values on Day 23 of the dosing phase of 96, 316 ng·h/mL, and 6028 ng/mL, respectively. In 
a repeat-dose study conducted in young adult dogs, GS-5806 was administered by oral gavage 
for 4 weeks at doses up to 20 mg/kg/day. The NOAEL for this study is 20 mg/kg/day, which 
corresponded to mean AUC0-t and Cmax values on Day 27 of the dosing phase of 
129,831 ng·h/mL and 8081 ng/mL, respectively.
GS-5806 was negative in the rat micronucleus study and did not cause mutations in the Ames 
assay or induce chromosomal damage in vitro with or without S9 metabolic activation. Thus, the 
potential for genetic toxicity is considered low.


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In an oral gavage dose range-finding developmental toxicity study in rats, females were 
administered GS-5806 at doses up to 100 mg/kg/day from gestational day (GD) 6 through 
GD 17 (12-day period), with scheduled necropsy occurring on GD 21. GS-5806 treatment 
resulted in significant reductions in maternal body weight, and the NOAEL for maternal toxicity 
was 30 mg/kg/day. There were no effects on embryo-fetal viability and growth and no fetal 
anomalies, and the NOEL for developmental toxicity was 100 mg/kg/day. 
In an oral gavage dose range-finding developmental toxicity study in rabbits, females were 
administered GS-5806 at dose levels up to50 mg/kg/day from GD 7 through GD 19 
(13-day period), with scheduled necropsy occurring on GD 29. GS-5806 treatment resulted in 
lower maternal body weight at doses ≥30 mg/kg/day. The early termination (moribund sacrifice) 
of 1 female in the 50 mg/kg/day group on GD 20 was attributed to GS-5806 administration, due 
to significant reductions in body weight and food consumption, and the NOEL for maternal 
toxicity was 10 mg/kg/day. There were no effects on embryo-fetal viability and growth and no 
treatment-related fetal anomalies. The NOEL for developmental toxicity was 50 mg/kg/day.
In a dose range-finding study in juvenile rats, GS-5806 was administered at doses up to 
100 mg/kg/day on postnatal day (PND) 7 through PND 14.  Noteworthy effects were limited to 
decreased body weight gain at doses ≥ 70 mg/kg/day and a mild to moderate (1.5- to 2.5-fold), 
dose-dependent increase in total bilirubin at doses ≥ 30 mg/kg/day.  The NOAEL was considered 
to be 30 mg/kg/day, corresponding to respective mean Cmax and AUC0-t values on PND 14 of 
2415 ng/mL and 44,179 ngh/mL. In a definitive juvenile rat study, GS-5806 was administered 
beginning on PND 4 through PND 21 at doses up to 100 mg/kg/day.  An increase in mortality 
was seen at doses ≥70 mg/kg/day.  Reflux-related inflammation and epithelial 
degeneration/erosion/ulcer in the upper respiratory tract occurred at doses ≥70 mg/kg/day, and 
the mortality was likely related to decreased milk intake secondary to the reflux-related 
inflammation in the upper respiratory tract. This is consistent with the observation that neither
clinical pathology data nor anatomic pathology data indicated  specific target organ toxicity as 
the cause of death for the pups that had treatment-related mortalities.  Surviving pups had no 
indications of systemic toxicity.  Based on the above results, the NOEL was considered to be 
30 mg/kg/day, which  corresponded to respective mean Cmax and AUC0-t on PND 21 of 
1430 ng/mL and 19,300 ng·h/mL, respectively.
In a 4-week juvenile dog study, GS-5806 was orally administered once daily on PND 11 through 
PND 38 at doses up to 20 mg/kg/day, with only minimal, transient effects on neonatal/juvenile 
development and no adverse target organ toxicity. The NOAEL was 20 mg/kg/day, 
corresponding to PND 38 Cmax and AUC0-t values of 7180 ng/mL and 139,000 ng·h/mL, 
respectively.
Additional details regarding nonclinical pharmacology and toxicology can be found in the 
GS-5806 IB. 


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1.2.4.
Clinical Trials of GS-5806
1.2.4.1.
GS-US-218-0101
This Phase 1, placebo-controlled, single- and multiple-dose ranging, first-in-human (FIH) study 
was conducted to evaluate safety, tolerability, and PK following oral administration of GS-5806 
to up to 70 unique subjects.  The study included 3 stages (Parts A, B, and C) with 8 total 
staggered cohorts (7 pre-specified, 1 adaptive). Within each cohort of Parts A and B, 8 unique 
subjects were randomized to receive blinded investigational medicinal product (IMP), either 
GS-5806 (n = 6) or placebo (n = 2). Within each cohort of Part C, 10 unique subjects were 
randomized to receive blinded IMP, either GS-5806 (n = 8) or placebo (n = 2). A maximum 
single dose of 300mg and multiple dose regimen of 75mg once daily for 7 days was achieved.  
GS-5806 PK was evaluated under fasting and fed states.
No deaths or serious adverse events (SAEs) were reported, and there were no dose-limiting 
toxicities. In the GS-5806-treated subjects, there were no discontinuations due to AEs. Among 
the 23 subjects who received single doses of GS-5806, 5 subjects (21.7%) experienced a total of 
11 AEs, with the most common AEs being presyncope and dermatitis (reported by 2 subjects 
each). Both incidents of presyncope, and 1 of the 2 events of dermatitis, were judged by the 
investigator to be related to study procedures; 1 event of dermatitis was inflammation of the skin 
of the right antecubital and 1 event was nonspecific dermatitis on the chest. Among the 
52 subjects receiving multiple doses of GS-5806, 20 subjects (38.4%) experienced a total of 
45 AEs, with diarrhea and nausea reported by 4 subjects and headache and contact dermatitis 
reported by 3 subjects. All other AEs experienced by subjects receiving multiple doses of 
GS-5806 were reported by ≤2 subjects each.
Twelve-lead ECGs were obtained at Baseline and Days 1, 15, and 21. Analysis of these ECGs 
demonstrated no clinically significant increase in the PR, QRS, QT, and QTcF intervals, and no 
clinically significant arrhythmias associated with administration of GS-5806.
GS-5806 exposures increased in an approximately dose-proportional manner over the dose range 
tested following single and multiple oral administrations under fasted conditions. GS-5806 
terminal half-lives ranged from 30 to 33 hours following single oral administration and 
approximately 36 hours following multiple oral administrations. Overall, the variability of the 
PK parameters was relatively low, with the majority of the PK parameters displaying CV% of 
30% or lower. In addition, the food effect on GS-5806 PK following single or multiple oral 
administration has been evaluated. Following single administration of GS-5806 at 25, 50, or 
75 mg, Cmax under fed conditions decreased approximately 20% to 40% compared to fasted 
conditions, but this effect was less pronounced following once daily dosing at the higher dose 
(75 mg) around steady-state.
1.2.4.2.
Study GS-US-218-0109
This Phase 1 mass-balance study was conducted to evaluate the PK, metabolism, and excretion 
of GS-5806. The primary objective of this study was to determine the mass balance of GS-5806 
following administration of a single, oral dose of radiolabeled [14C]-GS-5806.  The secondary 


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objectives of this study were to evaluate the PK of GS-5806 and metabolites, where possible and 
to determine the metabolite profile of GS-5806 in humans following administration of a single, 
oral dose of radiolabeled [14C]-GS-5806.
Eight subjects were enrolled and assessed for a period of a minimum of 10 days and a maximum 
of 21 days with a 7-day follow-up period. Following a single oral radiolabeled dose of GS-5806
(50 mg), the maximum mean concentrations of drug-derived radioactivity in blood and plasma 
were observed at 2 hours post-dose for both matrices.  The overall recovery of radioactivity was 
89.9%, with recovery primarily in feces (72.3%) versus urine (17.6%).  Mean blood to plasma 
concentration ratios ranged from 0.450 to 0.591 through 120 hours post-dose, indicating that 
radioactivity was primarily in the plasma, relative to the cellular components of the blood.
The circulating radioactivity consisted mainly of GS-5806 (88%) and low levels of minor 
metabolites 5-chloro-2-amino (N-methanesulfonyl) benzamide (M58; 7%), 
oxy-GS-5806-glucuronide (M47; 3%), and GS-557855 (M30B; 1%)). 
The major component excreted in feces was unchanged parent GS-5806 (18.5% of the dose; 
coeluted with dioxy-GS-5806-2 [M63]), along with other minor metabolites 
(dioxy-GS-5806-3 [M64; 5.42% of the dose] and dioxy-GS-557855-2 [M70; 3.51% of the 
dose]). The remaining identified 8 metabolites detected in feces each accounted for less than a 
mean of 2.5% of the dose. In urine, unchanged parent GS-5806 was the main species 
(~10.0% of the dose), and metabolite M47 represented ~3.59% of the dose. 
In summary, [14C]GS-5806 was primarily eliminated in the feces after oral administration to 
healthy subjects. Low levels of various metabolites were observed indicating the likely absence 
of a single dominant pathway. Radioactivity was eliminated as a combination of metabolites and 
unchanged parent drug. Overall, the pharmacokinetics of GS-5806 is not expected to be 
meaningfully altered in the setting of renal impairment (eg, mild to moderate).
1.2.4.3.
Study GS-US-218-0103
This Phase 2a, randomized, double-blind, placebo-controlled study was conducted to evaluate 
the safety, tolerability, and efficacy of GS-5806 in healthy adult volunteers infected with an RSV 
challenge virus (RSV-A Memphis 37b strain). The study included 7 quarantines, each 
comprising approximately 20 subjects. Each subject was admitted to the Quarantine Unit and 
inoculated with RSV on Study Day 0. Subjects were randomized and treated with GS-5806 or 
placebo when infection was documented in the nasal wash, or by the fifth day after inoculation, 
whichever occurred first.
For Quarantines 1 through 4 (pre-specified quarantines), subjects were randomized 1:1 to receive 
GS-5806 or placebo, administered as a 50 mg single dose on Dose Day 1, followed by 25 mg 
once daily on Dose Days 2 through 5.
For Quarantines 5 through 7 (adaptive quarantines), subjects were randomized 4:1 to receive 
GS-5806 or placebo. Subjects in Quarantine 5 were administered a 50 mg single dose on Dose 
Day 1, followed by 25 mg once daily on Dose Days 2 and 3. Subjects in Quarantine 6 were 
administered a 100 mg single dose. Subjects in Quarantine 7 were administered a 10 mg 
single dose on Dose Day 1, followed by 5 mg once daily on Dose Days 2 through 5.


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A total of 140 subjects were randomized into this study.  All subjects completed study drug and 
1 placebo subject discontinued the study due to investigator’s discretion.  Baseline demographics 
and characteristics were similar between treatment groups across all dose cohorts.  
Seventy-eight (78) subjects received the pre-specified dose in quarantines 1-4 (GS-5806 n=39, 
placebo n=39).  Of these, 54 subjects (69%) were documented to be RSV positive prior to 
randomization and were included in the primary and secondary analyses (GS-5806 n=27, 
placebo n=27).  A total of 87 subjects received GS-5806 across all quarantines. 
Treatment with GS-5806 resulted in the following:
Primary Endpoint:

Treatment with GS-5806 resulted in lower mean AUC viral load from initial dose through 
end of quarantine.  Viral load was assessed twice daily using nasal washes.  The mean AUC 
of viral load as measured by the RT-qPCR assay from first viral load measurement post 
initial dose of study drug through Day 12 was significantly lower in GS-5806 subjects 
compared to placebo subjects (Δ= 506.9 log10 PFUe*hour/mL, p<0.001).
Secondary Endpoints:

Treatment with GS-5806 resulted in lower mean AUC viral load during the entire quarantine 
period. The mean AUC of viral load post challenge through Study Day 12 as measured by 
the RT-qPCR assay was significantly lower in GS-5806 subjects compared to placebo 
subjects (Δ= 531.0 log10 PFUe*hour/mL, p=<0.001). 

Treatment with GS-5806 resulted in lower mean total mucus weight during dosing. The 
average weight of each unused tissue was determined prior to start of study. The daily mucus 
weight was calculated by first counting the number of tissues used each day, then subtracting 
the total weight of these tissues, unused, from the daily total weight of used tissues.  The 
mean total weight of mucus produced post-initial dose of study drug through the dose was 
significantly lower in the GS-5806 subjects compared to placebo subjects (Δ= 8.2 g, 
p=0.028). 

Treatment with GS-5806 resulted in a lower mean AUC of change from Baseline in total 
symptom score during the entire quarantine period. Ten symptoms (runny nose, stuffy nose, 
sneezing, sore throat, earache, malaise [tiredness], cough, shortness of breath, headache, and 
muscle and/or joint ache) were each scored from 0 (no symptoms) to 3 (quite bothersome 
most/all of the time). Total symptom scores (0-30) were the average score of questions 
answered by each subject, multiplied by 10.  The mean AUC of change from Baseline in total 
symptom score post initial dose of study drug through Study Day 12 was significantly lower 
in the GS-5806 subjects compared to placebo subjects (Δ= 225.1 score*hour, p=0.005).  The 
total symptoms score AUC was also significantly lower for GS-5806 treated subjects.


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In each of the adaptive quarantines statistically significant results were also achieved in the 
primary endpoint and each of the secondary endpoints described above with the exception of a 
reduction in mean total mucus weight in Quarantine 7. In addition, an exposure response effect 
was noted.
No subject experienced a serious AE. All AEs were mild or moderate (Grade 1 or 2) in severity, 
except for three Grade 3 AEs experienced by 1 placebo-treated subject (increased blood lactate 
dehydrogenase, alanine aminotransferase [ALT], and aspartate aminotransferase [AST]). 
Grade 1 pulmonary function decrease (<10% change) was the only treatment-related AE 
experienced by >2 subjects in either treatment group (GS-5806: 4.6%, n=4/87; placebo: 3.8%, 
n=2/53).  Changes in clinical laboratory values were Grade 1 or 2 in severity, except for one 
Grade 4 value (increased AST; reported for placebo-treated subject described above). Elevated 
ALT was more commonly reported among GS-5806-treated subjects (GS-5806: 14.9%; placebo: 
9.4%), but elevated AST was less commonly reported (GS-5806: 5.7%; placebo: 15.1%). Low 
neutrophil count was reported as Grade 1 in 11 subjects (2 received placebo) and Grade 2 in 
2 subjects (1 received placebo). Among the 9 subjects who experienced a Grade 1 low neutrophil 
count and received GS-5806, 2 had a Grade 1 low neutrophil count at Screening. Clinically 
relevant changes in vital signs or ECGs were not observed.
1.3.
Rationale for This Study
There is a significant unmet medical need for a safe, convenient, and effective treatment for RSV 
infection.  The only approved antiviral therapy for RSV, ribavarin, is approved for use in 
pediatric populations only, but is rarely used in clinical practice due to its limited efficacy and 
concerning safety profile. There is no approved antiviral therapy for RSV infection among HCT 
recipients, where the current standard of care is supportive or off-label use of ribavirin.
This study follows a Phase 1 FIH study (GS-US-218-0101) and a Phase 2a RSV challenge study 
(GS-US-218-0103), which evaluated the safety, tolerability, and PK of single and multiple doses 
of GS-5806 in 140 healthy adult volunteers.  In Study GS-US-218-0103, GS-5806 was shown to 
be efficacious in reducing RSV viral load and clinical symptoms in healthy adult subjects 
experimentally infected with RSV.  
Given these results from healthy adult volunteers studied in a controlled setting, 2 studies are 
being conducted to evaluate the efficacy, safety, and tolerability of GS-5806 in the HCT 
population. Study GS-US-218-0108 is being conducted in HCT patients with an RSV-related 
URTI. This study, which will be run concurrently, will enroll HCT patients with an RSV-related 
LRTI. Safety and efficacy data generated from these studies, together with currently available 
data, will be used to support further clinical development of GS-5806 in pediatric and adult 
patients infected with RSV.


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1.4.
Dose Rationale
The dose and administration schedule selected for this study is a single dose of 200 mg GS-5806 
administered orally in the fasted state on Days 1, 5, 9, 13, and 17. This regimen was selected 
based upon the PK characteristics of GS-5806 and the pharmacokinetic/pharmacodynamic 
(PK/PD) relationship established in the antiviral effect study with different doses/regimens in 
Study GS-US-218-0103. 
In Study GS-US-218-0103, a 5-day treatment regimen of GS-5806 (50 mg single dose on Dose 
Day 1, followed by 25 mg once daily on Dose Days 2 through 5) resulted in a significant 
reduction in RSV viral load. The mean AUC of RSV viral load as measured by the RT-qPCR
assay from first viral load measurement post initial dose of study drug through end of quarantine 
(Day 12) was significantly lower in GS-5806 subjects compared to placebo subjects 
(Δ= 506.9 log10 PFUe*hour/mL, p<0.001). This 5-day regimen was able to achieve GS-5806 
trough concentrations ~4-5 fold of paEC95 (52 ng/mL) for up to 120 hours following dose
initiation for the virus used in the challenge study, the M37 strain of RSV. 
In selecting the dose for the current study, the goal was to achieve GS-5806 trough 
concentrations above 4-fold of paEC95 for most of the clinical RSV isolates for the duration of 
RSV shedding in HCT patients. Longitudinal viral dynamics data from investigators at an 
academic HCT center also indicate that the majority of HCT patients shed RSV for 15 days, but 
some may shed for as long as 21 days (unpublished). Therefore, a total of 5 doses of GS-5806 
(200 mg each dose, every 4 days) is expected to provide > 4-fold paEC95 coverage for ~95% of 
75 wild-type clinical RSV isolates through Day 22, which is expected to result in significant 
durable antiviral effect. 
1.5.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.


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2.
OBJECTIVES
The primary objective of this study is:

To evaluate the effect of GS-5806 on RSV viral load in autologous or allogeneic HCT 
recipients with an acute RSV LRTI 
The secondary objectives of this study are:

To evaluate the effect of GS-5806 on rates of respiratory failure and all-cause mortality

To evaluate the PK, safety, and tolerability of GS-5806


GS-5806 
Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
3. 
STUDY DESIGN 
3.1. 
Endpoints 
The prima1y endpoint of this study is: 
Final 
Amendment2 
• 
Time-weighted average change in nasal RSV viral load (log10 copies/mL) from Baseline 
(Day 1) to Day 9 as measmed by RT-qPCR 
The key secondruy endpoints of this study ru·e: 
• 
Prop01tion of subjects developing respirat01y fail me (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28 
• 
Proportion of all-cause m01tality among subjects through Day 28 
The explorat01y endpoints ru·e: 
PPO 
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CONFIDENTIAL 
Page 31 
22 September 2014 


GS-5806 
Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
(]' 
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3.2. 
Study Design 
Final 
Amendment 2 
This is a randomized, double-blind, placebo-controlled study evaluating the effect of GS-5806 on 
efficacy, PK, safety, and tolerability in HCT recipients with RSV IRTI. This study will emoll 
approximately 60 subjects from approximately 30 intemational HCT centers. RSV positive 
subjects with evidence oflRTI will be randomized 1:1 to receive GS -5806 or placebo given as 
200mg eve1y 4 days for a total of 5 doses. Subjects will be followed for a total of 28 days, 
during which a total of 10 Study visits will be 
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3.3. 
Study Treatments 
Approximately 60 subjects will be randomized 1:1 to receive 200 mg (four 50 mg tablets) of 
IMP (GS-5806 or placebo) as a single dose on Days 1, 5, 9, 13, and 17. The IMP will be 
administered after the subject has fasted (with exception of clear liquids and medications) for at 
least 2 hours. The entire dose must be taken within 1 hour. Subjects will remain fasting for 
approximately 1 hour after dosing. Tablets are not to be cmshed, split, dissolved, or chewed. 
IMP should be dispensed with gloves. Subjects should avoid direct UV exposure for 8 days after 
receiving IMP. 
Subjects will remain in the clinic for 30 minutes post-dose for observation. If vomiting occurs 
within 30 minutes after IMP administration and undissolved tablets are present in the vomitus, 
the subject should receive another dose. If another dose is administered, the subject should 
remain in the clinic for an additional30 minutes post-dose for observation. 
CONFIDENTIAL 
Page 32 
22 September 2014 


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GS-5806 will be provided as white, plain-faced, film-coated, round tablets containing 50 mg 
GS-5806 (61 mg GS-5806-02, bis-hydrochloride salt dihydrate form of GS-5806). Placebo to 
Match will be provided as white, plain-faced, film-coated, round tablets containing no GS-5806.
The expected duration of subject participation is approximately 1 month, to include Screening 
through the final visit on Day 28.  
3.4.
Duration of Treatment
The treatment portion of the study is 17 days (a total of 5 doses administered as single doses on 
Days 1, 5, 9, 13, and 17).
3.5.
Discontinuation Criteria
Reasons for potential premature discontinuation from IMP dosing include:

Any Grade 3 or 4 AE or SAE

Intercurrent illness that would, in the judgment of the investigator, affect the subject’s ability 
to receive IMP (eg, unable to ingest oral dose). 
In the event any of the above criteria are met, the Principal Investigator (PI) will review the case 
in detail and discuss with the Gilead Medical Monitor whether the subject should be 
discontinued from IMP.
Reasons for premature discontinuation from the Study include:

Subject request to discontinue for any reason

Subject noncompliance

Pregnancy during the study; refer to Section 7.7.2

Discontinuation of the study at the request of Gilead, a regulatory agency or an institutional 
review board or independent ethics committee (IRB/IEC)
If a subject prematurely discontinues from IMP dosing, he/she will remain on study and will 
continue with all subsequent Study Visits and assessments, with the exception of IMP dosing.  
If a subject prematurely discontinues from the Study, every attempt should be made to bring the 
subject back for the Early Termination procedures.  See Section 6.9 for more information.
3.6.
Source Data
For the purposes of this study, study specific questionnaires (ie, respiratory symptom 
assessments) are considered source documents and are to be filed with the subject’s medical or 
study records.  Electronic data (ie, diagnostic machines that transcribe data directly to a database, 


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or data entered directly into an Electronic Medical Record system) is considered source data, 
provided the data is not recorded directly on the CRF/eCRF, and provided there is a clear audit 
trail in the electronic record(s).  Template source document worksheets will be prepared by 
Gilead and provided to sites to use at their discretion.  If source document worksheets are used, 
they are to be kept with the subject’s medical or study records as original source documents.  No 
data will be recorded directly on the CRF/eCRF, and any data recorded directly on the 
CRF/eCRF will not be considered source data.


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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
The subject population will consist of approximately 60 RSV-positive males and females 18 to 
75 years of age who have had an allogeneic or autologous HCT and have documented acute RSV 
related LRTI symptoms, recruited from approximately 30 centers in Asia Pacific, Australia, 
Canada, Europe, South America, and the United States.
4.2.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this 
study.
1. Received an autologous or allogeneic HCT using any conditioning regimen
2. Evidence of new abnormalities on chest X-ray obtained < 48 hours prior to Screening, 
determined to be consistent with LRTI by the local radiologist, relative to the most recent 
previous chest X-ray.  If chest X-ray is not available, a chest X-ray must be obtained for 
Screening.
3. Documented RSV in both the upper (eg, nasal swab, nasopharyngeal swab, nasal wash) and 
lower (eg, induced sputum, BAL, lung biopsy) respiratory tract as determined by local testing 
(eg, PCR, DFA, RVP assay, or culture).  All samples must have been collected ≤6 days prior 
to Day 1.
4. An informed consent document signed and dated by the subject or a legal guardian of the 
subject and investigator or his/her designee
5. A negative urine or serum pregnancy test is required for female subjects (unless surgically 
sterile or greater than two years post-menopausal)
6. Male and female subjects of childbearing potential must agree to contraceptive requirements
as described in Appendix 5
7. Willingness to complete necessary study procedures and have available a working telephone 
or email


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4.3.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
Related to concomitant or previous medication use:
1. Use of non-marketed (according to region) investigational agents within 30 days, OR use of 
any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of screening, whichever 
is longer, OR use of any investigational RSV vaccines after HCT
2. Use of a strong cytochrome P450 enzyme (CYP) inducer including but not limited to 
rifampin, St. John’s Wort, carbamazepine, and phenytoin, within 2 weeks prior to the 
first dose of IMP
Related to medical history:
3. Pregnant, breastfeeding, or lactating females 
4. Unable to tolerate nasal sampling required for this study, as determined by the investigator
5. Known history of HIV/AIDS with a CD4 count <200 cells/μL within the last month
6. History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent 
adherence to study activities
Related to medical conditions:
7. Requiring invasive mechanical ventilation at the time of randomization 
8. A relapse (including molecular relapse) of their underlying disease for which they received a 
transplant at Screening
9. Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, 
human rhinovirus, adenovirus, or human metapneumovirus), from the lower respiratory tract 
sample as determined by local testing
10. Clinically significant bacteremia or fungemia within 7 days prior to Screening that has not 
been adequately treated, as determined by the investigator
11. Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening 
that has not been adequately treated, as determined by the investigator
12. Excessive nausea/vomiting at screening, as determined by the investigator, or an inability to 
swallow pills that precludes oral administration of the IMP
13. Any condition which, in the opinion of the investigator, would prevent full participation in 
this trial or would interfere with the evaluation of the trial endpoints


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Related to allergies:
14. Known hypersensitivity or allergy to the IMP, its metabolites, or formulation excipients 
(microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl 
alcohol, titanium dioxide, polyethylene glycol and talc)
15. Allergy to sulfa drugs 
Related to laboratory results:
16. Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)
17. AST/ALT > 3x ULN
18. Total bilirubin > 3x ULN


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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Randomization, Blinding and Treatment Codes
This is a randomized, double-blind, placebo-controlled multi-center study. Eligible subjects will 
be stratified by the following factors:

Supplemental O2 requirement (≤2 L/min or > 2 L/min) at the time of randomization

Treatment of current RSV infection (yes or no) with ribavirin (oral, intravenous, or 
aerosolized)
Treatment of current RSV infection with ribavirin will be defined as ≥1 dose of ribavirin 
(oral, intravenous, or aerosolized) prior to randomization or with written orders for the initiation 
of therapy at the time of randomization.  Subjects will be randomized in a 1:1 ratio to receive 
IMP (GS-5806 or matching placebo).
Assignment to study treatment will be blinded to the study subjects, investigational site 
personnel, study vendors, and the Sponsor, except for the delegated personnel who will review 
and check the randomization and drug allocation for accuracy.
5.1.1.
Procedures for Breaking Treatment Codes
In the event of a medical emergency where breaking the blind is required to provide medical care 
to the subject, the investigator may obtain treatment assignment directly from the IXRS system 
for that subject. In the event of technology failure, the PI may call the IXRS help line to access 
treatment codes. Gilead recommends but does not require that the investigator contact the Gilead
medical monitor before breaking the blind. Treatment assignment should remain blinded unless 
that knowledge is necessary to determine subject emergency medical care. The rationale for 
unblinding must be clearly explained in source documentation and on the case report 
form/ electronic case report form (CRF/eCRF), along with the date on which the treatment 
assignment was obtained. The investigator is requested to contact the Gilead medical monitor 
promptly in case of any treatment unblinding. Details of unblinding will be provided in the 
study-specific Unblinding Plan.
Blinding of study treatment is critical to the integrity of this clinical trial and therefore, if a 
subject’s treatment assignment is disclosed to the investigator, the subject will have study 
treatment discontinued. All subjects will be followed until study completion unless consent to do 
so is specifically withdrawn by the subject.
Gilead Drug Safety and Public Health (DSPH) may independently unblind cases for expedited 
reporting of suspected unexpected serious adverse reactions (SUSARs).


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5.2.
Description and Handling of GS-5806
5.2.1.
Formulation
GS-5806 will be supplied as white, plain-faced, film-coated, round tablets containing 50 mg
GS-5806 (61 mg GS-5806-02, bis-hydrochloride salt dihydrate form of GS-5806). In addition to 
the active ingredient, GS-5806 tablets contain the following inactive ingredients: 
microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl 
alcohol, titanium dioxide, polyethylene glycol, and talc, all of which are common pharmaceutical 
excipients.
The supplied matching placebo tablets are identical in physical appearance to the 50 mg
GS-5806 tablets and contain the same inactive ingredients.
5.2.2.
Packaging and Labeling
GS-5806 tablets and matching placebo are packaged in white, high density polyethylene (HDPE) 
bottles with desiccant and polyester fiber coil. Each bottle contains 4 tablets and is capped with a 
white, continuous thread, child-resistant polypropylene screw cap fitted with an induction-sealed, 
aluminum-faced liner.
All labels for IMP distributed to investigative sites in the US and the rest of world (ROW) will 
meet all applicable requirements of the US Food and Drug Administration (FDA), the EU 
Annex 13 of Good Manufacturing Practices: Manufacture of investigational medicinal products 
(July 2010), and/or other local regulations, as applicable.
5.2.3.
Storage and Handling
Sufficient quantities of GS-5806 tablets and matching placebo will be shipped to the investigator 
or qualified designee from Gilead Sciences Materials & Logistics (or its designee).
GS-5806 tablets should be stored at controlled room temperature of 25°C (77°F); excursions are 
permitted between 15°C and 30°C (59°F and 86°F). Storage conditions are specified on the label.  
Until dispensed to the subjects, all bottles of IMP should be stored in a securely locked area, 
accessible only to authorized site personnel. The study center will be required to maintain a log 
of daily temperature readings in the storage area for the duration of the study. To ensure the 
stability and proper identification, the drug products will be stored in the containers in which 
they were supplied until units are dispensed to individual subjects at the site.
5.3.
Dosage and Administration of GS-5806
Eligible subjects will receive 200 mg GS-5806 or placebo on Days 1, 5, 9, 13, and 17. Doses will 
be administered with water, after the subject has fasted for at least 2 hours (with exception of 
clear liquids and medications). The entire dose must be taken within 1 hour.  Subjects will 
remain in a fasting condition for at least 1 hour after dosing. IMP is to be dispensed with gloves. 
Tablets are not to be crushed, split, dissolved, or chewed. Subjects will remain in the clinic for 


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30 minutes post-dose for observation.  If vomiting occurs within 30 minutes after IMP 
administration and undissolved tablets are present in the vomitus, the subject should receive 
another dose.  If another dose is administered, the subject should remain in the clinic for an 
additional 30 minutes post-dose for observation. Subjects should avoid direct UV exposure for 
8 days after receiving IMP.
5.4.
Prior and Concomitant Medications
GS-5806 has a low systemic clearance in humans, so significant drug-drug interactions, in which 
concomitantly administered drugs inhibit the metabolic clearance of GS-5806 by CYP enzymes, 
are unlikely. Low levels of minor metabolites were observed in the human mass balance study 
(GS-US-218-0109) indicating that metabolism of GS-5806 is mediated by multiple minor 
metabolic pathways with the likely absence of a single dominant pathway. As such, the net effect 
of strong induction of 1 or 2 pathways by a potent CYP inducer is unclear. Therefore, 
concomitant administration of strong CYP inducers (including but not limited to rifampin, 
St John’s Wort, carbamazepine, and phenytoin) is excluded to avoid potential drug resistance.
In vitro, GS-5806 is a substrate of the efflux transporters P glycoprotein (P-gp) and breast cancer 
resistance protein (BCRP). However, GS-5806 exhibits moderate to high bioavailability in 
nonclinical species and approximately dose-proportional increase in exposures following single 
(75 mg to 300 mg) or multiple (10 to 75 mg once daily) oral administrations in healthy adults, 
consistent with its high solubility and high membrane permeability. Therefore, the bioavailability 
of GS-5806 is not expected to be limited by P-gp and BCRP activities, and clinically relevant 
interactions with P-gp and BCRP inhibitors are not expected.
In vitro, GS-5806 is a substrate of the hepatic uptake organic anion transporter proteins (OATP) 
OATP1B1 and OATP1B3. Clinically, single doses of GS-5806 have been well tolerated up to 
800 mg (Cmax and AUC ~3.6-and ~5-fold of 200 mg, respectively) in healthy volunteers. 
GS-5806 exposures may be increased upon coadministration with OATP inhibitors (eg, rifampin,
cyclosporine, and gemfibrozil).
GS-5806 may cause concentration-dependent inhibition of multidrug and toxin extrusion via 
transporters MATE1 and MATE2-K with IC50 values of 0.50 and 3.8 μM, respectively. When 
co-administered with renally eliminated concomitant medications (ie, filtration plus secretion), 
GS-5806 may increase the exposures of substrates secreted by the MATEs transporters, such as 
ganciclovir, acyclovir, levofloxacin, metformin, captopril, procainamide, fexofenadine, 
cimetidine, cephradine, and cephalexin. Dosing and safety monitoring should be consistent with 
prescribing information, in particular for agents which require dose reductions in the setting of 
renal impairment.


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5.5.
Accountability for GS-5806
The investigator is responsible for ensuring adequate accountability of all used and unused IMP 
bottles. This includes acknowledgement of receipt of each shipment of IMP (quantity and 
condition). 
GS-5806 accountability records will be provided to each study site to:

Record the date and quantity of IMP bottles received

Record the date, subject number, subject initials, the IMP bottle number dispensed

Record the date, quantity of used and unused IMP bottles returned, along with the initials of 
the person recording the information.
5.5.1.
Investigational Medicinal Product Return or Disposal
At the site initiation visit or first monitoring visit, the study monitor will evaluate each study 
center’s IMP disposal procedures and provide appropriate instruction for return or destruction of 
unused IMP supplies. If the site has an appropriate Standard Operating Procedure (SOP) for drug 
destruction (as reviewed and approved by Gilead Sciences, Inc [GSI]), the site may destroy used 
and unused IMP supplies performed in accordance with the site’s (hospital/pharmacy) SOP after 
reconciliation has been completed by the site monitor. If the site does not have acceptable 
procedures in place for drug destruction, arrangements will be made between the site and GSI
(or GSI representative) for return of unused IMP supplies. A copy of the site’s SOP will be 
obtained for central files. Where possible, IMP will be destroyed at the site. 
Upon study completion, a copy of the Investigational Drug Accountability records must be filed 
at the site. Another copy will be returned to GSI. If drug is destroyed on site, the investigator 
must maintain accurate records for all IMP destroyed. Records must show the identification and 
quantity of each unit destroyed, the method of destruction, and person who disposed of the drug. 
All IMP records must be maintained at the site and copies must be submitted to GSI at the end of 
the study.


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6.
STUDY PROCEDURES
The study procedures to be conducted for each subject enrolled in the study are presented in 
tabular form in Appendix 2 and described in the text that follows. Additional information is 
provided in the study procedures manual.
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol. Investigators must document any deviation 
or departure from protocol procedures, regardless of causality, and notify the sponsor or contract 
research organization (CRO).
6.1.
Subject Enrollment and Treatment Assignment
6.1.1.
Visit 1: Screening Visit (Days -2 to -1)
Visit 1 must be performed in the hospital or clinic.  Potential subjects will have a documented
positive test for RSV from the upper and lower respiratory tract and be approached for informed 
consent.  The Principal Investigator or a medically qualified Sub-Investigator (eg, MD, DO, or 
nurse practitioner) must review and discuss the study with each subject prior to consent. All 
screening assessments must be performed after obtaining written consent. All screening labs and 
procedures will be performed locally and results will be reviewed by the investigator prior to 
IMP administration at Visit 2. 
The following procedures will be completed at Screening:

Obtain written informed consent

Collection of medical history and demographics

Review of concomitant medications

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

Height and Weight

O2 saturation (on room air)

Chest X-ray (chest X-rays obtained < 48 hours prior to Screening may be used)

Blood draw for screening labs for local laboratory analyses (labs obtained ≤6 days prior to 
Screening may be used)
Serum creatinine clearance
AST/ALT
Total bilirubin


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
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
Urine or serum pregnancy test (for women unable to confirm menopause, hysterectomy 
and/or bilateral oophorectomy)

Record any SAEs and all AEs related to protocol-mandated procedures occurring after 
signing of the consent form
Subjects meeting all of the inclusion criteria and none of the exclusion criteria will be 
randomized into the study.  Subjects must continue to meet all inclusion criteria and none of the 
exclusion criteria at the time of randomization.  If all lab results and procedures are available and 
satisfy the inclusion/exclusion criteria, Screening and Visit 2 (Day 1) may occur on the same 
day.  From the time of obtaining informed consent through the first administration of IMP, 
record all SAEs, as well as any AEs related to protocol-mandated procedures on the AE case 
report form (eCRF).  All other untoward medical occurrences observed during the Screening 
period, including exacerbation or changes in medical history are to be captured on the medical 
history eCRF.  See Section 7 Adverse Events and Toxicity Management for additional details.
6.1.2.
Visit 2: Baseline Assessments, Randomization, and Treatment Assessments 
(Day 1)
6.1.2.1.
Baseline Assessments
Visit 2 must be performed in the hospital or clinic and should occur within 24 hours of 
confirmation of the subject’s eligibility. Samples and assessments performed at Screening 
(Visit 1) may not be used as Visit 2 Baseline assessments.  Baseline (Visit 2) assessments should 
be performed in the following order and documented on Day 1 prior to IMP administration:

Review of concomitant medications, mechanical ventilation (invasive and non-invasive of 
any duration), and supplemental O2 use

Weight

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure) O2 saturation 
(on room air)

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include WBC with differential, Hgb, 
platelets, BUN, creatinine, serum albumin, AST, ALT, and total bilirubin)
Serum antibody titer to RSV
RSV viremia


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
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
Nasal samples (2 total, 1 from each nostril)

Urine or serum pregnancy test (for women unable to confirm menopause, hysterectomy 
and/or bilateral oophorectomy)

Obtain induced sputum for central laboratory analysis (unless induced sputum was used to 
demonstrate the presence of RSV in the lower respiratory tract ≤6 days prior to Day 1)
6.1.2.2.
Randomization and Treatment Assessments (Day 1)
After all Baseline assessments are complete, eligible subjects will be randomized via Interactive 
Voice/Web Response System (IXRS) and IMP will be administered.  
Randomization to GS-5806 or placebo will be based on a randomization schedule prepared by 
Gilead and/or designee before the start of the study. Subjects must continue to satisfy all 
inclusion/exclusion criteria at the time of randomization. At randomization, eligible subjects will 
be stratified by the following:

Supplemental O2 requirement (≤2 L/min or > 2 L/min) at the time of randomization

Treatment of current RSV infection (yes or no) with ribavirin (oral, intravenous, or 
aerosolized)
Treatment of current RSV infection with ribavirin will be defined as ≥1 dose of ribavirin 
(oral, intravenous, or aerosolized) prior to randomization or with written orders for the initiation 
of therapy at the time of randomization.  Subjects will be randomized in a 1:1 ratio to receive 
IMP (GS-5806 or matching placebo).
Subjects will receive 200 mg (four 50 mg tablets) of GS-5806 or matching placebo at Day 1. All 
IMP will be administered with water, after the subject has been fasting (with exception of clear 
liquids and medications) for a minimum of 2 hours. The entire dose must be taken within 1 hour.  
Subjects will remain in a fasting condition for 1 hour post-dose. Tablets are not to be crushed, 
chewed, split, or dissolved, and should always be dispensed with gloves.  Non-hospitalized 
subjects will remain in the clinic for 30 minutes post-dose for observation.  If vomiting occurs 
within 30 minutes after IMP administration and undissolved tablets are present in the vomitus, 
the subject should receive another dose.  If another dose is administered, the subject should 
remain in the clinic for an additional 30 minutes post-dose for observation.  Subjects should 
avoid direct UV exposure for 8 days after receiving IMP.
The following procedure will be performed and documented on Day 1 after IMP dosing:

Blood draw for central laboratory analysis:
Serum creatinine 4 hours post-dose
PK sampling 4 hours post-dose

Review of AEs


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
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6.1.2.3.
Post-dose Follow-up for Hospitalized Subjects 
For hospitalized subjects, a blood draw for central laboratory analysis of serum creatinine will be 
collected at 24 and 72 hours (±3 hours) post-first GS-5806 dose.  Subjects who are not 
hospitalized during this time will not return to the hospital or clinic for these blood draws.  
6.2.
Visit 3: Day 3 (± 24 hours)
Visit 3 assessments may be performed in the hospital, clinic, or at the subject’s home by the 
study coordinator or designee.  

For all subjects: nasal samples (2 total, 1 from each nostril)

For hospitalized subjects, a blood draw for central laboratory analysis at 48 hours (±3 hours) 
post-first GS-5806 dose:
Serum creatinine
PK sampling
6.3.
Visit 4: Day 5 (± 24 hours)
Visit 4 assessments must be performed in clinic or in hospital and should be performed in the 
following order and documented (also refer to Appendix 2 Study Procedures Table):

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure) 

O2 saturation (on room air)

Weight

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include to include WBC with 
differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total 
bilirubin)  
PK sampling: pre-dose
RSV viremia 

Nasal samples (2 total, 1 from each nostril)

Urine or serum pregnancy test (for women unable to confirm menopause, hysterectomy 
and/or bilateral oophorectomy)

IMP administration* 


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
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22 September 2014

Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use (≥2 L/min)
* Subjects will receive 200 mg (four 50 mg tablets) of GS-5806 or matching placebo at Day 5. 
IMP will be administered with water, after the subject has been fasting for a minimum of 2 hours 
(with exception of clear liquids and medications). The entire dose must be taken within 1 hour.  
Subjects will remain in a fasting condition for 1 hour post-dose. Tablets are not to be crushed, 
chewed, split, or dissolved, and should always be dispensed with gloves. Subjects will remain in 
the clinic for 30 minutes post-dose for observation.  If vomiting occurs within 30 minutes after 
IMP administration and undissolved tablets are present in the vomitus, the subject should receive 
another dose.  If another dose is administered, the subject should remain in the clinic for an 
additional 30 minutes post-dose for observation.  Subjects should avoid direct UV exposure for 
8 days after receiving IMP.
6.4.
Visit 5: Day 7 (± 24 hours)
Visit 5 assessments may be performed in the hospital, clinic, or at the subject’s home by the 
study coordinator or designee.  

Nasal samples (2 total, 1 from each nostril)
6.5.
Visits 6-8: Days 9, 13, and 17 (± 24 hours)
Visits 6-8 assessments must be performed in clinic or in hospital and should be performed in the 
following order and documented at these visits (also refer to Appendix 2, Study Procedures 
Table):

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

O2 saturation (on room air)

Weight

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include to include WBC with 
differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total 
bilirubin)  
PK sampling: pre-dose 
RSV viremia 

Nasal samples (2 total, 1 from each nostril)


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
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22 September 2014

Urine or serum pregnancy test (for women unable to confirm menopause, hysterectomy 
and/or bilateral oophorectomy)

IMP administration* 

Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use ( ≥2 L/min)
* Subjects will receive 200 mg (four 50 mg tablets) of GS-5806 or matching placebo at Days 9, 
13, and 17. All IMP will be administered with water, after the subject has been fasting for a 
minimum of 2 hours (with exception of clear liquids and medications). The entire dose must be 
taken within 1 hour.  Subjects will remain in a fasting condition for 1 hour post-dose. Tablets are 
not to be crushed, chewed, split, or dissolved, and should always be dispensed with gloves. 
Subjects will remain in the clinic for 30 minutes post-dose for observation.  If vomiting occurs 
within 30 minutes after IMP administration and undissolved tablets are present in the vomitus, 
the subject should receive another dose.  If another dose is administered, the subject should 
remain in the clinic for an additional 30 minutes post-dose for observation.  Subjects should 
avoid direct UV exposure for 8 days after receiving IMP.
6.6.
Visit 9: Day 22 (± 24 hours)
Visit 9 assessments must be performed in clinic or in hospital and should be performed in the 
following order and documented (also refer to Appendix 2, Study Procedures Table):

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

O2 saturation (on room air)

Weight

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include WBC with differential, Hgb, 
platelets, BUN, creatinine, serum albumin, AST, ALT, and total bilirubin)  
PK sampling
RSV viremia

Nasal samples (2 total, 1 from each nostril)

Obtain sample for local RSV testing* (refer to Section 6.11.8)


GS-5806 
Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
Final 
Amendment2 
• 
Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms ), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental 0 2 use ( ~ 2 Umin) 
6.7. 
Visit 10: End of Study/Day 28 (+ 3 days) 
Visit 10 assessments must be perf01med in clinic or in hospital. The visit will occur no earlier 
than Day 28 and no later than Day 31. Visit 10 assessments should be perf01med in the following 
order and documented (also refer to Appendix 2, Study Procedures Table): 
• 
Vital Signs (body temperature, heatt rate, respirat01y rate, and blood pressure) 
• 
0 2 saturation (on room air) 
• 
Weight 
• 
Blood draw for central laborat01y analysis: 
-
Safety Labs (hematology and sennn chemistiy to include WBC with differential, Hgb, 
platelets, BUN, creatinine, semm albumin, AST, ALT, and total bilimbin) 
-
Sennn antibody titer to RSV 
-
RSV viremia 
• 
Nasal samples (2 total, 1 from each nostril) 
• 
Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms ), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental 0 2 use ( ~ 2 Umin) 
6.8. 
Visits 11-14*: Day 35, 42, 49, and 56 (± 48 hours) 
Visits 11 - 14 assessments may be perfonned in the hospital, clinic, or at home. 
• 
Obtain nasal samples (2 total, 1 from each nosu·il) 
• 
Assessment of procedure-related AEs 
PD 
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GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 49
22 September 2014
6.9.
Assessments for Premature Discontinuation from IMP dosing and Early 
Withdrawal
Reasons for premature discontinuation from IMP dosing or the study are outlined in Section 3.5.  
6.9.1.
Assessments for Premature Discontinuation from IMP Administration
If a subject prematurely discontinues IMP dosing, the subject will remain on study and will
continue with all subsequent study visits and assessments through Visit 10, Day 28 (End of 
Study), with the exception of IMP administration.
6.9.2.
Assessments for Early Termination/Withdrawal
Every attempt should be made to keep subjects in the study and to perform the required 
study-related and follow-up procedures (see Sections 6.2 through 6.7). If this is not possible or 
acceptable to the subject or investigator, the subject may be withdrawn from the study. 
If a subject withdraws early from the study for any reason, every attempt should be made to 
bring the subject back to the clinic or hospital for the following early termination assessments:

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

O2 saturation (on room air)

Weight

Blood sample collection for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include to include WBC with 
differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total 
bilirubin) (only if the subject withdraws prior to Visit 9 [Day 22])
Serum antibody titer to RSV
RSV viremia

Nasal samples (2 total, 1 from each nostril)

Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use ( ≥ 2 L/min)
6.10.
Assessments for Unscheduled Visits
Assessments performed between scheduled study visits for hospitalized subjects do not have to 
be entered as an unscheduled visit.  If non-hospitalized subjects return to the hospital or clinic 


GS-5806 
Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
Final 
Amendment2 
between scheduled study visits, an lmscheduled visit should be perf01m ed and recorded. The 
following procedmes will be perfonned and docmnented at these visits: 
• 
Vital signs, including 0 2 satmation (on room air) 
• 
Collection of nasal samples for analysis at the central lab 
• 
Assessment of AEs, concomitant medications, re-hospitalizations, ICU admissions or 
utilization ofiCU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms ), mechanical ventilation (invasive and non-invasive of any dmation), and 
supplemental 0 2 use ( ~ 2 Llmin) 
6.11. 
Study Assessments 
6.11.1. 
Nasal Samples, Virology, and Antibody Titer 
At Screening (Visit 1 ), all subjects should be RSV positive in both the upper ( eg, nasal swab, 
nasopharyngeal swab, nasal wash) and lower (eg, induced sputum, BAL, lung biopsy) respirat01y 
tract, as dete1mined by locallaborat01y test methods (eg, PCR, DFA, RVP assay, or cultme) 
:S6 days prior to Day 1. If the subject meets eligibility criteria based on results of tests completed 
as pmi of standard of cm·e, Visit 1 and 2 procedmes, including randomization and IMP 
administration, may occm on the same day provided the subject continues to satisfy all 
inclusion/ exclusion criteria. 
Nasal samples will be obtained at each study visit, with the exception of Screening (Visit 1 ), for 
analysis at the centrallaborat01y. Two samples will be collected at each time point, 1 from each 
naris. Nasal samples will be analyzed using RT-qPCR to detennine RSV viral load, RSV 
sequencing to evaluate develOJ.)lnent of resistance (see Section 6.11.2), and a multij.)lex assay to 
identi 
co-infections. I PPD 
The procedme for collecting, storing and shipping induced sputum samples will be outlined in 
the Laborat01y Manual. 
Blood samples will be collected for RSV viremia evaluation (RT-qPCR) at Visits 2, 4, 6, 7, 8, 9, 
and 10 (Days 1, 5, 9, 13, 17, 22 and 28) prior to dosing, and RSV antibody titers at Visits 2 
and 10 (Days 1 and 28). Samples will be processed, stored and shipped to the central laborat01y 
as per instmctions outlined in the Laborat01y Manual. 
6.11.2. 
Virology and Resistance Monitoring 
To assess the potential for emergence of resistance to GS-5806, population sequencing of the 
RSV F gene will be conducted on evaluable nasal swab samples collected from GS-5806 and 
placebo-treated RSV -infected subjects according to the Resistance Analysis Plan. In addition, all 
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Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
Final 
Amendment2 
Population sequencing of the RSV F gene will be conducted on evaluable nasal swab 
samples from all GS-5806-treated RSV-infected subjects in this group. Any mutation in the 
F gene identified by population sequencing in GS-5806-u·eated subjects relative to the 
preu·eatment baseline sequence will be characterized phenotypically following their inu·oduction 
into wild-type RSV using an established reverse genetics system. The susceptibility of the 
F mutant recombinants to GS-5806 will be assessed in cell-based antiviral susceptibility assays 
to detennine whether each u·eahnent-emergent mutation (TEM) confers reduced susceptibility to 
the compound. 
6.11.3. 
Vital Signs 
This assessment will include body temperature, heatt rate, respirat01y rate, and blood pressure. 
The subject is required to sit quietly for approximately 2 minutes prior to obtaining VS. Vital 
signs will be collected at all study visits perf01med in the hospital or clinic, with the exception of 
the optional extended viral monitoring visits. 
6.11.4. 
Oxygen Saturation 
0 2 saturation assessment will begin by first asking the subject to sit quietly for 1 minute. 
0 2 saturation will be recorded while breathing room air, even if the subject is dependent on 
0 2 supplementation. If the subject is receiving supplemental 0 2, the 0 2 source will be removed 
for a period of 30 seconds prior to this assessment. The 0 2 saturation will be documented in the 
source at regular intervals (approximately evety 15 seconds) during the 2-minute testing period. 
0 2 saturation evaluation will be considered complete when the 2-minute period has elapsed, or 
when the subject achieves a saturation of 87%, whichever is achieved first. The lowest 
0 2 saturation recorded over the 2-minute interval will be captured in the eCRF. 0 2 saturation will 
be collected at all study visits perf01m ed in the hospital or clinic. Subjects undergoing invasive 
mechanical ventilation will not have the oxygen removed and "< 87%" should be recorded in the 
source documentation and the reason should be documented. If it is detennined by the 
investigator that it is lmsafe to remove the subject's supplemental 0 2 for assessment of 
0 2 saturation (eg, subject is on high-flow mask), then this should be recorded in the source 
documentation as "< 87%" and the reason should be documented. 
6.11.5. 
Plasma PK 
PK blood sampling will be perf01m ed using the site's local procedures and analyzed at a cenu·al 
laborat01y. PK blood samples will be processed, placed in individual tubes, and stored/shipped 
to the centi·allaboratOiy as per instructions outlined in the Laborat01y Manual. PK samples will 
be obtained for all subjects at Visits 2, 4, 6, 7, 8 and 9. For hospitalized subjects, an additional 
PK sample will be obtained at Visit 3 (48 hours [±3 hours] post-first GS-5806 dose) as outlined 
in Table 6-1. Subjects who are not hospitalized Visit 3 will not retum to the hospital or clinic for 
this blood draw. These plasma PK samples may also be used to evaluate the plasma PK of 
co-administered agents (eg, ganciclovir, acyclovir). 
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Final 
Gilead Sciences, Inc. 
Amendment 2 
Table 6-1. 
PK Timepoints 
Visit 2 
Visit 3 
Visit 4 
Visit 6 
Visit 7 
Visit 8 
Visit 9 
(Day 1) 
(Day 3) 
(Day 5) 
(Day 9) 
(Day 13) 
(Day 17) 
(Day 22) 
4hrs post-dose 
anytime 
pre-dose 
pre-dose 
pre-dose 
pre-dose 
anytime 
X (for 
PK samples 
X 
hospitalized 
X 
X 
X 
X 
X 
subjects only) 
6.11.6. 
Safety Labs 
When available, the most recent laborat01y values (obtained within 7 days prior to Screening 
[Visit 1]) may be used for eligibility assessment, with the exception of RSV results and 
pregnancy testing. If an existing laboratory value is not available for eligibility assessment, the 
test will be perf01med using the local laborat01y. All testing of samples obtained after the 
screening assessments will be perf01med at a centmllaborat01y selected by GSI. 
Testing of blood specimens will include WBC with differential, Hgb, platelets, BUN, creatinine, 
semm albumin, AST, ALT, and total bilimbin at Visits 2, 4, 6, 7, 8, 9, and 10 (Days 1, 5, 9, 13, 
17, 22, and 28). Blood samples will be collected pre-dose at all visits where IMP is 
administered. 
A blood specimen for senun creatinine will be collected 4 homs post-dose at Visit 2 (Day 1). 
For hospitalized subjects, blood specimens for senun creatinine will be collected on Days 2, 3, 
and 4 (24, 48, and 72 homs [±3 homs] post-first GS-5806 dose). Subjects who are not 
hospitalized dming this time will not retmn to the hospital or clinic for these blood draws. 
Urine or senun pregnancy tests will occm for all females of childbearing potential at Screening 
and at each dosing visit (Visits 2, 4, 6, 7, and 8) prior to adminisu·ation of IMP. 
6.11.7. 
Chest X-ray 
Results from chest X-rays and CT scans used for screening and eligibility, including the 
comparison chest radiograph, will be collected and stored elecu·onically for a possible cenu·al 
read. 
6.11.8. 
Optional Extended Viral Monitoring 
PD 
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Amendment 2
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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse 
Events
7.1.1.
Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical study subject 
administered a medicinal product, which does not necessarily have a causal relationship with the
treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease 
temporally associated with the use of a medicinal product, whether or not considered related to 
the medicinal product. AEs may also include pre- or post-treatment complications that occur as a 
result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or 
occupational exposure. Preexisting events that increase in severity or change in nature during or 
as a consequence of participation in the clinical study will also be considered AEs.
An AE does not include the following:

Medical or surgical procedures such as surgery, endoscopy, tooth extraction, and transfusion.
The condition that led to the procedure may be an adverse event and must be reported.

Pre-existing diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen

Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions)

Overdose without clinical sequelae 

Any medical condition or clinically significant laboratory abnormality with an onset date 
before the consent form is signed and not related to a protocol-associated procedure is not an 
AE. It is considered to be pre-existing and should be documented on the medical history 
CRF.
7.1.2.
Serious Adverse Events
A serious adverse event (SAE) is defined as an event that, at any dose, results in the following:

Death

Life-threatening (Note: The term “life-threatening” in the definition of “serious” refers to an 
event in which the subject was at risk of death at the time of the event; it does not refer to an 
event that hypothetically might have caused death if it were more severe.)

In-patient hospitalization or prolongation of existing hospitalization


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Amendment 2
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
Persistent or significant disability/incapacity

A congenital anomaly/birth defect

A medically important event or reaction: such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the subject or may 
require intervention to prevent one of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is a reportable 
under expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse. For the avoidance of doubt, infections resulting from contaminated medicinal 
product will be considered a medically important event and subject to expedited reporting 
requirements.
7.1.2.1.
Protocol-Specific Serious Adverse Event Instructions
Protocol-specific SAE reporting exemptions: In this study, death related to clinical progression
of underlying disease requiring HCT, or graft failure will not need to be reported as an SAE.
Death related to clinical progression of underlying disease requiring HCT, or graft failure should 
only be reported as SAEs on the eCRF, unless there is evidence suggesting a causal relationship 
between the IMP or study procedure and the event.  In that case, the investigator must 
immediately report the event as an SAE in accordance with the procedure in Section 7.3 below.  
Such clinical progression or graft failure which are assessed as not related to IMP/procedure) 
will be exempt from global expedited reporting requirements for the duration of the study.  The 
events will be collected and evaluated by Gilead and reported as appropriate in any relevant 
aggregate safety report, as well as the final clinical study report.
To minimize the possibility of exposing study subjects to unusual risk, the safety information 
from the study will also be reviewed by an independent DMC on an ongoing basis.   The DMC
may have access to partially blinded or unblinded data and will determine if it is safe to continue 
the study according to the protocol.
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not recorded as AEs or SAEs. 
However, laboratory abnormalities (eg, clinical chemistry, hematology, and urinalysis) that 
require medical or surgical intervention or lead to IMP interruption, modification, or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, electrocardiogram, X-rays, vital signs) that are 
associated with signs and/or symptoms must be recorded as an AE or SAE if they meet the 
definition of an AE or SAE as described in Sections 7.1.1 and 7.1.2. If the laboratory 
abnormality is part of a syndrome, record the syndrome or diagnosis (eg, anemia), not the 
laboratory result (ie, decreased hemoglobin).


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Amendment 2
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For specific information on handling of clinical laboratory abnormalities in this study, please 
refer to Section 7.5.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or a designated qualified subinvestigator is responsible for assessing AEs and 
SAEs for causality and severity, and for final review and confirmation of accuracy of event
information and assessments.
7.2.1.
Assessment of Causality for IMP and Procedures
The investigator or a designated qualified subinvestigator is responsible for assessing the 
relationship to IMP therapy using clinical judgment and the following considerations:

No: Evidence exists that the adverse event has an etiology other than the IMP. For SAEs, an 
alternative causality must be provided (eg, pre-existing condition, underlying disease, 
intercurrent illness, or concomitant medication).

Yes: There is reasonable possibility that the event may have been caused by the 
investigational medicinal product.
It should be emphasized that ineffective treatment should not be considered as causally related in 
the context of adverse event reporting. 
The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations:

No: Evidence exists that the adverse event has an etiology other than the study procedure.

Yes: The adverse event occurred as a result of protocol procedures (eg, venipuncture)
7.2.2.
Assessment of Severity
Severity should be recorded and graded according to the GSI Grading Scale for Severity of 
Adverse Events and Laboratory Abnormalities For AEs or SAEs associated with laboratory 
abnormalities, the event should be graded on the basis of the clinical severity in the context of 
the underlying conditions; this may or may not be in agreement with the grading of the 
laboratory abnormality.
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events 
and Serious Adverse Events to Gilead
Requirements for collection prior to IMP initiation:
After informed consent, but prior to initiation of study medication, the following types of events 
should be reported on the case report form (eCRF): all SAEs and adverse events related to 
protocol-mandated procedures.


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Adverse Events:
Following initiation of study medication, all AEs, regardless of cause or relationship, through the 
Day 28 End of Study visit must be reported to the eCRF database as instructed. All AEs should 
be followed up until resolution or until the adverse event is stable, if possible. Gilead Sciences 
may request that certain AEs be followed beyond the protocol defined follow up period, as 
determined by the Medical Monitor.
Serious Adverse Events:
All SAEs, regardless of cause or relationship, that occurs after the subject first consents to 
participate in the study (ie, signing the informed consent) and throughout the duration of the 
study, including the protocol-required post treatment follow-up period, must be reported to the 
eCRF database and Gilead Drug Safety and Public Health (DSPH) as instructed. This also 
includes any SAEs resulting from protocol-associated procedures performed after informed 
consent is signed.
Any SAEs and deaths that occur after the post treatment follow-up visit but within 30 days or 
4-weeks of the last dose of study IMP, regardless of causality, should also be reported. 
Investigators are not obligated to actively seek SAEs after the protocol defined follow up period
(the Day 28 End of Study visit), however, if the investigator learns of any SAEs that occur after 
study participation has concluded and the event is deemed relevant to the use of IMP, he/she 
should promptly document and report the event to Gilead DSPH.
During the optional extended viral monitoring period (through Day 56), AEs related to 
protocol-mandated procedures must be collected and reported to Gilead DSPH.
All AEs and SAEs will be recorded in the eCRF database within the timelines outlined in the 
eCRF completion guideline. 
Electronic Serious Adverse Event (eSAE) Reporting Process:

Site personnel record all SAE data in the eCRF database and from there transmit the SAE 
information to Gilead DSPH within 24 hours of the investigator’s knowledge of the event. 
Detailed instructions can be found in the eCRF completion guidelines.

If for any reason it is not possible to record the SAE information electronically (ie, the eCRF 
database is not functioning), record the SAE on the paper serious adverse event reporting 
form and submit within 24 hours to:
Gilead DSPH:
Fax:
+1-650-522-5477
E-mail:Safety_fc@gilead.com


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
As soon as it is possible to do so, any SAE reported via paper must be transcribed into the 
eCRF Database according to instructions in the eCRF completion guidelines.

If an SAE has been reported via a paper form because the eCRF database has been locked, no 
further action is necessary.

For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be submitted by e-mail or fax when requested and applicable. 
Transmission of such documents should occur without personal subject identification, 
maintaining the traceability of a document to the subject identifiers.

Additional information may be requested to ensure the timely completion of accurate safety 
reports.

Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the subject’s CRF/eCRF and the event description section of the SAE 
form.

Site personnel should record all SAE data in the eCRF database for those protocol-specific 
SAEs which are exempted from expedited reporting requirements (Section 7.1.2.1).  They 
should also transmit the SAE information to Gilead DSPH if the SAEs are assessed by the 
investigator as related to the IMP or study procedure.
7.4.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA Code of 
Federal Regulations, the EU Clinical Trials Directive (2001/20/EC) and relevant updates, and 
other country-specific legislation or regulations, Gilead may be required to expedite to 
worldwide regulatory agencies reports of SAEs, serious adverse drug reactions (SADRs), or 
suspected unexpected serious adverse reactions (SUSARs). In accordance with the EU Clinical 
Trials Directive (2001/20/EC), Gilead or a specified designee will notify worldwide regulatory 
agencies and the relevant Independent Ethics Committee (IEC) in concerned Member States of 
applicable SUSARs as outlined in current regulations.
Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the current GS-5806 IB or relevant local label as applicable. 
All investigators will receive a safety letter notifying them of relevant SUSAR reports associated 
with any study IMP. The investigator should notify the IRB or IEC of SUSAR reports as soon as 
is practical, where this is required by local regulatory agencies, and in accordance with the local 
institutional policy. 


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7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities are usually not recorded as AEs or SAEs. However, laboratory 
abnormalities (eg, clinical chemistry, hematology) independent of the underlying medical 
condition that require medical or surgical intervention or lead to IMP interruption or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, vital signs) that are associated with signs and/or 
symptoms must be recorded as an AE or SAE if they meet the definition of an AE or SAE, 
respectively, as described in Section 7.1. If the laboratory abnormality is part of a syndrome, 
record the syndrome or diagnosis (ie, anemia) not the laboratory result (ie, decreased 
hemoglobin).
Severity should be recorded and graded according to the GSI Grading Scale for Severity of 
Adverse Events and Laboratory Abnormalities Appendix 4. For AEs or SAEs associated with 
laboratory abnormalities, the event should be graded on the basis of the clinical severity in the 
context of the underlying conditions; this may or may not be in agreement with the grading of 
the laboratory abnormality.
7.6.
Toxicity Management 
All clinical and clinically significant laboratory toxicities will be managed according to uniform 
guidelines detailed in Appendix 3.
Any questions regarding toxicity management should be directed to the Gilead Sciences Medical
Monitor.
7.7.
Special Situations Reports
7.7.1.
Definitions of Special Situations
Special situation reports include all reports of medication error, abuse, misuse, overdose, reports 
of adverse events associated with product complaints, and pregnancy reports regardless of an 
associated AE.  
Medication error is any unintentional error in the prescribing, dispensing, or administration of a 
medicinal product while in the control of the health care provider, subject, or consumer.
Abuse is defined as persistent or sporadic intentional excessive use of a medicinal product by a 
subject.
Misuse is defined as any intentional and inappropriate use of a medicinal product that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a medicinal 
product given per administration or cumulatively which is above the maximum recommended 
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question). In cases of a discrepancy in drug accountability, overdose will be established only 
when it is clear that the subject has taken the excess dose(s). Overdose cannot be established 
when the subject cannot account for the discrepancy except in cases in which the investigator has 
reason to suspect that the subject has taken the additional dose(s).
Product complaint is defined as complaints arising from potential deviations in the manufacture, 
packaging, or distribution of the medicinal product.  
7.7.2.
Instructions for Reporting Special Situations
7.7.2.1.
Instructions for Reporting Pregnancies
The investigator should report pregnancies in female study subjects that are identified after 
initiation of study medication and throughout the study, including the post IMP follow-up period, 
to Gilead DSPH using the pregnancy report form within 24 hours of becoming aware of the 
pregnancy.
Refer to Section 7.3 and the eCRF completion guidelines for full instructions on the mechanism 
of pregnancy reporting.
The pregnancy itself is not considered an AE nor is an induced elective abortion to terminate a 
pregnancy without medical reasons.
Any premature termination of pregnancy (eg, a spontaneous abortion, an induced therapeutic 
abortion due to complications or other medical reasons) must be reported within 24 hours as an 
SAE. The underlying medical reason for this procedure should be recorded as the AE term.
A spontaneous abortion is always considered to be an SAE and will be reported as described in 
Section 7.3. Furthermore, any SAE occurring as an adverse pregnancy outcome post study must 
be reported to Gilead DSPH.
The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome should be reported to Gilead DSPH using the pregnancy outcome report 
form. If the end of the pregnancy occurs after the study has been completed, the outcome should 
be reported directly to Gilead DSPH. Gilead DSPH contact information is provided in 
Section 7.3.
Pregnancies of female partners of male study subjects exposed to Gilead or other investigational 
agents must also be reported and relevant information should be submitted Gilead DSPH using 
the pregnancy and pregnancy outcome forms within 24 hours. Monitoring of the subject should 
continue until the conclusion of the pregnancy. If the end of the pregnancy occurs after the study 
has been completed, the outcome should be reported directly to Gilead DSPH.
Refer to Appendix 5 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Requirements.


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7.7.2.2.
Reporting Other Special Situations
All other special situation reports must be reported on the special situations report form and 
forwarded to Gilead DSPH within 24 hours of the investigator becoming aware of the situation. 
These reports must consist of situations that involve study IMP and/or Gilead concomitant 
medications, but do not apply to non-Gilead concomitant medications. 
Special situations involving non-Gilead concomitant medications does not need to be reported on 
the special situations report form; however, for special situations that result in AEs due to a 
non-Gilead concomitant medication, the AE should be reported in the eCRFs. 
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
Refer to Section 7.3 and the CRF/eCRF completion guidelines for full instructions on the 
mechanism of special situations reporting.
All clinical sequelae in relation to these special situation reports will be reported as AEs or SAEs 
at the same time using the AE CRF/eCRF and/or the SAE report form. Details of the symptoms 
and signs, clinical management, and outcome will be reported, when available.


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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
The primary objective of this study is as follows:

To evaluate the effect of GS-5806 on RSV viral load in autologous or allogeneic HCT 
recipients with an acute RSV LRTI
The secondary objectives of this study are as follows: 

To evaluate the effect of GS-5806 on rates of respiratory failure and all-cause mortality

To evaluate the PK, safety and tolerability of GS-5806
8.1.2.
Primary Endpoint
The primary endpoint is the time-weighted average change in nasal RSV viral load
(log10 copies/mL) from Baseline (Day 1) to Day 9 as measured by RT-qPCR. The time-weighted 
average change in nasal RSV viral load from Baseline to Day 9 is defined as:
∑
  {0.5 × (. +
) × (
−
)} 
(
−
)
where Yi is the change from Baseline in RSV log10 viral load at Visit i, t is the time at the 
specified timepoint, a is the Baseline assessment at Day 1 and b is the last assessment at or prior 
to Day 9. The time-weighted average change, often referred to as the DAVG, provides the 
average viral burden in change from baseline during the time period of interest.
8.1.3.
Secondary Endpoint
Secondary endpoints are:

Proportion of subjects developing respiratory failure (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28

Proportion of all-cause mortality among subjects through Day 28
8.1.4.
Other Endpoints of Interest
Other endpoints of interest are:

RSV log10 viral load and change from baseline in RSV log10 viral load in the nasal samples  

Time-weighted average RSV log10 viral load and time-weighted average change from 
baseline in RSV log10 viral load in the nasal samples 


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
Proportion of subjects with detectable RSV in the nasal samples

Proportion of subjects requiring supplemental O2 (≥ 2 L/min) 

RSV log10 viral load and change from baseline in RSV log10 viral load in the blood 

Time-weighted average RSV log10 viral load and time-weighted average change from 
baseline in RSV log10 viral load in the blood

Proportion of subjects who have detectable RSV in the blood 

Proportion of subjects whose O2 saturation drops below 88% by Day 28

O2 saturation and change from baseline in O2 saturation

Time-weighted average O2 saturation and time-weighted average change from baseline in O2
saturation 

Proportion of subjects requiring ICU admission or equivalent ICU care (due to any cause) 
through Day 28 

Total number of ICU admissions or equivalent ICU care hours (for subjects receiving ICU 
care) through Day 28

Total number of mechanical ventilation (invasive or non-invasive) hours through Day 28

Duration of hospitalization through Day 28
8.2.
Analysis Conventions
8.2.1.
Analysis Sets
8.2.1.1.
Efficacy
The full analysis set (FAS) will include subjects who have an RSV log10 viral load greater than 
or equal to the LLOQ of the RT-qPCR assay in the pre-dose Day 1 nasal sample, as determined 
by RT-qPCR at the central lab, and have received at least 1 full dose of IMP.
8.2.1.2.
Safety
The primary analysis set for safety analyses is defined as all subjects who received at least a full 
dose of IMP.
All data collected during treatment will be included in the safety summaries.
8.2.1.3.
Pharmacokinetics 
The PK analysis set will include all subjects in the safety analysis set who have evaluable 
on-study PK measurements.


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8.3.
Data Handling Conventions
Missing data can have an impact upon the interpretation of the trial data. As this study is of short 
duration, it is anticipated that missing data will be minimal. In general, values for missing data 
will not be imputed. For laboratory data, a missing Baseline value will be replaced with a 
screening value, if available; otherwise it will be treated as normal (ie, Grade 0; no toxicity 
grade) for the summary of graded laboratory abnormalities. A retest value may be used if the 
first test is invalidated (eg, specimen hemolyzed).
Values will not be imputed for missing vital sign and other safety data; however, a missing 
Baseline value will be replaced with a Screening value, if available. 
Details for the handling of missing data due to subject discontinuation or other reasons, including 
unusable and spurious data, and rules for determining major and minor protocol deviations will 
be described in the SAP.
All available data for subjects that do not complete the study will be included in the data listings. 
Tables that include both individual subject PK data and summary statistics will present all 
available data, but only subjects in the PK analysis will be included in the summary statistics.
Viral load data will be log transformed prior to analyses.
8.4.
Demographic Data and Baseline Characteristics
Demographic and Baseline measurements will be summarized using standard descriptive 
methods.
Demographic summaries will include sex, race/ethnicity, randomization stratification group, and 
age.
Baseline data will include a summary of body weight, height, and BMI.
For categorical demographic and Baseline characteristics, a Fisher’s exact test will be used to 
compare treatment groups. For continuous demographic and Baseline characteristics, a Wilcoxon 
rank sum test will be used to compare treatment groups.
8.5.
Efficacy Analysis
8.5.1.
Primary Analysis
The primary endpoint is the time-weighted average change in nasal RSV viral load
(log10 copies/mL) from Day 1 to Day 9. The primary analysis will be performed on subjects 
included in the FAS population. To test the null hypothesis that there is no difference between 
the GS-5806 and placebo treatment groups in the time-weighted average change in viral load, a 
parametric analysis of covariance (ANCOVA) model with corresponding Baseline viral load as a 
covariate will be used, with a 2-sided 0.05 level. Adjusted means and 95% confidence intervals 
(CIs) will also be presented. 


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Secondary Analyses 
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The F AS will be used for all summaries and analyses of secondmy endpoints. All secondaiy 
endpoints will be analyzed using 2-sided tests to compare treatment differences. 
The proportion of subjects who develop respirat01y failure requiring mechanical ventilation and 
the proportion of subjects with all-cause mortality will be analyzed using Fisher's exact tests. 
In order to accmmt for multiple hypothesis testing of endpoints, a fainily alpha spending mle will 
be used to control the Type 1 en or rate of 0.05 across the primmy and secondaiy endpoints, 
testing for differences between u·eatment groups. The primmy endpoint analysis will serve as 
the gatekeeper for the seconda1y analyses. If the primmy null hypothesis is rejected, then the 
following secondmy endpoints will be tested sequentially at a = 0.05 based upon the closed 
testing procedure { 11631}. 
• 
Prop01tion of subjects developing respirat01y failure (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28 
• 
Proportion of all-cause m01tality among all subjects through Day 28 
8.5.3. 
Exploratory Analyses 
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Safety Analysis 
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All safety data collected on or after the date that IMP was first dispensed up to the date of last 
dose of IMP through Day 28 will be summarized by u·eatment group (according to the IMP 
received). Data for the preu·eatment and u·eahnent-free follow-up periods will be included in data 
listings only. Data for the u·eatment period will be summarized by u·eahnent (active or placebo) 
using the number of subjects (n and percent) with events/abnonnalities for categorical data and 
using descriptive statistics for continuous data. 
8.7. 
Extent of Exposure 
A subject's extent of exposure to IMP data will be generated from the IMP adminisu·ation data. 
Exposure data will be summarized by u·eahnent group. 
8.7.1. 
Adverse Events 
Clinical and laborat01y adverse events will be coded using the Medical Dictiomuy for 
Regulat01y Activities (MedDRA). System Organ Class (SOC), High-Level Group Te1m 
(HLGT), High-Level Te1m (HLT), Prefen ed Te1m (PT), and Lower-Level Te1m (LLT) will be 
attached to the clinical database. 
Events will be summarized on the basis of the date of onset for the event. A u·eatment-emergent 
adverse event will be defined as any adverse event that begins on or after the date of first dose of 
IMP up to the date oflast dose of IMP tluough Day 28. 
Summaries (number and percentage of subjects) ofu·eatment-emergent adverse events (by SOC, 
and PT) will be provided by u·eahnent group. 
8.7.2. 
Laboratory Evaluations 
Selected laborat01y data will be summarized using only observed data. Data and change from 
Baseline at all scheduled time points will be summarized. 
Graded laborat01y abn01malities will be defmed using the grading scheme in Appendix 4. 
Grading of laborat01y abn01malities for analysis purposes will be perfonned by GSI. 
fucidence ofu·eatment-emergent laborat01y abnonnalities, defined as values that increase at least 
1 toxicity grade from Baseline at any time post Baseline up to and including Day 28 will be 
summarized by u·eatment group. If Baseline data are missing, then any graded abn01mality 
(ie, at least a Grade 1) will be considered u·eahnent emergent. 
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Laboratory abnormalities that occur before the first dose of IMP or after the subject has been 
discontinued from treatment for at least 28 days will be included in a data listing.
8.7.3.
Other Safety Evaluations
Vital signs data will be summarized using descriptive statistics by the observed data and by the 
change from Baseline at each time point.
8.8.
Pharmacokinetic Analysis
Individual subject GS-5806 concentration-time data will be displayed using scheduled sampling 
times. Descriptive statistics (eg, n, mean, standard deviation, %CV, median, and range) will be 
calculated for each sampling time. PK/PD relationship may be explored as appropriate.
8.9.
Sample Size
Sample size calculations are based on results observed in a study that evaluated the efficacy of 
oral and aerosolized ribavirin treatment for preventing progression from upper to lower 
respiratory tract infection in hematopoietic cell transplant recipients with RSV infections
(unpublished data from Dr. 
).  The sample size calculation assumes the 
time-weighted average change in RSV log10 viral load from Day 1 to Day 9 in the placebo group 
will be -1.5 log10 copies/mL with a corresponding standard deviation (SD) of 1.75 and that 85% 
of the subjects will be evaluable.  Based on these assumptions, with 25 subjects per group there 
is approximately 85% power to detect a 1.5 log difference in time-weighted average change in 
log10 viral load between treatment groups using a 2-sided 0.05-level test.  Given an evaluable 
rate of 85%, a total of 60 subjects will need to be randomized into the study.
8.10.
Data Monitoring Committee
An external multidisciplinary data monitoring committee (DMC) will review the progress of the 
study and perform interim reviews of safety  data as specified in the DMC charter, and provide 
recommendation to Gilead whether the nature, frequency, and severity of adverse effects 
associated with study treatment warrant the early termination of the study in the best interests of 
the participants, whether the study should continue as planned, or the study should continue with 
modifications.   
The DMC’s specific activities will be defined by a mutually agreed charter, which will define the 
DMC’s membership, conduct and meeting schedule.
While the DMC will be asked to advise Gilead regarding future conduct of the study, including 
possible early study termination, Gilead retains final decision-making authority on all aspects of 
the study.
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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and 
South Africa), International Conference on Harmonisation (ICH) guidelines, or with the laws and 
regulations of the country in which the research is conducted, whichever affords the greater 
protection to the study subject. These standards are consistent with the European Union Clinical 
Trials Directive 2001/20/EC and Good Clinical Practice Directive 2005/28/EC.
The investigator will ensure adherence to the basic principles of Good Clinical Practice, as 
outlined in 21 CFR 312, subpart D, “Responsibilities of Sponsors and Investigators,” 21 CFR, 
part 50, 1998, and 21 CFR, part 56, 1998.
The investigator and all applicable subinvestigators will comply with 21 CFR, Part 54, 1998, 
providing documentation of their financial interest or arrangements with Gilead, or proprietary 
interests in the investigational drug under study. This documentation must be provided prior to 
the investigator’s (and any subinvestigator’s) participation in the study. The investigator and 
subinvestigator agree to notify Gilead of any change in reportable interests during the study and 
for 1 year following completion of the study. Study completion is defined as the date when the 
last subject completes the protocol-defined activities.
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval
The investigator (or sponsor as appropriate according to local regulations) will submit this 
protocol, informed consent form, and any accompanying material to be provided to the subject 
(such as advertisements, subject information sheets, or descriptions of the study used to obtain 
informed consent) to an IRB/IEC, depending on region. The investigator will not begin any study 
subject activities until approval from the IRB/IEC has been documented and provided as a letter 
to the investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC for any modifications made to the protocol or any accompanying material to be 
provided to the subject after initial approval, with the exception of those necessary to reduce 
immediate risk to study subjects.
9.1.3.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study and before undertaking any study-related procedures. The 


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investigator must use the most current IRB or IEC-approved consent form for documenting 
written informed consent. Each informed consent (or assent as applicable) will be appropriately 
signed and dated by the subject or the subject’s legally authorized representative and the person 
conducting the consent discussion, and also by an impartial witness if required by IRB/IEC or
local requirements.
9.1.4.
Confidentiality
The investigator must assure that subjects’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only subject initials, date of birth, another 
unique identifier (as allowed by local law) and an identification code will be recorded on any 
form or biological sample submitted to the Sponsor, IRB/IEC, or laboratory. Laboratory 
specimens must be labeled in such a manner as to protect subject identity while allowing the 
results to be recorded to the proper subject. Refer to specific laboratory instructions.  NOTE: The 
investigator must keep a screening log showing codes, names, and addresses for all subjects 
screened and for all subjects enrolled in the trial. Subject data will be processed in accordance 
with all applicable regulations.
The investigator agrees that all information received from Gilead, including but not limited to the 
investigator brochure, this protocol, CRF/eCRF, the IMP, and any other study information, 
remain the sole and exclusive property of Gilead during the conduct of the study and thereafter. 
This information is not to be disclosed to any third party (except employees or agents directly 
involved in the conduct of the study or as required by law) without prior written consent from 
Gilead. The investigator further agrees to take all reasonable precautions to prevent the 
disclosure by any employee or agent of the study site to any third party or otherwise into the 
public domain.
9.1.5.
Study Files and Retention of Records
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following two categories: (1) investigator’s study file, and 
(2) subject clinical source documents.
The investigator’s study file will contain the protocol/amendments, CRF and query forms,
IRB/IEC and governmental approval with correspondence, informed consent, drug records, staff 
curriculum vitae and authorization forms, and other appropriate documents and correspondence.
The required source data should include sequential notes containing at least the following 
information for each subject:

Subject identification (name, date of birth, gender);

Documentation that subject meets eligibility criteria, ie, history, physical examination, and 
confirmation of diagnosis (to support inclusion and exclusion criteria);


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
Documentation of the reason(s) a consented subject is not enrolled

Participation in study (including study number);

Study discussed and date of informed consent;

Dates of all visits;

Documentation that protocol specific procedures were performed;

Results of efficacy parameters, as required by the protocol;

Start and end date (including dose regimen) of IMP, including dates of dispensing and return;

Record of all adverse events and other safety parameters (start and end date, and including 
causality and severity);

Concomitant medication (including start and end date, dose if relevant; dose changes);

Date of study completion and reason for early discontinuation, if it occurs.
All clinical study documents must be retained by the investigator until at least 2 years or 
according to local laws, whichever is longer, after the last approval of a marketing application in 
an ICH region (ie, United States, Europe, or Japan) and until there are no pending or planned 
marketing applications in an ICH region; or, if no application is filed or if the application is not 
approved for such indication, until 2 years after the investigation is discontinued and regulatory 
authorities have been notified. Investigators may be required to retain documents longer if 
specified by regulatory requirements, by local regulations, or by an agreement with Gilead. The 
investigator must notify Gilead before destroying any clinical study records.
Should the investigator wish to assign the study records to another party or move them to another 
location, Gilead must be notified in advance.
If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and Gilead to store 
these records securely away from the site so that they can be returned sealed to the investigator 
in case of an inspection. When source documents are required for the continued care of the 
subject, appropriate copies should be made for storage away from the site.
9.1.6.
Case Report Forms
For each subject consented, an eCRF will be completed by an authorized study staff member 
whose training for this function is documented according to study procedures. eCRF should be 
completed on the day of the subject visit to enable the sponsor to perform central monitoring of 
safety data.  Subsequent to data entry, a study monitor will perform source data verification 
within the EDC system. Original entries as well as any changes to data fields will be stored in 


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Amendment 2
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the audit trail of the system.  Prior to database lock (or any interim time points as described in the 
clinical data management plan), the investigator will use his/her log in credentials to confirm that 
the forms have been reviewed, and that the entries accurately reflect the information in the 
source documents. The eCRF capture the data required per the protocol schedule of events and 
procedures. System-generated or manual queries will be issued to the investigative site staff as
data discrepancies are identified by the monitor or internal Gilead staff, who routinely review the 
data for completeness, correctness, and consistency. The site coordinator is responsible for 
responding to the queries in a timely manner, within the system, either by confirming the data as 
correct or updating the original entry, and providing the reason for the update (eg, data entry 
error). At the conclusion of the trial, Gilead will provide the site with a read-only archive copy 
of the data entered by that site. This archive must be stored in accordance with the records 
retention requirements outlined in Section 9.1.5.
9.1.7.
Data Quality Control and Quality Assurance
To insure accurate, complete, and reliable data, the Sponsor or its representatives will do the 
following:

Provide instructional material to the study sites, as appropriate.

Instruct the investigators and study personnel on the protocol, the completion of the CRFs, 
and study procedures.

Make periodic visits to the study site.

Be available to consultation and stay in contact with the study site personnel by mail, email, 
telephone, and/or fax.

Monitor the subject data recorded in the CRFs against source documents at the study site.

Review and evaluate CRF data and use standard computer edits to detect errors in data 
collection.
9.1.8.
Investigational Medicinal Product Accountability and Return
Gilead recommends that used and unused IMP supplies be destroyed on site if possible.  The 
study monitor will evaluate each study center’s IMP disposal procedures and provide appropriate 
instruction for destruction of unused IMP supplies. If the site has an appropriate standard 
operating procedure (SOP) for drug destruction as determined by Gilead QA, the site may 
destroy used (empty or partially empty) and unused IMP supplies in accordance with that site’s 
approved SOP. A copy of the site’s approved SOP will be obtained for central files. If IMP 
cannot be destroyed on site, the study monitor will provide instructions for return to Gilead or
the shipping facility from which it came for eventual destruction.


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If IMP is destroyed on site, the investigator must maintain accurate records for all IMP
destroyed. Records must show the identification and quantity of each unit destroyed, the method 
of destruction, and the person who disposed of the IMP. Upon study completion, copies of the 
IMP accountability records must be filed at the site. Another copy will be returned to Gilead.
The study monitor will review IMP supplies and associated records at periodic intervals.
9.1.9.
Inspections
The investigator will make available all source documents and other records for this trial to 
Gilead’s appointed study monitors, to IRB/IECs, or to regulatory authority or health authority 
inspectors.
9.1.10.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.
9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications, except those intended to reduce immediate risk to study subjects, may be 
made only by Gilead. The investigator must submit all protocol modifications to the IRB/IEC in 
accordance with local requirements and receive documented IRB/IEC approval before 
modifications can be implemented.
9.2.2.
Study Report and Publications
A clinical study report (CSR) will be prepared and provided to the applicable regulatory 
agencies. Gilead will ensure that the report meets the standards set out in the ICH Guideline for 
Structure and Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may 
be prepared in certain cases.
Investigators in this study may communicate, orally present, or publish in scientific journals or 
other scholarly media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent 
of Gilead in an abstract, manuscript, or presentation form or the study has been completed at 
all study sites for at least 2 years.

The investigator will submit to Gilead any proposed publication or presentation along with 
the respective scientific journal or presentation forum at least 30 days before submission of 
the publication or presentation. 


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Gilead Sciences, Inc.
Amendment 2
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
No such communication, presentation, or publication will include Gilead’s confidential 
information (see Section 9.1.4).

The investigator will comply with Gilead’s request to delete references to its confidential 
information (other than the study results) in any paper or presentation and agrees to withhold 
publication or presentation for an additional 60 days in order to obtain patent protection if 
deemed necessary.
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol (eg, attendance at Investigator's Meetings).  If required under the applicable statutory 
and regulatory requirements, Gilead will capture and disclose to Federal and State agencies any 
expenses paid or reimbursed for such services, including any clinical trial payments, meal, travel 
expenses or reimbursements, consulting fees, and any other transfer of value.
9.3.2.
Access to Information for Monitoring
In accordance with regulations and guidelines, the study monitor must have direct access to the 
investigator’s source documentation in order to verify the accuracy of the data recorded in the 
CRF/eCRF.
The monitor is responsible for routine review of the CRF/eCRF at regular intervals throughout 
the study to verify adherence to the protocol and the completeness, consistency, and accuracy of 
the data being entered on them. The monitor should have access to any subject records needed to 
verify the entries on the CRF/eCRF. The investigator agrees to cooperate with the monitor to 
ensure that any problems detected through any type of monitoring (central, on site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or of Gilead may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority the 
investigator agrees to notify the Gilead medical monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
Study Discontinuation
Both the sponsor and the investigator reserve the right to terminate the study at any time. Should 
this be necessary, both parties will arrange discontinuation procedures and notify the appropriate 
regulatory authority(ies), IRBs, and IECs. In terminating the study, Gilead and the investigator 
will assure that adequate consideration is given to the protection of the subjects’ interests.


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Gilead Sciences, Inc.
Amendment 2
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10.
REFERENCES
11631
Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials 
that do not require all primary effects to be significant. Statist Med 2003;22 
(15):2387-400.
19902
American Academy of Pediatrics Committee on Infectious Diseases: Use of 
ribavirin in the treatment of respiratory syncytial virus infection. Pediatrics 
1993;92 (3):501-4.
20222
Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, et al. 
Global burden of acute lower respiratory infections due to respiratory syncytial 
virus in young children: a systematic review and meta-analysis. Lancet 2010;375 
(9725):1545-55.
20227
Stockman LJ, Curns AT, Anderson LJ, Fischer-Langley G. Respiratory Syncytial 
Virus-associated Hospitalizations Among Infants and Young Children in the 
United States, 1997-2006. Pediatr Infect Dis J 2012;31 (1):5-9.
20233
Nichols WG, Gooley T, Boeckh M. Community-acquired respiratory syncytial 
virus and parainfluenza virus infections after hematopoietic stem cell 
transplantation: the Fred Hutchinson Cancer Research Center experience. Biol 
Blood Marrow Transplant 2001;7 Suppl:11S-5S.
26908
Shah JN, Chemaly RF. Management of RSV infections in adult recipients of 
hematopoietic stem cell transplantation. Blood 2011;117 (10):2755-63.
26937
Shah DP, Ghantoji SS, Shah JN, El Taoum KK, Jiang Y, Popat U, et al. Impact of 
aerosolized ribavirin on mortality in 280 allogeneic haematopoietic stem cell 
transplant recipients with respiratory syncytial virus infections. J Antimicrob 
Chemother 2013;68 (8):1872-80.
28640
Boeckh M, Englund J, Li Y, Miller C, Cross A, Fernandez H, et al. Randomized 
controlled multicenter trial of aerosolized ribavirin for respiratory syncytial virus 
upper respiratory tract infection in hematopoietic cell transplant recipients. Clin 
Infect Dis 2007;44 (2):245-9.
28641
Chemaly RF, Ghosh S, Bodey GP, Rohatgi N, Safdar A, Keating MJ, et al. 
Respiratory viral infections in adults with hematologic malignancies and human 
stem cell transplantation recipients: a retrospective study at a major cancer center. 
Medicine (Baltimore) 2006;85 (5):278-87.
28643
Erard V, Chien JW, Kim HW, Nichols WG, Flowers ME, Martin PJ, et al. 
Airflow decline after myeloablative allogeneic hematopoietic cell transplantation: 
the role of community respiratory viruses. J Infect Dis 2006;193 (12):1619-25.


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Final
Gilead Sciences, Inc.
Amendment 2
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28644
Harrington RD, Hooton TM, Hackman RC, Storch GA, Osborne B, Gleaves CA, 
et al. An outbreak of respiratory syncytial virus in a bone marrow transplant 
center. J Infect Dis 1992;165 (6):987-93.
28645
Khanna N, Widmer AF, Decker M, Steffen I, Halter J, Heim D, et al. Respiratory 
syncytial virus infection in patients with hematological diseases: single-center 
study and review of the literature. Clin Infect Dis 2008;46 (3):402-12.
28646
Avetisyan G, Mattsson J, Sparrelid E, Ljungman P. Respiratory syncytial virus 
infection in recipients of allogeneic stem-cell transplantation: a retrospective 
study of the incidence, clinical features, and outcome. Transplantation 2009;88 
(10):1222-6.
28647
Kim YJ, Boeckh M, Englund JA. Community respiratory virus infections in 
immunocompromised patients: hematopoietic stem cell and solid organ transplant 
recipients, and individuals with human immunodeficiency virus infection. 
Seminars in respiratory and critical care medicine 2007;28 (2):222-42.
28648
Kim YJ, Guthrie KA, Waghmare A, Walsh EE, Falsey AR, Kuypers J, et al. 
Respiratory syncytial virus in hematopoietic cell transplant recipients: factors 
determining progression to lower respiratory tract disease. J Infect Dis 2014:1-10.
28650
Martino R, Porras RP, Rabella N, Williams JV, Ramila E, Margall N, et al. 
Prospective study of the incidence, clinical features, and outcome of symptomatic 
upper and lower respiratory tract infections by respiratory viruses in adult 
recipients of hematopoietic stem cell transplants for hematologic malignancies. 
Biol Blood Marrow Transplant 2005;11 (10):781-96.
28652
Raboni SM, Nogueira MB, Tsuchiya LR, Takahashi GA, Pereira LA, Pasquini R, 
et al. Respiratory tract viral infections in bone marrow transplant patients. 
Transplantation 2003;76 (1):142-6.
28653
Schiffer JT, Kirby K, Sandmaier B, Storb R, Corey L, Boeckh M. Timing and 
severity of community acquired respiratory virus infections after myeloablative 
versus non-myeloablative hematopoietic stem cell transplantation. Haematologica 
2009;94 (8):1101-8.
28654
Seo S, Campbell AP, Xie H, Chien JW, Leisenring WM, Englund JA, et al. 
Outcome of respiratory syncytial virus lower respiratory tract disease in 
hematopoietic cell transplant recipients receiving aerosolized ribavirin: 
significance of stem cell source and oxygen requirement. Biol Blood Marrow 
Transplant 2013;19 (4):589-96.
28655
Shah DP, Ghantoji SS, Mulanovich VE, Ariza-Heredia EJ, Chemaly RF. 
Management of respiratory viral infections in hematopoietic cell transplant 
recipients. American journal of blood research 2012;2 (4):203-18.


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Gilead Sciences, Inc.
Amendment 2
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28656
Small TN, Casson A, Malak SF, Boulad F, Kiehn TE, Stiles J, et al. Respiratory 
syncytial virus infection following hematopoietic stem cell transplantation. Bone 
Marrow Transplant 2002;29 (4):321-7.
28657
Whimbey E, Champlin RE, Couch RB, Englund JA, Goodrich JM, Raad I, et al. 
Community respiratory virus infections among hospitalized adult bone marrow 
transplant recipients. Clin Infect Dis 1996;22 (5):778-82.
28723
Hirsch HH, Martino R, Ward KN, Boeckh M, Einsele H, Ljungman P. Fourth 
European Conference on Infections in Leukaemia (ECIL-4): guidelines for 
diagnosis and treatment of human respiratory syncytial virus, parainfluenza virus, 
metapneumovirus, rhinovirus, and coronavirus. Clin Infect Dis 2013;56 (2):258-
66.
28724
Ghosh S, Champlin RE, Englund J, Giralt SA, Rolston K, Raad I, et al. 
Respiratory syncytial virus upper respiratory tract illnesses in adult blood and 
marrow transplant recipients: combination therapy with aerosolized ribavirin and 
intravenous immunoglobulin. Bone Marrow Transplant 2000;25 (7):751-5.
28725
Whimbey E, Couch RB, Englund JA, Andreeff M, Goodrich JM, Raad, II, et al. 
Respiratory syncytial virus pneumonia in hospitalized adult patients with 
leukemia. Clin Infect Dis 1995;21 (2):376-9.


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Gilead Sciences, Inc.
Amendment 2
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11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Study Procedures Table
Appendix 3.
Management of Clinical and Laboratory Adverse Events
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements


GS-5806 
Protocol GS-US-218-1502 
Final 
Gilead Sciences, Inc. 
Amendment 2 
Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC 
199 E BLAINE ST 
SEATTLE, W A 98102 
STUDY ACKNOWLEDGEMENT 
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study 
Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in 
Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) 
Infection of the Lower Respiratory Tract 
GS-US-218-1502, Protocol Amendment 2, 22 September 2014 
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval. 
p p D 
S (?+k JObc.c Lt 
Name (Printed) 
Author 
Date 
Signature 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct t11is study as described. l will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
infom1ation provided by Gilead Sciences, lnc. I will discuss this material with them to ensure 
that they are fully informed about the drugs and the study. 
Principal Investigator Name (Printed) 
Signature 
Date 
Site Number 
CONFIDENTIAL 
Page 77 
22 September 20 14 


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Appendix 2.
Study Procedures Table
Visit 1: 
Screening
(Day -2 to 
-1)
Visit 2: Baseline 
Assessments,
Randomization, 
and Treatment 
Assessments
(Day 1)
Visit 
3: Day 
3
(±24 
hours)
Visit 
4: Day 
5
(±24 
hours)
Visit 
5: Day
7
(±24 
hours)
Visit 
6: Day 
9
(±24 
hours)
Visit 
7: Day 
13
(±24 
hours)
Visit 
8: Day 
17
(±24 
hours)
Visit 
9:
Day 
22
(±24 
hours)
Visit 10:
End of 
study/Day 
28
(+3 days)
Optional Extended Viral 
Monitoringl
Visit 
11:
Day 
35
(±48
hours)
Visit 
12:
Day 
42
(±48
hours)
Visit 
13:
Day 
49
(±48
hours)
Visit 
14:
Day 
56
(±48 
hours)
Must complete 
visit in the hospital 
or clinic
X
X
X
X
X
X
X
X
Written Informed 
Consent
X
Medical History
and Demographics
X
Chest X-ray
Xa
Screening Labs
Xb
Urine or Serum 
Pregnancy Testc
X
X
X
X
X
X
Vital Signs (inc. 
O2 Saturation d)
X
X
X
X
X
X
X
X
Height
X
Weight
X
X
X
X
X
X
X
X
Safety Labs e
X
X
X
X
X
X
X
RSV antibody titer
X
X


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Gilead Sciences, Inc.
Amendment 2
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Visit 1: 
Screening
(Day -2 to 
-1)
Visit 2: Baseline 
Assessments,
Randomization, 
and Treatment 
Assessments
(Day 1)
Visit 
3: Day 
3
(±24 
hours)
Visit 
4: Day 
5
(±24 
hours)
Visit 
5: Day
7
(±24 
hours)
Visit 
6: Day 
9
(±24 
hours)
Visit 
7: Day 
13
(±24 
hours)
Visit 
8: Day 
17
(±24 
hours)
Visit 
9:
Day 
22
(±24 
hours)
Visit 10:
End of 
study/Day 
28
(+3 days)
Optional Extended Viral 
Monitoringl
Visit 
11:
Day 
35
(±48
hours)
Visit 
12:
Day 
42
(±48
hours)
Visit 
13:
Day 
49
(±48
hours)
Visit 
14:
Day 
56
(±48 
hours)
RSV Viremia
X
X
X
X
X
X
X
Nasal Samples f
X
X
X
X
X
X
X
X
X
X
X
X
X
Local RSV 
Testing
Xk
Induced Sputum g
X
Randomization
X
IMP
Administration
X
X
X
X
X
PK Sample
Xh
Xj
Xh
Xh
Xh
Xh
Xh
Serum creatinine
Xi
Xi
Adverse Events
X
X
X
X
X
X
X
X
Xm
Xm
Xm
Xm
ICU admissions, 
re-hospitalizations,  
standard of care 
test results, 
mechanical 
ventilation, and 
supplemental O2
X
X
X
X
X
X
Concomitant 
Medications
X
X
X
X
X
X
X
X


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Amendment 2
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a
Chest X-ray obtained < 48 hours prior to Screening may be used
b
Existing values collected ≤ 6 days prior to Screening may be used
c
Required for women unable to confirm menopause, hysterectomy and/or bilateral oophorectomy
d
On room air
e
Hematology and serum chemistry to include WBC with differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total bilirubin
f
2 samples total, 1 from each nostril – collected prior to dosing on dosing days
g
Collected pre-dose if induced sputum was not used to demonstrate the presence of RSV in the lower respiratory tract ≤6 days prior to Day 1
h
PK samples collected for all subjects 4 hours post-dose Day 1; pre-dose on Days 5, 9, 13, and 17; and anytime on Day 22
i
For hospitalized subjects only: blood will be drawn for serum creatinine at 4 hours post-dose at Visit 2 (Day 1) and on Days 2, 3 and 4 (24, 48 and 72 hours [±3hours]
post-first GS-5806 dose if they remain hospitalized at those times. 
j
For hospitalized subjects only: PK sample collected at Visit 3 (48 hours [±3 hours] post-first GS-5806 dose)
k
Only for subjects who agree to the Optional Extended Viral Monitoring at the time of consent
l
Only for subjects who agree to the Optional Extended Viral Monitoring at the time of consent and test positive (or inconclusive) for RSV at Visit 9 (Day 22)
m
Assessment of procedure-related AEs only


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Gilead Sciences, Inc.
Amendment 2
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Appendix 3.
Management of Clinical and Laboratory Adverse Events
Grade 1
Grade 4
Grade 3
Grade 2
May continue 
dosing at the 
discretion of the 
investigator
Repeat lab to 
confirm toxicity 
grade
Repeat lab to 
confirm toxicity 
grade
If confirmed and possibly and/or probably related to 
investigational medicinal products:
1.
Withhold investigational medicinal products until Grade 2
2.
Restart all investigational medicinal products at full dose
If confirmed and unrelated to 
investigational medicinal products, 
dosing may continue at the 
discretion of the investigator
If confirmed and 
possibly or probably 
related to 
investigational 
medicinal products, 
discontinue 
investigational 
medicinal products
dosing permanently 
and follow at periodic 
intervals at least 
weekly until a return 
to Baseline or is 
otherwise explained
If Grade 3 or 4 recurrence that is confirmed and possibly or 
probably related to investigational medicinal products, discontinue 
all investigational medicinal products dosing permanently
If Grade 3 or 4 recurrence that is considered unrelated to 
investigational medicinal products, continue all investigational 
medicinal products at the same dose at the discretion of the 
investigator


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Protocol GS-US-218-1502
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Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
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Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
Version: 18Junel2012
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Hemoglobin
HIV POSITIVE
Adult and Pediatric 57 Days
8.5 to 10.0 g/dL 
85 to 100 g/L
7.5 to 8.5 g/dL 
75 to 85 g/L
6.5 to 7.5 g/dL 
65 to 75 g/L
6.5 g/dL
65 g/L
HIV NEGATIVE
Adult and Pediatric 57 Days 
10.0 to 10.9 g/dL
100 to 109 g/L
OR
Any decrease from Baseline
2.5 to 3.5 g/dL
25 to 35 g/L
9.0 to 10.0 g/dL
90 to 100 g/L
OR
Any decrease from Baseline
3.5 to 4.5 g/dL
35 to 45 g/L
7.0 to 9.0 g/dL
70 to 90 g/L
OR
Any decrease from Baseline
4.5 g/dL
45 g/L
7.0 g/dL
70 g/L
Infant, 36–56 Days
(HIV POSITIVE OR
NEGATIVE)
8.5 to 9.4 g/dL
85 to 94 g/L
7.0 to 8.5 g/dL
70 to 85 g/L
6.0 to 7.0 g/dL
60 to < 70 g/L
6.0 g/dL
< 60 g/L
Infant, 22–35 Days
(HIV POSITIVE OR
NEGATIVE)
9.5 to 10.5 g/dL
95 to 105 g/L
8.0 to 9.5 g/dL
80 to 95 g/L
7.0 to 8.0 g/dL
70 to 80 g/L
7.0 g/dL
70 g/L
Infant, 1–21 Days
(HIV POSITIVE OR
NEGATIVE)
12.0 to 13.0 g/dL
120 to 130 g/L
10.0 to 12.0 g/dL
100 to 120 g/L
9.0 to 10.0 g/dL
90 to 100 g/L
9.0 g/dL
90 g/L


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Protocol GS-US-218-1502
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Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 83
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HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Absolute Neutrophil Count 
(ANC)
Adult and Pediatric, 7 Days
1000 to 1300/mm3
750 to 1000/mm3
500 to 750/mm3
500/mm3
1.00 to 1.30 GI/L
0.75 to 1.00 GI/L
0.50 to 0.75 GI/L
0.50 GI/L
Infant, 2 – 7 Days
1250 to 1500/mm3
1.25 to 1.50 GI/L
1000 to 1250/mm3
1.00 to < 1.25 GI/L
750 to 1000/mm3
0.75 to < 1.00 GI/L
750/mm3
< 0.75 GI/L
Infant, 1 Day
4000 to 5000/mm3
4.00 to 5.00 GI/L
3000 to 4000/mm3
3.00 to < 4.00 GI/L
1500 to 3000/mm3
1.50 to < 3.00 GI/L
1500/mm3
< 1.50 GI/L
Absolute CD4+ Count
HIV NEGATIVE ONLY
Adult and Pediatric 
> 13 Years
300 to 400/mm3
300 to 400/μL
200 to 300/mm3
200 to 300/μL
100 to 200/mm3
100 to 200/μL
100/mm3
100/μL
Absolute Lymphocyte Count
HIV NEGATIVE ONLY
Adult and Pediatric 
13 Years
600 to 650/mm3
0.60 to 0.65 GI/L
500 to 600/mm3
0.50 to 0.60 GI/L
350 to 500/mm3
0.35 to 0.50 GI/L
350/mm3
0.35 GI/L
Platelets 
100,000 to < 125,000/mm3
100 to 125 GI/L
50,000 to 100,000/mm3
50 to 100 GI/L
25,000 to 50,000/mm3
25 to 50 GI/L
25,000/mm3
25 GI/L
WBCs 
2000/mm3 to 2500/mm3
1,500 to 2,000/mm3
1000 to 1,500/mm3
1000/mm3
2.00 GI/L to 2.50 GI/L
1.50 to 2.00 GI/L
1.00 to 1.50 GI/L
1.00 GI/L
Hypofibrinogenemia
100 to 200 mg/dL
75 to 100 mg/dL
50 to 75 mg/dL
50 mg/dL
1.00 to 2.00 g/L
0.75 to 1.00 g/L
0.50 to 0.75 g/L
0.50 g/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 84
22 September 2014
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Hyperfibrinogenemia
ULN to 600 mg/dL
600 mg/dL
—
—
ULN  to 6.0 g/L
6.0 g/L
—
—
Fibrin Split Product 
20 to 40 μg/mL
40 to 50 μg/mL
50 to 60 μg/mL
60 μg/mL
20 to 40 mg/L
40 to 50 mg/L
50 to 60 mg/L
60 mg/L
Prothrombin Time (PT)
1.00 to 1.25 ULN
1.25 to 1.50 ULN 
1.50 to 3.00 ULN 
3.00 ULN 
International Normalized Ratio 
of prothrombin time (INR)
1.1 to 1.5 x ULN
>1.5 to 2.0 x ULN
>2.0 to 3.0 x ULN
>3.0 x ULN
Activated Partial
Thromboplastin Time (APTT)
1.00 to 1.66 ULN
1.66 to 2.33 ULN
2.33 to 3.00 ULN
3.00 ULN
Methemoglobin 
5.0 to 10.0%
10.0 to 15.0%
15.0 to 20.0%
20.0% 


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 85
22 September 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hyponatremia 
130 to <LLN mEq/L
125 to 130 mEq/L
121 to 125 mEq/L
121 mEq/L
130 to <LLN mmol/L
125 to 130 mmol/L
121 to 125 mmol/L
121 mmol/L
Hypernatremia 
146  to 150 mEq/L
150 to 154 mEq/L
154 to 159 mEq/L
159 mEq/L
146  to 150 mmol/L
150 to 154 mmol/L
154 to 159 mmol/L
159 mmol/L
Hypokalemia 
3.0 to 3.4 mEq/L
2.5 to 3.0 mEq/L
2.0 to 2.5 mEq/L
2.0 mEq/L
3.0 to 3.4 mmol/L
2.5 to 3.0 mmol/L
2.0 to 2.5 mmol/L
2.0 mmol/L
Hyperkalemia 
5.6 to 6.0 mEq/L
6.0 to 6.5 mEq/L
6.5 to 7.0 mEq/L
7.0 mEq/L
5.6 to 6.0 mmol/L
6.0 to 6.5 mmol/L
6.5 to 7.0 mmol/L
7.0 mmol/L
Hypoglycemia
Adult and Pediatric
1 Month
55 to 64 mg/dL
40 to 55 mg/dL
30 to 40 mg/dL
30 mg/dL
3.03 to 3.58 mmol/L
2.20 to 3.03 mmol/L
1.64 to 2.20 mmol/L
1.64 mmol/L
Infant, 1 Month
50 to 54 mg/dL
2.8 to 3.0 mmol/L
40 to 50 mg/dL
2.2 to 2.8 mmol/L
30 to 40 mg/dL
1.7 to 2.2 mmol/L
30 mg/dL
1.7 mmol/L
Hyperglycemia, Nonfasting 
116 to 160 mg/dL
160 to 250 mg/dL
250 to 500 mg/dL
500 mg/dL
6.42 to 8.91 mmol/L
8.91 to 13.90 mmol/L
13.90 to 27.79 mmol/L
27.79 mmol/L
Hyperglycemia, Fasting
110 to 125 mg/dL
6.08 to 6.96 mmol/L
>125 to 250 mg/dL
>6.96 to 13.90 mmol/L
>250 to 500 mg/dL
>13.90 to 27.79 mmol/L
>500 mg/dL
>27.79 mmol/L
Hypocalcemia 
(corrected for albumin if 
appropriate*)
Adult and Pediatric
7 Days
7.8 to 8.4  mg/dL
7.0 to 7.8 mg/dL
6.1 to 7.0 mg/dL
6.1 mg/dL
1.94 to 2.10 mmol/L
1.74 to 1.94 mmol/L
1.51 to 1.74 mmol/L
1.51 mmol/L
Infant, 7 Days
6.5 to 7.5 mg/dL
1.61 to 1.88  mmol/L
6.0 to 6.5 mg/dL
1.49 to < 1.61 mmol/L
5.5 to 6.0 mg/dL
1.36 to < 1.49 mmol/L 
5.5 mg/dL
< 1.36 mmol/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 86
22 September 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hypercalcemia (corrected 
for albumin if appropriate*)
Adult and Pediatric 
7 Days
>ULN to 11.5 mg/dL
11.5 to 12.5 mg/dL
12.5 to 13.5 mg/dL
13.5 mg/dL
>ULN to 2.88 mmol/L
2.88 to 3.13 mmol/L
3.13 to 3.38 mmol/L
3.38 mmol/L
Infant, 7 Days
11.5 to 12.4 mg/dL
2.86 to 3.10  mmol/L
12.4 to 12.9 mg/dL
> 3.10 to 3.23  mmol/L
12.9 to 13.5 mg/dL
> 3.23 to 3.38  mmol/L
13.5 mg/dL
> 3.38 mmol/L
Hypocalcemia (ionized)
3.0 mg/dL to LLN
2.5 to < 3.0 mg/dL
2.0 to 2.5 mg/dL
2.0 mg/dL
0.74 mmol/L to LLN
0.62 to 0.74 mmol/L
0.49 to 0.62 mmol/L
0.49 mmol/L
Hypercalcemia (ionized)
ULN to 6.0 mg/dL
6.0 to 6.5 mg/dL
6.5 to 7.0 mg/dL
7.0 mg/dL
ULN to 1.50 mmol/L
1.50 to 1.63 mmol/L
1.63 to 1.75 mmol/L
1.75 mmol/L
Hypomagnesemia
1.40 to  <LLN mg/dL
1.2 to <LLN mEq/L
1.04 to 1.40 mg/dL
0.9 to 1.2 mEq/L
0.67 to 1.04 mg/dL
0.6 to 0.9 mEq/L
0.67 mg/dL
0.6 mEq/L
0.58 to <LLN mmol/L
0.43 to 0.58 mmol/L
0.28 to 0.43 mmol/L
0.28 mmol/L
Hypophosphatemia
Adult and Pediatric
14 Years
2.0 to < LLN mg/dL
1.5 to 2.0 mg/dL
1.0 to 1.5 mg/dL
1.0 mg/dL
0.63  to LLN mmol/L
0.47 to 0.63 mmol/L
0.31 to 0.47 mmol/L
0.31 mmol/L
Pediatric 1 Year–14 Years 
3.0 to 3.5 mg/dL
0.96 to 1.12 mmol/L
2.5 to 3.0 mg/dL
0.80 to < 0.96 mmol/L
1.5 to 2.5 mg/dL
0.47 to < 0.80 mmol/L
1.5 mg/dL
< 0.47 mmol/L
Pediatric 1 Year
3.5 to 4.5 mg/dL
1.12 to 1.46 mmol/L
2.5 to 3.5 mg/dL
0.80 to < 1.12 mmol/L
1.5 to 2.5 mg/dL
0.47 to < 0.80 mmol/L
1.5 mg/dL
< 0.47 mmol/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 87
22 September 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hyperbilirubinemia 
Adult and Pediatric 
> 14 Days
1.0 to 1.5 ULN 
1.5 to 2.5 ULN
2.5 to 5.0 ULN 
5.0 ULN 
Infant, 14 Days
(non-hemolytic)
NA
20.0 to 25.0 mg/dL
342 to 428 μmol/L
25.0 to 30.0 mg/dL
> 428 to 513 μmol/L
30.0 mg/dL
> 513 μmol/L
Infant, 14 Days
(hemolytic)
NA
NA
20.0 to 25.0 mg/dL
342 to 428 μmol/L
25.0 mg/dL
> 428 μmol/L
Blood Urea Nitrogen
1.25 to 2.50 ULN 
2.50 to 5.00 ULN 
5.00 to 10.00 ULN 
10.00 ULN
Hyperuricemia
>ULN to 10.0 mg/dL 
10.0 to 12.0 mg/dL 
12.0 to 15.0 mg/dL 
15.0 mg/dL
>ULN to 597 μmol/L
597 to 716 μmol/L
716 to 895 μmol/L
895 μmol/L
Hypouricemia
1.5 mg/dL to LLN
1.0 to 1.5 mg/dL
0.5 to 1.0 mg/dL
0.5 mg/dL
87 μmol/L to LLN
57 to 87 μmol/L
27 to 57 μmol/L
27 μmol/L
Creatinine 
1.50 to 2.00 mg/dL
2.00 to 3.00 mg/dL
3.00 to 6.00 mg/dL 
6.00 mg/dL
133 to 177 μmol/L
177 to 265 μmol/L
265 to 530 μmol/L
530 μmol/L
Bicarbonate
16.0 mEq/L to LLN 
11.0 to 16.0 mEq/L
8.0 to 11.0 mEq/L
8.0 mEq/L
16.0 mmol/L to LLN
11.0 to 16.0 mmol/L
8.0 to 11.0 mmol/L
8.0 mmol/L
Triglycerides
(Fasting)
NA
500 to 750 mg/dL
750 to 1200 mg/dL
1200 mg/dL
5.64–8.47 mmol/L
8.47–13.55 mmol/L
13.55 mmol/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 88
22 September 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
LDL
(Fasting)
130 to 160 mg/dL
>160 to 190 mg/dL
> 190 mg/dL
NA
3.35 to 4.15 mmol/L
>4.15 to 4.92 mmol/L
>4.92 mmol/L
Pediatric >2 to <18 years
110 to 130 mg/dL
>130 to 190 mg/dL
> 190 mg/dL
NA
2.84 to 3.37 mmol/L
>3.37 to  4.92 mmol/L
>4.92 mmol/L
Hypercholesterolemia
(Fasting)
200 to 239 mg/dL
239 to 300 mg/dL
300 mg/dL
NA
5.16 to 6.19 mmol/L
6.19 to 7.77 mmol/L
7.77 mmol/L
Pediatric 18 Years
170 to 199 mg/dL
4.39 to 5.15 mmol/L
199 to 300 mg/dL
5.15 to 7.77 mmol/L
300 mg/dL
7.77 mmol/L
NA
Creatine Kinase
3.0 to 6.0 ULN
6.0 to 10.0 ULN
10.0 to 20.0 ULN
20.0 ULN
*Calcium should be corrected for albumin if albumin is < 4.0 g/dL


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 89
22 September 2014
ENZYMES
Grade 1
Grade 2
Grade 3
Grade 4
AST (SGOT) 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
ALT (SGPT) 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
GGT
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
Alkaline Phosphatase 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
Total Amylase
1.0 to 1.5 ULN
1.5 to 2.0 ULN
2.0 to 5.0 ULN
5.0 ULN
Pancreatic Amylase
1.0 to 1.5 ULN
1.5 to 2.0 ULN
2.0 to 5.0 ULN
5.0 ULN
Lipase 
1.0 to 1.5 ULN
1.5 to 3.0 ULN
3.0 to 5.0 ULN
5.0 ULN
Albumin
3.0 g/dL to LLN
30 g/L to LLN
2.0 to 3.0 g/dL
20 to 30 g/L
2.0 g/dL
20 g/L
NA


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 90
22 September 2014
URINALYSIS
Grade 1
Grade 2
Grade 3
Grade 4
Hematuria (Dipstick) 
1
2
3-4+
NA
Hematuria (Quantitative) 
See Note below
                              Females
>ULN - 10 RBC/HPF
10-75 RBC/HPF
> 75 RBC/HPF
NA
                              Males
6-10 RBC/HPF
10-75 RBC/HPF
> 75 RBC/HPF
NA
Proteinuria (Dipstick)
1
2–3
4
NA
Proteinuria, 24 Hour Collection
Adult and Pediatric 
10 Years
200 to 999 mg/24 h
>999 to 1999 mg/24 h
>1999 to 3500 mg/24 h
3500 mg/24 h
Pediatric 3 Mo to 
< 10 Years
201 to 499 mg/m2/24 h
>499 to 799 mg/m2/24 h
>799 to 1000 mg/m2/24 h
1000 mg/ m2/24 h
Glycosuria (Dipstick)
1+
2-3
4
NA
Notes: 

Toxicity grades for Quantitative and Dipstick Hematuria will be assigned by Covance Laboratory, however for other laboratories, toxicity grades will only be assigned to 
Dipstick Hematuria.

With the exception of lipid tests, any graded laboratory test with a result that is between the LLN and ULN should be assigned Grade 0.

If the severity of a clinical AE could fall under either one of two grades (eg, the severity of an AE could be either Grade 2 or Grade 3), select the higher of the two grades for 
the AE.


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 91
22 September 2014
CARDIOVASCULAR
Grade 1
Grade 2
Grade 3
Grade 4
Cardiac Arrhythmia (general)
(By ECG or physical exam)
Asymptomatic AND No 
intervention indicated
Asymptomatic AND Non-
urgent medical intervention 
indicated
Symptomatic, non-life-
threatening AND Non-
urgent medical intervention 
indicated 
Life-threatening arrhythmia 
OR Urgent intervention 
indicated
Cardiac-ischemia/Infarction
NA
NA
Symptomatic ischemia 
(stable angina) OR Testing 
consistent with ischemia 
Unstable angina OR Acute 
myocardial infarction
Hemorrhage (significant acute 
blood loss)
NA
Symptomatic AND No 
transfusion indicated
Symptomatic AND 
Transfusion of 2 units 
packed RBCs (for children 
10 cc/kg) indicated 
Life-threatening hypotension 
OR Transfusion of 2 units 
packed RBCs indicated (for 
children 10 cc/kg) indicated
Hypertension (with repeat 
testing at same visit)
140–159 mmHg systolic 
OR 
90–99 mmHg diastolic
159–179 mmHg systolic 
OR 
99–109 mmHg diastolic
179 mmHg systolic 
OR 
109 mmHg diastolic
Life-threatening consequences 
(eg, malignant hypertension) 
OR Hospitalization (other than 
ER visit) indicated
Pediatric 17 Years (with 
repeat testing at same visit)
NA
91st–94th percentile adjusted 
for age, height, and gender 
(systolic and/or diastolic)
≥95th percentile adjusted 
for age, height, and gender 
(systolic and/or diastolic)
Life-threatening consequences 
(eg, malignant hypertension) 
OR Hospitalization indicated 
(other than emergency room 
visit)
Hypotension
NA
Symptomatic, corrected with 
oral fluid replacement
Symptomatic, IV fluids 
indicated
Shock requiring use of 
vasopressors or mechanical 
assistance to maintain blood 
pressure
Pericardial Effusion
Asymptomatic, small 
effusion requiring no 
intervention
Asymptomatic, moderate or 
larger effusion requiring no 
intervention
Effusion with non-life-
threatening physiologic 
consequences OR Effusion 
with nonurgent intervention 
indicated
Life-threatening consequences 
(eg, tamponade) OR Urgent 
intervention indicated


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 92
22 September 2014
CARDIOVASCULAR
Grade 1
Grade 2
Grade 3
Grade 4
Prolonged PR Interval
PR interval 
0.21 to 0.25 sec
PR interval
0.25 sec
Type II 2nd degree AV 
block OR Ventricular pause 
3.0 sec
Complete AV block 
Pediatric 16 Years
1st degree AV block
(PR > normal for age and 
rate)
Type I 2nd degree AV block 
Type II 2nd degree AV 
block 
Complete AV block
Prolonged QTc
Asymptomatic, QTc interval 
0.45 to 0.47 sec OR Increase 
interval 0.03 sec above 
baseline
Asymptomatic, QTc interval 
0.48 to 0.49 sec OR Increase 
in interval 0.03 to 0.05 sec 
above baseline
Asymptomatic, QTc interval 
0.50 sec OR Increase in 
interval 0.06 sec above 
baseline
Life-threatening 
consequences, eg, Torsade de 
pointes or other associated 
serious ventricular 
dysrhythmia
Pediatric 16 Years
Asymptomatic, QTc interval 
0.450 to 0.464 sec 
Asymptomatic, QTc interval 
0.465 to 0.479 sec 
Asymptomatic, QTc interval 
0.480 sec 
Life-threatening 
consequences, eg, Torsade de 
pointes or other associated 
serious ventricular 
dysrhythmia
Thrombosis/Embolism
NA
Deep vein thrombosis AND 
No intervention indicated (eg, 
anticoagulation, lysis filter, 
invasive procedure) 
Deep vein thrombosis AND 
Intervention indicated (eg, 
anticoagulation, lysis filter, 
invasive procedure) 
Embolic event (eg, pulmonary 
embolism, life-threatening 
thrombus) 
Vasovagal Episode (associated 
with a procedure of any kind)
Present without loss of 
consciousness 
Present with transient loss of 
consciousness
NA 
NA
Ventricular Dysfunction 
(congestive heart failure, 
CHF)
NA
Asymptomatic diagnostic 
finding AND intervention 
indicated
New onset with symptoms 
OR Worsening symptomatic 
CHF
Life-threatening CHF


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 93
22 September 2014
RESPIRATORY
Grade 1
Grade 2
Grade 3
Grade 4
Bronchospasm (acute)
FEV1 or peak flow reduced to 
70% to 80%
FEV1 or peak flow 50% to 69%
FEV1 or peak flow 25% to 
49% 
Cyanosis OR FEV1 or peak flow 
25% OR Intubation
Dyspnea or Respiratory 
Distress
Dyspnea on exertion with no 
or minimal interference with 
usual social & functional 
activities 
Dyspnea on exertion causing 
greater than minimal interference 
with usual social & functional 
activities 
Dyspnea at rest causing 
inability to perform usual 
social & functional activities 
Respiratory failure with 
ventilatory support indicated
Pediatric 14 Years
Wheezing OR minimal 
increase in respiratory rate for 
age
Nasal flaring OR Intercostal 
retractions OR Pulse oximetry 
90% to 95%
Dyspnea at rest causing 
inability to perform usual 
social & functional activities 
OR Pulse oximetry 90%
Respiratory failure with 
ventilatory support indicated
OCULAR/VISUAL
Grade 1
Grade 2
Grade 3
Grade 4
Uveitis
Asymptomatic but detectable 
on exam
Symptomatic anterior uveitis OR 
Medical intervention indicated
Posterior or pan-uveitis OR 
Operative intervention 
indicated
Disabling visual loss in affected 
eye(s) 
Visual Changes (from 
Baseline)
Visual changes causing no or 
minimal interference with 
usual social & functional 
activities
Visual changes causing greater 
than minimal interference with 
usual social & functional 
activities
Visual changes causing 
inability to perform usual 
social & functional activities
Disabling visual loss in affected 
eye(s)


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 94
22 September 2014
SKIN
Grade 1
Grade 2
Grade 3
Grade 4
Alopecia
Thinning detectable by 
study participant or  
caregiver (for disabled 
adults)
Thinning or patchy hair loss 
detectable by health care 
provider
Complete hair loss
NA
Cutaneous Reaction – Rash
Localized macular rash 
Diffuse macular, 
maculopapular, or 
morbilliform rash OR Target 
lesions 
Diffuse macular, 
maculopapular, or morbilliform 
rash with vesicles or limited 
number of bullae OR 
Superficial ulcerations of 
mucous membrane limited to 
one site
Extensive or generalized 
bullous lesions OR 
Stevens-Johnson syndrome 
OR Ulceration of mucous 
membrane involving two 
or more distinct mucosal 
sites OR Toxic epidermal 
necrolysis (TEN)
Hyperpigmentation
Slight or localized
Marked or generalized
NA
NA
Hypopigmentation
Slight or localized 
Marked or generalized
NA
NA
Pruritis (itching – no skin 
lesions) 
(See also Injection Site 
Reactions: Pruritis associated 
with injection)
Itching causing no or 
minimal interference with 
usual social & functional 
activities
Itching causing greater than 
minimal interference with 
usual social & functional 
activities
Itching causing inability to 
perform usual social & 
functional activities 
NA


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 95
22 September 2014
GASTROINTESTINAL
Grade 1
Grade 2
Grade 3
Grade 4
Anorexia
Loss of appetite without 
decreased oral intake
Loss of appetite associated with 
decreased oral intake without 
significant weight loss 
Loss of appetite associated 
with significant weight loss 
Life-threatening consequences 
OR Aggressive intervention 
indicated [eg, tube feeding or 
total parenteral nutrition]
Ascites
Asymptomatic
Symptomatic AND Intervention 
indicated (eg, diuretics or 
therapeutic paracentesis)
Symptomatic despite 
intervention
Life-threatening consequences
Cholecystitis
NA
Symptomatic AND Medical 
intervention indicated
Radiologic, endoscopic, or 
operative intervention 
indicated
Life-threatening consequences 
(eg, sepsis or perforation) 
Constipation 
NA
Persistent constipation requiring 
regular use of dietary 
modifications, laxatives, or 
enemas 
Obstipation with manual 
evacuation indicated
Life-threatening consequences 
(eg, obstruction)
Diarrhea 
Adult and Pediatric 
1 Year
Transient or intermittent 
episodes of unformed stools 
OR Increase of 3 stools 
over baseline/24 hr
Persistent episodes of unformed 
to watery stools OR Increase of 
4–6 stools over baseline per 
24 hrs. 
Bloody diarrhea OR Increase 
of 7 stools per 24-hour 
period OR IV fluid 
replacement indicated
Life-threatening consequences 
(eg, hypotensive shock)
Pediatric 1 Year
Liquid stools (more 
unformed than usual) but 
usual number of stools
Liquid stools with increased 
number of stools OR Mild 
dehydration
Liquid stools with moderate 
dehydration
Liquid stools resulting in 
severe dehydration with 
aggressive rehydration 
indicated OR Hypotensive 
shock
Dysphagia-Odynophagia 
Symptomatic but able to eat 
usual diet
Symptoms causing altered 
dietary intake without medical 
intervention indicated
Symptoms causing severely 
altered dietary intake with 
medical intervention indicated
Life-threatening reduction in 
oral intake


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 96
22 September 2014
GASTROINTESTINAL
Grade 1
Grade 2
Grade 3
Grade 4
Mucositis/Stomatitis 
(clinical exam)
See also Proctitis, 
Dysphagia-Odynophagia
Erythema of the mucosa
Patchy pseudomembranes or 
ulcerations 
Confluent pseudomembranes 
or ulcerations OR Mucosal 
bleeding with minor trauma
Tissue necrosis OR Diffuse 
spontaneous mucosal bleeding 
OR Life-threatening 
consequences (eg, aspiration, 
choking)
Nausea 
Transient (24 hours) or 
intermittent nausea with no 
or minimal interference with 
oral intake
Persistent nausea resulting in 
decreased oral intake for 24–48 
hours
Persistent nausea resulting in 
minimal oral intake for 48 
hours OR Aggressive 
rehydration indicated (eg, 
IV fluids)
Life-threatening consequences 
(eg, hypotensive shock)
Pancreatitis
NA
Symptomatic AND 
Hospitalization not indicated 
(other than ER visit)
Symptomatic AND 
Hospitalization indicated 
(other than ER visit)
Life-threatening consequences 
(eg, sepsis, circulatory failure, 
hemorrhage)
Proctitis (functional-
symptomatic)
Also see Mucositis/ 
Stomatitis for Clinical 
Exam
Rectal discomfort AND No 
intervention indicated
Symptoms causing greater than 
minimal interference with usual 
social & functional activities OR 
Medical intervention indicated 
Symptoms causing inability to 
perform usual social/ 
functional activities OR 
Operative intervention 
indicated 
Life-threatening consequences 
(eg, perforation)
Vomiting
Transient or intermittent 
vomiting with no or 
minimal interference with 
oral intake
Frequent episodes of vomiting 
with no or mild dehydration
Persistent vomiting resulting 
in orthostatic hypotension OR 
Aggressive rehydration 
indicated
Life-threatening consequences 
(eg, hypotensive shock)


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 97
22 September 2014
NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Alteration in Personality-
Behavior or in Mood (eg, 
agitation, anxiety, 
depression, mania, 
psychosis)
Alteration causing no or 
minimal interference with 
usual social & functional 
activities 
Alteration causing greater than 
minimal interference with 
usual social & functional 
activities 
Alteration causing inability to 
perform usual social & 
functional activities 
Behavior potentially harmful 
to self or others (eg, 
suicidal/homicidal ideation or 
attempt, acute psychosis) OR 
Causing inability to perform 
basic self-care functions
Altered Mental Status 
For Dementia, see Cognitive 
and Behavioral/Attentional 
Disturbance (including 
dementia and ADD)
Changes causing no or 
minimal interference with 
usual social & functional 
activities
Mild lethargy or somnolence 
causing greater than minimal 
interference with usual social 
& functional activities
Confusion, memory 
impairment, lethargy, or 
somnolence causing inability 
to perform usual social & 
functional activities
Delirium OR obtundation, OR 
coma
Ataxia 
Asymptomatic ataxia 
detectable on exam OR 
Minimal ataxia causing no 
or minimal interference with 
usual social & functional 
activities
Symptomatic ataxia causing 
greater than minimal 
interference with usual social 
& functional activities
Symptomatic ataxia causing 
inability to perform usual 
social & functional activities 
Disabling ataxia causing 
inability to perform basic 
self-care functions
Cognitive and 
Behavioral/Attentional 
Disturbance (including 
dementia and Attention 
Deficit Disorder) 
Disability causing no or 
minimal interference with 
usual social & functional 
activities OR Specialized 
resources not indicated
Disability causing greater than 
minimal interference with 
usual social & functional 
activities OR Specialized 
resources on part-time basis 
indicated
Disability causing inability to 
perform usual social & 
functional activities OR 
Specialized resources on a 
full-time basis indicated
Disability causing inability to 
perform basic self-care 
functions OR 
Institutionalization indicated
CNS Ischemia
(acute)
NA
NA
Transient ischemic attack
Cerebral vascular accident 
(CVA, stroke) with 
neurological deficit 


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 98
22 September 2014
NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Developmental delay –
Pediatric 16 Years
Mild developmental delay, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate 
for the setting 
Moderate developmental 
delay, either motor or 
cognitive, as determined by 
comparison with a 
developmental screening tool 
appropriate for the setting 
Severe developmental delay, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate for 
the setting 
Developmental regression, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate for 
the setting
Headache 
Symptoms causing no or 
minimal interference with 
usual social & functional 
activities
Symptoms causing greater 
than minimal interference with 
usual social & functional 
activities
Symptoms causing inability to 
perform usual social & 
functional activities
Symptoms causing inability to 
perform basic self-care 
functions OR Hospitalization 
indicated (other than ER visit) 
OR Headache with significant 
impairment of alertness or
other neurologic function 
Insomnia
NA
Difficulty sleeping causing 
greater than minimal 
interference with usual 
social/functional activities
Difficulty sleeping causing 
inability to perform usual 
social & functional activities
Disabling insomnia causing 
inability to perform basic 
self-care functions
Neuromuscular Weakness 
(including myopathy & 
neuropathy) 
Asymptomatic with 
decreased strength on exam 
OR Minimal muscle weak-
ness causing no or minimal 
interference with usual 
social & functional activities
Muscle weakness causing 
greater than minimal 
interference with usual social 
& functional activities
Muscle weakness causing 
inability to perform usual 
social & functional activities 
Disabling muscle weakness 
causing inability to perform 
basic self-care functions OR 
Respiratory muscle weakness 
impairing ventilation
Neurosensory Alteration 
(including paresthesia and 
painful neuropathy)
Asymptomatic with sensory 
alteration on exam or 
minimal paresthesia causing 
no or minimal interference 
with usual social &
functional activities 
Sensory alteration or 
paresthesia causing greater 
than minimal interference with 
usual social & functional 
activities 
Sensory alteration or 
paresthesia causing inability to 
perform usual social & 
functional activities
Disabling sensory alteration or 
paresthesia causing inability to 
perform basic self-care 
functions


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 99
22 September 2014
NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Seizure: (new onset) 
NA
1 seizure 
2–4 seizures 
Seizures of any kind that are 
prolonged, repetitive (eg, 
status epilepticus), or difficult 
to control (eg, refractory 
epilepsy)
Seizure: (pre-existing) 
For Worsening of Existing 
Epilepsy the Grades Should 
Be Based on an Increase 
from Previous Level of 
Control to Any of These 
Levels
NA
Increased frequency of pre-
existing seizures (non-
repetitive) without change in 
seizure character OR 
infrequent breakthrough 
seizures while on stable meds 
in a previously controlled 
seizure disorder
Change in seizure character 
from baseline either in 
duration or quality (eg, 
severity or focality) 
Seizures of any kind that are 
prolonged, repetitive (eg, 
status epilepticus), or difficult 
to control (eg, refractory 
epilepsy)
Seizure 
– Pediatric 18 Years
Seizure, generalized onset 
with or without secondary 
generalization, lasting 
< 5 minutes with < 24 hours 
post ictal state
Seizure, generalized onset 
with or without secondary 
generalization, lasting 5–20 
minutes with 
< 24 hours post ictal state
Seizure, generalized onset 
with or without secondary 
generalization, lasting 
> 20 minutes 
Seizure, generalized onset 
with or without secondary 
generalization, requiring 
intubation and sedation
Syncope (not associated 
with a procedure)
NA
Present
NA
NA
Vertigo
Vertigo causing no or 
minimal interference with 
usual social & functional 
activities
Vertigo causing greater than 
minimal interference with 
usual social & functional 
activities 
Vertigo causing inability to 
perform usual social & 
functional activities
Disabling vertigo causing 
inability to perform basic self-
care functions


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 100
22 September 2014
MUSCULOSKELETAL
Grade 1
Grade 2
Grade 3
Grade 4
Arthralgia
See also Arthritis
Joint pain causing no or 
minimal interference with 
usual social & functional 
activities
Joint pain causing greater than 
minimal interference with usual 
social & functional activities
Joint pain causing inability 
to perform usual social & 
functional activities
Disabling joint pain causing 
inability to perform basic self-
care functions
Arthritis
See also Arthralgia
Stiffness or joint swelling 
causing no or minimal 
interference with usual 
social & functional activities
Stiffness or joint swelling causing 
greater than minimal interference 
with usual social & functional 
activities
Stiffness or joint swelling 
causing inability to perform 
usual social & functional 
activities
Disabling joint stiffness or 
swelling causing inability to 
perform basic self-care 
functions
Bone Mineral Loss
BMD t-score or z-score
–2.5 to –1.0 
BMD t-score or z-score –2.5
Pathological fracture 
(including loss of vertebral 
height)
Pathologic fracture causing 
life-threatening consequences 
Pediatric 21 Years
BMD z-score 
–2.5 to –1.0
BMD z-score < –2.5
Pathological fracture 
(including loss of vertebral 
height)
Pathologic fracture causing 
life-threatening consequences 
Myalgia
(non-injection site)
Muscle pain causing no or 
minimal interference with 
usual social & functional 
activities
Muscle pain causing greater than 
minimal interference with usual 
social & functional activities
Muscle pain causing 
inability to perform usual 
social & functional activities
Disabling muscle pain causing 
inability to perform basic self-
care functions
Osteonecrosis
NA
Asymptomatic with radiographic 
findings AND No operative 
intervention indicated
Symptomatic bone pain with 
radiographic findings OR 
Operative intervention 
indicated
Disabling bone pain with 
radiographic findings causing 
inability to perform basic self-
care functions


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 101
22 September 2014
SYSTEMIC
Grade 1
Grade 2
Grade 3
Grade 4
Acute Systemic Allergic 
Reaction 
Localized urticaria 
(wheals) with no medical 
intervention indicated
Localized urticaria with medical 
intervention indicated OR Mild 
angioedema with no medical 
intervention indicated
Generalized urticaria OR 
Angioedema with medical 
intervention indicated OR 
Symptomatic mild 
bronchospasm
Acute anaphylaxis OR Life-
threatening bronchospasm OR 
laryngeal edema
Chills
Symptoms causing no or 
minimal interference with 
usual social & functional 
activities
Symptoms causing greater than 
minimal interference with usual 
social & functional activities 
Symptoms causing inability to 
perform usual social & 
functional activities
NA
Fatigue
Malaise
Symptoms causing no or 
minimal interference with 
usual social & functional 
activities
Symptoms causing greater than 
minimal interference with usual 
social & functional activities
Symptoms causing inability to 
perform usual social & 
functional activities
Incapacitating fatigue/malaise 
symptoms causing inability to 
perform basic self-care 
functions
Fever (nonaxillary)
37.7C to 38.6C
99.8F to 101.5F
38.7C to 39.3C
101.6F to 102.8F
39.4C to 40.5C
102.9F to 104.9F
40.5C 
104.9F
Pain- Indicate Body Site
See also Injection Site 
Pain, Headache, 
Arthralgia, and Myalgia
Pain causing no or 
minimal interference with 
usual social & functional 
activities
Pain causing greater than minimal 
interference with usual social & 
functional activities
Pain causing inability to 
perform usual social & 
functional activities
Disabling pain causing 
inability to perform basic self-
care functions OR 
Hospitalization (other than ER 
visit) indicated
Unintentional Weight 
Loss
NA
5% to 9% loss in body weight from 
baseline
10% to 19% loss in body 
weight from baseline
20% loss in body weight 
from baseline OR  Aggressive 
intervention indicated [eg, 
tube feeding or total parenteral 
nutrition]


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 102
22 September 2014
INJECTION SITE REACTION
Grade 1
Grade 2
Grade 3
Grade 4
Injection Site Pain (pain 
without touching)
Or Tenderness (pain when 
area is touched) 
Pain/tenderness causing no 
or minimal limitation of use 
of limb
Pain/tenderness limiting use of 
limb OR Pain/tenderness 
causing greater than minimal 
interference with usual social 
& functional activities
Pain/tenderness causing 
inability to perform usual 
social & functional activities
Pain/tenderness causing inability 
to perform basic self-care 
function OR Hospitalization 
(other than ER visit) indicated 
for management of 
pain/tenderness
Injection Site Reaction 
(Localized), 15 Years
Erythema OR Induration
of 5 5 cm to 9 9 cm (or 
2581 cm2)
Erythema OR Induration OR 
Edema 9 cm any diameter 
(or 81 cm2)
Ulceration OR Secondary 
infection OR Phlebitis OR 
Sterile abscess OR Drainage
Necrosis (involving dermis and 
deeper tissue)
Pediatric 15 Years
Erythema OR Induration 
OR Edema present but 
2.5 cm diameter
Erythema OR Induration 
OR Edema > 2.5 cm 
diameter but < 50% surface 
area of the extremity 
segment (eg, upper 
arm/thigh)
Erythema OR Induration 
OR Edema involving 
50% surface area of the 
extremity segment (eg, 
upper arm/thigh) OR 
Ulceration OR Secondary 
infection OR Phlebitis OR 
Sterile abscess OR 
Drainage
Necrosis (involving dermis and 
deeper tissue)
Pruritis Associated with 
Injection 
See also Skin: Pruritis 
(itching—no skin lesions)
Itching localized to injection 
site AND Relieved 
spontaneously or with 
48 h treatment 
Itching beyond the injection 
site but not generalized OR 
Itching localized to injection 
site requiring 48 h treatment 
Generalized itching causing 
inability to perform usual 
social & functional activities
NA


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 103
22 September 2014
ENDOCRINE/METABOLIC
Grade 1
Grade 2
Grade 3
Grade 4
Lipodystrophy (eg, back 
of neck, breasts, 
abdomen)
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious 
changes on casual visual 
inspection
NA
Diabetes Mellitus
NA
New onset without need to initiate 
medication OR Modification of 
current meds to regain glucose 
control
New onset with initiation of 
indicated med OR Diabetes 
uncontrolled despite treatment 
modification
Life-threatening consequences 
(eg, ketoacidosis, 
hyperosmolar non-ketotic 
coma) 
Gynecomastia
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious on 
casual visual inspection
NA
Hyperthyroidism 
Asymptomatic
Symptomatic causing greater than 
minimal interference with usual 
social & functional activities OR 
Thyroid suppression therapy 
indicated
Symptoms causing inability to 
perform usual social & 
functional activities OR 
Uncontrolled despite treatment 
modification 
Life-threatening consequences 
(eg, thyroid storm)
Hypothyroidism
Asymptomatic
Symptomatic causing greater than 
minimal interference with usual 
social & functional activities OR 
Thyroid replacement therapy 
indicated
Symptoms causing inability to 
perform usual social & 
functional activities OR 
Uncontrolled despite treatment 
modification 
Life-threatening consequences 
(eg, myxedema coma)
Lipoatrophy (eg, fat loss 
from the face, extremities, 
buttocks)
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious on 
casual visual inspection
NA


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 104
22 September 2014
GENITOURINARY
Grade 1
Grade 2
Grade 3
Grade 4
Intermenstrual Bleeding 
(IMB)
Spotting observed by participant 
OR Minimal blood observed 
during clinical or colposcopic 
exam
Intermenstrual bleeding not 
greater in duration or amount 
than usual menstrual cycle
Intermenstrual bleeding greater 
in duration or amount than usual 
menstrual cycle
Hemorrhage with life-
threatening hypotension OR 
Operative intervention 
indicated
Urinary Tract 
obstruction (eg, stone)
NA
Signs or symptoms of urinary 
tract obstruction without 
hydronephrosis or renal 
dysfunction
Signs or symptoms of urinary 
tract obstruction with 
hydronephrosis or renal 
dysfunction
Obstruction causing life-
threatening consequences
INFECTION
Grade 1
Grade 2
Grade 3
Grade 4
Infection (any other 
than HIV infection)
Localized, no systemic antiμbial 
treatment indicated AND 
Symptoms causing no or 
minimal interference with usual 
social & functional activities
Systemic antiμbial treatment 
indicated OR Symptoms 
causing greater than minimal 
interference with usual social 
& functional activities
Systemic antiμbial treatment 
indicated AND Symptoms 
causing inability to perform 
usual social & functional 
activities OR Operative 
intervention (other than simple 
incision and drainage) indicated
Life-threatening 
consequences (eg, septic 
shock)
Basic Self-care Functions: Activities such as bathing, dressing, toileting, transfer/movement, continence, and feeding.
Usual Social & Functional Activities: Adaptive tasks and desirable activities, such as going to work, shopping, cooking, use of transportation, pursuing a hobby, etc.


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 105
22 September 2014
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1) Pregnancy and Contraception Requirements for Males and Females of Childbearing 
Potential 
Pregnancy must be excluded before the start of treatment with study drug and prevented 
thereafter by reliable contraceptive methods. A urine or serum pregnancy test will be performed 
for all females of childbearing potential at the screening visit and at each dosing visit (Visits 2, 4, 
6, 7, and 8) prior to administration of study drug to ensure pregnant women are not included or 
treated with study drug in the trial. Please refer to the latest version of the investigator’s brochure 
for additional information about the effects of GS 5806. 
2) Definition of Female of Childbearing Potential
For the purposes of this study, a female subject of childbearing potential is a nonmenopausal 
female who has not had a hysterectomy, bilateral oophorectomy, or medically documented 
ovarian failure. This definition includes a pubertal female who has not yet started menstruating. 
A woman who has had a tubal sterilization is considered to be of childbearing potential.
A female subject may be considered menopausal in either of the following conditions:

Surgical menopause: Appropriate medical documentation of prior complete bilateral 
oophorectomy (ie, surgical removal of the ovaries and occurring at the age at which the 
procedure was performed)

Spontaneous menopause: Permanent cessation of previously occurring menses as a result of 
ovarian failure with documentation of hormonal deficiency by a certified health care 
provider. The worldwide mean age of spontaneous menopause is 49.24 (SD 1.73) years

A hormonal deficiency should be properly documented in the case of suspected spontaneous 
menopause as follows:
— If age 54 years and with the absence of normal menses: serum follicle stimulating 
hormone (FSH) level elevated to within the postmenopausal range based on the 
laboratory reference range where the hormonal assay is performed
— If age <54 years and with the absence of normal menses: negative serum or urine human 
chorionic gonadotropin (hCG) with concurrently elevated serum FSH level in the 
postmenopausal range, depressed estradiol (E2) level in the postmenopausal range, and 
absent serum progesterone level, based on the laboratory reference ranges where the 
hormonal assays are performed
3) Contraceptive Requirements 
Female subjects of childbearing potential and male subjects must agree to either continue 
abstinence from sexual intercourse or utilize protocol specified methods of contraception if they 
choose to engage in intercourse from the screening/enrollment visit throughout the study period 


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 106
22 September 2014
and for 30 days following the last dose of study drug (90 days for males). Female study subjects
of childbearing potential will undergo regular pregnancy testing while taking GS-5806. The 
investigator will counsel subjects on the protocol specified method(s) for avoiding pregnancy in 
case the subject chooses to engage in heterosexual intercourse.
Protocol specified contraceptive methods are as follows: (1) a combination of one hormonal 
method and one barrier method; (2) two barrier methods where one method is the male condom; 
or (3) use of an intrauterine device (IUD) or tubal sterilization; see Appendix Table 1 below. 
Acceptable hormonal methods include injectable progesterone, progesterone implants, 
combination oral contraceptives, transdermal contraceptive patch, and vaginal ring. Acceptable 
barrier methods include diaphragm with spermicide, cervical cap with spermicide, and the male 
condom with spermicide. Female subjects must use either a hormonal method or a barrier 
method if the partner has a vasectomy and the male partner should be the sole partner for that 
subject. For a vasectomy, appropriate post-vasectomy documentation of the absence of sperm in 
the ejaculate must be available. If a subject has undergone tubal sterilization or has had a Copper 
T 380A IUD or LNg 20 IUD inserted, no other contraception is needed.  
If tubal sterilization is via the Essure procedure, verification of tubal blockage by 
hysterosalpingogram (HSP) must be performed approximately 3 months after microinsertion. 
Prior to verification, Essure is not considered a reliable form of contraception and the 
contraception methods described below must be used. Female subjects who utilize hormonal 
contraceptives as one of their birth control methods must have used the same method for at least 
3 months before study dosing.
Female subjects of childbearing potential must have a negative urine or serum pregnancy test at 
screening and at each dosing visit (Visits 2, 4, 6, 7, and 8) prior to receiving study drug. 


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 107
22 September 2014
Appendix Table 1.
Protocol Specified Contraceptive Methods
Methods to Use by Themselves
Combination Methods
Hormone Methods
(choose one and use with a barrier 
method)
Barrier Methods
(use both OR choose one and use with 
a hormone method)
Intrauterine Devices (IUDs)

Copper T 380A IUD

LNg 20 IUD
Tubal Sterilization
Estrogen and Progesterone

Oral contraceptives

Transdermal patch

Vaginal ring
Progesterone

Injection

Implant

Diaphragm with spermicide
OR

Cervical cap with spermicide

Male condom (with spermicide)
Partner’s vasectomy must be used with a hormone or barrier method and the 
male partner should be the sole partner for that subject. For a vasectomy, 
appropriate post-vasectomy documentation of the absence of sperm in the 
ejaculate must be available.
The investigator will counsel all subjects on the most effective method(s) for avoiding pregnancy 
during the study.
4) Additional Requirements for Male Subjects
Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm 
donation while enrolled in the study and for at least 90 days after administration of the last dose 
of study medication.
Use of condoms, with spermicide, has been proven to decrease the risk of transmission of HIV 
and other sexually transmitted diseases. The use of spermicide is not recommended if the subject 
or subject’s partner is infected with HIV.
5) Procedures to be Followed in the Event of Pregnancy
Subjects will be instructed to notify the investigator if they become pregnant at any time during 
the study, or if they become pregnant within 30 days or 4 weeks of last study drug dose. Subjects 
who become pregnant or who suspect that they are pregnant during the study must report the 
information to the investigator and discontinue study drug immediately. Subjects whose partner 
has become pregnant or suspects she is pregnant during the study must report the information to 
the investigator. 
Instructions for reporting pregnancy, partner pregnancy, and pregnancy outcome are outlined in 
Section 7.7.2.1.

Prot_013.pdf: 


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Presatovir (GS-5806)
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 67
28 March 2016
8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
The primary objective of this study is as follows:

To evaluate the effect of presatovir on RSV viral load in autologous or allogeneic HCT 
recipients with an acute RSV LRTI
The secondary objectives of this study are as follows: 

To evaluate the effect of presatovir on being free of any supplemental oxygen, and rates of 
respiratory failure and all-cause mortality

To evaluate the PK, safety and tolerability of presatovir
8.1.2.
Primary Endpoint
The primary endpoint is the time-weighted average change in nasal RSV viral load 
(log10 copies/mL) from Baseline (Day 1) to Day 9 as measured by RT-qPCR. The time-weighted 
average change in nasal RSV viral load from Baseline to Day 9 is defined as:
∑
  ሼ0.5 ൈ ሺܻ௜൅ܻ௜ାଵሻൈሺݐ௜ାଵെݐ௜ሻሽ 
௕ିଵ
௜ୀ௔
ሺݐ௕െݐ௔ሻ
where <i is the change from Baseline in RSV log10 viral load at 9LVLW L, W is the time at the 
specified timepoint, D is the Baseline assessment at Day 1 and E is the last assessment at or prior 
to Day 9. The time-weighted average change, often referred to as the DAVG, provides the 
average viral burden in change from baseline during the time period of interest.
8.1.3.
Secondary Endpoint
Secondary endpoints are:

Number of supplemental O2 free days through Day 28

Proportion of subjects developing respiratory failure (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28

Proportion of all-cause mortality among subjects through Day 28


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SAP_015.pdf: 
 
 
STATISTICAL ANALYSIS PLAN 
 
 
Study Title: 
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled 
Multi-Center Study Evaluating Antiviral Effects, 
Pharmacokinetics, Safety, and Tolerability of GS-5806 in 
Hematopoietic Cell Transplant (HCT) Recipients with 
Respiratory Syncytial Virus (RSV) Infection of the Lower 
Respiratory Tract 
 
 
Name of Test Drug: 
Presatovir (GS-5806) 
 
 
Study Number: 
GS-US-218-1502 
 
 
Protocol Version: 
Amendment 7 
 
 
Protocol Date: 
28 March 2016 
 
 
Analysis Type: 
Final 
 
 
Analysis Plan Version: 
Version 1.0 
 
 
Analysis Plan Date: 
27 June 2017 
 
 
Analysis Plan Author: 
 
 
 
CONFIDENTIAL AND PROPRIETARY INFORMATION 
 
PPD


Presatovir (GS-5806) 
GS-US-218-1502 
Statistical Analysis Plan 
Version 1.0 
CONFIDENTIAL 
Page 2 
27 June 2017 
TABLE OF CONTENTS 
TABLE OF CONTENTS .............................................................................................................................................. 2 
LIST OF IN-TEXT FIGURES ...................................................................................................................................... 3 
LIST OF ABBREVIATIONS ........................................................................................................................................ 4 
1. 
INTRODUCTION ................................................................................................................................................ 6 
1.1. 
Study Objectives ...................................................................................................................................... 6 
1.2. 
Study Design ............................................................................................................................................ 6 
1.3. 
Sample Size and Power ............................................................................................................................ 7 
2. 
TYPE OF PLANNED ANALYSIS ...................................................................................................................... 8 
2.1. 
Data Monitoring Committee Analyses ..................................................................................................... 8 
2.2. 
Final Analysis .......................................................................................................................................... 8 
3. 
GENERAL CONSIDERATIONS FOR DATA ANALYSES .............................................................................. 9 
3.1. 
Analysis Sets ............................................................................................................................................ 9 
3.1.1. 
All Randomized Analysis Set ................................................................................................. 9 
3.1.2. 
Full Analysis Set .................................................................................................................... 9 
3.1.3. 
Per Protocol Analysis Set ....................................................................................................... 9 
3.1.4. 
Safety Analysis Set ............................................................................................................... 10 
3.1.5. 
Pharmacokinetic Analysis Set .............................................................................................. 10 
3.2. 
Subject Grouping ................................................................................................................................... 10 
3.3. 
Strata and Covariates .............................................................................................................................. 10 
3.4. 
Examination of Subject Subgroups ........................................................................................................ 11 
3.5. 
Multiple Comparisons ............................................................................................................................ 11 
3.6. 
Missing Data and Outliers ...................................................................................................................... 12 
3.6.1. 
Missing Data ........................................................................................................................ 12 
3.6.2. 
Outliers ................................................................................................................................. 12 
3.7. 
Data Handling Conventions and Transformations ................................................................................. 12 
3.8. 
Analysis Visit ......................................................................................................................................... 13 
3.8.1. 
Definition of Study Day ....................................................................................................... 13 
3.8.2. 
Analysis Visit ....................................................................................................................... 13 
3.8.3. 
Selection of Data in the Event of Multiple Records ............................................................. 14 
4. 
SUBJECT DISPOSITION .................................................................................................................................. 15 
4.1. 
Subject Enrollment and Disposition ....................................................................................................... 15 
4.2. 
Extent of Study Drug Exposure and Adherence ..................................................................................... 16 
4.2.1. 
Duration of Exposure to Study Drug .................................................................................... 16 
4.2.2. 
Adherence to Study Drug ..................................................................................................... 16 
4.3. 
Protocol Deviations ................................................................................................................................ 17 
5. 
BASELINE CHARACTERISTICS .................................................................................................................... 18 
5.1. 
Demographics ........................................................................................................................................ 18 
5.2. 
Other Baseline Characteristics ............................................................................................................... 18 
5.3. 
Medical History ...................................................................................................................................... 19 
6. 
EFFICACY ANALYSES ................................................................................................................................... 20 
6.1. 
Primary Efficacy Endpoint ..................................................................................................................... 20 
6.1.1. 
Definition of the Primary Efficacy Endpoint ....................................................................... 20 
6.1.2. 
Analysis for the Primary Efficacy Endpoint ......................................................................... 20 
6.1.3. 
Sensitivity Analysis for Primary Efficacy Endpoint ............................................................ 21 


Presatovir (GS-5806) 
GS-US-218-1502 
Statistical Analysis Plan 
Version 1.0 
CONFIDENTIAL 
Page 3 
27 June 2017 
6.1.4. 
Imputation of Missing Data .................................................................................................. 21 
6.2. 
Secondary Efficacy Endpoints ............................................................................................................... 21 
6.2.1. 
Definition of Secondary Efficacy Endpoints ........................................................................ 21 
6.2.2. 
Analysis Methods for Secondary Efficacy Endpoints .......................................................... 21 
6.2.3. 
Sensitivity Analysis for Secondary Efficacy Endpoints ....................................................... 22 
6.3. 
Exploratory Efficacy Endpoints ............................................................................................................. 22 
6.3.1. 
Definition of Exploratory Efficacy Endpoints ...................................................................... 22 
6.3.2. 
Analysis Methods for Exploratory Efficacy Endpoints ........................................................ 22 
6.4. 
Changes From Protocol-Specified Efficacy Analyses............................................................................ 24 
7. 
SAFETY ANALYSES ........................................................................................................................................ 25 
7.1. 
Adverse Events and Deaths .................................................................................................................... 25 
7.1.1. 
Adverse Event Dictionary .................................................................................................... 25 
7.1.2. 
Adverse Event Severity ........................................................................................................ 25 
7.1.3. 
Relationship of Adverse Events to Study Drug .................................................................... 25 
7.1.4. 
Serious Adverse Events ........................................................................................................ 25 
7.1.5. 
Treatment-Emergent Adverse Events ................................................................................... 25 
7.1.6. 
Summaries of Adverse Events and Deaths ........................................................................... 26 
7.1.7. 
Additional Analysis of Adverse Events ............................................................................... 27 
7.2. 
Laboratory Evaluations .......................................................................................................................... 27 
7.2.1. 
Summaries of Numeric Laboratory Results ......................................................................... 28 
7.2.2. 
Graded Laboratory Values ................................................................................................... 28 
7.2.3. 
Liver-related Laboratory Evaluations ................................................................................... 29 
7.3. 
Body Weight and Vital Signs ................................................................................................................. 30 
7.4. 
Prior and Concomitant Medications ....................................................................................................... 30 
7.4.1. 
Prior Medications ................................................................................................................. 31 
7.4.2. 
Concomitant Medications ..................................................................................................... 31 
7.5. 
Electrocardiogram Assessment .............................................................................................................. 32 
7.6. 
Other Safety Measures ........................................................................................................................... 32 
7.7. 
Changes From Protocol-Specified Safety Analyses ............................................................................... 33 
8. 
PHARMACOKINETIC (PK) ANALYSES ........................................................................................................ 34 
9. 
REFERENCES ................................................................................................................................................... 35 
10. SOFTWARE ....................................................................................................................................................... 36 
11. SAP REVISION .................................................................................................................................................. 37 
12. PROPOSED TABLES, FIGURES AND LISTINGS ......................................................................................... 38 
12.1. 
Tables ..................................................................................................................................................... 38 
12.2. 
Figures .................................................................................................................................................... 44 
12.3. 
Listings ................................................................................................................................................... 46 
13. APPENDICES .................................................................................................................................................... 48 
 
Appendix 1. 
Study Procedures Table .......................................................................................................... 48 
Appendix 2. 
Cardiac Adverse Events of Interest ........................................................................................ 51 
Appendix 3. 
Sample SAS Code for MMRM Model ................................................................................... 52 
Appendix 4. 
Sample SAS Code for Negative Binomial Model .................................................................. 53 
 
 
LIST OF IN-TEXT FIGURES 
Figure 1-1. 
Study Visits .............................................................................................................................. 7 
 


Presatovir (GS-5806) 
GS-US-218-1502 
Statistical Analysis Plan 
Version 1.0 
CONFIDENTIAL 
Page 4 
27 June 2017 
LIST OF ABBREVIATIONS 
AE 
adverse event 
ALT 
alanine aminotransferase 
ANCOVA 
analysis of covariance 
AST 
aspartate aminotransferase 
ATC 
Anatomical Therapeutic Chemical (drug class) 
BLQ 
below the limit of quantification  
BMI 
body mass index 
CI 
confidence interval  
CSR 
clinical study report 
DAVG 
difference between time-weighted average post-baseline and baseline 
DMC 
Data Monitoring Committee 
ECG 
electrocardiogram 
eCRF 
electronic case report forms 
EOT 
end of treatment 
FAS 
Full Analysis Set 
HCT 
hematopoietic cell transplant 
HLT 
high level term 
HLGT 
high level group term 
ICH 
International Conference on Harmonisation 
ICU 
Intensive Care Unit 
ID 
identification 
IMP 
investigational medicinal product 
IWRS 
interactive web response system 
LLT 
lower level term 
LOQ 
limit of quantification 
LRTI 
lower respiratory tract infection 
MedDRA 
medical dictionary for regulatory activities 
ml 
milliliter 
MMRM 
mixed-effect model with repeated measures 
PK 
pharmacokinetics 
PP 
Per Protocol 
PT 
preferred term 
Q1 
first quartile 
Q3 
third quartile 
RSV 
respiratory syncytial virus 
RT-qPCR 
quantitative real time polymerase chain reaction 
SAP 
statistical analysis plan 
SD 
standard deviation 


Presatovir (GS-5806) 
GS-US-218-1502 
Statistical Analysis Plan 
Version 1.0 
CONFIDENTIAL 
Page 5 
27 June 2017 
SE 
standard error 
SOC 
system organ class 
TEAE 
treatment-emergent adverse event 
TFLs 
tables, figures, and listings 
WHO 
World Health Organization 
 


Presatovir (GS-5806) 
GS-US-218-1502 
Statistical Analysis Plan 
Version 1.0 
CONFIDENTIAL 
Page 6 
27 June 2017 
1. 
INTRODUCTION 
This statistical analysis plan (SAP) describes the statistical analysis methods and data 
presentations to be used in tables, figures, and listings (TFLs) in the clinical study report (CSR) 
for Study GS-US-218-1502. This SAP is based on the study protocol Amendment 7 dated 
28 March 2016 and the electronic case report forms (eCRF) for this study. The SAP will be 
finalized before the database finalization. Any changes made after the finalization of the SAP 
will be documented in the CSR. 
1.1. 
Study Objectives 
Primary Objective  
• To evaluate the effect of presatovir on RSV viral load in autologous or allogeneic 
hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract 
infection (LRTI) 
Secondary Objectives   
• To evaluate the effect of presatovir on being free of any supplemental oxygen, and rates of 
respiratory failure and all-cause mortality 
• To evaluate the PK, safety, and tolerability of presatovir 
1.2. 
Study Design 
This is a randomized, double-blind, placebo-controlled study evaluating the effect of presatovir 
on efficacy, PK, safety, and tolerability in HCT recipients with RSV LRTI.  
All subjects will be permitted to receive the standard of care therapy for RSV infection per their 
local medical practices, in addition to the investigational medicinal product (IMP).  
Approximately 60 subjects will be enrolled from approximately 45 international HCT centers.  
Subjects will be randomized in a 1:1 ratio to receive IMP (presatovir or placebo) and will be 
stratified by 2 factors: 
• Supplemental O2 requirement (≤ 2 L/min or > 2 L/min) at the time of randomization 
• Treatment of current RSV infection (yes or no) with ribavirin (oral, intravenous, or 
aerosolized) 
A single dose of 200 mg (four 50 mg tablets) of presatovir or placebo will be administered on 
Study Days 1, 5, 9, 13, and 17. The study will consist of the following visits: screening (Day -1), 
baseline/randomization/IMP administration (Day 1), optional Visit 3 (Day 3), Visit 4 (Day 5), 


Presatovir (GS-5806)
GS-US-218-1502 
Statistical Analysis Plan 
Version 1.0 
CONFIDENTIAL 
Page 7 
27 June 2017 
Visit 5 (Day 7), Visit 6 (Day 9), Visit 7 (Day 13), Visit 8 (Day 17), Visit 9 (Day 22), and end of 
study (Day 28). Four additional visits at Days 35, 42, 49, and 56 will only be completed for 
subjects who consent to the optional extended viral monitoring and test positive for RSV at Visit 
9 (Day  22) (see Figure 1-1).  
Figure 1-1. 
Study Visits 
 
1.3.
Sample Size and Power 
Sample size calculations are based on results observed in a study that evaluated the efficacy of 
oral and aerosolized ribavirin treatment for preventing progression from upper to lower 
respiratory tract infection in hematopoietic cell transplant recipients with RSV infections 
(unpublished data from Dr. 
). The sample size calculation assumes the 
time-weighted average change in RSV log10 viral load from Day 1 to Day 9 in the placebo group 
will be -1.5 log10 copies/mL with a corresponding standard deviation (SD) of 1.75, and that 85% 
of the subjects will be evaluable. Based on these assumptions, with 25 subjects per group there is 
approximately 85% power to detect a 1.5 log difference in time-weighted average change in 
log10 viral load between treatment groups using a 2-sided 0.05-level test. Given an evaluable rate 
of 85%, a total of 60 subjects will need to be randomized into the study.  
PPD


Presatovir (GS-5806)
GS-US-218-1502 
Statistical Analysis Plan 
Version 1.0 
CONFIDENTIAL 
Page 7 
27 June 2017 
Visit 5 (Day 7), Visit 6 (Day 9), Visit 7 (Day 13), Visit 8 (Day 17), Visit 9 (Day 22), and end of 
study (Day 28). Four additional visits at Days 35, 42, 49, and 56 will only be completed for 
subjects who consent to the optional extended viral monitoring and test positive for RSV at Visit 
9 (Day  22) (see Figure 1-1).  
Figure 1-1. 
Study Visits 
 
1.3.
Sample Size and Power 
Sample size calculations are based on results observed in a study that evaluated the efficacy of 
oral and aerosolized ribavirin treatment for preventing progression from upper to lower 
respiratory tract infection in hematopoietic cell transplant recipients with RSV infections 
(unpublished data from Dr. 
). The sample size calculation assumes the 
time-weighted average change in RSV log10 viral load from Day 1 to Day 9 in the placebo group 
will be -1.5 log10 copies/mL with a corresponding standard deviation (SD) of 1.75, and that 85% 
of the subjects will be evaluable. Based on these assumptions, with 25 subjects per group there is 
approximately 85% power to detect a 1.5 log difference in time-weighted average change in 
log10 viral load between treatment groups using a 2-sided 0.05-level test. Given an evaluable rate 
of 85%, a total of 60 subjects will need to be randomized into the study.  
PPD


Presatovir (GS-5806) 
GS-US-218-1502 
Statistical Analysis Plan 
Version 1.0 
CONFIDENTIAL 
Page 8 
27 June 2017 
2. 
TYPE OF PLANNED ANALYSIS 
2.1. 
Data Monitoring Committee Analyses 
An external multidisciplinary Data Monitoring Committee (DMC) will review the progress of 
the study and perform interim reviews of safety data in order to protect subject welfare and 
preserve study integrity. To ensure the best interests of the participants, the DMC will 
recommend to the sponsor if the nature, frequency, and severity of adverse effects associated 
with study treatment warrant the early termination of the study, the continuation of the study, or 
the continuation of the study with modifications.  
The DMC’s role and responsibilities and the scope of analysis to be provided to the DMC are 
provided in a mutually agreed upon charter, which defines the DMC membership, meeting 
logistics, and meeting frequency.  
The initial safety review occurred after approximately 25% of the planned 60 subjects were 
enrolled and completed Day 28 visit or discontinued the study. No additional meetings were 
scheduled due to the reasons specified in Section 7.7.   
2.2. 
Final Analysis 
After all subjects have completed the study, outstanding data queries have been resolved, and the 
data have been cleaned and finalized, the study blind will be broken and the final analysis of the 
data will be performed. 


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3. 
GENERAL CONSIDERATIONS FOR DATA ANALYSES 
Analysis results will be presented using descriptive statistics. For categorical variables, the 
number and percentage of subjects in each category will be presented; for continuous variables, 
the number of subjects (n), mean, standard deviation (SD) or standard error (SE), median, first 
quartile (Q1), third quartile (Q3), minimum, and maximum will be presented. 
By-subject listings will be presented for all subjects in the relevant analysis set, and sorted by 
subject ID number, visit date, and time (if applicable). Data collected on log forms, such as AEs, 
will be presented in chronological order within the subject. The treatment group to which 
subjects were randomized will be used in the listings. Age, sex at birth, race, and ethnicity will 
be included in the listings, as space permits. 
3.1. 
Analysis Sets 
Analysis sets define the subjects to be included in an analysis. Analysis sets and their definitions 
are provided in this section. Subjects included in each analysis set will be determined before the 
study blind is broken for analysis. The analysis set will be identified and included as a subtitle of 
each table, figure, and listing.  
For each analysis set, the number and percentage of subjects eligible for inclusion, as well as the 
number and percentage of subjects who were excluded, will be summarized by treatment group. 
A listing of reasons for exclusion from analysis sets will be provided by subject. 
3.1.1. 
All Randomized Analysis Set 
All Randomized Analysis Set includes all subjects who were randomized in the study.  
3.1.2. 
Full Analysis Set 
The Full Analysis Set (FAS) includes all randomized subjects who received at least 1 full dose of 
study drug, and have an RSV viral load greater than or equal to the lower limit of quantification 
of the RT-qPCR assay in the Day 1 nasal sample, as determined by RT-qPCR at the central lab.  
This is the primary analysis set for efficacy analyses. 
3.1.3. 
Per Protocol Analysis Set 
The Per-Protocol (PP) Analysis Set includes subjects in the FAS who meet the following criteria: 
• Did not violate the following major inclusion criteria (IC) 
 IC #2: Received an autologous or allogeneic HCT using any conditioning regimen 
 IC #3: Chest X-ray obtained < 48 hours prior to Screening 
 IC #4: Documented RSV in both the upper and lower respiratory tract as determined by 
local testing collected ≤ 6 days prior to Day 1 


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• Did not administered invalid (eg, expired, damaged, quarantined, improperly stored) study 
drug  
• Not be dispensed incorrect study drug (wrong bottle) or drug from another study 
• Missed < 1 dose (200 mg) in the first 9 study days 
• Missed < 3 nasal swab samples over the course of the study 
The PP Analysis Set is the secondary analysis set for efficacy analyses. 
3.1.4. 
Safety Analysis Set 
The Safety Analysis Set includes subjects who took at least 1 full dose of study drug. This is the 
primary analysis set for safety analyses. 
3.1.5. 
Pharmacokinetic Analysis Set 
The Pharmacokinetic (PK) Analysis Set includes all subjects in the Safety Analysis Set who have 
evaluable on-study PK measurements. This is the primary analysis set for all PK analyses.  
3.2. 
Subject Grouping 
For analyses based on the FAS and PP Analysis Set, subjects will be grouped according to the 
treatment to which they were randomized. For analyses based on the Safety Analysis Set, 
subjects will be grouped according to the actual treatment received. The actual treatment 
received will differ from the randomized treatment only when their actual treatment differs from 
randomized treatment for the entire treatment duration.  
For the PK Analysis Set, subjects will be grouped according to the actual treatment they 
received. 
3.3. 
Strata and Covariates 
Subjects will be randomly assigned to treatment groups via the interactive web response system 
(IWRS) in a 1:1 ratio using a stratified randomization schedule. Stratification will be based on 
the following parameters:  
• Supplemental O2 requirement (≤ 2 L/min or > 2 L/min) at the time of randomization 
• Treatment of current RSV infection (yes or no) with ribavirin (oral, intravenous, or 
aerosolized) 
If there are discrepancies in stratification factor values between the IWRS and the clinical 
database, the values recorded in the clinical database will be used for analyses. 


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Efficacy endpoints will be evaluated using stratification factors as covariates for analyses, as 
specified in Section 6.  In the event the number of subjects within a stratum of the stratification 
factor is small (eg. ≤ 4 subjects), the stratum will be collapsed with the adjacent stratum for the 
analysis. 
For efficacy endpoints, the baseline value of the efficacy variables will be included as a covariate 
in the efficacy analysis model. 
3.4. 
Examination of Subject Subgroups 
The primary and secondary efficacy endpoints will be examined using the following subgroups: 
• Actual ribavirin use at the first dosing date (Yes or No) 
• Supplemental O2 requirement (≤ 2 L/min or > 2 L/min) at the time of randomization 
The primary efficacy endpoint will also be examined by RSV type (RSV A or RSV B). 
The safety endpoints will be examined using the following subgroups: 
• Age (< 65 years and ≥ 65 years) 
• Sex (male and female) 
3.5. 
Multiple Comparisons 
In order to account for multiple hypothesis testing of endpoints, a sequential testing procedure 
will be used to control the Type 1 error rate of 0.05 across the primary and secondary endpoints. 
The primary endpoint analysis will serve as the gatekeeper for the secondary analyses, ie, the 
primary efficacy hypothesis must be rejected at the 2-sided 0.05 significance level before the 
efficacy hypotheses for the secondary efficacy endpoints can be evaluated.  
If the primary null hypothesis is rejected, then the following secondary endpoints will be tested 
sequentially at 2-sided α = 0.05 significance level in the order listed below based upon the closed 
testing procedure {Dmitrienko 2003}. 
• Number of supplemental O2 free days through Day 28 
• Proportion of subjects developing respiratory failure (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28 
• Proportion of all-cause mortality among all subjects through Day 28 


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3.6. 
Missing Data and Outliers 
3.6.1. 
Missing Data 
In general, missing data will not be imputed unless methods for handling missing data are 
specified. Exceptions are presented in this document. 
For missing last dosing date of study drug, imputation rules are described in Section 4.2.1. The 
handling of missing or incomplete dates for AE onset is described in Section 7.1.5.2 and for prior 
and concomitant medications in Section 7.4. The handling of missing data in analyses of the 
efficacy endpoints is discussed in Section 6. 
3.6.2. 
Outliers 
Outliers will be identified during the data management and data analysis process, but no 
sensitivity analyses will be conducted. All data will be included in the data analyses.  
3.7. 
Data Handling Conventions and Transformations 
In general, age (in years) on the date of the first dose of study drug will be used for analyses and 
presentation in listings. If an enrolled subject was not dosed with any study drug, the 
randomization date will be used instead of the first dosing date of study drug. For screen failures, 
the date the informed consent was signed will be used for age calculation. If only the birth year is 
collected on the eCRF, “01 January” will be used for the unknown birth day and month for the 
purpose of age calculation. If only birth year and month are collected, “01” will be used for the 
unknown birth day. 
Non-PK data that are continuous in nature but are less than the lower limit of quantitation (LOQ) 
or above the upper LOQ will be imputed as follows: 
• A value that is 1 unit less than the LOQ will be used to calculate descriptive statistics if the 
datum is reported in the form of “< x” (where x is considered the LOQ). For example, if the 
values are reported as < 50 and < 5.0, values of 49 and 4.9, respectively, will be used to 
calculate summary statistics. An exception to this rule is any value reported as < 1 or < 0.1, 
etc. For values reported as < 1 or < 0.1, a value of 0.9 or 0.09, respectively, will be used to 
calculate summary statistics. 
• A value that is 1 unit above the LOQ will be used to calculate descriptive statistics if the 
datum is reported in the form of “> x” (where x is considered the LOQ). Values with decimal 
points will follow the same logic as above. 
• The LOQ will be used to calculate descriptive statistics if the datum is reported in the form of 
“≤ x” or “≥ x” (where x is considered the LOQ). 


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If methods based on the assumption that the data are normally distributed are not adequate, 
analyses may be performed on transformed data (eg, log-transformed data) or nonparametric 
analysis methods may be used, as appropriate. 
Plasma concentration values that are below the limit of quantitation (BLQ) will be presented as 
“BLQ” in the concentration data listing. Values that are BLQ will be treated as 0 at predose time 
points, and one-half the value of the LOQ at post-baseline time points. 
The following conventions will be used for the presentation of summary and order statistics:  
• If at least 1 subject has a concentration value of BLQ for the time point, the minimum value 
will be displayed as “BLQ.” 
• If more than 25% of the subjects have a concentration data value of BLQ for a given time 
point, the minimum and Q1 values will be displayed as “BLQ.” 
• If more than 50% of the subjects have a concentration data value of BLQ for a given time 
point, the minimum, Q1, and median values will be displayed as “BLQ.” 
• If more than 75% of the subjects have a concentration data value of BLQ for a given time 
point, the minimum, Q1, median, and Q3 values will be displayed as “BLQ.” 
• If all subjects have concentration data values of BLQ for a given time point, all order 
statistics (minimum, Q1, median, Q3, and maximum) will be displayed as “BLQ.” 
3.8. 
Analysis Visit  
3.8.1. 
Definition of Study Day  
Study day will be calculated from the first dosing date of study drug and derived as follows: 
• For post-dose study days: Assessment Date – First Dosing Date + 1 
• For days prior to the first dose: Assessment Date – First Dosing Date  
Therefore, study day 1 is the day of first dose of study drug administration. 
3.8.2. 
Analysis Visit  
The nominal visit as recorded on the eCRF will be used when data are summarized by visit. Any 
data relating to unscheduled visits will not be assigned to a particular visit or time point. 
However, the following exception will be made:  
• An unscheduled visit prior to the first dosing of study drug may be included in the calculation 
of the baseline value, if applicable. 
• Unscheduled visits after the first dose of study drug will be included in determining the 
maximum post-baseline toxicity grade. 


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• For subjects who prematurely discontinue from the study, early termination (ET) data will be 
assigned to the next scheduled visit where the respective data were scheduled to be collected.  
• Data collected on an extended viral load monitoring visit will be summarized as a separate 
visit, and labeled as Day 35, 42, 49, or 56. 
3.8.3. 
Selection of Data in the Event of Multiple Records  
Depending on the statistical analysis method, single values may be required for each analysis 
visit. If multiple valid, nonmissing, continuous measurements exist in one visit, records will be 
chosen based on the following rules if a single value is needed: 
• In general, the baseline value will be the last nonmissing value on or prior to the first dosing 
date of study drug, unless specified differently. If multiple measurements occur on the same 
day, the last nonmissing value prior to the time of first dosing of study drug will be 
considered as the baseline value. If these multiple measurements occur at the same time or 
the time is not available, the average of these measurements (for continuous data) will be 
considered the baseline value. For the efficacy endpoints, if no measurements occur prior to 
the time of first dosing of study drug, the first nonmissing value on the first dosing date of 
study drug will be considered as the baseline value. 
• For postbaseline values:  
 The record closest to the nominal day for that visit will be selected.   
 If there are 2 records that are equidistant from the nominal day, the later record will be 
selected. 
 If there is more than 1 record on the selected day, the average will be taken, unless 
otherwise specified. 
If multiple valid, non-missing, categorical measurements exist for one visit, records will be 
chosen based on the following rules if a single value is needed: 
• For baseline, the last available record on or prior to the date of the first dose of study drug 
will be selected. If there are multiple records at the same time or no time recorded on the 
same day, the value with the lowest severity will be selected unless otherwise specified.  
• For postbaseline values: 
 The record closest to the nominal day for that visit will be selected.   
 If there are 2 records that are equidistant from the nominal day, the later record will be 
selected. 
 If there is more than 1 record on the selected day, the value with the worst severity will 
be used. 


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4. 
SUBJECT DISPOSITION 
4.1. 
Subject Enrollment and Disposition 
A summary of subject enrollment will be provided by treatment group for each country, 
investigator within a country, and overall. The summary will present the number and percentage 
of subjects enrolled. For each column, the denominator for the percentage calculation will be the 
total number of subjects analyzed for that column.  
A similar enrollment table will be provided by randomization stratum. The denominator for the 
percentage of subjects in the stratum will be the total number of randomized subjects. If there are 
discrepancies in the value used for stratification assignment between the IWRS and the clinical 
database or other source documents, the value collected in the clinical database will be used for 
the summary. A listing of subjects with discrepancies in the value used for stratification 
assignment between the IWRS and the clinical database at the time of data finalization will be 
provided.  
The randomization schedule used for the study will be provided as an appendix to the CSR. 
A summary of subject disposition will be provided by treatment group. This summary will 
present the number of subjects screened, the number of subjects who met all eligibility criteria 
but were not randomize with reasons subjects not randomized, the number of subjects 
randomized, and the number of subjects in each of the categories listed below: 
• Full Analysis Set 
• Safety Analysis Set  
• Per-Protocol Analysis Set 
• PK Analysis Set 
• Completed study drug  
• Did not complete study drug with reasons for premature discontinuation of study drug 
• Completed study 
• Did not complete the study with reasons for premature discontinuation of study 
• Completed Extended Viral Load Monitoring Period 
• Did not complete the Extended Viral Load Monitoring Period with reasons for premature 
discontinuation of Extended Viral Load Monitoring Period 


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For the status of study drug and study completion and reasons for premature discontinuation, the 
number and percentage of subjects in each category will be provided. The denominator for the 
percentage calculation will be the total number of subjects in the Safety Analysis Set 
corresponding to that column.  
The following by-subject listings will be provided by subject identification (ID) number in 
ascending order to support the above summary tables: 
• Reasons for premature study drug or study discontinuation  
• Reasons for screen failure (will be provided by screening ID number in ascending order) 
4.2. 
Extent of Study Drug Exposure and Adherence 
Extent of exposure to study drug will be examined by assessing the total duration of exposure to 
study drug and the level of adherence to the study drug specified in the protocol.  
4.2.1. 
Duration of Exposure to Study Drug 
Total duration of exposure to study drug will be defined as last dosing date minus first dosing 
date plus 4, regardless of any temporary interruptions in study drug administration, and will be 
expressed in days using up to 1 decimal place (eg, 4.5 days). If the last study drug dosing date is 
missing, the latest date among the study drug end date, clinical visit date, laboratory sample 
collection date, and vital signs assessment date that occurred during the on-treatment period will 
be used. 
The total duration of exposure to study drug will be summarized using descriptive statistics (n, 
mean, SD, median, Q1, Q3, minimum, and maximum), and using the number and percentage of 
subjects exposed through the following time periods: Day 1 (Baseline), Day 5, Day 9, Day 13, 
and Day 17. Summaries will be provided by treatment group for the Safety Analysis Set.  
No formal statistical testing is planned.  
4.2.2. 
Adherence to Study Drug 
The total number of tablets administered will be summarized using descriptive statistics.  
The presumed total number of tablets administered to a subject will be determined by the data 
collected on the drug accountability eCRF using the following formula: 
(
)
∑
=
Visits
 
Dosing
Study 
at 
  
Dispensed
 
Tablets
 
of
 
No.
 
ed
Administer
 
Tablets
 
of
Number 
 
Total
 
The level of prescribed adherence to the study drug regimen will be determined by the total 
amount of study drug administered relative to the total amount of study drug specified by the 
protocol for a subject who completes treatment in the study. 


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The level of prescribed adherence will be expressed as a percentage using the following formula: 
Total Amount of Study Drug Administered
Prescribed Adherence (%) =
 x 100
Total Amount of Study Drug Specified by Protocol






 
Descriptive statistics for adherence (sample size, mean, SD, median, Q1, Q3, minimum, and 
maximum) along with the number and percentage of subjects belonging to adherence categories 
(eg, < 80%  and  ≥ 80%) will be provided by treatment group for the Safety Analysis Set.   
No formal statistical testing is planned. 
A by-subject listing of study drug administration and drug accountability will be provided 
separately by subject ID number (in ascending order) and visit (in chronological order). 
4.3. 
Protocol Deviations 
Subjects who did not meet the eligibility criteria for study entry, but enrolled in the study will be 
summarized regardless of whether they were exempted by the sponsor or not. The summary will 
present the number and percentage of subjects who did not meet at least 1 eligibility criterion and 
the number of subjects who did not meet specific entry criteria by treatment group based on the 
All Randomized Analysis Set. A by-subject listing will be provided for those subjects who did 
not meet at least 1 eligibility (inclusion or exclusion) criterion. The listing will present the 
eligibility criterion (or criteria if more than 1 deviation) that subjects did not meet and related 
comments, if collected. 
Protocol deviations occurring after subjects entered the study are documented during routine 
monitoring. The number and percentage of subjects with important protocol deviations by 
deviation reason (eg, nonadherence to study drug, violation of selected inclusion/exclusion 
criteria) will be summarized by treatment group for All Randomized Analysis Set. A by-subject 
listing will be provided for those subjects with any protocol deviation. 


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5. 
BASELINE CHARACTERISTICS 
5.1. 
Demographics  
Subject demographic variables (ie, age, sex, race, and ethnicity) will be summarized by treatment 
group and overall using descriptive statistics for age, and using number and percentage of 
subjects for sex, race, and ethnicity. The summary of demographic data will be provided for the 
Safety Analysis Set. 
In addition, a similar summary table will be provided by the consent status of participation in the 
Extended Viral Load Monitoring (yes or no). 
A by-subject demographic listing, including the informed consent date, will be provided by 
subject ID number in ascending order.  
5.2. 
Other Baseline Characteristics   
Other baseline characteristics include: 
• Weight (kg) 
• Height (cm) 
• Body mass index (BMI; in kg/m2) 
• RSV types (RSV A or RSV B) 
• Vital signs (pulse rate, systolic and diastolic blood pressure, body temperature, and 
respiratory rate) 
• Smoking history 
• Viral load 
• Detectable RSV in nasal swab samples 
• Co-pathogen types 
• Duration of respiratory symptoms prior to the first dosing date 
• Stratification factors 
• Hospitalization (including hospitalization on the date of the first study drug administration 
Yes/No, hospitalized types, duration of hospitalization prior to the date of the first study drug 
administration, hospitalization reasons, hospitalization related to RSV infection) 


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These baseline characteristics will be summarized by treatment groups and overall using 
descriptive statistics (n, mean, SD, median, Q1, Q3, minimum, and maximum) for continuous 
variables and using number and percentage of subjects for categorical variables. In addition, 
baseline characteristics will be summarized by the consent status of participation in the Extended 
Viral Load Monitoring (yes or no) in a separate table. The summary of baseline characteristics 
will be provided for the Safety Analysis Set. No formal statistical testing is planned. 
A by-subject listing of the baseline characteristics will be provided by subject ID number in 
ascending order. 
5.3. 
Medical History 
Medical history will be collected at screening for disease-specific and general conditions 
(ie, conditions not specific to the disease being studied). 
HCT-specific medical history (eg, transplant type, graft versus host disease [GVHD], cell source, 
cytomegalovirus [CMV] status, and time from transplant to the first dosing date) will be 
summarized by treatment group and overall using descriptive statistics (n, mean, SD, median, 
Q1, Q3, minimum, and maximum) for continuous variables and using the numbers and 
percentages of subjects for categorical variables. A summary of HCT-specific medical history 
will be provided for the Safety Analysis Set. No formal statistical testing is planned. 
General medical history will not be coded, but will be listed only. 


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6. 
EFFICACY ANALYSES  
6.1. 
Primary Efficacy Endpoint 
6.1.1. 
Definition of the Primary Efficacy Endpoint 
The primary efficacy endpoint for this study is the time-weighted average change in log10 RSV 
viral load from Baseline (Day 1) to Day 9, defined as:  
 
where Yi is the change from Baseline in RSV log10 viral load at Visit i, t is the time at the 
specified timepoint (the actual study day), a is the baseline assessment at Day 1, and b is the last 
assessment at or prior to Day 9.  
The time-weighted average change, often referred to as the DAVG, provides the average viral 
burden change from baseline. 
6.1.2. 
Analysis for the Primary Efficacy Endpoint 
The primary analysis will test for the superiority of the presatovir group compared to the placebo 
group based on the time-weighted average change in log10 RSV viral load from Day 1 to Day 9 
in the Full Analysis Set at the 2-sided 0.05 level. The null and alternative hypotheses for the 
superiority test on the primary efficacy endpoint are as follows: 
• H0:  There is no difference between presatovir and placebo in the time-weighted average 
change in RSV log10 viral load from Day 1 to Day 9  
• H1:  There is difference between presatovir and placebo in the time-weighted average change 
in RSV log10 viral load from Day 1 to Day 9  
To test the null hypothesis above, a parametric analysis of covariance (ANCOVA) model with 
corresponding baseline viral load and stratification factors (supplemental O2 use and treatment of 
current RSV infection) as covariates will be used, at a 2-sided 0.05 level. Adjusted means and 
95% confidence intervals (CIs) will be provided.  The stratified Wilcoxon rank sum test will be 
implemented as a sensitivity analysis. 
Viral load values below the limit of detection (LOD) will be assigned as 0 if it is reported in the 
form of ‘not detected’. A value of 1 unit less than the LOQ will be used for analysis if the viral 
load is reported in the form of “< x” (where x is considered the LOQ). Viral load data will be 
transformed using the base 10 logarithm for the analyses and summaries. To account for 
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6.1.3. 
Sensitivity Analysis for Primary Efficacy Endpoint 
Sensitivity analyses of the primary efficacy endpoint will be performed in the PP analysis set. 
6.1.4. 
Imputation of Missing Data 
Missing viral load data due to premature discontinuation of the study will not be imputed as all 
available data will be included in the time-weighted average calculations. Intermediate missing 
viral load data will be imputed using the trapezoidal rule for the time-weighted average 
calculations.  
6.2. 
Secondary Efficacy Endpoints 
6.2.1. 
Definition of Secondary Efficacy Endpoints 
Secondary efficacy endpoints include: 
• Number of supplemental O2 free days through Day 28  
• Proportion of subjects developing respiratory failure (of any cause) requiring mechanical  
ventilation (invasive or noninvasive) through Day 28 
• Proportion of all-cause mortality among subjects through Day 28 
6.2.2. 
Analysis Methods for Secondary Efficacy Endpoints 
In order to account for multiple hypothesis testing of endpoints, a sequential testing procedure 
described in Section 3.5 will be used to control the overall Type 1 error rate of 0.05 across the 
primary and secondary endpoints. 
The FAS will be used for all summaries and analyses of secondary endpoints. All secondary 
endpoints will be analyzed using 2-sided tests to compare treatment differences. 
The number of supplemental O2-free days through Day 28 will be analyzed using a negative 
binomial model with stratification factors as covariates and an offset parameter to account for the 
on-study duration. Subjects who die prior to Day 28 (inclusive) or are receiving supplemental O2 
on all days of the study period are assigned 0 supplemental O2-free days. All survivors accrue 1 
supplemental O2-free day for each day that they are both alive and on the use of supplemental O2 
less than 12 hours per 24 hours (0:00 to 23:59) when they are on study.  
The proportion of subjects who develop respiratory failure requiring mechanical ventilation and 
the proportion of subjects with all-cause mortality will be analyzed using 
Cochran-Mantel-Haenszel (CMH) test adjusting for the stratification factors at the 2-sided 
0.05-level. The 2-sided 95% exact CI of the respiratory failure rate or mortality rate based on the 
Clopper-Pearson method will be provided for each treatment group. In the case of a small 
number of events, the exact method will be used. 


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Sensitivity Analysis for Secondary Efficacy Endpoints 
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Sensitivity analyses of the seconda~y efficacy endpoints, the number of supplemental 0 2-free 
days through Day 28, the prop01iion of subjects who develop respirat01y failure requi1ing 
mechanical ventilation through Day 28, and the prop01iion of subjects with all-cause mo1iality 
through Day 28,will be perf01m ed in the PP analysis set. 
6.3. 
6.3.1. 
PPD 
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PPD 
Exploratory Efficacy Endpoints 
Definition of Exploratory Efficacy Endpoints 
Analysis Methods for Exploratory Efficacy Endpoints 
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The number of supplemental 0 2-free days through Day 28 will be analyzed using a negative 
binomial model with stratification factors as covariates. An offset parameter will be included 
to accmmt for differential study durations. 
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7. 
SAFETY ANALYSES 
7.1. 
Adverse Events and Deaths 
7.1.1. 
Adverse Event Dictionary 
Clinical and laboratory AEs will be coded using the current version of the Medical Dictionary 
for Regulatory Activities (MedDRA). System organ class (SOC), high level group term (HLGT), 
high level term (HLT), preferred term (PT), and lower level term (LLT) will be provided in the 
AE dataset. 
7.1.2. 
Adverse Event Severity 
Severity of adverse events will be determined by the investigator as Grade 1 (mild), Grade 2 
(moderate), Grade 3 (severe), or Grade 4 (life-threatening). The severity of events for which the 
investigator did not record severity will be categorized as “missing” for tabular summaries and 
data listings. The missing category will be listed last in summary presentation. 
7.1.3. 
Relationship of Adverse Events to Study Drug 
Related AEs are those for which the investigator selected “Related” on the AE eCRF to the 
question of “Related to Study Treatment.” Relatedness will always default to the investigator’s 
choice, not that of the medical monitor. Events for which the investigator did not record 
relationships to study drug will be considered related to study drug for summary purposes. 
However, by-subject data listings will show the relationship as missing.  
7.1.4. 
Serious Adverse Events 
Serious adverse events will be identified and captured as SAEs if AEs met the definitions of 
SAEs that were specified in the study protocol. SAEs captured and stored in the clinical database 
will be reconciled with the SAE database from the Gilead Drug Safety and Public Health 
Department before database finalization. 
7.1.5. 
Treatment-Emergent Adverse Events 
7.1.5.1. 
Definition of Treatment-Emergent Adverse Events 
Treatment-emergent adverse events (TEAE) are defined as 1 or both of the following: 
• Any AEs with an onset date on or after the study drug start date up to the Day 28, or up to 28 
days if a subject withdraws early (prior to Day 28) from the study 
• Any AEs leading to premature discontinuation of study drug 


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7.1.5.2. 
Incomplete Dates 
If the onset date of the AE is incomplete and the AE stop date is not prior to the first dosing date 
of study drug, then the month and year (or year alone if month is not recorded) of onset 
determine whether an AE is treatment emergent. The event is considered treatment emergent if 
both of the following 2 criteria are met: 
• The AE onset is the same as or after the month and year (or year) of the first dosing date of 
study drug, and 
• The AE onset date is the same as or before the month and year (or year) of the Day 28  
An AE with completely missing onset and stop dates, or with the onset date missing and a stop 
date later than the first dosing date of study drug, will be considered to be treatment emergent. In 
addition, an AE with the onset date missing and incomplete stop date with the same or later 
month and year (or year alone if month is not recorded) as the first dosing date of study drug will 
be considered treatment emergent. 
7.1.6. 
Summaries of Adverse Events and Deaths 
Treatment-emergent (TE) AEs will be summarized based on the Safety Analysis Set. 
The number and percentage of subjects who experienced at least 1 TEAE will be provided and 
summarized by SOC and PT, and treatment group. For other AEs described below, summaries 
will be provided by SOC, PT, and treatment group: 
• TEAE by maximum severity 
• TEAEs of Grade 3 or higher (by maximum severity) 
• TEAEs of Grade 2 or higher 
• All TE treatment-related AEs 
• All TE treatment-related AEs by maximum severity 
• TE treatment-related AEs of Grade 3 or higher (by maximum severity) 
• TE treatment-related AEs of Grade 2 or higher 
• All TE SAEs 
• All TE treatment-related SAEs  
• All TEAEs leading to premature discontinuation of study drug 


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• All TEAEs leading to premature discontinuation of study 
• All AEs leading to death (ie, outcome of death) 
A brief, high-level summary of AEs described above will be provided by treatment group and by 
the number and percentage of subjects who experienced the above AEs. All deaths observed in 
the study will be also included in this summary. 
Multiple events will be counted only once per subject in each summary. Adverse events will be 
summarized and listed first in alphabetic order of SOC and HLT within each SOC (if applicable), 
and then by PT in descending order of total frequency within each SOC. For summaries by 
severity grade, the most severe grade will be used for those AEs that occurred more than once in 
an individual subject during the study.  
In addition to the above summary tables, all TEAEs, TE treatment-related AEs, and TE SAE will 
be summarized by PT only, in descending order of total frequency. 
In addition, data listings will be provided for the following: 
• All AEs, indicating whether the event is treatment emergent 
• All AEs of Grade 3 or higher 
• All AEs of Grade 2 or higher 
• SAEs 
• Deaths 
• All AEs leading to death (ie, outcome of death) 
• AEs leading to premature discontinuation of study drug  
• AEs leading to premature discontinuation of study 
7.1.7. 
Additional Analysis of Adverse Events 
Summaries (number and percentage) of subjects who experienced any cardiac related events will 
be provided for each treatment group using the Safety Analysis Set by AE of interest categories 
and the associated PTs (see Appendix 2). 
7.2. 
Laboratory Evaluations 
Laboratory data collected during the study will be analyzed and summarized using both 
quantitative and qualitative methods. Summaries of laboratory data will be provided for the 
Safety Analysis Set and will include data collected up to Day 28. The analysis will be based on 
values reported in conventional units. When values are below the LOQ, they will be listed as 


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such, and the closest imputed value will be used for the purpose of calculating summary statistics 
as specified in Section 3.7. Hemolized test results will not be included in the analysis, but they 
will be listed in by-subject laboratory listings. 
A by-subject listing for laboratory test results will be provided by subject ID number and visit in 
chronological order for hematology and serum chemistry separately. Values falling outside of the 
relevant reference range and/or having a severity grade of 1 or higher on the Gilead Grading 
Scale for Severity of Adverse Events and Laboratory Abnormalities will be flagged in the data 
listings, as appropriate. 
No formal testing will be generated. 
7.2.1. 
Summaries of Numeric Laboratory Results 
Descriptive statistics will be provided by treatment group for each laboratory test specified in the 
study protocol as follows: 
• Baseline values  
• Values at each postbaseline visit 
• Change from baseline at each postbaseline visit  
A baseline laboratory value will be defined as the last measurement obtained on or prior to the 
date/time of first dose of study drug. Change from baseline to a postbaseline visit will be defined 
as the visit value minus the baseline value. The mean, median, Q1, Q3, minimum, and maximum 
will be displayed to the reported number of digits; SD values will be displayed to the reported 
number of digits plus 1.  
Median (Q1, Q3) of the observed values for the laboratory tests will be plotted using a line plot 
by treatment group and visit.  
In the case of multiple values in an analysis visit, data will be selected for analysis as described 
in Section 3.8.3. 
7.2.2. 
Graded Laboratory Values 
The Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities will be 
used for assigning toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 includes all 
values that do not meet the criteria for an abnormality of at least Grade 1. For laboratory tests 
with criteria for both increased and decreased levels, analyses for each direction (ie, increased, 
decreased) will be presented separately.  


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7.2.2.1. 
Treatment-Emergent Laboratory Abnormalities 
Treatment-emergent laboratory abnormalities are defined as values that increase at least 
1 toxicity grade from baseline at any postbaseline time point, up to and including Day 28. If the 
relevant baseline laboratory value is missing, any abnormality of at least Grade 1 observed 
within the time frame specified above will be considered treatment emergent. 
7.2.2.2. 
Treatment-Emergent Marked Laboratory Abnormalities   
Treatment-emergent marked laboratory abnormalities are defined as values that increase from 
baseline by at least 3 toxicity grades at any postbaseline time point, up to and including Day 28.  
If the relevant baseline laboratory value is missing, then any Grade 3 or 4 values observed within 
the timeframe specified above will be considered treatment-emergent marked abnormalities. 
7.2.2.3. 
Summaries of Laboratory Abnormalities 
Laboratory data that are categorical will be summarized using the number and percentage of 
subjects in the study with the given response at baseline and each scheduled postbaseline visit. 
The following summaries (number and percentage of subjects) for treatment-emergent laboratory 
abnormalities will be provided by treatment group; subjects will be categorized according to the 
most severe postbaseline abnormality grade for a given lab test: 
• Graded laboratory abnormalities 
• Grade 3 or 4 laboratory abnormalities  
• Marked laboratory abnormalities 
For all summaries of laboratory abnormalities, the denominator is the number of subjects with 
nonmissing postbaseline values up to and including Day 28.   
A by-subject listing of treatment-emergent Grade 3 or 4 laboratory abnormalities and marked 
laboratory abnormalities will be provided by subject ID number and visit in chronological order. 
This listing will include all test results that were collected throughout the study for the lab test of 
interest, with all applicable severity grades displayed. 
7.2.3. 
Liver-related Laboratory Evaluations 
Liver-related abnormalities after initial study drug dosing will be examined and summarized 
using the number and percentage of subjects who were reported to have the following laboratory 
test values for post-baseline measurements: 
• Aspartate aminotransferase (AST): (a) > 3 times of the upper limit of reference range  
(ULN); (b) > 5 x ULN; (c) > 10 x ULN; (d) > 20 x ULN 
• Alanine aminotransferase (ALT): (a) > 3 x ULN; (b) > 5 x ULN; (c) > 10 x ULN; (d) > 20 x 
ULN 


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• AST or ALT: (a) > 3 x ULN; (b) > 5 x ULN; (c) > 10 x ULN; (d) > 20 x ULN 
• Total bilirubin: (a) > 1 x ULN; (b) > 2 x ULN 
• Alkaline phosphatase (ALP) > 1.5 x ULN 
• AST or ALT > 3 x ULN and total bilirubin: (a) > 1.5 x ULN; (b) > 2 x ULN 
• AST or ALT > 3 x ULN, total bilirubin  > 2 x ULN and ALP < 2 x ULN  
The summary will include data from all post-baseline visits up to and including Day 28. For 
individual laboratory tests, subjects will be counted once based on the most severe post-baseline 
values. For both the composite endpoint of AST or ALT and total bilirubin, subjects will be 
counted once when the criteria are met at the same post-baseline visit date. The denominator is 
the number of subjects in the Safety Analysis Set who have nonmissing post-baseline values of 
all relevant tests at the same post-baseline visit date. A listing of subjects who met at least 1 of 
the above criteria will be provided. 
7.3. 
Body Weight and Vital Signs 
Descriptive statistics will be provided by treatment group for body weight and vital signs as 
follows: 
• Baseline value 
• Values at each postbaseline time point  
• Change from baseline at each postbaseline time point  
Median (Q1, Q3) of the observed values for vital signs will be plotted by treatment group and 
visit. 
A baseline value will be defined as the last available value collected on or prior to the date/time 
of first dose of study drug. Change from baseline to a post-baseline visit will be defined as the 
post-baseline value minus the baseline value.  
In the case of multiple values at a visit assessment, data will be selected for analysis as described 
in Section 3.8.3. No inferential statistics will be generated. 
A by-subject listing of vital signs will be provided by subject ID number and visit in 
chronological order. Body weight will be included in the vital signs listing, if space permits. If 
not, they will be provided separately. 
7.4. 
Prior and Concomitant Medications 
Medications collected at screening and during the study will be coded using the current version 
of the World Health Organization (WHO) Drug dictionary.  


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7.4.1. 
Prior Medications 
Prior medications are defined as any medications taken before a subject took the first study drug.  
Prior medications will be summarized by Anatomical Therapeutic Chemical (ATC) drug class 
Level 2 and preferred name using the number and percentage of subjects for each treatment 
group and overall. A subject reporting the same medication more than once will be counted only 
once when calculating the number and percentage of subjects who received that medication. The 
summary will be ordered alphabetically by ATC classes and then by preferred term in order of 
descending overall frequency within each ATC medical class. For drugs with the same 
frequency, sorting will be done alphabetically. 
For the purposes of analysis, any medication with a start date prior to the first dosing date of 
study drug will be included in the prior medication summary regardless of when the stop date is. 
If a partial start date is entered the medication will be considered prior unless the month and year 
(if day is missing) or year (if day and month are missing) of the start date are after the first 
dosing date. Medications with a completely missing start date will be included in the prior 
medication summary, unless otherwise specified. Summaries will be based on the Safety 
Analysis Set. No formal statistical testing is planned.  
Prior ribavirin use will be summarized separately from other prior general medications. 
7.4.2. 
Concomitant Medications 
Concomitant medications are defined as medications taken while a subject took study drug. Use 
of concomitant medications will be summarized by Anatomical Therapeutic Chemical (ATC) 
drug class Level 2 and preferred name using the number and percentage of subjects for each 
treatment group. A subject reporting the same medication more than once will be counted only 
once when calculating the number and percentage of subjects who received that medication. The 
summary will be ordered alphabetically by ATC medical class and then by preferred term in 
descending overall frequency within each ATC medical class. For drugs with the same 
frequency, sorting will be done alphabetically. 
For the purposes of analysis, any medication with a start date prior to or on the first dosing date 
of study drug and continued to take after the first dosing date, or started after the first dosing date 
but prior to or on the last dosing date of study drug will be considered concomitant medications. 
Medications started and stopped on the same day as the first dosing date or the last dosing date of 
study drug will also be considered concomitant. Medications with a stop date prior to the date of 
first dosing date of study drug or a start date after the last dosing date of study drug will be 
excluded from the concomitant medication summary. If a partial stop date is entered, any 
medication with the month and year (if day is missing) or year (if day and month are missing) 
prior to the date of first study drug administration will be excluded from the concomitant 
medication summary. If a partial start date is entered, any medication with the month and year 
(if day is missing) or year (if day and month are missing) after the study drug stop date will be 
excluded from the concomitant medication summary. Medications with completely missing start 


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and stop dates will be included in the concomitant medication summary, unless otherwise 
specified. Summaries will be based on the Safety Analysis Set. No formal statistical testing is 
planned.  
Concomitant ribavirin use will be summarized separately from other concomitant general 
medications. 
All prior and concomitant medications (other than per-protocol study drugs) will be provided in a 
by-subject listing sorted by subject ID number and administration date in chronological order.  
7.5. 
Electrocardiogram Assessment 
Number and percent of subjects with new ECG abnormalities at postbaseline visits including 
those assessments obtained for the purpose of standard of care will by summarize by treatments. 
Only subjects with baseline ECG assessments will be included in this analysis. 
A shift table of the central assessment of ECG results at postbaseline visit including those 
assessments obtained for the purpose of standard of care compared with baseline values will be 
presented by treatment group using the following categories: normal, no new abnormality, new 
abnormality, or missing. The number and percentage of subjects in each cross-classification 
group of the shift table will be presented. Subjects with a missing value at baseline or 
postbaseline will not be included in the denominator for percentage calculation. No formal 
statistical testing is planned. 
A by-subject listing for ECG central assessment and ECG abnormalities, including those not 
required by the protocol (ie. standard of care), will be provided by subject ID number and time 
point in chronological order. 
7.6. 
Other Safety Measures 
A shift table of troponin results at postbaseline visit including those obtained for the purposes of 
standard of care compared with baseline values will be presented by treatment group using the 
following categories: normal, abnormal, or missing. The number and percentage of subjects in 
each cross-classification group of the shift table will be presented. Subjects with a missing value 
at baseline or postbaseline will not be included in the denominator for percentage calculation. No 
formal statistical testing is planned. 
If multiple troponin results exist for one visit due to multiple troponin assay tests performed, the 
results obtained from Troponin I test will be used for the analysis. 
A by-subject listing for all troponin results, including those not required by the protocol 
(ie, standard of care), will be provided by subject ID number and visit in chronological order. 
A data listing will be provided for subjects experiencing pregnancy during the study. 


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7.7. 
Changes From Protocol-Specified Safety Analyses 
In accordance with the DMC Charter, the additional safety DMC meetings were scheduled to 
occur after approximately 50% and 75% of the subjects were enrolled. The winter 2016/2017 
RSV season resulted in higher rates of enrollment for this study compared to previous RSV 
seasons.  The enrollment was completed in this study on 20 March 2017 with 60 subjects 
enrolled. Due to quicker than expected enrollment and the time required to prepare for a DMC 
meeting, it would not have been possible to hold the planned DMC meeting prior to all subjects 
completing treatment with presatovir. Since the findings of the DMC would not have been 
actionable upon subjects in the study, the DMC Chairperson agreed to forgo the meeting 


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8. 
PHARMACOKINETIC (PK) ANALYSES 
Individual subject concentration data for presatovir will be listed and summarized using 
descriptive statistics. Summary statistics (n, mean, SD, coefficient of variation [%CV], median, 
min, max, Q1, and Q3) will be calculated for individual subject concentration data by time point.  
Individual concentration data listings and summaries will include all subjects with concentration 
data. The sample size for each time point will be based on the number of subjects with 
nonmissing concentration data at that time point. The number of subjects with concentration 
BLQ will be presented for each time point. For summary statistics, BLQ values will be treated as 
0 at pre-dose and one-half of the lower LOQ for post-dose time points. 
The following table will be provided for presatovir: 
• Individual subject concentration data and summary statistics 
The following figures will be provided for presatovir: 
• Mean (± SD) concentration data versus time (on linear and semilogarithmic scales) 
Individual, mean, and median post-dose concentration values that are ≤ lower LOQ will not be 
displayed in the figures and remaining points connected. 
PK sampling details by subject, including procedures, differences in scheduled and actual draw 
times, and sample age will be provided in listings. 


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9. 
REFERENCES 
Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not 
require all primary effects to be significant. Statist Med 2003;22 (15):2387-400. 
 


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10. 
SOFTWARE 
SAS® Software Version 9.4. SAS Institute Inc., Cary, NC, USA. 


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11. 
SAP REVISION 
Revision Date 
(dd month, yyyy) 
Section 
Summary of Revision 
Reason for Revision 
 
 
 
 
 
 
 
 
 


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12. 
PROPOSED TABLES, FIGURES AND LISTINGS 
12.1. 
Tables 
Table Number 
Title 
Analysis Set 
15.8.1.1 
Enrollment by Country and Investigator 
All Randomized Analysis Set  
15.8.1.2 
Enrollment by Randomization Stratum 
All Randomized Analysis Set  
15.8.1.3 
Subject Disposition 
All Screened Subjects 
15.8.2.1 
Eligibility Criteria Deviations 
All Randomized Analysis Set 
15.8.2.2 
Important Protocol Deviations  
All Randomized Analysis Set 
15.8.3.1.1 
Demographics  
Safety Analysis Set 
15.8.3.1.2 
Demographics by Consent for Participating in the 
Extended Viral Load Monitoring 
Safety Analysis Set 
15.8.3.2.1 
Baseline Characteristics 
Safety Analysis Set 
15.8.3.2.2 
Baseline Characteristics by Consent for Participating in 
the Extended Viral Load Monitoring  
Safety Analysis Set 
15.8.3.3 
Hematopoietic Cell Transplant Medical History 
Safety Analysis Set 
15.8.4 
Adherence to Study Drug  
Safety Analysis Set 
15.8.5 
Analysis Sets  
All Randomized Analysis Set  
15.9.1.1 
Time-Weighted Average Change in Nasal RSV Viral 
Load (log10 copies/ml) from Baseline to Day 9   
Full Analysis Set 
15.9.1.2 
Time-Weighted Average Change in Nasal RSV Viral 
Load (log10 copies/ml) from Baseline to Day 9   
Per Protocol Analysis Set  
15.9.1.3 
Time-Weighted Average Change in Nasal RSV Viral 
Load (log10 copies/ml) from Baseline to Day 9 by Actual 
Ribavirin Use at Date of First Study Drug Administration 
Full Analysis Set  
15.9.1.4 
Time-Weighted Average Change in Nasal RSV Viral 
Load (log10 copies/ml) from Baseline to Day 9 by 
Supplemental O2 Use at Randomization 
Full Analysis Set  
15.9.1.5 
Time-Weighted Average Change in Nasal RSV Viral 
Load (log10 copies/ml) from Baseline to Day 9 by RSV 
Type 
Full Analysis Set  
15.9.2.1.1 
Number of Supplemental O2 Free Days through Day 28   
Full Analysis Set 
15.9.2.1.2 
Number of Supplemental O2 Free Days through Day 28   
Per Protocol Analysis Set  
15.9.2.1.3 
Number of Supplemental O2 Free Days through Day 28 
by Actual Ribavirin Use at Date of First Study Drug 
Administration 
Full Analysis Set 
15.9.2.1.4 
Number of Supplemental O2 Free Days through Day 28 
by Supplemental O2 Use at Randomization 
Full Analysis Set 


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Table Number 
Title 
Analysis Set 
15.9.2.2.1 
Proportion of Subjects Developing Respiratory Failure 
Requiring Mechanical Ventilation Through Day 28  
Full Analysis Set 
15.9.2.2.2 
Proportion of Subjects Developing Respiratory Failure 
Requiring Mechanical Ventilation Through Day 28 
Per Protocol Analysis Set  
15.9.2.2.3 
Proportion of Subjects Developing Respiratory Failure 
Requiring Mechanical Ventilation Through Day 28 by 
Actual Ribavirin Use at Date of First Study Drug 
Administration 
Full Analysis Set 
15.9.2.2.4 
Proportion of Subjects Developing Respiratory Failure 
Requiring Mechanical Ventilation Through Day 28 by 
Supplemental O2 Use at Randomization 
Full Analysis Set 
15.9.2.3.1 
Proportion of All-cause Mortality Among Subjects 
Through Day 28   
Full Analysis Set 
15.9.2.3.2 
Proportion of All-cause Mortality Among Subjects 
Through Day 28   
Per Protocol Analysis Set  
15.9.2.3.3 
Proportion of All-cause Mortality Among Subjects 
Through Day 28 by Actual Ribavirin Use at Date of First 
Study Drug Administration 
Full Analysis Set 
15.9.2.3.4 
Proportion of All-cause Mortality Among Subjects 
Through Day 28 by Supplemental O2 Use at 
Randomization 
Full Analysis Set 
15.9.3.1.1 
RSV Viral Load (log10 copies/ml) and Change from 
Baseline in Nasal Samples  
Full Analysis Set 
15.9.3.1.2 
RSV Viral Load (log10 copies/ml) and Change from 
Baseline in Nasal Samples for the Extended Viral Load 
Monitoring   
Full Analysis Set 
15.9.3.1.3 
RSV Viral Load (log10 copies/ml) and Change from 
Baseline in the Nasal Samples by Consent for 
Participating in the Extended Viral Load Monitoring   
Full Analysis Set 
15.9.3.2 
Time-weighted Average and Time-weighted Average 
Change from Baseline in Nasal RSV Viral Load (log10 
copies/ml)  
Full Analysis Set 
15.9.3.3.1 
Proportion of Subjects with Detectable RSV in Nasal 
Samples by Visit 
Full Analysis Set 
15.9.3.3.2 
Proportion of Subjects with Detectable RSV in Nasal 
Samples by Consent for Participating in the Extended 
Viral Load Monitoring 
Full Analysis Set  
15.9.3.4 
Proportion of Subjects on Supplemental O2 (≥ 2 L/min 
for > 24 hours ) through Day 28 
Full Analysis Set 
15.9.3.5 
Proportion of Subjects whose O2 Saturation Drops ≤ 88% 
by Day 28 
Full Analysis Set 
15.9.3.6 
O2 Saturation and Change from Baseline in O2 
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Table Number 
Title 
Analysis Set 
Saturation 
15.9.3.7 
Time-weighted Average O2 Saturation and Time-
weighted Average Change from Baseline in O2 
Saturation 
Full Analysis Set 
15.9.3.8 
Proportion of Subjects Requiring ICU Admission or 
Equivalent of ICU Care (due to Any Cause) through Day 
28 
Full Analysis Set 
15.9.3.9 
Number of ICU Free Days through Day 28 
Full Analysis Set 
15.9.3.10 
Number of Mechanical Ventilation (Invasive or Non-
invasive) Free Days through Day 28 
Full Analysis Set 
15.9.3.11 
Number of Hospital Free Days through Day 28 
Full Analysis Set 
15.10.1.1 
Individual Data and Summary Statistics of Plasma 
Concentration (ng/mL) at Protocol Specified Sampling 
Time 
PK Analysis Set 
15.11.1.1 
Extent of Exposure to Study Drug 
Safety Analysis Set 
15.11.2.1.1.1 
Treatment Emergent Adverse Events: Overall Summary 
Safety Analysis Set 
15.11.2.1.1.2 
Treatment Emergent Adverse Events by Age Group (<65 
Years or ≥65 Years): Overall Summary 
Safety Analysis Set 
15.11.2.1.1.3 
Treatment Emergent Adverse Events by Sex (Male or 
Female): Overall Summary 
Safety Analysis Set 
15.11.2.1.2.1 
Treatment Emergent Adverse Events by System Organ 
Class and Preferred Term 
Safety Analysis Set 
15.11.2.1.2.2 
Treatment Emergent Adverse Events by System Organ 
Class and Preferred Term by Age Group (<65 Years or 
≥65 Years) 
Safety Analysis Set 
15.11.2.1.2.3 
Treatment Emergent Adverse Events by System Organ 
Class and Preferred Term by Sex (Male or Female) 
Safety Analysis Set 
15.11.2.1.3 
Treatment Emergent Adverse Events by Preferred Term 
Safety Analysis Set 
15.11.2.2.1 
Treatment Emergent Adverse Events by System Organ 
Class, Preferred Term, and Severity 
Safety Analysis Set 
15.11.2.2.2.1 
Treatment-Emergent Adverse Events with Severity of 
Grade 3 or Above by System Organ Class and 
Preferred Term 
Safety Analysis Set 
15.11.2.2.2.2 
Treatment-Emergent Adverse Events with Severity of 
Grade 2 or Above by System Organ Class and 
Preferred Term 
Safety Analysis Set 
15.11.2.2.2.3 
Treatment-Emergent Adverse Events with Severity of 
Grade 3 or Above by Preferred Term 
Safety Analysis Set 
15.11.2.2.2.4 
Treatment-Emergent Adverse Events with Severity of 
Grade 2 or Above by Preferred Term 
Safety Analysis Set 


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Table Number 
Title 
Analysis Set 
15.11.2.3.1.1                   Treatment-Emergent Treatment-Related Adverse Events 
by System Organ Class and Preferred Term 
Safety Analysis Set 
15.11.2.3.1.2                   Treatment-Emergent Treatment-Related Adverse Events 
by Preferred Term 
Safety Analysis Set 
15.11.2.3.2                      Treatment-Emergent Treatment-Related Adverse Events, 
Preferred Term, and Severity 
Safety Analysis Set 
15.11.2.3.3.1                   
Treatment-Emergent Treatment-Related Adverse Events 
with Severity of Grade 3 or Above by System Organ Class 
and Preferred Term 
Safety Analysis Set 
15.11.2.3.3.2                   
Treatment-Emergent Treatment-Related Adverse Events 
with Severity of Grade 2 or Above by System Organ Class 
and Preferred Term 
Safety Analysis Set 
15.11.2.3.3.3                   Treatment-Emergent Treatment-Related Adverse Events 
with Severity of Grade 3 or Above by Preferred Term 
Safety Analysis Set 
15.11.2.3.3.4                   Treatment-Emergent Treatment-Related Adverse Events 
with Severity of Grade 2 or Above by Preferred Term 
Safety Analysis Set 
15.11.2.4 
Treatment-Emergent Adverse Events of Interest (Cardiac 
Adverse Event) by System Organ Class and Preferred 
Term 
Safety Analysis Set 
15.11.3 
Treatment-Emergent Adverse Events Leading to Death 
by System Organ Class and Preferred Term 
Safety Analysis Set 
15.11.4.1 
Treatment Emergent Serious Adverse Event by System 
Organ Class and Preferred Term 
Safety Analysis Set 
15.11.4.2 
Treatment Emergent Serious Adverse Event by Preferred 
Term 
Safety Analysis Set 
15.11.4.3.1 
Treatment Emergent Treatment-Related Serious Adverse 
Events by System Organ Class and Preferred Term  
Safety Analysis Set 
15.11.4.3.2 
Treatment Emergent Treatment-Related Serious Adverse 
Events by Preferred Term 
Safety Analysis Set 
15.11.4.4 
Treatment-Emergent Serious Adverse Events of Interest 
(Cardiac Adverse Event) by System Organ Class and 
Preferred Term 
Safety Analysis Set 
15.11.5.1 
Treatment-Emergent Adverse Events Leading to 
Premature Discontinuation of Study Drug by System 
Organ Class and Preferred Term 
Safety Analysis Set 
15.11.5.2 
Treatment-Emergent Adverse Events Leading to 
Premature Discontinuation of Study by System Organ 
Class and Preferred Term 
Safety Analysis Set 
15.11.6.1.1 
Hematology Test: Hemoglobin (g/dL) and Change from 
Baseline  
Safety Analysis Set 
15.11.6.1.2 
Hematology Test: Lymphocytes (x10^3/µL) and Change 
from Baseline 
Safety Analysis Set 


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Table Number 
Title 
Analysis Set 
15.11.6.1.3 
Hematology Test: Lymphocytes (%) and Change from 
Baseline 
Safety Analysis Set 
15.11.6.1.4 
Hematology Test: Monocytes (x10^3/µL) and Change 
from Baseline 
Safety Analysis Set 
15.11.6.1.5 
Hematology Test: Monocytes (%) and Change from 
Baseline 
Safety Analysis Set 
15.11.6.1.6 
Hematology Test: Neutrophils (x10^3/µL) and Change 
from Baseline 
Safety Analysis Set 
15.11.6.1.7 
Hematology Test: Neutrophils (%) and Change from 
Baseline 
Safety Analysis Set 
15.11.6.1.8 
Hematology Test: Platelets (x10^3/µL) and Change from 
Baseline 
Safety Analysis Set 
15.11.6.1.9 
Hematology Test: Leukocytes (x10^3/µL) and Change 
from Baseline  
Safety Analysis Set 
15.11.6.2.1 
Chemistry Test: ALT (U/L) and Change from Baseline  
Safety Analysis Set 
15.11.6.2.2 
Chemistry Test: AST (U/L) and Change from Baseline  
Safety Analysis Set 
15.11.6.2.3 
Chemistry Test: ALP (SGPT) (U/L) and Change from 
Baseline  
Safety Analysis Set 
15.11.6.2.4 
Chemistry Test: Total Bilirubin (mg/dL) and Change 
from Baseline  
Safety Analysis Set 
15.11.6.2.5 
Chemistry Test: Blood Urea Nitrogen (mg/dL) and 
Change from Baseline  
Safety Analysis Set 
15.11.6.2.6 
Chemistry Test: Creatinine (mg/dL) and Change from 
Baseline  
Safety Analysis Set 
15.11.6.2.7 
Chemistry Test: Creatinine Clearance (mL/min) and 
Change from Baseline  
Safety Analysis Set 
15.11.6.2.8 
Chemistry Test: Albumin (g/dL) and Change from 
Baseline  
Safety Analysis Set 
15.11.6.2.9 
Chemistry: Creatinine (mg/dL) and Change from 
Baseline by Hourly Timepoint for Hospitalized Subjects 
Safety Analysis Set 
15.11.6.4.1.1 
Treatment Emergent Laboratory Abnormalities 
Safety Analysis Set 
15.11.6.4.1.2 
Treatment Emergent Laboratory Abnormalities by Age 
Group (<65 Years or ≥65 Years) 
Safety Analysis Set 
15.11.6.4.1.3 
Treatment Emergent Laboratory Abnormalities by Sex 
(Male or Female) 
Safety Analysis Set 
15.11.6.4.2 
Treatment Emergent Grade 3 or Above Laboratory 
Abnormalities 
Safety Analysis Set 
15.11.6.4.3 
Treatment Emergent Marked Laboratory Abnormalities 
Safety Analysis Set 
15.11.6.5 
Liver-Related Laboratory Abnormalities  
Safety Analysis Set 


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Table Number 
Title 
Analysis Set 
15.11.6.6 
Shift in Troponin Results   
Safety Analysis Set 
15.11.7.1.1 
Vital Signs: Diastolic Blood Pressure (mmHg) and 
Change from Baseline  
Safety Analysis Set 
15.11.7.1.2 
Vital Signs: Systolic Blood Pressure (mmHg) and 
Change from Baseline  
Safety Analysis Set 
15.11.7.1.3 
Vital Signs: Pulse (beats per minute) and Change from 
Baseline  
Safety Analysis Set 
15.11.7.1.4 
Vital Signs: Respiratory Rate (breaths per minute) and 
Change from Baseline  
Safety Analysis Set 
15.11.7.1.5 
Vital Signs: Temperature (Celsius) and Change from 
Baseline  
Safety Analysis Set 
15.11.7.2.1 
Body Weight (kg) and Change from Baseline  
Safety Analysis Set 
15.11.7.3.1 
Prior Medications by Drug Class and Preferred Drug 
Name 
Safety Analysis Set 
15.11.7.3.2 
Concomitant Medications by Drug Class and 
Preferred Drug Name 
Safety Analysis Set 
15.11.7.3.3 
Prior Ribavirin  
Safety Analysis Set 
15.11.7.3.4 
Concomitant Ribavirin  
Safety Analysis Set 
15.11.9.1 
Shift in Electrocardiogram Results   
Safety Analysis Set 
15.11.9.2 
Subject with New Abnormalities ECG at Postbaseline 
Safety Analysis Set 
 


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12.2. 
Figures 
Figure  
Title 
Analysis Set 
15.8.1 
Histogram of Number of Subjects Enrolled by Site 
All Randomized Analysis Set 
15.8.2 
Histogram of Number of Subjects Enrolled by Country 
All Randomized Analysis Set 
15.9.1.1 
Mean (SD) Viral Load (log10 copies/ml) at Each Visit  
Full Analysis Set 
15.9.1.2 
Mean (SD) Change from Baseline in Viral Load (log10 
copies/ml) at Each Visit 
Full Analysis Set 
15.9.2.1 
Mean (SD) O2 Saturation at Each Visit 
Full Analysis Set 
15.9.2.2 
Mean (SD) Change from Baseline in O2 Saturation at Each Visit  Full Analysis Set 
15.10.1.1 
Mean (SD) Plasma Concentrations vs. Time  
PK Analysis Set 
15.11.6.1.1  
Median (Q1, Q3) Hematology Test: Hemoglobin (g/dL) by 
Visit   
Safety Analysis Set 
15.11.6.1.2 
Median (Q1, Q3) Hematology Test: Lymphocytes (x10^3/µL) 
by Visit   
Safety Analysis Set 
15.11.6.1.3 
Median (Q1, Q3) Hematology Test: Lymphocytes (%) by Visit   
Safety Analysis Set 
15.11.6.1.4  
Median (Q1, Q3) Hematology Test: Monocytes (x10^3/µL) by 
Visit   
Safety Analysis Set 
15.11.6.1.5  
Median (Q1, Q3) Hematology Test: Monocytes (%) by Visit   
Safety Analysis Set 
15.11.6.1.6  
Median (Q1, Q3) Hematology Test: Neutrophils (x10^3/µL) by 
Visit   
Safety Analysis Set 
15.11.6.1.7  
Median (Q1, Q3) Hematology Test: Neutrophils (%) by Visit   
Safety Analysis Set 
15.11.6.1.8  
Median (Q1, Q3) Hematology Test: Leukocytes (x10^3/uL) by 
Visit   
Safety Analysis Set 
15.11.6.1.9  
Median (Q1, Q3) Hematology Test: Platelet Count (x10^3/uL) 
by Visit   
Safety Analysis Set 
15.11.6.2.1  
Median (Q1, Q3) Chemistry Test: ALT (U/L) by Visit 
Safety Analysis Set 
15.11.6.2.2  
Median (Q1, Q3) Chemistry Test: AST (U/L) by Visit 
Safety Analysis Set 
15.11.6.2.3  
Median (Q1, Q3) Chemistry Test: Alkaline Phosphatase (U/L) 
by Visit 
Safety Analysis Set 
15.11.6.2.4  
Median (Q1, Q3) Chemistry Test: Total Bilirubin (mg/dL) by 
Visit 
Safety Analysis Set 
15.11.6.2.5  
Median (Q1, Q3) Chemistry Test: Blood Urea Nitrogen 
(mg/dL) by Visit 
Safety Analysis Set 
15.11.6.2.6  
Median (Q1, Q3) Chemistry Test: Creatinine (mg/dL) by Visit 
Safety Analysis Set 
15.11.6.2.7 
Median (Q1, Q3) Chemistry Test: Creatinine Clearance 
(mL/min) by Visit 
Safety Analysis Set 
15.11.6.2.8 
Median (Q1, Q3) Chemistry Test: Albumin (g/dL) by Visit 
Safety Analysis Set 


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Figure  
Title 
Analysis Set 
15.11.7.1.1  
Median (Q1, Q3) Vital Signs: Diastolic Blood Pressure (mmHg) 
by Visit 
Safety Analysis Set 
15.11.7.1.2 
Median (Q1, Q3) Vital Signs: Systolic Blood Pressure (mmHg) 
by Visit 
Safety Analysis Set 
15.11.7.1.3 
Median (Q1, Q3) Vital Signs: Pulse Rate (beats per minute) by 
Visit 
Safety Analysis Set 
15.11.7.1.4 
Median (Q1, Q3) Vital Signs: Respiratory Rate (breaths per 
minute) by Visit 
Safety Analysis Set 
15.11.7.1.5 
Median (Q1, Q3) Vital Signs: Temperature (Celsius) by Visit 
Safety Analysis Set 
 


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12.3. 
Listings 
Listing 
Title 
Analysis Set 
16.1.6 
Subjects Who Received Study Drug from Specific Batches 
Safety Analysis Set  
16.1.7 
Randomization Schema and Codes 
All Randomized Analysis Set  
16.2.1.1 
Subject Profiles 
All Randomized Analysis Set  
16.2.1.2 
Enrollment 
All Randomized Analysis Set  
16.2.1.3 
Subject Disposition 
All Randomized Analysis Set 
16.2.1.4 
Reasons for Screen Failure 
Subjects Screened but Not 
Enrolled 
16.2.2.1 
Eligibility Criteria Deviations 
All Randomized Analysis Set 
16.2.2.2 
Important Protocol Deviations  
All Randomized Analysis Set 
16.2.2.3 
Randomization Stratification Discrepancies Between IWRS 
and Clinical Database 
All Randomized Analysis Set 
16.2.2.4 
Subjects who Received Incorrect Study Drug 
All Randomized Analysis Set 
16.2.3.1 
Subjects Excluded from Any Analysis Set  
All Randomized Analysis Set  
16.2.3.2 
Subjects Who were in the Full Analysis Set but Excluded from 
the Per Protocol Analysis Set  
Full Analysis Set 
16.2.4.1 
Demographics  
All Randomized Analysis Set  
16.2.4.2 
Baseline Characteristics 
All Randomized Analysis Set  
16.2.4.3.1 
Hematopoietic Cell Transplant Medical History 
All Randomized Analysis Set  
16.2.4.3.2 
Medical History 
All Randomized Analysis Set  
16.2.4.4.1 
Prior and Concomitant Medications 
All Randomized Analysis Set  
16.2.4.4.2 
Prior and Concomitant Ribavirin  
All Randomized Analysis Set 
16.2.5.1 
Study Drug Administration  
All Randomized Analysis Set  
16.2.5.2 
Subjects Who Prematurely Discontinued Study Drug 
All Randomized Analysis Set  
16.2.5.3 
Study Drug Accountability 
All Randomized Analysis Set  
16.2.5.4 
Plasma Pharmacokinetic Sampling Details and Concentrations 
PK Analysis Set 
16.2.6.1 
Viral Load Measurements 
Full Analysis Set 
16.2.6.2 
Hospitalizations and ICU 
Full Analysis Set 
16.2.6.3 
Oxygen Saturation  
Full Analysis Set 
16.2.6.4 
Supplemental Oxygen  
Full Analysis Set 
16.2.6.5 
Supplemental Oxygen Use Prior to RSV Infection 
Full Analysis Set 
16.2.6.6 
Mechanical Ventilation 
Full Analysis Set 
16.2.6.7 
Healthcare Related Efficacy Endpoints 
Full Analysis Set 
16.2.7.1 
All Adverse Events 
Safety Analysis Set 


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Listing 
Title 
Analysis Set 
16.2.7.2.1 
Deaths 
All Randomized Analysis Set 
16.2.7.2.2 
Adverse Events Leading to Death 
Safety Analysis Set 
16.2.7.3 
Serious Adverse Events 
Safety Analysis Set 
16.2.7.4.1 
Adverse Events with Severity of Grade 3 or Higher 
Safety Analysis Set 
16.2.7.4.2 
Adverse Events with Severity of Grade 2 or Higher 
Safety Analysis Set 
16.2.7.5.1 
Adverse Events Leading to Premature Discontinuation of Study 
Drug 
Safety Analysis Set 
16.2.7.5.2 
Adverse Events Leading to Premature Discontinuation of Study 
Safety Analysis Set 
16.2.8.1.1.1 
Hematology Results: Part 1 
Safety Analysis Set 
16.2.8.1.1.2 
Hematology Results: Part 2 
Safety Analysis Set 
16.2.8.1.2.1 
Chemistry Results: Part 1 
Safety Analysis Set 
16.2.8.1.2.2 
Chemistry Results: Part 2 
Safety Analysis Set 
16.2.8.1.2.3 
Creatinine Results for Hospitalized Subjects  
Safety Analysis Set 
16.2.8.1.4 
Treatment Emergent Marked Laboratory Abnormalities 
Safety Analysis Set 
16.2.8.1.5 
Treatment Emergent Grade 3 or Above Laboratory 
Abnormalities 
Safety Analysis Set 
16.2.8.1.6 
Liver-Related Laboratory Abnormalities 
Safety Analysis Set 
16.2.8.1.7 
Laboratory Tests Reference Ranges 
 
16.2.8.1.8 
Laboratory Test Troponin Results 
Safety Analysis Set 
16.2.8.2.1 
Vital Signs  
Safety Analysis Set 
16.2.8.2.2 
Body Weight, Height and BMI 
Safety Analysis Set 
16.2.8.3 
Overall ECG Assessment 
Safety Analysis Set 
16.2.8.4 
Pregnancy Report 
Safety Analysis Set 
16.2.8.5 
General Comments 
All Randomized Analysis Set 
 


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13. 
APPENDICES 
Appendix 1. 
 
Study Procedures Table 
 
Visit 1: 
Screening 
(Day -2 
to -1) 
Visit 2: Baseline 
Assessments, 
Randomization, 
and Treatment 
Assessments 
(Day 1) 
Visit 
3: 
Day 
3p 
(±24 
hours) 
Visit 
4: 
Day 5 
(±24 
hours) 
Visit 
5: 
Day 7 
(±24 
hours) 
Visit 
6: 
Day 9 
(±24 
hours) 
Visit 
7: Day 
13 
(±24 
hours) 
Visit 
8: Day 
17 
(±24 
hours) 
Visit 
9: 
Day 
22 
(±24 
hours) 
Visit 10: 
End of 
study/Day 
28 
 (+3 days) 
Optional Extended Viral 
Monitoringk 
Visit 
11: 
Day 
35 
(±48 
hours) 
Visit 
12: 
Day 
42 
(±48 
hours) 
Visit 
13: 
Day 
49 
(±48 
hours) 
Visit 
14: 
Day 
56 
(±48 
hours) 
Must complete 
visit in the 
hospital or clinic 
X 
X 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
Written Informed 
Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical History 
and Demographics  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Chest X-ray 
Xa 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening Labs 
Xb 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine or Serum 
Pregnancy Testc  
X 
X 
 
X 
 
X 
X 
X 
 
 
 
 
 
 
Vital Signs (inc. 
O2 Saturation d) 
X 
X 
Xm 
X 
Xm 
X 
X 
X 
X 
X 
 
 
 
 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight 
X 
X 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
12-lead ECG 
 
X 
 
 
 
 
 
X 
 
X 
 
 
 
 


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Visit 1: 
Screening 
(Day -2 
to -1) 
Visit 2: Baseline 
Assessments, 
Randomization, 
and Treatment 
Assessments 
(Day 1) 
Visit 
3: 
Day 
3p 
(±24 
hours) 
Visit 
4: 
Day 5 
(±24 
hours) 
Visit 
5: 
Day 7 
(±24 
hours) 
Visit 
6: 
Day 9 
(±24 
hours) 
Visit 
7: Day 
13 
(±24 
hours) 
Visit 
8: Day 
17 
(±24 
hours) 
Visit 
9: 
Day 
22 
(±24 
hours) 
Visit 10: 
End of 
study/Day 
28 
 (+3 days) 
Optional Extended Viral 
Monitoringk 
Visit 
11: 
Day 
35 
(±48 
hours) 
Visit 
12: 
Day 
42 
(±48 
hours) 
Visit 
13: 
Day 
49 
(±48 
hours) 
Visit 
14: 
Day 
56 
(±48 
hours) 
Local Troponin 
Testn 
 
X 
 
 
 
 
 
X 
 
X 
 
 
 
 
Safety Labs e 
 
X 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
RSV antibody titer 
 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
RSV Viremia 
 
X 
 
X 
 
X 
X 
X 
X 
X 
 
 
 
 
Nasal Samples f 
Xo 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Local RSV 
Testing 
Xo 
 
 
 
 
 
 
 
Xj 
 
 
 
 
 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
IMP 
Administration 
 
X 
 
X 
 
X 
X 
X 
 
 
 
 
 
 
PK Sample 
 
Xg 
Xi 
Xg 
 
Xg 
Xg 
Xg 
Xg 
 
 
 
 
 
Serum creatinine 
 
Xh 
Xh 
 
 
 
 
 
 
 
 
 
 
 
Adverse Events 
X 
X 
Xl 
X 
Xl 
X 
X 
X 
X 
X 
Xl 
Xl 
Xl 
Xl 
Review ICU 
admissions, 
hospitalizations,  
standard of care 
test results, 
mechanical 
ventilation, and 
supplemental O2 
 
X 
Xm 
X 
Xm 
X 
X 
X 
X 
X 
 
 
 
 


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Visit 1: 
Screening 
(Day -2 
to -1) 
Visit 2: Baseline 
Assessments, 
Randomization, 
and Treatment 
Assessments 
(Day 1) 
Visit 
3: 
Day 
3p 
(±24 
hours) 
Visit 
4: 
Day 5 
(±24 
hours) 
Visit 
5: 
Day 7 
(±24 
hours) 
Visit 
6: 
Day 9 
(±24 
hours) 
Visit 
7: Day 
13 
(±24 
hours) 
Visit 
8: Day 
17 
(±24 
hours) 
Visit 
9: 
Day 
22 
(±24 
hours) 
Visit 10: 
End of 
study/Day 
28 
 (+3 days) 
Optional Extended Viral 
Monitoringk 
Visit 
11: 
Day 
35 
(±48 
hours) 
Visit 
12: 
Day 
42 
(±48 
hours) 
Visit 
13: 
Day 
49 
(±48 
hours) 
Visit 
14: 
Day 
56 
(±48 
hours) 
Concomitant 
Medications 
X 
X 
Xm 
X 
Xm 
X 
X 
X 
X 
X 
 
 
 
 
a 
Chest X-ray obtained < 48 hours prior to Screening may be used 
b 
Existing values collected ≤ 6 days prior to Screening may be used 
c 
Required for women unable to confirm menopause, hysterectomy and/or bilateral oophorectomy 
d 
On room air 
e 
Central laboratory testing: hematology and serum chemistry to include WBC with differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, ALP, and total 
bilirubin 
f 
2 samples total, 1 from each nostril – collected prior to dosing on dosing days 
g 
PK samples collected for all subjects 4 hours (± 30 mins) post-dose Day 1;  pre-dose on Days 5, 9, 13, and 17;  and anytime on Day 22 
h 
For hospitalized subjects only: blood will be drawn for serum creatinine at 4 hours (± 30 mins)  post-dose at Visit 2 (Day 1) and at any time on Days 2, 3 and 4 
(approximately 24, 48 and 72 hours post-first presatovir dose if they remain hospitalized at those times.  
i 
For hospitalized subjects only: PK sample collected at Visit 3 (48 hours [±3 hours] post-first presatovir dose) 
j 
Only for subjects who agree to the Optional Extended Viral Monitoring at the time of consent 
k 
Only for subjects who agree to the Optional Extended Viral Monitoring at the time of consent and test positive (or inconclusive) for RSV at Visit 9 (Day 22) 
l 
Assessment of procedure-related AEs only, if home visit.  
m 
Not required if home visit. 
n 
Local troponin testing will be done pre-dose in accordance with the standard assay available and used at the site.  Point-of-care “rapid” troponin tests are not acceptable for 
protocol-mandated troponin testing.  
o 
If only the upper or lower respiratory tract was assessed prior to consent, a separate local RSV test in the tract not previously assessed must be performed. Subjects who were 
not tested for RSV as standard of care may consent to the study and be tested for RSV during the Screening visit.  
p 
Visit 3 Day 3 is an optional study visit for subjects who are not hospitalized.  
 


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Appendix 2. 
Cardiac Adverse Events of Interest 
The following search criteria are used to identify cardiac adverse events:  
• All PTs from Cardiac disorders SOC 
• Narrow scope PTs from the below SMQs, and associated sub-SMQs:  
 Cardiac arrhythmias (SMQ) 
 Cardiac failure (SMQ) 
 Cardiomyopathy (SMQ)  
 Ischaemic heart disease (SMQ) 
 Torsade de pointes/QT prolongation (SMQ) 
• Select PTs from HLTs:  
 Cardiac histopathology procedures,  
 Skeletal and cardiac muscle analyses,  
 Arterial therapeutic procedures (excl aortic),  
 ECG investigations, Cardiac function diagnostic procedures,  
 Heart rate and pulse investigations 
Duplicate PTs were removed where necessary. 


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Appendix 3. 
Sample SAS Code for MMRM Model 
The following model statement may be used for the analyses of viral load and FLU-PRO as 
described in Sections 6.3.2: 
proc mixed data=change; 
class trt visit subjid strata; 
model change = baseline strata trt visit trt*visit / s ddfm=kr; 
repeated visit / type=un subject=subjid(trt); 
lsmeans trt*visit / cl; 
run; 
Note that since the response variable is change from baseline, the Visit 2 (baseline) value will 
always be 0 and should not be included in the above model.  
An unstructured covariance will be assumed (type=un); if there are convergence or model fitting 
issues, then the alternative covariance structure of Toeplitz will be assumed (type=toep). 


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Appendix 4. 
Sample SAS Code for Negative Binomial Model 
The following model statement may be used for the analyses of number of hospital-free day, 
ICU-free day, and ventilator-free day described in Section 6.3.2: 
proc genmod data=dataset; 
   class trt strata; 
   model count = trt strata / offset=logt dist=NB; 
run; 
where logt is the offset parameter defined as the natural logarithm of study duration for each 
subject to account for potential differential study durations due to early discontinuations. 
In the event that the negative binomial model fails to converge, a zero-inflated negative binomial 
model may be fit (dist=ZINB). 

Prot_011.pdf: 
Study Title: 
Sponsor: 
IND Number: 
EudraCT Number: 
Clinical Trials.gov 
Identifier: 
Indication: 
Protocol ID: 
Clinical Program 
Manager: 
Gilead Medical Monitor: 
Protocol Version/Date: 
(rJ GILEAU 
CLINICAL STUDY PROTOCOL 
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled 
Multi-Center Study Evaluating Antiviral Effects, 
Phrumacokinetics, Safety, and Tolerability ofGS-5806 in 
Hematopoietic Cell Transplant (HCT) Recipients with Respirat01y 
Syncytial Vims (RSV) Infection of the Lower Respirat01y Tract 
Gilead Sciences, Inc. 
199 E Blaine St. 
Seattle, W A 98102 
114498 
2014-002475-29 
TBD 
Respirat01y Syncytial Vims (RSV) 
GS-US-218-1502 
Name: 
Telephone: 
Fax: 
Name: 
Telephone: 
Fax: 
Mobile: 
Original 
Amendment 1 
Amendment2 
Amendment3 
PPD 
PPD 
PPD 
Seth Toback, MD 
PPD 
PPD 
PPD 
09 Jlme 2014 
31 July 2014 
22 September 2014 
21 October 2014 
CONFIDENTIALITY STATEMENT 
The inf01mation contained in this document, pruiiculru·ly unpublished data, is the prope1iy or 
under control of Gilead Sciences, Inc., and is provided to you in confidence as an investigator, 
potential investigator, or consultant, for review by you, your staff, and an applicable Institutional 
Review Board or Independent Ethics Committee. The infonnation is only to be used by you in 
connection with authorized clinical studies of the investigational dmg described in the protocol. 
You will not disclose any of the infonnation to others without written authorization from 
Gilead Sciences, Inc., except to the extent necessa1y to obtain infonned consent from those 
persons to whom the dmg may be administered. 


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 2
21 October 2014
TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................................................2
LIST OF IN-TEXT TABLES........................................................................................................................................4
PROTOCOL SYNOPSIS ..............................................................................................................................................5
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS....................................................................17
1.
INTRODUCTION ..............................................................................................................................................21
1.1.
Background ............................................................................................................................................21
1.2.
GS-5806 .................................................................................................................................................22
1.2.1.
General Information .............................................................................................................22
1.2.2.
Nonclinical Pharmacokinetics..............................................................................................23
1.2.3.
Nonclinical Pharmacology and Toxicology .........................................................................23
1.2.4.
Clinical Trials of GS-5806 ...................................................................................................25
1.3.
Rationale for This Study ........................................................................................................................28
1.4.
Dose Rationale .......................................................................................................................................29
1.5.
Compliance ............................................................................................................................................29
2.
OBJECTIVES.....................................................................................................................................................30
3.
STUDY DESIGN................................................................................................................................................31
3.1.
Endpoints ...............................................................................................................................................31
3.2.
Study Design..........................................................................................................................................32
3.3.
Study Treatments ...................................................................................................................................32
3.4.
Duration of Treatment............................................................................................................................33
3.5.
Discontinuation Criteria.........................................................................................................................33
3.6.
Source Data............................................................................................................................................33
4.
SUBJECT POPULATION..................................................................................................................................35
4.1.
Number of Subjects and Subject Selection ............................................................................................35
4.2.
Inclusion Criteria....................................................................................................................................35
4.3.
Exclusion Criteria...................................................................................................................................36
5.
INVESTIGATIONAL MEDICINAL PRODUCTS ...........................................................................................38
5.1.
Randomization, Blinding and Treatment Codes ....................................................................................38
5.1.1.
Procedures for Breaking Treatment Codes...........................................................................38
5.2.
Description and Handling of GS-5806...................................................................................................39
5.2.1.
Formulation..........................................................................................................................39
5.2.2.
Packaging and Labeling .......................................................................................................39
5.2.3.
Storage and Handling...........................................................................................................39
5.3.
Dosage and Administration of GS-5806 ................................................................................................39
5.4.
Prior and Concomitant Medications.......................................................................................................40
5.5.
Accountability for GS-5806...................................................................................................................41
5.5.1.
Investigational Medicinal Product Return or Disposal.........................................................41
6.
STUDY PROCEDURES ....................................................................................................................................42
6.1.
Subject Enrollment and Treatment Assignment.....................................................................................42
6.1.1.
Visit 1: Screening Visit (Days -2 to -1)................................................................................42
6.1.2.
Visit 2: Baseline Assessments, Randomization, and Treatment 
Assessments (Day 1)............................................................................................................43
6.2.
Visit 3: Day 3 (± 24 hours).....................................................................................................................45
6.3.
Visit 4: Day 5 (± 24 hours).....................................................................................................................45


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6.4.
Visit 5: Day 7 (± 24 hours).....................................................................................................................46
6.5.
Visits 6-8: Days 9, 13, and 17 (± 24 hours)............................................................................................46
6.6.
Visit 9: Day 22 (± 24 hours)...................................................................................................................47
6.7.
Visit 10: End of Study/Day 28 (+ 3 days)..............................................................................................48
6.8.
Visits 11 – 14*: Day 35, 42, 49, and 56 (± 48 hours).............................................................................48
6.9.
Assessments for Premature Discontinuation from IMP dosing and Early Withdrawal..........................49
6.9.1.
Assessments for Premature Discontinuation from IMP Administration ..............................49
6.9.2.
Assessments for Early Termination/Withdrawal..................................................................49
6.10.
Assessments for Unscheduled Visits......................................................................................................49
6.11.
Study Assessments.................................................................................................................................50
6.11.1.
Nasal Samples, Virology, and Antibody Titer .....................................................................50
6.11.2.
Virology and Resistance Monitoring....................................................................................50
6.11.3.
Vital Signs............................................................................................................................51
6.11.4.
Oxygen Saturation................................................................................................................51
6.11.5.
Plasma PK ............................................................................................................................51
6.11.6.
Safety Labs...........................................................................................................................52
6.11.7.
Chest X-ray ..........................................................................................................................52
6.11.8.
Optional Extended Viral Monitoring....................................................................................52
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT...............................................................................53
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events.................................53
7.1.1.
Adverse Events.....................................................................................................................53
7.1.2.
Serious Adverse Events........................................................................................................53
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events .........................................................................54
7.2.
Assessment of Adverse Events and Serious Adverse Events.................................................................55
7.2.1.
Assessment of Causality for IMP and Procedures................................................................55
7.2.2.
Assessment of Severity ........................................................................................................55
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events and Serious 
Adverse Events to Gilead.......................................................................................................................55
7.4.
Gilead Reporting Requirements.............................................................................................................57
7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events..........................................................................................................................58
7.6.
Toxicity Management ............................................................................................................................58
7.7.
Special Situations Reports......................................................................................................................58
7.7.1.
Definitions of Special Situations..........................................................................................58
7.7.2.
Instructions for Reporting Special Situations.......................................................................59
8.
STATISTICAL CONSIDERATIONS................................................................................................................61
8.1.
Analysis Objectives and Endpoints........................................................................................................61
8.1.1.
Analysis Objectives..............................................................................................................61
8.1.2.
Primary Endpoint .................................................................................................................61
8.1.3.
Secondary Endpoint .............................................................................................................61
8.1.4.
Other Endpoints of Interest ..................................................................................................61
8.2.
Analysis Conventions.............................................................................................................................62
8.2.1.
Analysis Sets ........................................................................................................................62
8.3.
Data Handling Conventions ...................................................................................................................63
8.4.
Demographic Data and Baseline Characteristics ...................................................................................63
8.5.
Efficacy Analysis ...................................................................................................................................63
8.5.1.
Primary Analysis..................................................................................................................63
8.5.2.
Secondary Analyses .............................................................................................................64
8.5.3.
Exploratory Analyses ...........................................................................................................64
8.6.
Safety Analysis.......................................................................................................................................65
8.7.
Extent of Exposure.................................................................................................................................65


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8.7.1.
Adverse Events.....................................................................................................................65
8.7.2.
Laboratory Evaluations ........................................................................................................65
8.7.3.
Other Safety Evaluations......................................................................................................66
8.8.
Pharmacokinetic Analysis......................................................................................................................66
8.9.
Sample Size............................................................................................................................................66
8.10.
Data Monitoring Committee ..................................................................................................................66
9.
RESPONSIBILITIES..........................................................................................................................................67
9.1.
Investigator Responsibilities ..................................................................................................................67
9.1.1.
Good Clinical Practice..........................................................................................................67
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval...........................................................................................................67
9.1.3.
Informed Consent.................................................................................................................67
9.1.4.
Confidentiality......................................................................................................................68
9.1.5.
Study Files and Retention of Records ..................................................................................68
9.1.6.
Case Report Forms...............................................................................................................69
9.1.7.
Data Quality Control and Quality Assurance.......................................................................70
9.1.8.
Investigational Medicinal Product Accountability and Return.............................................70
9.1.9.
Inspections............................................................................................................................71
9.1.10.
Protocol Compliance............................................................................................................71
9.2.
Sponsor Responsibilities ........................................................................................................................71
9.2.1.
Protocol Modifications.........................................................................................................71
9.2.2.
Study Report and Publications .............................................................................................71
9.3.
Joint Investigator/Sponsor Responsibilities ...........................................................................................72
9.3.1.
Payment Reporting...............................................................................................................72
9.3.2.
Access to Information for Monitoring..................................................................................72
9.3.3.
Access to Information for Auditing or Inspections ..............................................................72
9.3.4.
Study Discontinuation..........................................................................................................72
10.
REFERENCES ...................................................................................................................................................73
11.
APPENDICES ....................................................................................................................................................76
Appendix 1.
Investigator Signature Page....................................................................................................77
Appendix 2.
Study Procedures Table..........................................................................................................78
Appendix 3.
Management of Clinical and Laboratory Adverse Events......................................................81
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities...............82
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements.................................................................................................105
LIST OF IN-TEXT TABLES
Table 6-1.
PK Timepoints........................................................................................................................52


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PROTOCOL SYNOPSIS
Gilead Sciences, Inc.
199 E Blaine St.
Seattle, WA 98102
Study Title: 
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled 
Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, 
Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant 
(HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection 
of the Lower Respiratory Tract
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
114498
2014-002475-29
TBD
Study Centers 
Planned:
Approximately 30 centers in Asia Pacific, Australia, Canada, Europe, 
South America, and the United States
Objectives:
The primary objective of this study is as follows:

To evaluate the effect of GS-5806 on RSV viral load in 
autologous or allogeneic HCT recipients with an acute RSV lower 
respiratory tract infection (LRTI)
The secondary objectives of this study are as follows: 

To evaluate the effect of GS-5806 on rates of respiratory failure
and all-cause mortality

To evaluate the pharmacokinetics (PK), safety, and tolerability of 
GS-5806
Study Design:
Randomized, double-blind, placebo-controlled study evaluating the 
effect of GS-5806 on efficacy, PK, safety, and tolerability in HCT 
recipients with RSV LRTI.  
All subjects will be permitted to receive the standard of care therapy 
for RSV infection per their local medical practices, in addition to the
investigational medicinal product (IMP).


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Subjects will be randomized in a 1:1 ratio to receive IMP 
(GS-5806 or placebo) and will be stratified by 2 criteria: 
1. Supplemental O2 requirement (≤ 2 L/min or > 2 L/min) at the time 
of randomization
2. Treatment of current RSV infection (yes or no) with ribavirin 
(oral, intravenous, or aerosolized)
Number of Subjects 
Planned:
Approximately 60 RSV-positive subjects
Target Population:
Males and females 18 to 75 years of age who have had an allogeneic 
or autologous HCT and have documented RSV LRTI 
Duration of 
Treatment:
5 doses over 17 days
Diagnosis and
Eligibility Criteria:
For a complete list of study inclusion and exclusion criteria, please 
refer to Section 4.2.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria at the time 
of randomization to be eligible for participation in this study:
1. Received an autologous or allogeneic HCT using any 
conditioning regimen
2. Evidence of new abnormalities on chest X-ray obtained 
< 48 hours prior to Screening, determined to be consistent with 
LRTI by the local radiologist, relative to the most recent previous 
chest X-ray.  If chest X-ray is not available, a chest X-ray must be 
obtained for Screening
3. Documented RSV in both the upper (eg, nasal swab, 
nasopharyngeal swab, nasal wash) and lower (eg, induced 
sputum, bronchoalveolar lavage [BAL], lung biopsy) respiratory 
tract as determined by local testing (eg, polymerase chain reaction 
[PCR], direct fluorescence antibody [DFA], respiratory viral 
panel [RVP] assay, or culture).  All samples must have been 
collected ≤6 days prior to Day 1
4. An informed consent document signed and dated by the subject or 
a legal guardian of the subject and investigator or his/her designee


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5. A negative urine or serum pregnancy test is required for female 
subjects (unless surgically sterile or greater than two years 
post-menopausal)
6. Male and female subjects of childbearing potential must agree to
contraceptive requirements as described in Appendix 5
7. Willingness to complete necessary study procedures and have 
available a working telephone or email
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to 
be enrolled in this study.
Related to concomitant or previous medication use:
1. Use of non-marketed (according to region) investigational agents 
within 30 days, OR use of any monoclonal anti-RSV antibodies 
within 4 months or 5 half-lives of screening, whichever is longer, 
OR use of any investigational RSV vaccines after HCT
2. Use of a strong cytochrome P450 enzyme (CYP) inducer 
including but not limited to rifampin, St. John’s Wort, 
carbamazepine, and phenytoin, within 2 weeks prior to the 
first dose of IMP
Related to medical history:
1. Pregnant, breastfeeding, or lactating females 
2. Unable to tolerate nasal sampling required for this study, as 
determined by the investigator
3. Known history of HIV/AIDS with a CD4 count < 200 cells/μL
within the last month
4. History of drug and/or alcohol abuse that, in the opinion of the 
investigator, may prevent adherence to study activities
Related to medical conditions:
1. Requiring invasive mechanical ventilation at the time of 
randomization
2. A relapse (including molecular relapse) of their underlying 
disease for which they received a transplant at Screening


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3. Documented to be positive for other respiratory viruses (limited to 
influenza, parainfluenza, human rhinovirus, adenovirus, or human 
metapneumovirus), from the lower respiratory tract sample as 
determined by local testing  
4. Clinically significant bacteremia or fungemia within 7 days prior 
to Screening that has not been adequately treated, as determined 
by the investigator
5. Clinically significant bacterial, fungal, or viral pneumonia within 
2 weeks prior to Screening that has not been adequately treated, as 
determined by the investigator
6. Excessive nausea/vomiting at screening, as determined by the 
investigator, or an inability to swallow pills that precludes oral 
administration of the IMP
7. Any condition which, in the opinion of the investigator, would 
prevent full participation in this trial or would interfere with the 
evaluation of the trial endpoints
Related to allergies:
1. Known hypersensitivity or allergy to the IMP, its metabolites, or 
formulation excipients (microcrystalline cellulose, mannitol, 
croscarmellose sodium, magnesium stearate, polyvinyl alcohol, 
titanium dioxide, polyethylene glycol and talc)
2. Allergy to sulfa drugs 
Related to laboratory results:
1. Creatinine clearance < 30 mL/min (calculated using the 
Cockcroft-Gault method)
2. AST/ALT > 3x ULN
3. Total bilirubin > 3x ULN
Study Procedures/
Frequency:
For a complete overview of study procedures and visits, please refer 
to Section 6 and Appendix 2.
Study Procedures
Vital signs (VS): Vital signs will be measured at Visits 1, 2, 4, 6, 7, 
8, 9, and 10 (Days -2 to -1, 1, 5, 9, 13, 17, 22, and 28), and will
include body temperature, heart rate, respiratory rate, and blood 
pressure. 
O2 saturation: O2 saturation will be recorded at Visits 1, 2, 4, 6, 7, 8, 
9, and 10 (Days -2 to -1, 1, 5, 9, 13, 17, 22, and 28), while breathing 
room air, even if the subject is dependent on supplemental O2. Refer 
to Section 6.11.4 for procedure instructions.


GS-5806 
Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
CONFIDENTIAL 
Final 
Amendment3 
Laboratory tests: When available, existing laborat01y values 
:::; 6 days prior to Screening (Visit 1) may be used for eligibility 
assessment. Study staff will perfonn urine or senun pregnancy tests 
on site at Screening and at each dosing visit (Visits 2, 4, 6, 7, and 8) 
prior to administration of IMP (as necessaty). Blood specimens for 
safety at Visits 2, 4, 6, 7, 8, 9, and 10 (Days 1, 5, 9, 13, 17, 22, 
and 28), RSV vireinia evaluation (using quantitative real time 
polymerase chain reaction [RT-qPCR]) at Visits 2, 4, 6, 7, 8, 9, and 
10 (Days 1, 5, 9, 13, 17, 22, and 28), and sennn antibody titers to 
RSV at Visits 2 and 10 (Days 1 and 28) will be collected prior to 
dosing. A blood specimen for senun creatinine will be collected 
4 hours post-dose at Visit 2 (Day 1). For hospitalized subjects only, 
additional blood specimens for senun creatinine will be collected on 
Days 2, 3, and 4 (24, 48, and 72 hours [±3 hours] post-fu·st GS-5806 
dose). 
PK blood draws: PK samples will be collected from all subjects at 
the following time points: 4 hours post-dose at Visit 2 (Day 1), 
pre-dose at Visits 4, 6, 7 and 8 (Days 5, 9, 13, and 17), and anytime at 
Visit 9 (Day 22). For hospitalized subjects only, an additional PK 
sample will be collected from hospitalized subjects at Visit 3 (Day 3, 
48 hours [±3 hours] post-first GS-5806 dose). 
Nasal sam ling: Nasal sampling will be j)erfonned at all study visits 
PPD 
wttli tlie exception of tlie Screening 
~~~~~--~---~·--~~~ 
visit (Visit 1 ), and stored and shipped to a central laborat01y for 
testing according to specifications in the study procedures manual. 
All samples must be collected prior to dosing. Two nasal samples will 
be obtained, 1 from each nostril, each time nasal sampling is 
perf01med. Nasal samples will be used for RSV sequencing to 
evaluate development of resistance and a multiplex assay to identify 
co-infections. 
Induced sputum: If an induced sputum was not used to demonstrate 
RSV in the lower respirat01y tract at Screening (ie, another lower 
respirat01y tract sample such as BAL was used), an induced sputum 
will be obtained on Day 1 prior to dosing. This sample will be 
analyzed at a central laboratory using RT-qPCR to detetmine RSV 
viral load and a multiplex assay to identify any viral co-infections. 
RSV testing: RSV present in both the upper and lower respirat01y 
tract samples as detennined by local testing (eg, PCR, DFA, RVP 
assay, or culture) must be documented prior to Screening. All RSV 
samples (from upper and lower respirat01y tract) used for Screening 
Page9 
21 October 2014 


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Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
CONFIDENTIAL 
Final 
Amendment3 
must have been collected :::; 6 days prior to Day 1. For all study 
related nasal samples, one of the nasal samples collected at each study 
visit will be analyzed at a central laborat01y using RT -qPCR to 
detennine RSV viral load. 
0 tional Extended Viral Monitoring: 
PO 
Study Visits 
Visit 1: Screening (Day -2 to -1) 
This visit must be perf01med in the hospital or clinic. The following 
Screening procedures/labs are required: 
• 
Obtain written inf01med consent 
• 
Collection of medical hist01y and demographics 
• 
Review of concomitant medications 
• 
VS, including 0 2 saturation 
• 
Height and weight 
• 
Chest X-ray (chest X-rays obtained < 48 hours prior to Screening 
maybe used) 
• 
Blood draw for Screening labs for local laborat01y analyses, 
unless existing laborat01y values collected :::; 6 days prior to 
Screening can be obtained for review 
• 
Urine or senun pregnancy test in women unable to confi1m 
menopause, hysterectomy, and/or bilateral oophorectomy 
• 
Review of any adverse events (AEs) occmTing after signing of the 
consent fonn 
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21 October 2014 


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Visit 2: Baseline Assessments, Randomization, and IMP 
Administration (Day 1) 
If the subject meets all eligibility criteria, Visits 1 and 2 may occur on 
the same day. The IMP must be administered under supervision by 
the study staff. Visit 2 must occur in the hospital or clinic.  Visit 2 
assessments should be performed in the following order:

VS, including O2 saturation

Weight

Blood draw (for safety labs, serum antibody titer to RSV, and 
RSV viremia)

Obtain 2 nasal samples 

Urine or serum pregnancy test in women unable to confirm 
menopause, hysterectomy, and/or bilateral oophorectomy

Obtain induced sputum (unless induced sputum was used to 
demonstrate the presence of RSV ≤6 days prior to Day 1).  

Randomization via IXRS

IMP administration 

Blood draw at 4 hours post-dose for PK and serum creatinine

Assessment of AEs and concomitant medications

For hospitalized subjects only: blood draw at 24 (Day 2) and 
72 (Day 4) hours (±3 hours) post-first GS-5806 dose for serum 
creatinine
Visit 3: Day 3 (± 24 hours)
This visit may be performed in the hospital, clinic, or at home.

For all subjects: obtain 2 nasal samples

For hospitalized subjects only: blood draw at 48 hours (±3 hours) 
post-first GS-5806 dose for PK and serum creatinine
Visit 4:  Day 5 (± 24 hours) 
This visit must be performed in the hospital or clinic, and should be 
performed in the following order :

VS, including O2 saturation

Weight

PK blood draw: pre-dose


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Gilead Sciences, Inc.
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
Blood draw (for safety labs and RSV viremia)

Obtain 2 nasal samples 

Urine or serum pregnancy test in women unable to confirm 
menopause, hysterectomy, and/or bilateral oophorectomy

IMP administration

Assessment of AEs, concomitant medications, re-hospitalizations, 
admission to intensive care unit (ICU) or utilization of ICU care, 
mechanical ventilation (invasive and non-invasive of any 
duration), and supplemental O2 use ( ≥ 2 L/min)
Visit 5: Day 7 (± 24 hours)
This visit may be performed in the hospital, clinic, or at home.

Obtain 2 nasal samples 
Visits 6 – 8:  Days 9, 13, and 17 (± 24 hours)
These visits must be performed in the hospital or clinic. Visits 6-8 
assessments should be performed in the following order:

VS, including O2 saturation

Weight

PK blood draw: pre-dose 

Blood draw (for safety labs and RSV viremia)

Obtain 2 nasal samples 

Urine or serum pregnancy test in women unable to confirm 
menopause, hysterectomy, and/or bilateral oophorectomy

IMP administration 

Assessment of AEs, concomitant medications, re-hospitalizations,
admission to ICU or utilization of ICU care, mechanical 
ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use ( ≥2 L/min)
Visit 9 and 10: Day 22 (± 24 hours) and End of Study/Day 28
(+ 3 days)
These visits must be performed in the hospital or clinic. Visit 10 may 
occur no earlier than Day 28 and no later than Day 31. Visit 9 and 
10 assessments should be performed in the following order:

VS, including O2 saturation 

Weight


GS-5806 
Protocol GS-US-218-1502 
Final 
Gilead Sciences, Inc. 
Amendment 3 
Test Product, Dose, 
and Mode of 
Administration: 
Reference Therapy, 
Dose, and Mode of 
Administration: 
CONFIDENTIAL 
• 
PK blood draw (Day 22 only) 
• 
Blood draw for safety labs, for senun antibody titer to RSV 
(Day 28 only), and for RSV viremia 
• 
Obtain 2 nasal samples 
• 
Obtain sample for local RSV testing* (Day 22 only) (refer to 
Section 6.11.8) 
• 
Assessment of AEs and concomitant medications, 
re-hospitalizations, admission to ICU or utilization of ICU care, 
mechanical ventilation (invasive and non-invasive of any 
duration), and supplemental 0 2 use (:::: 2 Llmin) 
* PPD 
Visits 11-14*: Day 35, 42, 49, and 56(± 48 hours) 
Visits 11- 14 assessments may be perf01med in the hospital, clinic, 
or at home. 
• 
Obtain 2 nasal samples 
• 
Assessment of procedure-related AEs 
PPD 
200 mg GS-5806 (four 50 mg tablets) administered orally on Study 
Days 1, 5, 9, 13, and 17 
The IMP must be administered after the subject has been fasting 
(with exception of clear liquids and medications) for at least 2 hours. 
The subject will remain in a fasting condition for approximately 
1 hour after dosing. The entire dose must be taken within 1 hour. 
Tablets are not to be cmshed, split, dissolved, or chewed. The subject 
should be observed for 30 minutes after IMP adminisu·ation. If 
vomiting occurs within the 30 minutes observation period and 
undissolved tablets are present in the vomitus, the subject may 
receive a second dose. If a second dose is given, the subject should be 
observed for an additional 30 minutes. Subjects should avoid direct 
ulu·aviolet (UV) exposure for 8 days after receiving IMP. 
Placebo to Match tablets administered orally. Adminisu·ation is the 
same as for GS-5806. 
Page 13 
21 October 2014 


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Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
Criteria for 
Evaluation: 
Safety: 
Efficacy: 
CONFIDENTIAL 
Final 
Amendment3 
Safety will be assessed by the reporting of AEs and serious adverse 
events (SAEs) throughout the study, clinicallaborat01y tests, and VS 
at various time points during the study. 
The primmy endpoint is the time-weighted average change in nasal 
RSV viral load (log10 copies/mL) from Baseline (Day 1) to Day 9 as 
measured by R T -qPCR. 
The key secondmy endpoints are: 
• 
Prop01tion of subjects developing respirat01y failure (of any 
cause) requiring mechanical ventilation (invasive or noninvasive) 
through Day 28 
• 
Prop01tion of all-cause m01tality among subjects through Day 28 
The explorat01y endpoints are: 
IT 
I 
I 
I 
I 
I 
I 
I 
I 
I 
I 
Page 14 
21 October 2014 


GS-5806 
Protocol GS-US-218-1502 
Gilead Sciences, Inc. 
Statistical Methods: 
CONFIDENTIAL 
IT 
I 
I 
Final 
Amendment3 
The full analysis set (F AS) will include subjects who have an RSV 
log10 viral load greater than or equal to the LLOQ of the RT-qPCR 
assay in the pre-dose Day 1 nasal sample, as detennined by R T -qPCR 
at the central lab, and have received at least 1 full dose ofiMP. 
The primruy efficacy analysis of time-weighted average change in 
RSV log10 viral load from Day 1 through Day 9 will be perfonned on 
subjects included in the FAS. To test the null hypothesis that there is 
no difference between the GS-5806 and placebo u·eatment groups in 
the time-weighted average change in RSV viral load, a parameu·ic 
analysis of covru·iance (ANCOV A) model with conesponding 
Baseline RSV viral load as a covru·iate will be used, with a 2-sided 
0.05 level. Adjusted means and 95% confidence intervals (Cis) will 
also be presented. 
The F AS analysis set will be used for all smnmru·ies and analyses of 
secondruy endpoints. All secondruy and other endpoints will be 
analyzed using 2-sided tests for u·eatment differences. The prop01iion 
of subjects who develop respirat01y failure requiring mechanical 
ventilation and the prop01iion of subjects with all-cause m01iality will 
be analyzed using Fisher's exact tests. 
PD 
All endpoints will be sUIIllnru·ized using descriptive statistics 
(sample size, mean, standard deviation [SD], median, Q1, Q3, 
minimum, and maximum) for continuous data and by the number and 
percent of subjects for categorical data. 
Safety analyses will be perf01med on all subjects who received at 
least one dose of IMP. Safety data will be collected and smnmarized 
from screening through Day 28. Safety data will be listed by subject 
and smnmarized by u·eatment (active or placebo) using the number 
(percent) of subjects with events/abnonnalities for categorical data 
and using descriptive statistics for continuous data. 
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Concentrations of GS-5806 in plasma will be determined using a 
validated bioanalytical assay(s). Individual subject GS-5806 
concentration-time data will be displayed using scheduled sampling 
times. Descriptive statistics (eg, n, mean, standard deviation, %CV, 
median, and range) will be calculated for each sampling time. 
Pharmacokinetic/pharmacodynamic (PK/PD) relationship may be 
explored as appropriate.
Sample size calculations are based on results observed in a study that 
evaluated the efficacy of oral and aerosolized ribavirin treatment for 
preventing progression from upper to lower respiratory tract infection 
in hematopoietic cell transplant recipients with RSV infections
(unpublished data from Dr. 
).  The sample size 
calculation assumes the time-weighted average change in RSV log10
viral load from Day 1 to Day 9 in the placebo group will 
be -1.5 log10 copies/mL with a corresponding standard deviation (SD) 
of 1.75 and that 85% of the subjects will be evaluable.  Based on 
these assumptions, with 25 subjects per group there is approximately
85% power to detect a 1.5 log difference in time-weighted average
change in log10 viral load treatment groups using a 2-sided 0.05-level 
test.  Given an evaluable rate of 85%, a total of 60 subjects will need 
to be randomized into the study.
All safety data will be monitored by a Data Monitoring Committee 
(DMC). 
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) 
including archiving of essential documents.
PPD


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
C 
degrees Celsius
F
degrees Fahrenheit
AE
adverse event
AhR
aryl hydrocarbon
AIDS
auto-immune deficiency syndrome
ALT
alanine aminotransferase
ANC
absolute neutrophil count
ANCOVA
analysis of covariance
ANOVA
analysis of variance
AST
aspartate aminotransferase
AUC
area under the plasma/serum/peripheral blood mononuclear cell concentration 
versus time curve
BAL
bronchoalveolar lavage
BCRP
breast cancer resistance protein
BID
twice a day 
BMI
body mass index
BUN
blood urea nitrogen
CBC
complete blood count
CCM
cell culture medium
CI
confidence interval
Cmax
the maximum observed serum/plasma/peripheral blood mononuclear (PBMC) 
concentration of drug
CRF
case report form(s)
CRO
contract (or clinical) research organization 
CSR
clinical study report
CT
computerized tomography
CYPxx
cytochrome P450 enzyme xx
DAVG
time-weighted average change
DDI
drug-drug interactions
DFA
direct fluorescence antibody
DMC
Data Monitoring Committee
DSPH
Drug Safety and Public Health
EC
ethics committee
EC50
concentration of drug to reach 50% inhibition of virus replication
ECG
electrocardiogram
eCRF
electronic case report form(s)
EDC
electronic data capture
ELF
epithelial lining fluid
EMR
electronic medical records


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
EudraCT
European clinical trials database
FAS
full analysis set
FIH
First in human
FDA
(United States) Food and Drug Administration
GCP
Good Clinical Practice (Guidelines)
GD 
gestational day
GI
gastrointestinal
GLP
good laboratory practice
GSI
Gilead Sciences, Inc.
hr
hour
HCT
Hematopoietic Cell Transplant
HDPE
high-density polyethylene
hERG
human ether-à-go-go-related gene
HIV
human immunodeficiency virus
HLGT
high level group term
HLT
high level term 
HSP
hysterosalpingogram
IB
investigator’s brochure
IC50
concentration of drug to reach 50% inhibition
ICH
International Conference on Harmonisation
ICU
Intensive Care Unit
IEC
independent ethics committee
IMP
Investigational Medicinal Product
IND
Investigational New Drug (Application)
IRB
institutional review board
IUD
intrauterine device
IVIG
Intravenous Immunoglobulin
IXRS
interactive voice/web response system
kg
kilogram
LLN
lower limit of the normal range
LLOQ
lower limit of quantification
LLT
lower level term
LRTI
lower respiratory tract infection
MedDRA
Medical Dictionary for Regulatory Activities
mg
milligram
min
minute
mL
milliliter
mmHg
millimeters mercury
MMRM
mixed-effect model repeated measures
NA
not applicable
ND
not detectable


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
nM
nanomolar
NOAEL
no-observed-adverse-effect level
NOEL
no-observed-effect level
O2
oxygen
OATP
organic anion transporter proteins
PD
Pharmacodynamic
PFUe
plaque forming unit equivalents
Pgp
P glycoprotein
PK
pharmacokinetic
PO
oral administration (per os, by mouth)
PR
the interval between the beginning of the P wave and the beginning of the QRS 
complex on ECG
PT
preferred term
PXR
pregnane x receptor
Q1
first quartile
Q3
third quartile
QA
quality assurance
QRS
part of electrocardiographic wave representing ventricular depolarization
QT
interval between the start of the Q wave and the end of the T wave on ECG
QTc
corrected QT
QTcF
QT interval corrected for heart rate using the Fridericia formula
RNA
ribonucleic acid
ROW
rest of world
RSV
respiratory syncytial virus
RT-qPCR
quantitative real time polymerase chain reaction
SAE
serious adverse event
SAP
Statistical Analysis Plan
SD
standard deviation
SOC
system organ class
SOP
standard operating procedure
SpO2
oxygen saturation
SUSAR
Suspected Unexpected Serious Adverse Reaction
TBD
to be determined
tmax
the time (observed time point) of Cmax
t½
an estimate of the terminal elimination half-life of the drug in 
serum/plasma/PBMC, calculated by dividing the natural log of 2 by the terminal 
elimination rate constant (λz)
UV
ultraviolet
µL
microliter
ULN
upper limit of the normal range
URTI
upper respiratory tract infection


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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS (CONTINUED)
US
United States
RVP
respiratory viral panel
VS
vital signs
Vss
apparent volume of distribution at steady state
v/v
volume/volume
WBC
white blood cell count


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1.
INTRODUCTION
1.1.
Background
Respiratory syncytial virus (RSV), a member of the family Paramyxoviridae, is an enveloped 
virus with a negative single-strand ribonucleic acid (RNA) genome. The RSV genome encodes 
for 11 proteins, including 3 surface glycoproteins (F, G, and SH) and several proteins that 
comprise the viral RNA polymerase complex (N, P, L, and M2-1). Two major antigenic 
subgroups of RSV are known, RSV A and RSV B, that differ primarily in the genetic sequence 
of the G glycoprotein while maintaining a higher degree of homology across other parts of the 
genome. Both subgroups show comparable pathogenicity and can co-circulate in the same 
community during a seasonal epidemic, but their individual prevalence usually varies from 
season to season.
RSV infection is the most common cause of admissions to pediatric general inpatient units in the 
United States (US) and Western Europe {20222}. Unfortunately, the rate of hospitalization 
among RSV-infected children has remained unchanged in the US over the last decade. From 
1997 to 2006, RSV-coded hospitalizations accounted for 24% of an estimated 5.5 million lower 
respiratory tract infection (LRTI) hospitalizations among children < 5 years of age. During this 
period, it was estimated that approximately 172,000 hospitalizations each year were caused by 
RSV infection among children < 5 years of age; approximately 73% of these hospitalizations 
occur among children < 12 months of age {20227}.
RSV infection is also a cause of respiratory disease in the adult population.  Adult recipients of 
autologous or allogeneic hematopoietic cell transplants (HCT) are at high risk for RSV infection 
related morbidity and mortality.  Based upon retrospective epidemiologic data, 2-17% of HCT 
recipients will develop RSV infection of the respiratory tract {28652} {26908} {28657} {28645}
{28650} {28653} {20233}.  Progression from upper respiratory tract infection (URTI) to LRTI 
may occur in 17-84% of these RSV-infected patients {28641} {26937} {28657} {28650} {28653}
{20233} {28646} {28724} {28654} {28648}. Once RSV progresses from URTI to LRTI, the 
morbidity and mortality is high.  Progression to LRTI often requires hospitalization and at times, 
intensive care unit admission for supportive care (eg oxygenation, mechanical ventilation, 
intravenous fluids, vasopressors).  LRTI is associated with high mortality rates, ranging from 
6.5-26.7%. {28647} {28646} {28656} {28641} {28725} {28643} {28644} {28652} {28650}.  A long 
term sequelae seen among survivors of RSV LRTI is airflow decline documented at 1 year after 
the initial infection {28643}.
Currently there are no effective vaccines or approved prophylactic treatment options for RSV 
infection in the HCT population.  Once hospitalized, treatment for RSV infection in HCT 
patients is supportive, with intravenous hydration, supplemental oxygen, and mechanical 
ventilation.   Although treatment options such as antiviral agents, corticosteroids, and 
immunoglobulin are frequently used, there is no definitive treatment for RSV infection in the 
HCT population.  Synagis® (palivizumab), a monoclonal antibody against RSV approved for 
prophylaxis against RSV infection among high risk infants, has never been evaluated in a 
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retrospective analysis suggests that palivizumab is not effective for treatment of RSV LRTI in 
the HCT population {28654}.  Virazole® (ribavirin), an inhaled antiviral agent, is approved for 
treatment of RSV infection in the pediatric population but is not used in general pediatric 
practice because of concerns regarding its efficacy and tolerability, as well as the complexity of 
the specialized aerosol delivery system that is required {19902}.  A randomized study of inhaled 
ribavirin has been attempted in the HCT population; however, due to the aforementioned
concerns, only 14 subjects were recruited over a 5-year period {28640}. A recent review of 
published epidemiologic studies suggests that ribavirin-based therapy, oral or aerosolized, had 
variable success rates for preventing RSV-associated morbidity or mortality in high risk HCT 
patients {28655}.  A single center retrospective analysis also suggested that ribavirin treatment, 
when administered during the URTI phase, resulted in lower rates of progression to LRTI in 
treated versus untreated patients (16% versus 45%) and mortality (35% versus 70%) {26937}.  
Taking into account the limited available efficacy data from controlled clinical trials, the current 
guidelines for diagnosis and treatment of RSV infection do not provide recommendations 
regarding whether patients should be treated with any treatments other than supportive care at the 
LRTI versus URTI phase {28723}.  Therefore, variability in standard practices for treatment of 
RSV infection in HCT patients exists around the world.
1.2.
GS-5806
1.2.1.
General Information
GS-5806 is an oral RSV fusion inhibitor with potent and selective anti-RSV activity in vitro. 
When tested in vitro against 75 diverse clinical isolates of RSV type A and B, the EC50 values 
(concentration of drug to reach 50% inhibition of virus replication) ranged from 0.15 to 1.09 nM, 
with a mean EC50 value of 0.43 0.22 nM. In vivo efficacy data from cotton rats infected with 
human RSV demonstrated that administration of GS-5806 at 0.3 to 30 mg/kg resulted in a 
dose-dependent reduction in viral load in both the upper respiratory tract and lungs. The 
steady-state pharmacokinetic (PK) volume of distribution (Vss) in all nonclinical species tested 
was 2- to10-fold higher than the volume of total body water and the oral bioavailability was 
moderate to high. The exposure to GS-5806 in the lung and lung epithelial lining fluid (ELF) 
was also assessed in Sprague-Dawley rats and yielded lung tissue/plasma and ELF/plasma ratios 
of approximately 30 and 9, respectively. Concentrations in lung tissue and ELF declined 
approximately in parallel to those in plasma indicating rapid equilibration between the lung and 
plasma compartments. GS-5806 exhibited low cytotoxicity in cell culture and did not interact 
with pharmacologically relevant receptors that are predictive of off-target toxicity.  Based on in 
vitro and nonclinical pharmacokinetic studies, GS-5806 did not demonstrate the potential for 
significant drug-drug interactions (DDI).
Additional details regarding nonclinical pharmacokinetics, pharmacology, and toxicology can be 
found in the current GS-5806 Investigator’s Brochure (IB).


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1.2.2.
Nonclinical Pharmacokinetics
Consistent with the high, concentration-independent forward permeability across 
Caco-2 monolayers and low, concentration-independent efflux, GS-5806 exhibited moderate to 
high bioavailability in nonclinical species. Systemic clearance of GS-5806 in nonclinical species 
is well predicted from the rates of metabolism by hepatic microsomal fractions and primary 
hepatocytes.  Biliary excretion is likely to be the major route of elimination of GS-5806 and its 
metabolites as < 2% of radiolabeled GS-5806 dosed orally to rats was recovered in urine.  The 
major routes of metabolism of GS-5806 are oxidative deamination and N-acetylation. In humans, 
the deamination pathway is likely catalyzed by multiple CYP enzymes such as CYP1A2, 
CYP2B6, and CYP2C19.  GS-5806 shows weak inhibition of OATP1B1, OATP1B3, Pgp 
(IC50 values of 98, 100, and 92 μM, respectively). GS-5806 is a weak inhibitor of OCT1, OCT2, 
and BSEP with IC50 values of 40.2, 16.7, and 29.3 μM, respectively. No inhibition of OAT1 or 
OAT3 was observed for GS-5806 at concentrations up to 80 μM. Therefore, drug interactions of 
GS-5806 with substrates of these transporters are unlikely in the expected clinically relevant 
concentration range.
Additional details regarding nonclinical pharmacokinetics can be found in the GS-5806 IB. 
1.2.3.
Nonclinical Pharmacology and Toxicology
The IC50 for the inhibitory effect of GS-5806 on hERG potassium current was 7.8 µM. 
Cardiovascular effects of GS-5806 were evaluated in dogs at doses up to 75 mg/kg. The principal 
hemodynamic findings were lower heart rate values, and higher arterial pulse and systolic 
pressure values. All hemodynamic effects dissipated by 22 hours post-dose. All 
electrocardiograms (ECGs) were qualitatively within normal limits, and no GS-5806-related 
arrhythmias or abnormal waveforms were detected. Slight GS-5806-related higher PR and QTc 
interval values were expected physiological responses secondary to concomitant 
GS-5806-related lower heart rate values. These changes were not considered physiologically 
important in the context of this study. 
In a repeat dose study, GS-5806 was administered by oral gavage for 4 weeks to young adult rats 
once daily at doses up to100 mg/kg/day. Two animals administered 100 mg/kg/day were found 
dead during the dosing phase. Although the cause of death for these 2 animals was 
undetermined, an association with GS-5806 cannot be excluded. Based on the results of this 
study, the NOAEL for GS-5806 is 70 mg/kg/day, which corresponded to mean AUC0-t and 
Cmax values on Day 23 of the dosing phase of 96, 316 ng·h/mL, and 6028 ng/mL, respectively. In 
a repeat-dose study conducted in young adult dogs, GS-5806 was administered by oral gavage 
for 4 weeks at doses up to 20 mg/kg/day. The NOAEL for this study is 20 mg/kg/day, which 
corresponded to mean AUC0-t and Cmax values on Day 27 of the dosing phase of 
129,831 ng·h/mL and 8081 ng/mL, respectively.
GS-5806 was negative in the rat micronucleus study and did not cause mutations in the Ames 
assay or induce chromosomal damage in vitro with or without S9 metabolic activation. Thus, the 
potential for genetic toxicity is considered low.


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In an oral gavage dose range-finding developmental toxicity study in rats, females were 
administered GS-5806 at doses up to 100 mg/kg/day from gestational day (GD) 6 through 
GD 17 (12-day period), with scheduled necropsy occurring on GD 21. GS-5806 treatment 
resulted in significant reductions in maternal body weight, and the NOAEL for maternal toxicity 
was 30 mg/kg/day. There were no effects on embryo-fetal viability and growth and no fetal 
anomalies, and the NOEL for developmental toxicity was 100 mg/kg/day. 
In an oral gavage dose range-finding developmental toxicity study in rabbits, females were 
administered GS-5806 at dose levels up to50 mg/kg/day from GD 7 through GD 19 
(13-day period), with scheduled necropsy occurring on GD 29. GS-5806 treatment resulted in 
lower maternal body weight at doses ≥30 mg/kg/day. The early termination (moribund sacrifice) 
of 1 female in the 50 mg/kg/day group on GD 20 was attributed to GS-5806 administration, due 
to significant reductions in body weight and food consumption, and the NOEL for maternal 
toxicity was 10 mg/kg/day. There were no effects on embryo-fetal viability and growth and no 
treatment-related fetal anomalies. The NOEL for developmental toxicity was 50 mg/kg/day.
In a dose range-finding study in juvenile rats, GS-5806 was administered at doses up to 
100 mg/kg/day on postnatal day (PND) 7 through PND 14.  Noteworthy effects were limited to 
decreased body weight gain at doses ≥ 70 mg/kg/day and a mild to moderate (1.5- to 2.5-fold), 
dose-dependent increase in total bilirubin at doses ≥ 30 mg/kg/day.  The NOAEL was considered 
to be 30 mg/kg/day, corresponding to respective mean Cmax and AUC0-t values on PND 14 of 
2415 ng/mL and 44,179 ngh/mL. In a definitive juvenile rat study, GS-5806 was administered 
beginning on PND 4 through PND 21 at doses up to 100 mg/kg/day.  An increase in mortality 
was seen at doses ≥70 mg/kg/day.  Reflux-related inflammation and epithelial 
degeneration/erosion/ulcer in the upper respiratory tract occurred at doses ≥70 mg/kg/day, and 
the mortality was likely related to decreased milk intake secondary to the reflux-related 
inflammation in the upper respiratory tract. This is consistent with the observation that neither
clinical pathology data nor anatomic pathology data indicated  specific target organ toxicity as 
the cause of death for the pups that had treatment-related mortalities.  Surviving pups had no 
indications of systemic toxicity.  Based on the above results, the NOEL was considered to be 
30 mg/kg/day, which  corresponded to respective mean Cmax and AUC0-t on PND 21 of 
1430 ng/mL and 19,300 ng·h/mL, respectively.
In a 4-week juvenile dog study, GS-5806 was orally administered once daily on PND 11 through 
PND 38 at doses up to 20 mg/kg/day, with only minimal, transient effects on neonatal/juvenile 
development and no adverse target organ toxicity. The NOAEL was 20 mg/kg/day, 
corresponding to PND 38 Cmax and AUC0-t values of 7180 ng/mL and 139,000 ng·h/mL, 
respectively.
Additional details regarding nonclinical pharmacology and toxicology can be found in the 
GS-5806 IB. 


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1.2.4.
Clinical Trials of GS-5806
1.2.4.1.
GS-US-218-0101
This Phase 1, placebo-controlled, single- and multiple-dose ranging, first-in-human (FIH) study 
was conducted to evaluate safety, tolerability, and PK following oral administration of GS-5806 
to up to 70 unique subjects.  The study included 3 stages (Parts A, B, and C) with 8 total 
staggered cohorts (7 pre-specified, 1 adaptive). Within each cohort of Parts A and B, 8 unique 
subjects were randomized to receive blinded investigational medicinal product (IMP), either 
GS-5806 (n = 6) or placebo (n = 2). Within each cohort of Part C, 10 unique subjects were 
randomized to receive blinded IMP, either GS-5806 (n = 8) or placebo (n = 2). A maximum 
single dose of 300mg and multiple dose regimen of 75mg once daily for 7 days was achieved.  
GS-5806 PK was evaluated under fasting and fed states.
No deaths or serious adverse events (SAEs) were reported, and there were no dose-limiting 
toxicities. In the GS-5806-treated subjects, there were no discontinuations due to AEs. Among 
the 23 subjects who received single doses of GS-5806, 5 subjects (21.7%) experienced a total of 
11 AEs, with the most common AEs being presyncope and dermatitis (reported by 2 subjects 
each). Both incidents of presyncope, and 1 of the 2 events of dermatitis, were judged by the 
investigator to be related to study procedures; 1 event of dermatitis was inflammation of the skin 
of the right antecubital and 1 event was nonspecific dermatitis on the chest. Among the 
52 subjects receiving multiple doses of GS-5806, 20 subjects (38.4%) experienced a total of 
45 AEs, with diarrhea and nausea reported by 4 subjects and headache and contact dermatitis 
reported by 3 subjects. All other AEs experienced by subjects receiving multiple doses of 
GS-5806 were reported by ≤2 subjects each.
Twelve-lead ECGs were obtained at Baseline and Days 1, 15, and 21. Analysis of these ECGs 
demonstrated no clinically significant increase in the PR, QRS, QT, and QTcF intervals, and no 
clinically significant arrhythmias associated with administration of GS-5806.
GS-5806 exposures increased in an approximately dose-proportional manner over the dose range 
tested following single and multiple oral administrations under fasted conditions. GS-5806 
terminal half-lives ranged from 30 to 33 hours following single oral administration and 
approximately 36 hours following multiple oral administrations. Overall, the variability of the 
PK parameters was relatively low, with the majority of the PK parameters displaying CV% of 
30% or lower. In addition, the food effect on GS-5806 PK following single or multiple oral 
administration has been evaluated. Following single administration of GS-5806 at 25, 50, or 
75 mg, Cmax under fed conditions decreased approximately 20% to 40% compared to fasted 
conditions, but this effect was less pronounced following once daily dosing at the higher dose 
(75 mg) around steady-state.
1.2.4.2.
Study GS-US-218-0109
This Phase 1 mass-balance study was conducted to evaluate the PK, metabolism, and excretion 
of GS-5806. The primary objective of this study was to determine the mass balance of GS-5806 
following administration of a single, oral dose of radiolabeled [14C]-GS-5806.  The secondary 


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objectives of this study were to evaluate the PK of GS-5806 and metabolites, where possible and 
to determine the metabolite profile of GS-5806 in humans following administration of a single, 
oral dose of radiolabeled [14C]-GS-5806.
Eight subjects were enrolled and assessed for a period of a minimum of 10 days and a maximum 
of 21 days with a 7-day follow-up period. Following a single oral radiolabeled dose of GS-5806
(50 mg), the maximum mean concentrations of drug-derived radioactivity in blood and plasma 
were observed at 2 hours post-dose for both matrices.  The overall recovery of radioactivity was 
89.9%, with recovery primarily in feces (72.3%) versus urine (17.6%).  Mean blood to plasma 
concentration ratios ranged from 0.450 to 0.591 through 120 hours post-dose, indicating that 
radioactivity was primarily in the plasma, relative to the cellular components of the blood.
The circulating radioactivity consisted mainly of GS-5806 (88%) and low levels of minor 
metabolites 5-chloro-2-amino (N-methanesulfonyl) benzamide (M58; 7%), 
oxy-GS-5806-glucuronide (M47; 3%), and GS-557855 (M30B; 1%)). 
The major component excreted in feces was unchanged parent GS-5806 (18.5% of the dose; 
coeluted with dioxy-GS-5806-2 [M63]), along with other minor metabolites 
(dioxy-GS-5806-3 [M64; 5.42% of the dose] and dioxy-GS-557855-2 [M70; 3.51% of the 
dose]). The remaining identified 8 metabolites detected in feces each accounted for less than a 
mean of 2.5% of the dose. In urine, unchanged parent GS-5806 was the main species 
(~10.0% of the dose), and metabolite M47 represented ~3.59% of the dose. 
In summary, [14C]GS-5806 was primarily eliminated in the feces after oral administration to 
healthy subjects. Low levels of various metabolites were observed indicating the likely absence 
of a single dominant pathway. Radioactivity was eliminated as a combination of metabolites and 
unchanged parent drug. Overall, the pharmacokinetics of GS-5806 is not expected to be 
meaningfully altered in the setting of renal impairment (eg, mild to moderate).
1.2.4.3.
Study GS-US-218-0103
This Phase 2a, randomized, double-blind, placebo-controlled study was conducted to evaluate 
the safety, tolerability, and efficacy of GS-5806 in healthy adult volunteers infected with an RSV 
challenge virus (RSV-A Memphis 37b strain). The study included 7 quarantines, each 
comprising approximately 20 subjects. Each subject was admitted to the Quarantine Unit and 
inoculated with RSV on Study Day 0. Subjects were randomized and treated with GS-5806 or 
placebo when infection was documented in the nasal wash, or by the fifth day after inoculation, 
whichever occurred first.
For Quarantines 1 through 4 (pre-specified quarantines), subjects were randomized 1:1 to receive 
GS-5806 or placebo, administered as a 50 mg single dose on Dose Day 1, followed by 25 mg 
once daily on Dose Days 2 through 5.
For Quarantines 5 through 7 (adaptive quarantines), subjects were randomized 4:1 to receive 
GS-5806 or placebo. Subjects in Quarantine 5 were administered a 50 mg single dose on Dose 
Day 1, followed by 25 mg once daily on Dose Days 2 and 3. Subjects in Quarantine 6 were 
administered a 100 mg single dose. Subjects in Quarantine 7 were administered a 10 mg 
single dose on Dose Day 1, followed by 5 mg once daily on Dose Days 2 through 5.


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A total of 140 subjects were randomized into this study.  All subjects completed study drug and 
1 placebo subject discontinued the study due to investigator’s discretion.  Baseline demographics 
and characteristics were similar between treatment groups across all dose cohorts.  
Seventy-eight (78) subjects received the pre-specified dose in quarantines 1-4 (GS-5806 n=39, 
placebo n=39).  Of these, 54 subjects (69%) were documented to be RSV positive prior to 
randomization and were included in the primary and secondary analyses (GS-5806 n=27, 
placebo n=27).  A total of 87 subjects received GS-5806 across all quarantines. 
Treatment with GS-5806 resulted in the following:
Primary Endpoint:

Treatment with GS-5806 resulted in lower mean AUC viral load from initial dose through 
end of quarantine.  Viral load was assessed twice daily using nasal washes.  The mean AUC 
of viral load as measured by the RT-qPCR assay from first viral load measurement post 
initial dose of study drug through Day 12 was significantly lower in GS-5806 subjects 
compared to placebo subjects (Δ= 506.9 log10 PFUe*hour/mL, p<0.001).
Secondary Endpoints:

Treatment with GS-5806 resulted in lower mean AUC viral load during the entire quarantine 
period. The mean AUC of viral load post challenge through Study Day 12 as measured by 
the RT-qPCR assay was significantly lower in GS-5806 subjects compared to placebo 
subjects (Δ= 531.0 log10 PFUe*hour/mL, p=<0.001). 

Treatment with GS-5806 resulted in lower mean total mucus weight during dosing. The 
average weight of each unused tissue was determined prior to start of study. The daily mucus 
weight was calculated by first counting the number of tissues used each day, then subtracting 
the total weight of these tissues, unused, from the daily total weight of used tissues.  The 
mean total weight of mucus produced post-initial dose of study drug through the dose was 
significantly lower in the GS-5806 subjects compared to placebo subjects (Δ= 8.2 g, 
p=0.028). 

Treatment with GS-5806 resulted in a lower mean AUC of change from Baseline in total 
symptom score during the entire quarantine period. Ten symptoms (runny nose, stuffy nose, 
sneezing, sore throat, earache, malaise [tiredness], cough, shortness of breath, headache, and 
muscle and/or joint ache) were each scored from 0 (no symptoms) to 3 (quite bothersome 
most/all of the time). Total symptom scores (0-30) were the average score of questions 
answered by each subject, multiplied by 10.  The mean AUC of change from Baseline in total 
symptom score post initial dose of study drug through Study Day 12 was significantly lower 
in the GS-5806 subjects compared to placebo subjects (Δ= 225.1 score*hour, p=0.005).  The 
total symptoms score AUC was also significantly lower for GS-5806 treated subjects.


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In each of the adaptive quarantines statistically significant results were also achieved in the 
primary endpoint and each of the secondary endpoints described above with the exception of a 
reduction in mean total mucus weight in Quarantine 7. In addition, an exposure response effect 
was noted.
No subject experienced a serious AE. All AEs were mild or moderate (Grade 1 or 2) in severity, 
except for three Grade 3 AEs experienced by 1 placebo-treated subject (increased blood lactate 
dehydrogenase, alanine aminotransferase [ALT], and aspartate aminotransferase [AST]). 
Grade 1 pulmonary function decrease (<10% change) was the only treatment-related AE 
experienced by >2 subjects in either treatment group (GS-5806: 4.6%, n=4/87; placebo: 3.8%, 
n=2/53).  Changes in clinical laboratory values were Grade 1 or 2 in severity, except for one 
Grade 4 value (increased AST; reported for placebo-treated subject described above). Elevated 
ALT was more commonly reported among GS-5806-treated subjects (GS-5806: 14.9%; placebo: 
9.4%), but elevated AST was less commonly reported (GS-5806: 5.7%; placebo: 15.1%). Low 
neutrophil count was reported as Grade 1 in 11 subjects (2 received placebo) and Grade 2 in 
2 subjects (1 received placebo). Among the 9 subjects who experienced a Grade 1 low neutrophil 
count and received GS-5806, 2 had a Grade 1 low neutrophil count at Screening. Clinically 
relevant changes in vital signs or ECGs were not observed.
1.3.
Rationale for This Study
There is a significant unmet medical need for a safe, convenient, and effective treatment for RSV 
infection.  The only approved antiviral therapy for RSV, ribavarin, is approved for use in 
pediatric populations only, but is rarely used in clinical practice due to its limited efficacy and 
concerning safety profile. There is no approved antiviral therapy for RSV infection among HCT 
recipients, where the current standard of care is supportive or off-label use of ribavirin.
This study follows a Phase 1 FIH study (GS-US-218-0101) and a Phase 2a RSV challenge study 
(GS-US-218-0103), which evaluated the safety, tolerability, and PK of single and multiple doses 
of GS-5806 in 140 healthy adult volunteers.  In Study GS-US-218-0103, GS-5806 was shown to 
be efficacious in reducing RSV viral load and clinical symptoms in healthy adult subjects 
experimentally infected with RSV.  
Given these results from healthy adult volunteers studied in a controlled setting, 2 studies are 
being conducted to evaluate the efficacy, safety, and tolerability of GS-5806 in the HCT 
population. Study GS-US-218-0108 is being conducted in HCT patients with an RSV-related 
URTI. This study, which will be run concurrently, will enroll HCT patients with an RSV-related 
LRTI. Safety and efficacy data generated from these studies, together with currently available 
data, will be used to support further clinical development of GS-5806 in pediatric and adult 
patients infected with RSV.


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1.4.
Dose Rationale
The dose and administration schedule selected for this study is a single dose of 200 mg GS-5806 
administered orally in the fasted state on Days 1, 5, 9, 13, and 17. This regimen was selected 
based upon the PK characteristics of GS-5806 and the pharmacokinetic/pharmacodynamic 
(PK/PD) relationship established in the antiviral effect study with different doses/regimens in 
Study GS-US-218-0103. 
In Study GS-US-218-0103, a 5-day treatment regimen of GS-5806 (50 mg single dose on Dose 
Day 1, followed by 25 mg once daily on Dose Days 2 through 5) resulted in a significant 
reduction in RSV viral load. The mean AUC of RSV viral load as measured by the RT-qPCR
assay from first viral load measurement post initial dose of study drug through end of quarantine 
(Day 12) was significantly lower in GS-5806 subjects compared to placebo subjects 
(Δ= 506.9 log10 PFUe*hour/mL, p<0.001). This 5-day regimen was able to achieve GS-5806 
trough concentrations ~4-5 fold of paEC95 (52 ng/mL) for up to 120 hours following dose
initiation for the virus used in the challenge study, the M37 strain of RSV. 
In selecting the dose for the current study, the goal was to achieve GS-5806 trough 
concentrations above 4-fold of paEC95 for most of the clinical RSV isolates for the duration of 
RSV shedding in HCT patients. Longitudinal viral dynamics data from investigators at an 
academic HCT center also indicate that the majority of HCT patients shed RSV for 15 days, but 
some may shed for as long as 21 days (unpublished). Therefore, a total of 5 doses of GS-5806 
(200 mg each dose, every 4 days) is expected to provide > 4-fold paEC95 coverage for ~95% of 
75 wild-type clinical RSV isolates through Day 22, which is expected to result in significant 
durable antiviral effect. 
1.5.
Compliance
This study will be conducted in compliance with this protocol, Good Clinical Practice (GCP), 
and all applicable regulatory requirements.


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2.
OBJECTIVES
The primary objective of this study is:

To evaluate the effect of GS-5806 on RSV viral load in autologous or allogeneic HCT 
recipients with an acute RSV LRTI 
The secondary objectives of this study are:

To evaluate the effect of GS-5806 on rates of respiratory failure and all-cause mortality

To evaluate the PK, safety, and tolerability of GS-5806


GS-5806 
Protocol GS-US-218-1502 
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3. 
STUDY DESIGN 
3.1. 
Endpoints 
The prima1y endpoint of this study is: 
Final 
Amendment3 
• 
Time-weighted average change in nasal RSV viral load (log10 copies/mL) from Baseline 
(Day 1) to Day 9 as measmed by RT-qPCR 
The key secondruy endpoints of this study ru·e: 
• 
Prop01tion of subjects developing respirat01y fail me (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28 
• 
Proportion of all-cause m01tality among subjects through Day 28 
The explorat01y endpoints ru·e: 
PPO 
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GS-5806 
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Gilead Sciences, Inc. 
(]' 
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3.2. 
Study Design 
Final 
Amendment 3 
This is a randomized, double-blind, placebo-controlled study evaluating the effect of GS-5806 on 
efficacy, PK, safety, and tolerability in HCT recipients with RSV IRTI. This study will emoll 
approximately 60 subjects from approximately 30 intemational HCT centers. RSV positive 
subjects with evidence oflRTI will be randomized 1:1 to receive GS -5806 or placebo given as 
200mg eve1y 4 days for a total of 5 doses. Subjects will be followed for a total of 28 days, 
during which a total of 10 Study visits will be 
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3.3. 
Study Treatments 
Approximately 60 subjects will be randomized 1:1 to receive 200 mg (four 50 mg tablets) of 
IMP (GS-5806 or placebo) as a single dose on Days 1, 5, 9, 13, and 17. The IMP will be 
administered after the subject has fasted (with exception of clear liquids and medications) for at 
least 2 hours. The entire dose must be taken within 1 hour. Subjects will remain fasting for 
approximately 1 hour after dosing. Tablets are not to be cmshed, split, dissolved, or chewed. 
IMP should be dispensed with gloves. Subjects should avoid direct UV exposure for 8 days after 
receiving IMP. 
Subjects will remain in the clinic for 30 minutes post-dose for observation. If vomiting occurs 
within 30 minutes after IMP administration and undissolved tablets are present in the vomitus, 
the subject should receive another dose. If another dose is administered, the subject should 
remain in the clinic for an additional30 minutes post-dose for observation. 
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GS-5806 will be provided as white, plain-faced, film-coated, round tablets containing 50 mg 
GS-5806 (61 mg GS-5806-02, bis-hydrochloride salt dihydrate form of GS-5806). Placebo to 
Match will be provided as white, plain-faced, film-coated, round tablets containing no GS-5806.
The expected duration of subject participation is approximately 1 month, to include Screening 
through the final visit on Day 28.  
3.4.
Duration of Treatment
The treatment portion of the study is 17 days (a total of 5 doses administered as single doses on 
Days 1, 5, 9, 13, and 17).
3.5.
Discontinuation Criteria
Reasons for potential premature discontinuation from IMP dosing include:

Any Grade 3 or 4 AE or SAE

Intercurrent illness that would, in the judgment of the investigator, affect the subject’s ability 
to receive IMP (eg, unable to ingest oral dose). 
In the event any of the above criteria are met, the Principal Investigator (PI) will review the case 
in detail and discuss with the Gilead Medical Monitor whether the subject should be 
discontinued from IMP.
Reasons for premature discontinuation from the Study include:

Subject request to discontinue for any reason

Subject noncompliance

Pregnancy during the study; refer to Section 7.7.2

Discontinuation of the study at the request of Gilead, a regulatory agency or an institutional 
review board or independent ethics committee (IRB/IEC)
If a subject prematurely discontinues from IMP dosing, he/she will remain on study and will 
continue with all subsequent Study Visits and assessments, with the exception of IMP dosing.  
If a subject prematurely discontinues from the Study, every attempt should be made to bring the 
subject back for the Early Termination procedures.  See Section 6.9 for more information.
3.6.
Source Data
For the purposes of this study, study specific questionnaires (ie, respiratory symptom 
assessments) are considered source documents and are to be filed with the subject’s medical or 
study records.  Electronic data (ie, diagnostic machines that transcribe data directly to a database, 


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or data entered directly into an Electronic Medical Record system) is considered source data, 
provided the data is not recorded directly on the CRF/eCRF, and provided there is a clear audit 
trail in the electronic record(s).  Template source document worksheets will be prepared by 
Gilead and provided to sites to use at their discretion.  If source document worksheets are used, 
they are to be kept with the subject’s medical or study records as original source documents.  No 
data will be recorded directly on the CRF/eCRF, and any data recorded directly on the 
CRF/eCRF will not be considered source data.


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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
The subject population will consist of approximately 60 RSV-positive males and females 18 to 
75 years of age who have had an allogeneic or autologous HCT and have documented acute RSV 
related LRTI symptoms, recruited from approximately 30 centers in Asia Pacific, Australia, 
Canada, Europe, South America, and the United States.
4.2.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this 
study.
1. Received an autologous or allogeneic HCT using any conditioning regimen
2. Evidence of new abnormalities on chest X-ray obtained < 48 hours prior to Screening, 
determined to be consistent with LRTI by the local radiologist, relative to the most recent 
previous chest X-ray.  If chest X-ray is not available, a chest X-ray must be obtained for 
Screening.
3. Documented RSV in both the upper (eg, nasal swab, nasopharyngeal swab, nasal wash) and 
lower (eg, induced sputum, BAL, lung biopsy) respiratory tract as determined by local testing 
(eg, PCR, DFA, RVP assay, or culture).  All samples must have been collected ≤6 days prior 
to Day 1.
4. An informed consent document signed and dated by the subject or a legal guardian of the 
subject and investigator or his/her designee
5. A negative urine or serum pregnancy test is required for female subjects (unless surgically 
sterile or greater than two years post-menopausal)
6. Male and female subjects of childbearing potential must agree to contraceptive requirements
as described in Appendix 5
7. Willingness to complete necessary study procedures and have available a working telephone 
or email


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4.3.
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
Related to concomitant or previous medication use:
1. Use of non-marketed (according to region) investigational agents within 30 days, OR use of 
any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of screening, whichever 
is longer, OR use of any investigational RSV vaccines after HCT
2. Use of a strong cytochrome P450 enzyme (CYP) inducer including but not limited to 
rifampin, St. John’s Wort, carbamazepine, and phenytoin, within 2 weeks prior to the 
first dose of IMP
Related to medical history:
3. Pregnant, breastfeeding, or lactating females 
4. Unable to tolerate nasal sampling required for this study, as determined by the investigator
5. Known history of HIV/AIDS with a CD4 count <200 cells/μL within the last month
6. History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent 
adherence to study activities
Related to medical conditions:
7. Requiring invasive mechanical ventilation at the time of randomization 
8. A relapse (including molecular relapse) of their underlying disease for which they received a 
transplant at Screening
9. Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, 
human rhinovirus, adenovirus, or human metapneumovirus), from the lower respiratory tract 
sample as determined by local testing
10. Clinically significant bacteremia or fungemia within 7 days prior to Screening that has not 
been adequately treated, as determined by the investigator
11. Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening 
that has not been adequately treated, as determined by the investigator
12. Excessive nausea/vomiting at screening, as determined by the investigator, or an inability to 
swallow pills that precludes oral administration of the IMP
13. Any condition which, in the opinion of the investigator, would prevent full participation in 
this trial or would interfere with the evaluation of the trial endpoints


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Related to allergies:
14. Known hypersensitivity or allergy to the IMP, its metabolites, or formulation excipients 
(microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl 
alcohol, titanium dioxide, polyethylene glycol and talc)
15. Allergy to sulfa drugs 
Related to laboratory results:
16. Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)
17. AST/ALT > 3x ULN
18. Total bilirubin > 3x ULN


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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Randomization, Blinding and Treatment Codes
This is a randomized, double-blind, placebo-controlled multi-center study. Eligible subjects will 
be stratified by the following factors:

Supplemental O2 requirement (≤2 L/min or > 2 L/min) at the time of randomization

Treatment of current RSV infection (yes or no) with ribavirin (oral, intravenous, or 
aerosolized)
Treatment of current RSV infection with ribavirin will be defined as ≥1 dose of ribavirin 
(oral, intravenous, or aerosolized) prior to randomization or with written orders for the initiation 
of therapy at the time of randomization.  Subjects will be randomized in a 1:1 ratio to receive 
IMP (GS-5806 or matching placebo).
Assignment to study treatment will be blinded to the study subjects, investigational site 
personnel, study vendors, and the Sponsor, except for the delegated personnel who will review 
and check the randomization and drug allocation for accuracy.
5.1.1.
Procedures for Breaking Treatment Codes
In the event of a medical emergency where breaking the blind is required to provide medical care 
to the subject, the investigator may obtain treatment assignment directly from the IXRS system 
for that subject. In the event of technology failure, the PI may call the IXRS help line to access 
treatment codes. Gilead recommends but does not require that the investigator contact the Gilead
medical monitor before breaking the blind. Treatment assignment should remain blinded unless 
that knowledge is necessary to determine subject emergency medical care. The rationale for 
unblinding must be clearly explained in source documentation and on the case report 
form/ electronic case report form (CRF/eCRF), along with the date on which the treatment 
assignment was obtained. The investigator is requested to contact the Gilead medical monitor 
promptly in case of any treatment unblinding. Details of unblinding will be provided in the 
study-specific Unblinding Plan.
Blinding of study treatment is critical to the integrity of this clinical trial and therefore, if a 
subject’s treatment assignment is disclosed to the investigator, the subject will have study 
treatment discontinued. All subjects will be followed until study completion unless consent to do 
so is specifically withdrawn by the subject.
Gilead Drug Safety and Public Health (DSPH) may independently unblind cases for expedited 
reporting of suspected unexpected serious adverse reactions (SUSARs).


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5.2.
Description and Handling of GS-5806
5.2.1.
Formulation
GS-5806 will be supplied as white, plain-faced, film-coated, round tablets containing 50 mg
GS-5806 (61 mg GS-5806-02, bis-hydrochloride salt dihydrate form of GS-5806). In addition to 
the active ingredient, GS-5806 tablets contain the following inactive ingredients: 
microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl 
alcohol, titanium dioxide, polyethylene glycol, and talc, all of which are common pharmaceutical 
excipients.
The supplied matching placebo tablets are identical in physical appearance to the 50 mg
GS-5806 tablets and contain the same inactive ingredients.
5.2.2.
Packaging and Labeling
GS-5806 tablets and matching placebo are packaged in white, high density polyethylene (HDPE) 
bottles with desiccant and polyester fiber coil. Each bottle contains 4 tablets and is capped with a 
white, continuous thread, child-resistant polypropylene screw cap fitted with an induction-sealed, 
aluminum-faced liner.
All labels for IMP distributed to investigative sites in the US and the rest of world (ROW) will 
meet all applicable requirements of the US Food and Drug Administration (FDA), the EU 
Annex 13 of Good Manufacturing Practices: Manufacture of investigational medicinal products 
(July 2010), and/or other local regulations, as applicable.
5.2.3.
Storage and Handling
Sufficient quantities of GS-5806 tablets and matching placebo will be shipped to the investigator 
or qualified designee from Gilead Sciences Materials & Logistics (or its designee).
GS-5806 tablets should be stored at controlled room temperature of 25°C (77°F); excursions are 
permitted between 15°C and 30°C (59°F and 86°F). Storage conditions are specified on the label.  
Until dispensed to the subjects, all bottles of IMP should be stored in a securely locked area, 
accessible only to authorized site personnel. The study center will be required to maintain a log 
of daily temperature readings in the storage area for the duration of the study. To ensure the 
stability and proper identification, the drug products will be stored in the containers in which 
they were supplied until units are dispensed to individual subjects at the site.
5.3.
Dosage and Administration of GS-5806
Eligible subjects will receive 200 mg GS-5806 or placebo on Days 1, 5, 9, 13, and 17. Doses will 
be administered with water, after the subject has fasted for at least 2 hours (with exception of 
clear liquids and medications). The entire dose must be taken within 1 hour.  Subjects will 
remain in a fasting condition for at least 1 hour after dosing. IMP is to be dispensed with gloves. 
Tablets are not to be crushed, split, dissolved, or chewed. Subjects will remain in the clinic for 


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30 minutes post-dose for observation.  If vomiting occurs within 30 minutes after IMP 
administration and undissolved tablets are present in the vomitus, the subject should receive 
another dose.  If another dose is administered, the subject should remain in the clinic for an 
additional 30 minutes post-dose for observation. Subjects should avoid direct UV exposure for 
8 days after receiving IMP.
5.4.
Prior and Concomitant Medications
GS-5806 has a low systemic clearance in humans, so significant drug-drug interactions, in which 
concomitantly administered drugs inhibit the metabolic clearance of GS-5806 by CYP enzymes, 
are unlikely. Low levels of minor metabolites were observed in the human mass balance study 
(GS-US-218-0109) indicating that metabolism of GS-5806 is mediated by multiple minor 
metabolic pathways with the likely absence of a single dominant pathway. As such, the net effect 
of strong induction of 1 or 2 pathways by a potent CYP inducer is unclear. Therefore, 
concomitant administration of strong CYP inducers (including but not limited to rifampin, 
St John’s Wort, carbamazepine, and phenytoin) is excluded to avoid potential drug resistance.
In vitro, GS-5806 is a substrate of the efflux transporters P glycoprotein (P-gp) and breast cancer 
resistance protein (BCRP). However, GS-5806 exhibits moderate to high bioavailability in 
nonclinical species and approximately dose-proportional increase in exposures following single 
(75 mg to 300 mg) or multiple (10 to 75 mg once daily) oral administrations in healthy adults, 
consistent with its high solubility and high membrane permeability. Therefore, the bioavailability 
of GS-5806 is not expected to be limited by P-gp and BCRP activities, and clinically relevant 
interactions with P-gp and BCRP inhibitors are not expected.
In vitro, GS-5806 is a substrate of the hepatic uptake organic anion transporter proteins (OATP) 
OATP1B1 and OATP1B3. Clinically, single doses of GS-5806 have been well tolerated up to 
800 mg (Cmax and AUC ~3.6-and ~5-fold of 200 mg, respectively) in healthy volunteers. 
GS-5806 exposures may be increased upon coadministration with OATP inhibitors (eg, rifampin,
cyclosporine, and gemfibrozil).
GS-5806 may cause concentration-dependent inhibition of multidrug and toxin extrusion via 
transporters MATE1 and MATE2-K with IC50 values of 0.50 and 3.8 μM, respectively. When 
co-administered with renally eliminated concomitant medications (ie, filtration plus secretion), 
GS-5806 may increase the exposures of substrates secreted by the MATEs transporters, such as 
ganciclovir, acyclovir, levofloxacin, metformin, captopril, procainamide, fexofenadine, 
cimetidine, cephradine, and cephalexin. Dosing and safety monitoring should be consistent with 
prescribing information, in particular for agents which require dose reductions in the setting of 
renal impairment.


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5.5.
Accountability for GS-5806
The investigator is responsible for ensuring adequate accountability of all used and unused IMP 
bottles. This includes acknowledgement of receipt of each shipment of IMP (quantity and 
condition). 
GS-5806 accountability records will be provided to each study site to:

Record the date and quantity of IMP bottles received

Record the date, subject number, subject initials, the IMP bottle number dispensed

Record the date, quantity of used and unused IMP bottles returned, along with the initials of 
the person recording the information.
5.5.1.
Investigational Medicinal Product Return or Disposal
At the site initiation visit or first monitoring visit, the study monitor will evaluate each study 
center’s IMP disposal procedures and provide appropriate instruction for return or destruction of 
unused IMP supplies. If the site has an appropriate Standard Operating Procedure (SOP) for drug 
destruction (as reviewed and approved by Gilead Sciences, Inc [GSI]), the site may destroy used 
and unused IMP supplies performed in accordance with the site’s (hospital/pharmacy) SOP after 
reconciliation has been completed by the site monitor. If the site does not have acceptable 
procedures in place for drug destruction, arrangements will be made between the site and GSI
(or GSI representative) for return of unused IMP supplies. A copy of the site’s SOP will be 
obtained for central files. Where possible, IMP will be destroyed at the site. 
Upon study completion, a copy of the Investigational Drug Accountability records must be filed 
at the site. Another copy will be returned to GSI. If drug is destroyed on site, the investigator 
must maintain accurate records for all IMP destroyed. Records must show the identification and 
quantity of each unit destroyed, the method of destruction, and person who disposed of the drug. 
All IMP records must be maintained at the site and copies must be submitted to GSI at the end of 
the study.


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6.
STUDY PROCEDURES
The study procedures to be conducted for each subject enrolled in the study are presented in 
tabular form in Appendix 2 and described in the text that follows. Additional information is 
provided in the study procedures manual.
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol. Investigators must document any deviation 
or departure from protocol procedures, regardless of causality, and notify the sponsor or contract 
research organization (CRO).
6.1.
Subject Enrollment and Treatment Assignment
6.1.1.
Visit 1: Screening Visit (Days -2 to -1)
Visit 1 must be performed in the hospital or clinic.  Potential subjects will have a documented
positive test for RSV from the upper and lower respiratory tract and be approached for informed 
consent.  The Principal Investigator or a medically qualified Sub-Investigator (eg, MD, DO, or 
nurse practitioner) must review and discuss the study with each subject prior to consent. All 
screening assessments must be performed after obtaining written consent. All screening labs and 
procedures will be performed locally and results will be reviewed by the investigator prior to 
IMP administration at Visit 2. 
The following procedures will be completed at Screening:

Obtain written informed consent

Collection of medical history and demographics

Review of concomitant medications

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

Height and Weight

O2 saturation (on room air)

Chest X-ray (chest X-rays obtained < 48 hours prior to Screening may be used)

Blood draw for screening labs for local laboratory analyses (labs obtained ≤6 days prior to 
Screening may be used)
Serum creatinine clearance
AST/ALT
Total bilirubin


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
Urine or serum pregnancy test (for women unable to confirm menopause, hysterectomy 
and/or bilateral oophorectomy)

Record any SAEs and all AEs related to protocol-mandated procedures occurring after 
signing of the consent form
Subjects meeting all of the inclusion criteria and none of the exclusion criteria will be 
randomized into the study.  Subjects must continue to meet all inclusion criteria and none of the 
exclusion criteria at the time of randomization.  If all lab results and procedures are available and 
satisfy the inclusion/exclusion criteria, Screening and Visit 2 (Day 1) may occur on the same 
day.  From the time of obtaining informed consent through the first administration of IMP, 
record all SAEs, as well as any AEs related to protocol-mandated procedures on the AE case 
report form (eCRF).  All other untoward medical occurrences observed during the Screening 
period, including exacerbation or changes in medical history are to be captured on the medical 
history eCRF.  See Section 7 Adverse Events and Toxicity Management for additional details.
6.1.2.
Visit 2: Baseline Assessments, Randomization, and Treatment Assessments 
(Day 1)
6.1.2.1.
Baseline Assessments
Visit 2 must be performed in the hospital or clinic and should occur within 24 hours of 
confirmation of the subject’s eligibility. Samples and assessments performed at Screening 
(Visit 1) may not be used as Visit 2 Baseline assessments.  Baseline (Visit 2) assessments should 
be performed in the following order and documented on Day 1 prior to IMP administration:

Review of concomitant medications, mechanical ventilation (invasive and non-invasive of 
any duration), and supplemental O2 use

Weight

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure) O2 saturation 
(on room air)

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include WBC with differential, Hgb, 
platelets, BUN, creatinine, serum albumin, AST, ALT, and total bilirubin)
Serum antibody titer to RSV
RSV viremia


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
Nasal samples (2 total, 1 from each nostril)

Urine or serum pregnancy test (for women unable to confirm menopause, hysterectomy 
and/or bilateral oophorectomy)

Obtain induced sputum for central laboratory analysis (unless induced sputum was used to 
demonstrate the presence of RSV in the lower respiratory tract ≤6 days prior to Day 1)
6.1.2.2.
Randomization and Treatment Assessments (Day 1)
After all Baseline assessments are complete, eligible subjects will be randomized via Interactive 
Voice/Web Response System (IXRS) and IMP will be administered.  
Randomization to GS-5806 or placebo will be based on a randomization schedule prepared by 
Gilead and/or designee before the start of the study. Subjects must continue to satisfy all 
inclusion/exclusion criteria at the time of randomization. At randomization, eligible subjects will 
be stratified by the following:

Supplemental O2 requirement (≤2 L/min or > 2 L/min) at the time of randomization

Treatment of current RSV infection (yes or no) with ribavirin (oral, intravenous, or 
aerosolized)
Treatment of current RSV infection with ribavirin will be defined as ≥1 dose of ribavirin 
(oral, intravenous, or aerosolized) prior to randomization or with written orders for the initiation 
of therapy at the time of randomization.  Subjects will be randomized in a 1:1 ratio to receive 
IMP (GS-5806 or matching placebo).
Subjects will receive 200 mg (four 50 mg tablets) of GS-5806 or matching placebo at Day 1. All 
IMP will be administered with water, after the subject has been fasting (with exception of clear 
liquids and medications) for a minimum of 2 hours. The entire dose must be taken within 1 hour.  
Subjects will remain in a fasting condition for 1 hour post-dose. Tablets are not to be crushed, 
chewed, split, or dissolved, and should always be dispensed with gloves.  Non-hospitalized 
subjects will remain in the clinic for 30 minutes post-dose for observation.  If vomiting occurs 
within 30 minutes after IMP administration and undissolved tablets are present in the vomitus, 
the subject should receive another dose.  If another dose is administered, the subject should 
remain in the clinic for an additional 30 minutes post-dose for observation.  Subjects should 
avoid direct UV exposure for 8 days after receiving IMP.
The following procedure will be performed and documented on Day 1 after IMP dosing:

Blood draw for central laboratory analysis:
Serum creatinine 4 hours post-dose
PK sampling 4 hours post-dose

Review of AEs


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6.1.2.3.
Post-dose Follow-up for Hospitalized Subjects 
For hospitalized subjects, a blood draw for central laboratory analysis of serum creatinine will be 
collected at 24 and 72 hours (±3 hours) post-first GS-5806 dose.  Subjects who are not 
hospitalized during this time will not return to the hospital or clinic for these blood draws.  
6.2.
Visit 3: Day 3 (± 24 hours)
Visit 3 assessments may be performed in the hospital, clinic, or at the subject’s home by the 
study coordinator or designee.  

For all subjects: nasal samples (2 total, 1 from each nostril)

For hospitalized subjects, a blood draw for central laboratory analysis at 48 hours (±3 hours) 
post-first GS-5806 dose:
Serum creatinine
PK sampling
6.3.
Visit 4: Day 5 (± 24 hours)
Visit 4 assessments must be performed in clinic or in hospital and should be performed in the 
following order and documented (also refer to Appendix 2 Study Procedures Table):

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure) 

O2 saturation (on room air)

Weight

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include to include WBC with 
differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total 
bilirubin)  
PK sampling: pre-dose
RSV viremia 

Nasal samples (2 total, 1 from each nostril)

Urine or serum pregnancy test (for women unable to confirm menopause, hysterectomy 
and/or bilateral oophorectomy)

IMP administration* 


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Amendment 3
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
Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use (≥2 L/min)
* Subjects will receive 200 mg (four 50 mg tablets) of GS-5806 or matching placebo at Day 5. 
IMP will be administered with water, after the subject has been fasting for a minimum of 2 hours 
(with exception of clear liquids and medications). The entire dose must be taken within 1 hour.  
Subjects will remain in a fasting condition for 1 hour post-dose. Tablets are not to be crushed, 
chewed, split, or dissolved, and should always be dispensed with gloves. Subjects will remain in 
the clinic for 30 minutes post-dose for observation.  If vomiting occurs within 30 minutes after 
IMP administration and undissolved tablets are present in the vomitus, the subject should receive 
another dose.  If another dose is administered, the subject should remain in the clinic for an 
additional 30 minutes post-dose for observation.  Subjects should avoid direct UV exposure for 
8 days after receiving IMP.
6.4.
Visit 5: Day 7 (± 24 hours)
Visit 5 assessments may be performed in the hospital, clinic, or at the subject’s home by the 
study coordinator or designee.  

Nasal samples (2 total, 1 from each nostril)
6.5.
Visits 6-8: Days 9, 13, and 17 (± 24 hours)
Visits 6-8 assessments must be performed in clinic or in hospital and should be performed in the 
following order and documented at these visits (also refer to Appendix 2, Study Procedures 
Table):

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

O2 saturation (on room air)

Weight

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include to include WBC with 
differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total 
bilirubin)  
PK sampling: pre-dose 
RSV viremia 

Nasal samples (2 total, 1 from each nostril)


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
Urine or serum pregnancy test (for women unable to confirm menopause, hysterectomy 
and/or bilateral oophorectomy)

IMP administration* 

Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use ( ≥2 L/min)
* Subjects will receive 200 mg (four 50 mg tablets) of GS-5806 or matching placebo at Days 9, 
13, and 17. All IMP will be administered with water, after the subject has been fasting for a 
minimum of 2 hours (with exception of clear liquids and medications). The entire dose must be 
taken within 1 hour.  Subjects will remain in a fasting condition for 1 hour post-dose. Tablets are 
not to be crushed, chewed, split, or dissolved, and should always be dispensed with gloves. 
Subjects will remain in the clinic for 30 minutes post-dose for observation.  If vomiting occurs 
within 30 minutes after IMP administration and undissolved tablets are present in the vomitus, 
the subject should receive another dose.  If another dose is administered, the subject should 
remain in the clinic for an additional 30 minutes post-dose for observation.  Subjects should 
avoid direct UV exposure for 8 days after receiving IMP.
6.6.
Visit 9: Day 22 (± 24 hours)
Visit 9 assessments must be performed in clinic or in hospital and should be performed in the 
following order and documented (also refer to Appendix 2, Study Procedures Table):

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

O2 saturation (on room air)

Weight

Blood draw for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include WBC with differential, Hgb, 
platelets, BUN, creatinine, serum albumin, AST, ALT, and total bilirubin)  
PK sampling
RSV viremia

Nasal samples (2 total, 1 from each nostril)

Obtain sample for local RSV testing* (refer to Section 6.11.8)


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• 
Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms ), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental 0 2 use ( ~ 2 Umin) 
6.7. 
Visit 10: End of Study/Day 28 (+ 3 days) 
Visit 10 assessments must be perf01med in clinic or in hospital. The visit will occur no earlier 
than Day 28 and no later than Day 31. Visit 10 assessments should be perf01med in the following 
order and documented (also refer to Appendix 2, Study Procedures Table): 
• 
Vital Signs (body temperature, heatt rate, respirat01y rate, and blood pressure) 
• 
0 2 saturation (on room air) 
• 
Weight 
• 
Blood draw for central laborat01y analysis: 
-
Safety Labs (hematology and sennn chemistiy to include WBC with differential, Hgb, 
platelets, BUN, creatinine, semm albumin, AST, ALT, and total bilimbin) 
-
Sennn antibody titer to RSV 
-
RSV viremia 
• 
Nasal samples (2 total, 1 from each nostril) 
• 
Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms ), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental 0 2 use ( ~ 2 Umin) 
6.8. 
Visits 11-14*: Day 35, 42, 49, and 56 (± 48 hours) 
Visits 11 - 14 assessments may be perfonned in the hospital, clinic, or at home. 
• 
Obtain nasal samples (2 total, 1 from each nosu·il) 
• 
Assessment of procedure-related AEs 
PD 
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6.9.
Assessments for Premature Discontinuation from IMP dosing and Early 
Withdrawal
Reasons for premature discontinuation from IMP dosing or the study are outlined in Section 3.5.  
6.9.1.
Assessments for Premature Discontinuation from IMP Administration
If a subject prematurely discontinues IMP dosing, the subject will remain on study and will
continue with all subsequent study visits and assessments through Visit 10, Day 28 (End of 
Study), with the exception of IMP administration.
6.9.2.
Assessments for Early Termination/Withdrawal
Every attempt should be made to keep subjects in the study and to perform the required 
study-related and follow-up procedures (see Sections 6.2 through 6.7). If this is not possible or 
acceptable to the subject or investigator, the subject may be withdrawn from the study. 
If a subject withdraws early from the study for any reason, every attempt should be made to 
bring the subject back to the clinic or hospital for the following early termination assessments:

Vital Signs (body temperature, heart rate, respiratory rate, and blood pressure)

O2 saturation (on room air)

Weight

Blood sample collection for central laboratory analysis:
Safety Labs (hematology and serum chemistry to include to include WBC with 
differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total 
bilirubin) (only if the subject withdraws prior to Visit 9 [Day 22])
Serum antibody titer to RSV
RSV viremia

Nasal samples (2 total, 1 from each nostril)

Review of AEs, concomitant medications, re-hospitalizations, ICU admissions or utilization 
of ICU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms), mechanical ventilation (invasive and non-invasive of any duration), and 
supplemental O2 use ( ≥ 2 L/min)
6.10.
Assessments for Unscheduled Visits
Assessments performed between scheduled study visits for hospitalized subjects do not have to 
be entered as an unscheduled visit.  If non-hospitalized subjects return to the hospital or clinic 


GS-5806 
Protocol GS-US-218-1502 
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Final 
Amendment3 
between scheduled study visits, an lmscheduled visit should be perf01m ed and recorded. The 
following procedmes will be perfonned and docmnented at these visits: 
• 
Vital signs, including 0 2 satmation (on room air) 
• 
Collection of nasal samples for analysis at the central lab 
• 
Assessment of AEs, concomitant medications, re-hospitalizations, ICU admissions or 
utilization ofiCU care, standard of care test results (ie, chest radiographs, microbiology, 
echocardiograms ), mechanical ventilation (invasive and non-invasive of any dmation), and 
supplemental 0 2 use ( ~ 2 Llmin) 
6.11. 
Study Assessments 
6.11.1. 
Nasal Samples, Virology, and Antibody Titer 
At Screening (Visit 1 ), all subjects should be RSV positive in both the upper ( eg, nasal swab, 
nasopharyngeal swab, nasal wash) and lower (eg, induced sputum, BAL, lung biopsy) respirat01y 
tract, as dete1mined by locallaborat01y test methods (eg, PCR, DFA, RVP assay, or cultme) 
:S6 days prior to Day 1. If the subject meets eligibility criteria based on results of tests completed 
as pmi of standard of cm·e, Visit 1 and 2 procedmes, including randomization and IMP 
administration, may occm on the same day provided the subject continues to satisfy all 
inclusion/ exclusion criteria. 
Nasal samples will be obtained at each study visit, with the exception of Screening (Visit 1 ), for 
analysis at the centrallaborat01y. Two samples will be collected at each time point, 1 from each 
naris. Nasal samples will be analyzed using RT-qPCR to detennine RSV viral load, RSV 
sequencing to evaluate develOJ.)lnent of resistance (see Section 6.11.2), and a multij.)lex assay to 
identi 
co-infections. PPD 
The procedme for collecting, storing and shipping induced sputum samples will be outlined in 
the Laborat01y Manual. 
Blood samples will be collected for RSV viremia evaluation (RT-qPCR) at Visits 2, 4, 6, 7, 8, 9, 
and 10 (Days 1, 5, 9, 13, 17, 22 and 28) prior to dosing, and RSV antibody titers at Visits 2 
and 10 (Days 1 and 28). Samples will be processed, stored and shipped to the central laborat01y 
as per instmctions outlined in the Laborat01y Manual. 
6.11.2. 
Virology and Resistance Monitoring 
To assess the potential for emergence of resistance to GS-5806, population sequencing of the 
RSV F gene will be conducted on evaluable nasal swab samples collected from GS-5806 and 
placebo-treated RSV -infected subjects according to the Resistance Analysis Plan. In addition, all 
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Final 
Amendment3 
Population sequencing of the RSV F gene will be conducted on evaluable nasal swab 
samples from all GS-5806-treated RSV-infected subjects in this group. Any mutation in the 
F gene identified by population sequencing in GS-5806-u·eated subjects relative to the 
preu·eatment baseline sequence will be characterized phenotypically following their inu·oduction 
into wild-type RSV using an established reverse genetics system. The susceptibility of the 
F mutant recombinants to GS-5806 will be assessed in cell-based antiviral susceptibility assays 
to detennine whether each u·eahnent-emergent mutation (TEM) confers reduced susceptibility to 
the compound. 
6.11.3. 
Vital Signs 
This assessment will include body temperature, heatt rate, respirat01y rate, and blood pressure. 
The subject is required to sit quietly for approximately 2 minutes prior to obtaining VS. Vital 
signs will be collected at all study visits perf01med in the hospital or clinic, with the exception of 
the optional extended viral monitoring visits. 
6.11.4. 
Oxygen Saturation 
02 saturation assessment will begin by first asking the subject to sit quietly for 1 minute. 
02 saturation will be recorded while breathing room air, even if the subject is dependent on 
0 2 supplementation. If the subject is receiving supplemental 0 2, the 0 2 source will be removed 
for a period of 30 seconds prior to this assessment. The 02 saturation will be documented in the 
source at regular intervals (approximately evety 15 seconds) during the 2-minute testing period. 
02 saturation evaluation will be considered complete when the 2-minute period has elapsed, or 
when the subject achieves a saturation of 87%, whichever is achieved first. The lowest 
0 2 saturation recorded over the 2-minute interval will be captured in the eCRF. 0 2 saturation will 
be collected at all study visits perf01med in the hospital or clinic. Subjects undergoing invasive 
mechanical ventilation will not have the oxygen removed and "< 87%" should be recorded in the 
source documentation and the reason should be documented. If it is detennined by the 
investigator that it is lmsafe to remove the subject's supplemental 02 for assessment of 
0 2 saturation (eg, subject is on high-flow mask), then this should be recorded in the source 
documentation as "< 87%" and the reason should be documented. 
6.11.5. 
Plasma PK 
PK blood sampling will be perf01med using the site's local procedures and analyzed at a cenu·al 
laborat01y. PK blood samples will be processed, placed in individual tubes, and stored/shipped 
to the centi·allaboratOiy as per instructions outlined in the Laborat01y Manual. PK samples will 
be obtained for all subjects at Visits 2, 4, 6, 7, 8 and 9. For hospitalized subjects, an additional 
PK sample will be obtained at Visit 3 (48 hours [±3 hours] post-first GS-5806 dose) as outlined 
in Table 6-1. Subjects who are not hospitalized Visit 3 will not retum to the hospital or clinic for 
this blood draw. These plasma PK samples may also be used to evaluate the plasma PK of 
co-administered agents (eg, ganciclovir, acyclovir). 
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Table 6-1. 
PK Timepoints 
Visit 2 
Visit 3 
Visit 4 
Visit 6 
Visit 7 
Visit 8 
Visit 9 
(Day 1) 
(Day 3) 
(Day 5) 
(Day 9) 
(Day 13) 
(Day 17) 
(Day 22) 
4hrs post-dose 
anytime 
pre-dose 
pre-dose 
pre-dose 
pre-dose 
anytime 
X (for 
PK samples 
X 
hospitalized 
X 
X 
X 
X 
X 
subjects only) 
6.11.6. 
Safety Labs 
When available, the most recent laborat01y values (obtained within 7 days prior to Screening 
[Visit 1]) may be used for eligibility assessment, with the exception of RSV results and 
pregnancy testing. If an existing laboratory value is not available for eligibility assessment, the 
test will be perf01med using the local laborat01y. All testing of samples obtained after the 
screening assessments will be perf01med at a centmllaborat01y selected by GSI. 
Testing of blood specimens will include WBC with differential, Hgb, platelets, BUN, creatinine, 
semm albumin, AST, ALT, and total bilimbin at Visits 2, 4, 6, 7, 8, 9, and 10 (Days 1, 5, 9, 13, 
17, 22, and 28). Blood samples will be collected pre-dose at all visits where IMP is 
administered. 
A blood specimen for senun creatinine will be collected 4 homs post-dose at Visit 2 (Day 1). 
For hospitalized subjects, blood specimens for senun creatinine will be collected on Days 2, 3, 
and 4 (24, 48, and 72 homs [±3 homs] post-first GS-5806 dose). Subjects who are not 
hospitalized dming this time will not retmn to the hospital or clinic for these blood draws. 
Urine or senun pregnancy tests will occm for all females of childbearing potential at Screening 
and at each dosing visit (Visits 2, 4, 6, 7, and 8) prior to adminisu·ation of IMP. 
6.11.7. 
Chest X-ray 
Results from chest X-rays and CT scans used for screening and eligibility, including the 
comparison chest radiograph, will be collected and stored elecu·onically for a possible cenu·al 
read. 
6.11.8. 
Optional Extended Viral Monitoring 
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7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse 
Events
7.1.1.
Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical study subject 
administered a medicinal product, which does not necessarily have a causal relationship with the
treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease 
temporally associated with the use of a medicinal product, whether or not considered related to 
the medicinal product. AEs may also include pre- or post-treatment complications that occur as a 
result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or 
occupational exposure. Preexisting events that increase in severity or change in nature during or 
as a consequence of participation in the clinical study will also be considered AEs.
An AE does not include the following:

Medical or surgical procedures such as surgery, endoscopy, tooth extraction, and transfusion.
The condition that led to the procedure may be an adverse event and must be reported.

Pre-existing diseases, conditions, or laboratory abnormalities present or detected before the 
screening visit that do not worsen

Situations where an untoward medical occurrence has not occurred (eg, hospitalization for 
elective surgery, social and/or convenience admissions)

Overdose without clinical sequelae 

Any medical condition or clinically significant laboratory abnormality with an onset date 
before the consent form is signed and not related to a protocol-associated procedure is not an 
AE. It is considered to be pre-existing and should be documented on the medical history 
CRF.
7.1.2.
Serious Adverse Events
A serious adverse event (SAE) is defined as an event that, at any dose, results in the following:

Death

Life-threatening (Note: The term “life-threatening” in the definition of “serious” refers to an 
event in which the subject was at risk of death at the time of the event; it does not refer to an 
event that hypothetically might have caused death if it were more severe.)

In-patient hospitalization or prolongation of existing hospitalization


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
Persistent or significant disability/incapacity

A congenital anomaly/birth defect

A medically important event or reaction: such events may not be immediately 
life-threatening or result in death or hospitalization but may jeopardize the subject or may 
require intervention to prevent one of the other outcomes constituting SAEs. Medical and 
scientific judgment must be exercised to determine whether such an event is a reportable 
under expedited reporting rules. Examples of medically important events include intensive 
treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or 
convulsions that do not result in hospitalization; and development of drug dependency or 
drug abuse. For the avoidance of doubt, infections resulting from contaminated medicinal 
product will be considered a medically important event and subject to expedited reporting 
requirements.
7.1.2.1.
Protocol-Specific Serious Adverse Event Instructions
Protocol-specific SAE reporting exemptions: In this study, death related to clinical progression
of underlying disease requiring HCT, or graft failure will not need to be reported as an SAE.
Death related to clinical progression of underlying disease requiring HCT, or graft failure should 
only be reported as SAEs on the eCRF, unless there is evidence suggesting a causal relationship 
between the IMP or study procedure and the event.  In that case, the investigator must 
immediately report the event as an SAE in accordance with the procedure in Section 7.3 below.  
Such clinical progression or graft failure which are assessed as not related to IMP/procedure) 
will be exempt from global expedited reporting requirements for the duration of the study.  The 
events will be collected and evaluated by Gilead and reported as appropriate in any relevant 
aggregate safety report, as well as the final clinical study report.
To minimize the possibility of exposing study subjects to unusual risk, the safety information 
from the study will also be reviewed by an independent DMC on an ongoing basis.   The DMC
may have access to partially blinded or unblinded data and will determine if it is safe to continue 
the study according to the protocol.
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities without clinical significance are not recorded as AEs or SAEs. 
However, laboratory abnormalities (eg, clinical chemistry, hematology, and urinalysis) that 
require medical or surgical intervention or lead to IMP interruption, modification, or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, electrocardiogram, X-rays, vital signs) that are 
associated with signs and/or symptoms must be recorded as an AE or SAE if they meet the 
definition of an AE or SAE as described in Sections 7.1.1 and 7.1.2. If the laboratory 
abnormality is part of a syndrome, record the syndrome or diagnosis (eg, anemia), not the 
laboratory result (ie, decreased hemoglobin).


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For specific information on handling of clinical laboratory abnormalities in this study, please 
refer to Section 7.5.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The investigator or a designated qualified subinvestigator is responsible for assessing AEs and 
SAEs for causality and severity, and for final review and confirmation of accuracy of event
information and assessments.
7.2.1.
Assessment of Causality for IMP and Procedures
The investigator or a designated qualified subinvestigator is responsible for assessing the 
relationship to IMP therapy using clinical judgment and the following considerations:

No: Evidence exists that the adverse event has an etiology other than the IMP. For SAEs, an 
alternative causality must be provided (eg, pre-existing condition, underlying disease, 
intercurrent illness, or concomitant medication).

Yes: There is reasonable possibility that the event may have been caused by the 
investigational medicinal product.
It should be emphasized that ineffective treatment should not be considered as causally related in 
the context of adverse event reporting. 
The relationship to study procedures (eg, invasive procedures such as venipuncture or biopsy) 
should be assessed using the following considerations:

No: Evidence exists that the adverse event has an etiology other than the study procedure.

Yes: The adverse event occurred as a result of protocol procedures (eg, venipuncture)
7.2.2.
Assessment of Severity
Severity should be recorded and graded according to the GSI Grading Scale for Severity of 
Adverse Events and Laboratory Abnormalities For AEs or SAEs associated with laboratory 
abnormalities, the event should be graded on the basis of the clinical severity in the context of 
the underlying conditions; this may or may not be in agreement with the grading of the 
laboratory abnormality.
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events 
and Serious Adverse Events to Gilead
Requirements for collection prior to IMP initiation:
After informed consent, but prior to initiation of study medication, the following types of events 
should be reported on the case report form (eCRF): all SAEs and adverse events related to 
protocol-mandated procedures.


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Adverse Events:
Following initiation of study medication, all AEs, regardless of cause or relationship, through the 
Day 28 End of Study visit must be reported to the eCRF database as instructed. All AEs should 
be followed up until resolution or until the adverse event is stable, if possible. Gilead Sciences 
may request that certain AEs be followed beyond the protocol defined follow up period, as 
determined by the Medical Monitor.
Serious Adverse Events:
All SAEs, regardless of cause or relationship, that occurs after the subject first consents to 
participate in the study (ie, signing the informed consent) and throughout the duration of the 
study, including the protocol-required post treatment follow-up period, must be reported to the 
eCRF database and Gilead Drug Safety and Public Health (DSPH) as instructed. This also 
includes any SAEs resulting from protocol-associated procedures performed after informed 
consent is signed.
Any SAEs and deaths that occur after the post treatment follow-up visit but within 30 days or 
4-weeks of the last dose of study IMP, regardless of causality, should also be reported. 
Investigators are not obligated to actively seek SAEs after the protocol defined follow up period
(the Day 28 End of Study visit), however, if the investigator learns of any SAEs that occur after 
study participation has concluded and the event is deemed relevant to the use of IMP, he/she 
should promptly document and report the event to Gilead DSPH.
During the optional extended viral monitoring period (through Day 56), AEs related to 
protocol-mandated procedures must be collected and reported to Gilead DSPH.
All AEs and SAEs will be recorded in the eCRF database within the timelines outlined in the 
eCRF completion guideline. 
Electronic Serious Adverse Event (eSAE) Reporting Process:

Site personnel record all SAE data in the eCRF database and from there transmit the SAE 
information to Gilead DSPH within 24 hours of the investigator’s knowledge of the event. 
Detailed instructions can be found in the eCRF completion guidelines.

If for any reason it is not possible to record the SAE information electronically (ie, the eCRF 
database is not functioning), record the SAE on the paper serious adverse event reporting 
form and submit within 24 hours to:
Gilead DSPH:
Fax:
+1-650-522-5477
E-mail:Safety_fc@gilead.com


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
As soon as it is possible to do so, any SAE reported via paper must be transcribed into the 
eCRF Database according to instructions in the eCRF completion guidelines.

If an SAE has been reported via a paper form because the eCRF database has been locked, no 
further action is necessary.

For fatal or life-threatening events, copies of hospital case reports, autopsy reports, and other 
documents are also to be submitted by e-mail or fax when requested and applicable. 
Transmission of such documents should occur without personal subject identification, 
maintaining the traceability of a document to the subject identifiers.

Additional information may be requested to ensure the timely completion of accurate safety 
reports.

Any medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the subject’s CRF/eCRF and the event description section of the SAE 
form.

Site personnel should record all SAE data in the eCRF database for those protocol-specific 
SAEs which are exempted from expedited reporting requirements (Section 7.1.2.1).  They 
should also transmit the SAE information to Gilead DSPH if the SAEs are assessed by the 
investigator as related to the IMP or study procedure.
7.4.
Gilead Reporting Requirements
Depending on relevant local legislation or regulations, including the applicable US FDA Code of 
Federal Regulations, the EU Clinical Trials Directive (2001/20/EC) and relevant updates, and 
other country-specific legislation or regulations, Gilead may be required to expedite to 
worldwide regulatory agencies reports of SAEs, serious adverse drug reactions (SADRs), or 
suspected unexpected serious adverse reactions (SUSARs). In accordance with the EU Clinical 
Trials Directive (2001/20/EC), Gilead or a specified designee will notify worldwide regulatory 
agencies and the relevant Independent Ethics Committee (IEC) in concerned Member States of 
applicable SUSARs as outlined in current regulations.
Assessment of expectedness for SAEs will be determined by Gilead using reference safety 
information specified in the current GS-5806 IB or relevant local label as applicable. 
All investigators will receive a safety letter notifying them of relevant SUSAR reports associated 
with any study IMP. The investigator should notify the IRB or IEC of SUSAR reports as soon as 
is practical, where this is required by local regulatory agencies, and in accordance with the local 
institutional policy. 


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7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities are usually not recorded as AEs or SAEs. However, laboratory 
abnormalities (eg, clinical chemistry, hematology) independent of the underlying medical 
condition that require medical or surgical intervention or lead to IMP interruption or 
discontinuation must be recorded as an AE, as well as an SAE, if applicable. In addition, 
laboratory or other abnormal assessments (eg, vital signs) that are associated with signs and/or 
symptoms must be recorded as an AE or SAE if they meet the definition of an AE or SAE, 
respectively, as described in Section 7.1. If the laboratory abnormality is part of a syndrome, 
record the syndrome or diagnosis (ie, anemia) not the laboratory result (ie, decreased 
hemoglobin).
Severity should be recorded and graded according to the GSI Grading Scale for Severity of 
Adverse Events and Laboratory Abnormalities Appendix 4. For AEs or SAEs associated with 
laboratory abnormalities, the event should be graded on the basis of the clinical severity in the 
context of the underlying conditions; this may or may not be in agreement with the grading of 
the laboratory abnormality.
7.6.
Toxicity Management 
All clinical and clinically significant laboratory toxicities will be managed according to uniform 
guidelines detailed in Appendix 3.
Any questions regarding toxicity management should be directed to the Gilead Sciences Medical
Monitor.
7.7.
Special Situations Reports
7.7.1.
Definitions of Special Situations
Special situation reports include all reports of medication error, abuse, misuse, overdose, reports 
of adverse events associated with product complaints, and pregnancy reports regardless of an 
associated AE.  
Medication error is any unintentional error in the prescribing, dispensing, or administration of a 
medicinal product while in the control of the health care provider, subject, or consumer.
Abuse is defined as persistent or sporadic intentional excessive use of a medicinal product by a 
subject.
Misuse is defined as any intentional and inappropriate use of a medicinal product that is not in 
accordance with the protocol instructions or the local prescribing information.
An overdose is defined as an accidental or intentional administration of a quantity of a medicinal 
product given per administration or cumulatively which is above the maximum recommended 
dose as per protocol or in the product labelling (as it applies to the daily dose of the subject in 


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question). In cases of a discrepancy in drug accountability, overdose will be established only 
when it is clear that the subject has taken the excess dose(s). Overdose cannot be established 
when the subject cannot account for the discrepancy except in cases in which the investigator has 
reason to suspect that the subject has taken the additional dose(s).
Product complaint is defined as complaints arising from potential deviations in the manufacture, 
packaging, or distribution of the medicinal product.  
7.7.2.
Instructions for Reporting Special Situations
7.7.2.1.
Instructions for Reporting Pregnancies
The investigator should report pregnancies in female study subjects that are identified after 
initiation of study medication and throughout the study, including the post IMP follow-up period, 
to Gilead DSPH using the pregnancy report form within 24 hours of becoming aware of the 
pregnancy.
Refer to Section 7.3 and the eCRF completion guidelines for full instructions on the mechanism 
of pregnancy reporting.
The pregnancy itself is not considered an AE nor is an induced elective abortion to terminate a 
pregnancy without medical reasons.
Any premature termination of pregnancy (eg, a spontaneous abortion, an induced therapeutic 
abortion due to complications or other medical reasons) must be reported within 24 hours as an 
SAE. The underlying medical reason for this procedure should be recorded as the AE term.
A spontaneous abortion is always considered to be an SAE and will be reported as described in 
Section 7.3. Furthermore, any SAE occurring as an adverse pregnancy outcome post study must 
be reported to Gilead DSPH.
The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. The outcome should be reported to Gilead DSPH using the pregnancy outcome report 
form. If the end of the pregnancy occurs after the study has been completed, the outcome should 
be reported directly to Gilead DSPH. Gilead DSPH contact information is provided in 
Section 7.3.
Pregnancies of female partners of male study subjects exposed to Gilead or other investigational 
agents must also be reported and relevant information should be submitted Gilead DSPH using 
the pregnancy and pregnancy outcome forms within 24 hours. Monitoring of the subject should 
continue until the conclusion of the pregnancy. If the end of the pregnancy occurs after the study 
has been completed, the outcome should be reported directly to Gilead DSPH.
Refer to Appendix 5 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Requirements.


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7.7.2.2.
Reporting Other Special Situations
All other special situation reports must be reported on the special situations report form and 
forwarded to Gilead DSPH within 24 hours of the investigator becoming aware of the situation. 
These reports must consist of situations that involve study IMP and/or Gilead concomitant 
medications, but do not apply to non-Gilead concomitant medications. 
Special situations involving non-Gilead concomitant medications does not need to be reported on 
the special situations report form; however, for special situations that result in AEs due to a 
non-Gilead concomitant medication, the AE should be reported in the eCRFs. 
Any inappropriate use of concomitant medications prohibited by this protocol should not be 
reported as “misuse,” but may be more appropriately documented as a protocol deviation.
Refer to Section 7.3 and the CRF/eCRF completion guidelines for full instructions on the 
mechanism of special situations reporting.
All clinical sequelae in relation to these special situation reports will be reported as AEs or SAEs 
at the same time using the AE CRF/eCRF and/or the SAE report form. Details of the symptoms 
and signs, clinical management, and outcome will be reported, when available.


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8. 
STATISTICAL CONSIDERATIONS 
8.1. 
Analysis Objectives and Endpoints 
8.1.1. 
Analysis Objectives 
The primary objective of this study is as follows: 
• To evaluate the effect of GS-5806 on RSV viral load in autologous or allogeneic HCT 
recipients with an acute RSV LRTI 
The secondary objectives of this study are as follows:  
• To evaluate the effect of GS-5806 on rates of respiratory failure and all-cause mortality 
• To evaluate the PK, safety and tolerability of GS-5806 
8.1.2. 
Primary Endpoint 
The primary endpoint is the time-weighted average change in nasal RSV viral load 
(log10 copies/mL) from Baseline (Day 1) to Day 9 as measured by RT-qPCR. The time-weighted 
average change in nasal RSV viral load from Baseline to Day 9 is defined as: 
∑
  {0.5 × (𝑌𝑖+ 𝑌𝑖+1) × (𝑡𝑖+1 −𝑡𝑖)} 
𝑏−1
𝑖=𝑎
(𝑡𝑏−𝑡𝑎)
 
where Yi is the change from Baseline in RSV log10 viral load at Visit i, t is the time at the 
specified timepoint, a is the Baseline assessment at Day 1 and b is the last assessment at or prior 
to Day 9. The time-weighted average change, often referred to as the DAVG, provides the 
average viral burden in change from baseline during the time period of interest. 
8.1.3. 
Secondary Endpoint 
Secondary endpoints are: 
• Proportion of subjects developing respiratory failure (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28 
• Proportion of all-cause mortality among subjects through Day 28 
8.1.4. 
Other Endpoints of Interest 
Other endpoints of interest are: 
• RSV log10 viral load and change from baseline in RSV log10 viral load in the nasal samples   
• Time-weighted average RSV log10 viral load and time-weighted average change from 
baseline in RSV log10 viral load in the nasal samples  


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
Proportion of subjects with detectable RSV in the nasal samples

Proportion of subjects requiring supplemental O2 (≥ 2 L/min) 

RSV log10 viral load and change from baseline in RSV log10 viral load in the blood 

Time-weighted average RSV log10 viral load and time-weighted average change from 
baseline in RSV log10 viral load in the blood

Proportion of subjects who have detectable RSV in the blood 

Proportion of subjects whose O2 saturation drops below 88% by Day 28

O2 saturation and change from baseline in O2 saturation

Time-weighted average O2 saturation and time-weighted average change from baseline in O2
saturation 

Proportion of subjects requiring ICU admission or equivalent ICU care (due to any cause) 
through Day 28 

Total number of ICU admissions or equivalent ICU care hours (for subjects receiving ICU 
care) through Day 28

Total number of mechanical ventilation (invasive or non-invasive) hours through Day 28

Duration of hospitalization through Day 28
8.2.
Analysis Conventions
8.2.1.
Analysis Sets
8.2.1.1.
Efficacy
The full analysis set (FAS) will include subjects who have an RSV log10 viral load greater than 
or equal to the LLOQ of the RT-qPCR assay in the pre-dose Day 1 nasal sample, as determined 
by RT-qPCR at the central lab, and have received at least 1 full dose of IMP.
8.2.1.2.
Safety
The primary analysis set for safety analyses is defined as all subjects who received at least a full 
dose of IMP.
All data collected during treatment will be included in the safety summaries.
8.2.1.3.
Pharmacokinetics 
The PK analysis set will include all subjects in the safety analysis set who have evaluable 
on-study PK measurements.


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8.3.
Data Handling Conventions
Missing data can have an impact upon the interpretation of the trial data. As this study is of short 
duration, it is anticipated that missing data will be minimal. In general, values for missing data 
will not be imputed. For laboratory data, a missing Baseline value will be replaced with a 
screening value, if available; otherwise it will be treated as normal (ie, Grade 0; no toxicity 
grade) for the summary of graded laboratory abnormalities. A retest value may be used if the 
first test is invalidated (eg, specimen hemolyzed).
Values will not be imputed for missing vital sign and other safety data; however, a missing 
Baseline value will be replaced with a Screening value, if available. 
Details for the handling of missing data due to subject discontinuation or other reasons, including 
unusable and spurious data, and rules for determining major and minor protocol deviations will 
be described in the SAP.
All available data for subjects that do not complete the study will be included in the data listings. 
Tables that include both individual subject PK data and summary statistics will present all 
available data, but only subjects in the PK analysis will be included in the summary statistics.
Viral load data will be log transformed prior to analyses.
8.4.
Demographic Data and Baseline Characteristics
Demographic and Baseline measurements will be summarized using standard descriptive 
methods.
Demographic summaries will include sex, race/ethnicity, randomization stratification group, and 
age.
Baseline data will include a summary of body weight, height, and BMI.
For categorical demographic and Baseline characteristics, a Fisher’s exact test will be used to 
compare treatment groups. For continuous demographic and Baseline characteristics, a Wilcoxon 
rank sum test will be used to compare treatment groups.
8.5.
Efficacy Analysis
8.5.1.
Primary Analysis
The primary endpoint is the time-weighted average change in nasal RSV viral load
(log10 copies/mL) from Day 1 to Day 9. The primary analysis will be performed on subjects 
included in the FAS population. To test the null hypothesis that there is no difference between 
the GS-5806 and placebo treatment groups in the time-weighted average change in viral load, a 
parametric analysis of covariance (ANCOVA) model with corresponding Baseline viral load as a 
covariate will be used, with a 2-sided 0.05 level. Adjusted means and 95% confidence intervals 
(CIs) will also be presented. 


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Secondary Analyses 
Final 
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The F AS will be used for all summaries and analyses of secondmy endpoints. All secondaiy 
endpoints will be analyzed using 2-sided tests to compare treatment differences. 
The proportion of subjects who develop respirat01y failure requiring mechanical ventilation and 
the proportion of subjects with all-cause mortality will be analyzed using Fisher's exact tests. 
In order to accmmt for multiple hypothesis testing of endpoints, a fainily alpha spending mle will 
be used to control the Type 1 en or rate of 0.05 across the primmy and secondaiy endpoints, 
testing for differences between u·eatment groups. The primmy endpoint analysis will serve as 
the gatekeeper for the seconda1y analyses. If the primmy null hypothesis is rejected, then the 
following secondmy endpoints will be tested sequentially at a = 0.05 based upon the closed 
testing procedure { 11631}. 
• 
Prop01tion of subjects developing respirat01y failure (of any cause) requiring mechanical 
ventilation (invasive or noninvasive) through Day 28 
• 
Proportion of all-cause m01tality among all subjects through Day 28 
8.5.3. 
Exploratory Analyses 
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Safety Analysis 
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All safety data collected on or after the date that IMP was first dispensed up to the date of last 
dose of IMP through Day 28 will be summarized by u·eatment group (according to the IMP 
received). Data for the preu·eatment and u·eahnent-free follow-up periods will be included in data 
listings only. Data for the u·eatment period will be summarized by u·eahnent (active or placebo) 
using the number of subjects (n and percent) with events/abnonnalities for categorical data and 
using descriptive statistics for continuous data. 
8.7. 
Extent of Exposure 
A subject's extent of exposure to IMP data will be generated from the IMP adminisu·ation data. 
Exposure data will be summarized by u·eahnent group. 
8.7.1. 
Adverse Events 
Clinical and laborat01y adverse events will be coded using the Medical Dictiomuy for 
Regulat01y Activities (MedDRA). System Organ Class (SOC), High-Level Group Te1m 
(HLGT), High-Level Te1m (HLT), Prefen ed Te1m (PT), and Lower-Level Te1m (LLT) will be 
attached to the clinical database. 
Events will be summarized on the basis of the date of onset for the event. A u·eatment-emergent 
adverse event will be defined as any adverse event that begins on or after the date of first dose of 
IMP up to the date oflast dose of IMP tluough Day 28. 
Summaries (number and percentage of subjects) ofu·eatment-emergent adverse events (by SOC, 
and PT) will be provided by u·eahnent group. 
8.7.2. 
Laboratory Evaluations 
Selected laborat01y data will be summarized using only observed data. Data and change from 
Baseline at all scheduled time points will be summarized. 
Graded laborat01y abn01malities will be defmed using the grading scheme in Appendix 4. 
Grading of laborat01y abn01malities for analysis purposes will be perfonned by GSI. 
fucidence ofu·eatment-emergent laborat01y abnonnalities, defined as values that increase at least 
1 toxicity grade from Baseline at any time post Baseline up to and including Day 28 will be 
summarized by u·eatment group. If Baseline data are missing, then any graded abn01mality 
(ie, at least a Grade 1) will be considered u·eahnent emergent. 
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Laboratory abnormalities that occur before the first dose of IMP or after the subject has been 
discontinued from treatment for at least 28 days will be included in a data listing.
8.7.3.
Other Safety Evaluations
Vital signs data will be summarized using descriptive statistics by the observed data and by the 
change from Baseline at each time point.
8.8.
Pharmacokinetic Analysis
Individual subject GS-5806 concentration-time data will be displayed using scheduled sampling 
times. Descriptive statistics (eg, n, mean, standard deviation, %CV, median, and range) will be 
calculated for each sampling time. PK/PD relationship may be explored as appropriate.
8.9.
Sample Size
Sample size calculations are based on results observed in a study that evaluated the efficacy of 
oral and aerosolized ribavirin treatment for preventing progression from upper to lower 
respiratory tract infection in hematopoietic cell transplant recipients with RSV infections
(unpublished data from Dr. 
).  The sample size calculation assumes the 
time-weighted average change in RSV log10 viral load from Day 1 to Day 9 in the placebo group 
will be -1.5 log10 copies/mL with a corresponding standard deviation (SD) of 1.75 and that 85% 
of the subjects will be evaluable.  Based on these assumptions, with 25 subjects per group there 
is approximately 85% power to detect a 1.5 log difference in time-weighted average change in 
log10 viral load between treatment groups using a 2-sided 0.05-level test.  Given an evaluable 
rate of 85%, a total of 60 subjects will need to be randomized into the study.
8.10.
Data Monitoring Committee
An external multidisciplinary data monitoring committee (DMC) will review the progress of the 
study and perform interim reviews of safety  data as specified in the DMC charter, and provide 
recommendation to Gilead whether the nature, frequency, and severity of adverse effects 
associated with study treatment warrant the early termination of the study in the best interests of 
the participants, whether the study should continue as planned, or the study should continue with 
modifications.   
The DMC’s specific activities will be defined by a mutually agreed charter, which will define the 
DMC’s membership, conduct and meeting schedule.
While the DMC will be asked to advise Gilead regarding future conduct of the study, including 
possible early study termination, Gilead retains final decision-making authority on all aspects of 
the study.
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9.
RESPONSIBILITIES
9.1.
Investigator Responsibilities
9.1.1.
Good Clinical Practice
The investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and 
South Africa), International Conference on Harmonisation (ICH) guidelines, or with the laws and 
regulations of the country in which the research is conducted, whichever affords the greater 
protection to the study subject. These standards are consistent with the European Union Clinical 
Trials Directive 2001/20/EC and Good Clinical Practice Directive 2005/28/EC.
The investigator will ensure adherence to the basic principles of Good Clinical Practice, as 
outlined in 21 CFR 312, subpart D, “Responsibilities of Sponsors and Investigators,” 21 CFR, 
part 50, 1998, and 21 CFR, part 56, 1998.
The investigator and all applicable subinvestigators will comply with 21 CFR, Part 54, 1998, 
providing documentation of their financial interest or arrangements with Gilead, or proprietary 
interests in the investigational drug under study. This documentation must be provided prior to 
the investigator’s (and any subinvestigator’s) participation in the study. The investigator and 
subinvestigator agree to notify Gilead of any change in reportable interests during the study and 
for 1 year following completion of the study. Study completion is defined as the date when the 
last subject completes the protocol-defined activities.
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval
The investigator (or sponsor as appropriate according to local regulations) will submit this 
protocol, informed consent form, and any accompanying material to be provided to the subject 
(such as advertisements, subject information sheets, or descriptions of the study used to obtain 
informed consent) to an IRB/IEC, depending on region. The investigator will not begin any study 
subject activities until approval from the IRB/IEC has been documented and provided as a letter 
to the investigator.
Before implementation, the investigator will submit to and receive documented approval from 
the IRB/IEC for any modifications made to the protocol or any accompanying material to be 
provided to the subject after initial approval, with the exception of those necessary to reduce 
immediate risk to study subjects.
9.1.3.
Informed Consent
The investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and 
potential hazards of the study and before undertaking any study-related procedures. The 


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investigator must use the most current IRB or IEC-approved consent form for documenting 
written informed consent. Each informed consent (or assent as applicable) will be appropriately 
signed and dated by the subject or the subject’s legally authorized representative and the person 
conducting the consent discussion, and also by an impartial witness if required by IRB/IEC or
local requirements.
9.1.4.
Confidentiality
The investigator must assure that subjects’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only subject initials, date of birth, another 
unique identifier (as allowed by local law) and an identification code will be recorded on any 
form or biological sample submitted to the Sponsor, IRB/IEC, or laboratory. Laboratory 
specimens must be labeled in such a manner as to protect subject identity while allowing the 
results to be recorded to the proper subject. Refer to specific laboratory instructions.  NOTE: The 
investigator must keep a screening log showing codes, names, and addresses for all subjects 
screened and for all subjects enrolled in the trial. Subject data will be processed in accordance 
with all applicable regulations.
The investigator agrees that all information received from Gilead, including but not limited to the 
investigator brochure, this protocol, CRF/eCRF, the IMP, and any other study information, 
remain the sole and exclusive property of Gilead during the conduct of the study and thereafter. 
This information is not to be disclosed to any third party (except employees or agents directly 
involved in the conduct of the study or as required by law) without prior written consent from 
Gilead. The investigator further agrees to take all reasonable precautions to prevent the 
disclosure by any employee or agent of the study site to any third party or otherwise into the 
public domain.
9.1.5.
Study Files and Retention of Records
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following two categories: (1) investigator’s study file, and 
(2) subject clinical source documents.
The investigator’s study file will contain the protocol/amendments, CRF and query forms,
IRB/IEC and governmental approval with correspondence, informed consent, drug records, staff 
curriculum vitae and authorization forms, and other appropriate documents and correspondence.
The required source data should include sequential notes containing at least the following 
information for each subject:

Subject identification (name, date of birth, gender);

Documentation that subject meets eligibility criteria, ie, history, physical examination, and 
confirmation of diagnosis (to support inclusion and exclusion criteria);


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
Documentation of the reason(s) a consented subject is not enrolled

Participation in study (including study number);

Study discussed and date of informed consent;

Dates of all visits;

Documentation that protocol specific procedures were performed;

Results of efficacy parameters, as required by the protocol;

Start and end date (including dose regimen) of IMP, including dates of dispensing and return;

Record of all adverse events and other safety parameters (start and end date, and including 
causality and severity);

Concomitant medication (including start and end date, dose if relevant; dose changes);

Date of study completion and reason for early discontinuation, if it occurs.
All clinical study documents must be retained by the investigator until at least 2 years or 
according to local laws, whichever is longer, after the last approval of a marketing application in 
an ICH region (ie, United States, Europe, or Japan) and until there are no pending or planned 
marketing applications in an ICH region; or, if no application is filed or if the application is not 
approved for such indication, until 2 years after the investigation is discontinued and regulatory 
authorities have been notified. Investigators may be required to retain documents longer if 
specified by regulatory requirements, by local regulations, or by an agreement with Gilead. The 
investigator must notify Gilead before destroying any clinical study records.
Should the investigator wish to assign the study records to another party or move them to another 
location, Gilead must be notified in advance.
If the investigator cannot provide for this archiving requirement at the study site for any or all of 
the documents, special arrangements must be made between the investigator and Gilead to store 
these records securely away from the site so that they can be returned sealed to the investigator 
in case of an inspection. When source documents are required for the continued care of the 
subject, appropriate copies should be made for storage away from the site.
9.1.6.
Case Report Forms
For each subject consented, an eCRF will be completed by an authorized study staff member 
whose training for this function is documented according to study procedures. eCRF should be 
completed on the day of the subject visit to enable the sponsor to perform central monitoring of 
safety data.  Subsequent to data entry, a study monitor will perform source data verification 
within the EDC system. Original entries as well as any changes to data fields will be stored in 


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the audit trail of the system.  Prior to database lock (or any interim time points as described in the 
clinical data management plan), the investigator will use his/her log in credentials to confirm that 
the forms have been reviewed, and that the entries accurately reflect the information in the 
source documents. The eCRF capture the data required per the protocol schedule of events and 
procedures. System-generated or manual queries will be issued to the investigative site staff as
data discrepancies are identified by the monitor or internal Gilead staff, who routinely review the 
data for completeness, correctness, and consistency. The site coordinator is responsible for 
responding to the queries in a timely manner, within the system, either by confirming the data as 
correct or updating the original entry, and providing the reason for the update (eg, data entry 
error). At the conclusion of the trial, Gilead will provide the site with a read-only archive copy 
of the data entered by that site. This archive must be stored in accordance with the records 
retention requirements outlined in Section 9.1.5.
9.1.7.
Data Quality Control and Quality Assurance
To insure accurate, complete, and reliable data, the Sponsor or its representatives will do the 
following:

Provide instructional material to the study sites, as appropriate.

Instruct the investigators and study personnel on the protocol, the completion of the CRFs, 
and study procedures.

Make periodic visits to the study site.

Be available to consultation and stay in contact with the study site personnel by mail, email, 
telephone, and/or fax.

Monitor the subject data recorded in the CRFs against source documents at the study site.

Review and evaluate CRF data and use standard computer edits to detect errors in data 
collection.
9.1.8.
Investigational Medicinal Product Accountability and Return
Gilead recommends that used and unused IMP supplies be destroyed on site if possible.  The 
study monitor will evaluate each study center’s IMP disposal procedures and provide appropriate 
instruction for destruction of unused IMP supplies. If the site has an appropriate standard 
operating procedure (SOP) for drug destruction as determined by Gilead QA, the site may 
destroy used (empty or partially empty) and unused IMP supplies in accordance with that site’s 
approved SOP. A copy of the site’s approved SOP will be obtained for central files. If IMP 
cannot be destroyed on site, the study monitor will provide instructions for return to Gilead or
the shipping facility from which it came for eventual destruction.


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Amendment 3
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If IMP is destroyed on site, the investigator must maintain accurate records for all IMP
destroyed. Records must show the identification and quantity of each unit destroyed, the method 
of destruction, and the person who disposed of the IMP. Upon study completion, copies of the 
IMP accountability records must be filed at the site. Another copy will be returned to Gilead.
The study monitor will review IMP supplies and associated records at periodic intervals.
9.1.9.
Inspections
The investigator will make available all source documents and other records for this trial to 
Gilead’s appointed study monitors, to IRB/IECs, or to regulatory authority or health authority 
inspectors.
9.1.10.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.
9.2.
Sponsor Responsibilities
9.2.1.
Protocol Modifications
Protocol modifications, except those intended to reduce immediate risk to study subjects, may be 
made only by Gilead. The investigator must submit all protocol modifications to the IRB/IEC in 
accordance with local requirements and receive documented IRB/IEC approval before 
modifications can be implemented.
9.2.2.
Study Report and Publications
A clinical study report (CSR) will be prepared and provided to the applicable regulatory 
agencies. Gilead will ensure that the report meets the standards set out in the ICH Guideline for 
Structure and Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may 
be prepared in certain cases.
Investigators in this study may communicate, orally present, or publish in scientific journals or 
other scholarly media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent 
of Gilead in an abstract, manuscript, or presentation form or the study has been completed at 
all study sites for at least 2 years.

The investigator will submit to Gilead any proposed publication or presentation along with 
the respective scientific journal or presentation forum at least 30 days before submission of 
the publication or presentation. 


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
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21 October 2014

No such communication, presentation, or publication will include Gilead’s confidential 
information (see Section 9.1.4).

The investigator will comply with Gilead’s request to delete references to its confidential 
information (other than the study results) in any paper or presentation and agrees to withhold 
publication or presentation for an additional 60 days in order to obtain patent protection if 
deemed necessary.
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol (eg, attendance at Investigator's Meetings).  If required under the applicable statutory 
and regulatory requirements, Gilead will capture and disclose to Federal and State agencies any 
expenses paid or reimbursed for such services, including any clinical trial payments, meal, travel 
expenses or reimbursements, consulting fees, and any other transfer of value.
9.3.2.
Access to Information for Monitoring
In accordance with regulations and guidelines, the study monitor must have direct access to the 
investigator’s source documentation in order to verify the accuracy of the data recorded in the 
CRF/eCRF.
The monitor is responsible for routine review of the CRF/eCRF at regular intervals throughout 
the study to verify adherence to the protocol and the completeness, consistency, and accuracy of 
the data being entered on them. The monitor should have access to any subject records needed to 
verify the entries on the CRF/eCRF. The investigator agrees to cooperate with the monitor to 
ensure that any problems detected through any type of monitoring (central, on site) are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or of Gilead may conduct inspections or audits of the 
clinical study. If the investigator is notified of an inspection by a regulatory authority the 
investigator agrees to notify the Gilead medical monitor immediately. The investigator agrees to 
provide to representatives of a regulatory agency or Gilead access to records, facilities, and 
personnel for the effective conduct of any inspection or audit.
9.3.4.
Study Discontinuation
Both the sponsor and the investigator reserve the right to terminate the study at any time. Should 
this be necessary, both parties will arrange discontinuation procedures and notify the appropriate 
regulatory authority(ies), IRBs, and IECs. In terminating the study, Gilead and the investigator 
will assure that adequate consideration is given to the protection of the subjects’ interests.


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 73
21 October 2014
10.
REFERENCES
11631
Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials 
that do not require all primary effects to be significant. Statist Med 2003;22 
(15):2387-400.
19902
American Academy of Pediatrics Committee on Infectious Diseases: Use of 
ribavirin in the treatment of respiratory syncytial virus infection. Pediatrics 
1993;92 (3):501-4.
20222
Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ, et al. 
Global burden of acute lower respiratory infections due to respiratory syncytial 
virus in young children: a systematic review and meta-analysis. Lancet 2010;375 
(9725):1545-55.
20227
Stockman LJ, Curns AT, Anderson LJ, Fischer-Langley G. Respiratory Syncytial 
Virus-associated Hospitalizations Among Infants and Young Children in the 
United States, 1997-2006. Pediatr Infect Dis J 2012;31 (1):5-9.
20233
Nichols WG, Gooley T, Boeckh M. Community-acquired respiratory syncytial 
virus and parainfluenza virus infections after hematopoietic stem cell 
transplantation: the Fred Hutchinson Cancer Research Center experience. Biol 
Blood Marrow Transplant 2001;7 Suppl:11S-5S.
26908
Shah JN, Chemaly RF. Management of RSV infections in adult recipients of 
hematopoietic stem cell transplantation. Blood 2011;117 (10):2755-63.
26937
Shah DP, Ghantoji SS, Shah JN, El Taoum KK, Jiang Y, Popat U, et al. Impact of 
aerosolized ribavirin on mortality in 280 allogeneic haematopoietic stem cell 
transplant recipients with respiratory syncytial virus infections. J Antimicrob 
Chemother 2013;68 (8):1872-80.
28640
Boeckh M, Englund J, Li Y, Miller C, Cross A, Fernandez H, et al. Randomized 
controlled multicenter trial of aerosolized ribavirin for respiratory syncytial virus 
upper respiratory tract infection in hematopoietic cell transplant recipients. Clin 
Infect Dis 2007;44 (2):245-9.
28641
Chemaly RF, Ghosh S, Bodey GP, Rohatgi N, Safdar A, Keating MJ, et al. 
Respiratory viral infections in adults with hematologic malignancies and human 
stem cell transplantation recipients: a retrospective study at a major cancer center. 
Medicine (Baltimore) 2006;85 (5):278-87.
28643
Erard V, Chien JW, Kim HW, Nichols WG, Flowers ME, Martin PJ, et al. 
Airflow decline after myeloablative allogeneic hematopoietic cell transplantation: 
the role of community respiratory viruses. J Infect Dis 2006;193 (12):1619-25.


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 74
21 October 2014
28644
Harrington RD, Hooton TM, Hackman RC, Storch GA, Osborne B, Gleaves CA, 
et al. An outbreak of respiratory syncytial virus in a bone marrow transplant 
center. J Infect Dis 1992;165 (6):987-93.
28645
Khanna N, Widmer AF, Decker M, Steffen I, Halter J, Heim D, et al. Respiratory 
syncytial virus infection in patients with hematological diseases: single-center 
study and review of the literature. Clin Infect Dis 2008;46 (3):402-12.
28646
Avetisyan G, Mattsson J, Sparrelid E, Ljungman P. Respiratory syncytial virus 
infection in recipients of allogeneic stem-cell transplantation: a retrospective 
study of the incidence, clinical features, and outcome. Transplantation 2009;88 
(10):1222-6.
28647
Kim YJ, Boeckh M, Englund JA. Community respiratory virus infections in 
immunocompromised patients: hematopoietic stem cell and solid organ transplant 
recipients, and individuals with human immunodeficiency virus infection. 
Seminars in respiratory and critical care medicine 2007;28 (2):222-42.
28648
Kim YJ, Guthrie KA, Waghmare A, Walsh EE, Falsey AR, Kuypers J, et al. 
Respiratory syncytial virus in hematopoietic cell transplant recipients: factors 
determining progression to lower respiratory tract disease. J Infect Dis 2014:1-10.
28650
Martino R, Porras RP, Rabella N, Williams JV, Ramila E, Margall N, et al. 
Prospective study of the incidence, clinical features, and outcome of symptomatic 
upper and lower respiratory tract infections by respiratory viruses in adult 
recipients of hematopoietic stem cell transplants for hematologic malignancies. 
Biol Blood Marrow Transplant 2005;11 (10):781-96.
28652
Raboni SM, Nogueira MB, Tsuchiya LR, Takahashi GA, Pereira LA, Pasquini R, 
et al. Respiratory tract viral infections in bone marrow transplant patients. 
Transplantation 2003;76 (1):142-6.
28653
Schiffer JT, Kirby K, Sandmaier B, Storb R, Corey L, Boeckh M. Timing and 
severity of community acquired respiratory virus infections after myeloablative 
versus non-myeloablative hematopoietic stem cell transplantation. Haematologica 
2009;94 (8):1101-8.
28654
Seo S, Campbell AP, Xie H, Chien JW, Leisenring WM, Englund JA, et al. 
Outcome of respiratory syncytial virus lower respiratory tract disease in 
hematopoietic cell transplant recipients receiving aerosolized ribavirin: 
significance of stem cell source and oxygen requirement. Biol Blood Marrow 
Transplant 2013;19 (4):589-96.
28655
Shah DP, Ghantoji SS, Mulanovich VE, Ariza-Heredia EJ, Chemaly RF. 
Management of respiratory viral infections in hematopoietic cell transplant 
recipients. American journal of blood research 2012;2 (4):203-18.


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
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21 October 2014
28656
Small TN, Casson A, Malak SF, Boulad F, Kiehn TE, Stiles J, et al. Respiratory 
syncytial virus infection following hematopoietic stem cell transplantation. Bone 
Marrow Transplant 2002;29 (4):321-7.
28657
Whimbey E, Champlin RE, Couch RB, Englund JA, Goodrich JM, Raad I, et al. 
Community respiratory virus infections among hospitalized adult bone marrow 
transplant recipients. Clin Infect Dis 1996;22 (5):778-82.
28723
Hirsch HH, Martino R, Ward KN, Boeckh M, Einsele H, Ljungman P. Fourth 
European Conference on Infections in Leukaemia (ECIL-4): guidelines for 
diagnosis and treatment of human respiratory syncytial virus, parainfluenza virus, 
metapneumovirus, rhinovirus, and coronavirus. Clin Infect Dis 2013;56 (2):258-
66.
28724
Ghosh S, Champlin RE, Englund J, Giralt SA, Rolston K, Raad I, et al. 
Respiratory syncytial virus upper respiratory tract illnesses in adult blood and 
marrow transplant recipients: combination therapy with aerosolized ribavirin and 
intravenous immunoglobulin. Bone Marrow Transplant 2000;25 (7):751-5.
28725
Whimbey E, Couch RB, Englund JA, Andreeff M, Goodrich JM, Raad, II, et al. 
Respiratory syncytial virus pneumonia in hospitalized adult patients with 
leukemia. Clin Infect Dis 1995;21 (2):376-9.


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 76
21 October 2014
11.
APPENDICES
Appendix 1.
Investigator Signature Page
Appendix 2.
Study Procedures Table
Appendix 3.
Management of Clinical and Laboratory Adverse Events
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements


GS-5806 
Protocol GS-US-2 18-1502 
Final 
Gilead Sciences, Inc. 
Amendment 3 
Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC 
199 E BLAINE ST 
SEATTLE, WA 98102 
STUDY ACKNOWLEDGEMENT 
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study 
Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in 
Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) 
Infection of the Lower Respiratory Tract 
GS-US-218-1502, Protocol Amendment 3, 21 October 2014 
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval. 
arne (Printed) 
Author 
Date 
PPD 
----1 
Signature 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. 1 will conduct this study as 
outlined herein and will make a reasonable effort to complete the study within the time 
designated. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Gilead Sciences, Inc. I will discuss this material with them to ensure 
that they are fully informed about the drugs and the study. 
Principal Investigator Name (Printed) 
Signature 
Date 
Site Number 
CONFIDENTIAL 
Page 77 
21 October 2014 


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 78
21 October 2014
Appendix 2.
Study Procedures Table
Visit 1: 
Screening
(Day -2 to 
-1)
Visit 2: Baseline 
Assessments,
Randomization, 
and Treatment 
Assessments
(Day 1)
Visit 
3: Day 
3
(±24 
hours)
Visit 
4: Day 
5
(±24 
hours)
Visit 
5: Day
7
(±24 
hours)
Visit 
6: Day 
9
(±24 
hours)
Visit 
7: Day 
13
(±24 
hours)
Visit 
8: Day 
17
(±24 
hours)
Visit 
9:
Day 
22
(±24 
hours)
Visit 10:
End of 
study/Day 
28
(+3 days)
Optional Extended Viral 
Monitoringl
Visit 
11:
Day 
35
(±48
hours)
Visit 
12:
Day 
42
(±48
hours)
Visit 
13:
Day 
49
(±48
hours)
Visit 
14:
Day 
56
(±48 
hours)
Must complete 
visit in the hospital 
or clinic
X
X
X
X
X
X
X
X
Written Informed 
Consent
X
Medical History
and Demographics
X
Chest X-ray
Xa
Screening Labs
Xb
Urine or Serum 
Pregnancy Testc
X
X
X
X
X
X
Vital Signs (inc. 
O2 Saturation d)
X
X
X
X
X
X
X
X
Height
X
Weight
X
X
X
X
X
X
X
X
Safety Labs e
X
X
X
X
X
X
X
RSV antibody titer
X
X


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 79
21 October 2014
Visit 1: 
Screening
(Day -2 to 
-1)
Visit 2: Baseline 
Assessments,
Randomization, 
and Treatment 
Assessments
(Day 1)
Visit 
3: Day 
3
(±24 
hours)
Visit 
4: Day 
5
(±24 
hours)
Visit 
5: Day
7
(±24 
hours)
Visit 
6: Day 
9
(±24 
hours)
Visit 
7: Day 
13
(±24 
hours)
Visit 
8: Day 
17
(±24 
hours)
Visit 
9:
Day 
22
(±24 
hours)
Visit 10:
End of 
study/Day 
28
(+3 days)
Optional Extended Viral 
Monitoringl
Visit 
11:
Day 
35
(±48
hours)
Visit 
12:
Day 
42
(±48
hours)
Visit 
13:
Day 
49
(±48
hours)
Visit 
14:
Day 
56
(±48 
hours)
RSV Viremia
X
X
X
X
X
X
X
Nasal Samples f
X
X
X
X
X
X
X
X
X
X
X
X
X
Local RSV 
Testing
Xk
Induced Sputum g
X
Randomization
X
IMP
Administration
X
X
X
X
X
PK Sample
Xh
Xj
Xh
Xh
Xh
Xh
Xh
Serum creatinine
Xi
Xi
Adverse Events
X
X
X
X
X
X
X
X
Xm
Xm
Xm
Xm
ICU admissions, 
re-hospitalizations,  
standard of care 
test results, 
mechanical 
ventilation, and 
supplemental O2
X
X
X
X
X
X
Concomitant 
Medications
X
X
X
X
X
X
X
X


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 80
21 October 2014
a
Chest X-ray obtained < 48 hours prior to Screening may be used
b
Existing values collected ≤ 6 days prior to Screening may be used
c
Required for women unable to confirm menopause, hysterectomy and/or bilateral oophorectomy
d
On room air
e
Hematology and serum chemistry to include WBC with differential, Hgb, platelets, BUN, creatinine, serum albumin, AST, ALT, and total bilirubin
f
2 samples total, 1 from each nostril – collected prior to dosing on dosing days
g
Collected pre-dose if induced sputum was not used to demonstrate the presence of RSV in the lower respiratory tract ≤6 days prior to Day 1
h
PK samples collected for all subjects 4 hours post-dose Day 1; pre-dose on Days 5, 9, 13, and 17; and anytime on Day 22
i
For hospitalized subjects only: blood will be drawn for serum creatinine at 4 hours post-dose at Visit 2 (Day 1) and on Days 2, 3 and 4 (24, 48 and 72 hours [±3hours]
post-first GS-5806 dose if they remain hospitalized at those times. 
j
For hospitalized subjects only: PK sample collected at Visit 3 (48 hours [±3 hours] post-first GS-5806 dose)
k
Only for subjects who agree to the Optional Extended Viral Monitoring at the time of consent
l
Only for subjects who agree to the Optional Extended Viral Monitoring at the time of consent and test positive (or inconclusive) for RSV at Visit 9 (Day 22)
m
Assessment of procedure-related AEs only


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 81
21 October 2014
Appendix 3.
Management of Clinical and Laboratory Adverse Events
Grade 1
Grade 4
Grade 3
Grade 2
May continue 
dosing at the 
discretion of the 
investigator
Repeat lab to 
confirm toxicity 
grade
Repeat lab to 
confirm toxicity 
grade
If confirmed and possibly and/or probably related to 
investigational medicinal products:
1.
Withhold investigational medicinal products until Grade 2
2.
Restart all investigational medicinal products at full dose
If confirmed and unrelated to 
investigational medicinal products, 
dosing may continue at the 
discretion of the investigator
If confirmed and 
possibly or probably 
related to 
investigational 
medicinal products, 
discontinue 
investigational 
medicinal products
dosing permanently 
and follow at periodic 
intervals at least 
weekly until a return 
to Baseline or is 
otherwise explained
If Grade 3 or 4 recurrence that is confirmed and possibly or 
probably related to investigational medicinal products, discontinue 
all investigational medicinal products dosing permanently
If Grade 3 or 4 recurrence that is considered unrelated to 
investigational medicinal products, continue all investigational 
medicinal products at the same dose at the discretion of the 
investigator


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 82
21 October 2014
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
Version: 18Junel2012
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Hemoglobin
HIV POSITIVE
Adult and Pediatric 57 Days
8.5 to 10.0 g/dL 
85 to 100 g/L
7.5 to 8.5 g/dL 
75 to 85 g/L
6.5 to 7.5 g/dL 
65 to 75 g/L
6.5 g/dL
65 g/L
HIV NEGATIVE
Adult and Pediatric 57 Days 
10.0 to 10.9 g/dL
100 to 109 g/L
OR
Any decrease from Baseline
2.5 to 3.5 g/dL
25 to 35 g/L
9.0 to 10.0 g/dL
90 to 100 g/L
OR
Any decrease from Baseline
3.5 to 4.5 g/dL
35 to 45 g/L
7.0 to 9.0 g/dL
70 to 90 g/L
OR
Any decrease from Baseline
4.5 g/dL
45 g/L
7.0 g/dL
70 g/L
Infant, 36–56 Days
(HIV POSITIVE OR
NEGATIVE)
8.5 to 9.4 g/dL
85 to 94 g/L
7.0 to 8.5 g/dL
70 to 85 g/L
6.0 to 7.0 g/dL
60 to < 70 g/L
6.0 g/dL
< 60 g/L
Infant, 22–35 Days
(HIV POSITIVE OR
NEGATIVE)
9.5 to 10.5 g/dL
95 to 105 g/L
8.0 to 9.5 g/dL
80 to 95 g/L
7.0 to 8.0 g/dL
70 to 80 g/L
7.0 g/dL
70 g/L
Infant, 1–21 Days
(HIV POSITIVE OR
NEGATIVE)
12.0 to 13.0 g/dL
120 to 130 g/L
10.0 to 12.0 g/dL
100 to 120 g/L
9.0 to 10.0 g/dL
90 to 100 g/L
9.0 g/dL
90 g/L


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Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 83
21 October 2014
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Absolute Neutrophil Count 
(ANC)
Adult and Pediatric, 7 Days
1000 to 1300/mm3
750 to 1000/mm3
500 to 750/mm3
500/mm3
1.00 to 1.30 GI/L
0.75 to 1.00 GI/L
0.50 to 0.75 GI/L
0.50 GI/L
Infant, 2 – 7 Days
1250 to 1500/mm3
1.25 to 1.50 GI/L
1000 to 1250/mm3
1.00 to < 1.25 GI/L
750 to 1000/mm3
0.75 to < 1.00 GI/L
750/mm3
< 0.75 GI/L
Infant, 1 Day
4000 to 5000/mm3
4.00 to 5.00 GI/L
3000 to 4000/mm3
3.00 to < 4.00 GI/L
1500 to 3000/mm3
1.50 to < 3.00 GI/L
1500/mm3
< 1.50 GI/L
Absolute CD4+ Count
HIV NEGATIVE ONLY
Adult and Pediatric 
> 13 Years
300 to 400/mm3
300 to 400/μL
200 to 300/mm3
200 to 300/μL
100 to 200/mm3
100 to 200/μL
100/mm3
100/μL
Absolute Lymphocyte Count
HIV NEGATIVE ONLY
Adult and Pediatric 
13 Years
600 to 650/mm3
0.60 to 0.65 GI/L
500 to 600/mm3
0.50 to 0.60 GI/L
350 to 500/mm3
0.35 to 0.50 GI/L
350/mm3
0.35 GI/L
Platelets 
100,000 to < 125,000/mm3
100 to 125 GI/L
50,000 to 100,000/mm3
50 to 100 GI/L
25,000 to 50,000/mm3
25 to 50 GI/L
25,000/mm3
25 GI/L
WBCs 
2000/mm3 to 2500/mm3
1,500 to 2,000/mm3
1000 to 1,500/mm3
1000/mm3
2.00 GI/L to 2.50 GI/L
1.50 to 2.00 GI/L
1.00 to 1.50 GI/L
1.00 GI/L
Hypofibrinogenemia
100 to 200 mg/dL
75 to 100 mg/dL
50 to 75 mg/dL
50 mg/dL
1.00 to 2.00 g/L
0.75 to 1.00 g/L
0.50 to 0.75 g/L
0.50 g/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 84
21 October 2014
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Hyperfibrinogenemia
ULN to 600 mg/dL
600 mg/dL
—
—
ULN  to 6.0 g/L
6.0 g/L
—
—
Fibrin Split Product 
20 to 40 μg/mL
40 to 50 μg/mL
50 to 60 μg/mL
60 μg/mL
20 to 40 mg/L
40 to 50 mg/L
50 to 60 mg/L
60 mg/L
Prothrombin Time (PT)
1.00 to 1.25 ULN
1.25 to 1.50 ULN 
1.50 to 3.00 ULN 
3.00 ULN 
International Normalized Ratio 
of prothrombin time (INR)
1.1 to 1.5 x ULN
>1.5 to 2.0 x ULN
>2.0 to 3.0 x ULN
>3.0 x ULN
Activated Partial
Thromboplastin Time (APTT)
1.00 to 1.66 ULN
1.66 to 2.33 ULN
2.33 to 3.00 ULN
3.00 ULN
Methemoglobin 
5.0 to 10.0%
10.0 to 15.0%
15.0 to 20.0%
20.0% 


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 85
21 October 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hyponatremia 
130 to <LLN mEq/L
125 to 130 mEq/L
121 to 125 mEq/L
121 mEq/L
130 to <LLN mmol/L
125 to 130 mmol/L
121 to 125 mmol/L
121 mmol/L
Hypernatremia 
146  to 150 mEq/L
150 to 154 mEq/L
154 to 159 mEq/L
159 mEq/L
146  to 150 mmol/L
150 to 154 mmol/L
154 to 159 mmol/L
159 mmol/L
Hypokalemia 
3.0 to 3.4 mEq/L
2.5 to 3.0 mEq/L
2.0 to 2.5 mEq/L
2.0 mEq/L
3.0 to 3.4 mmol/L
2.5 to 3.0 mmol/L
2.0 to 2.5 mmol/L
2.0 mmol/L
Hyperkalemia 
5.6 to 6.0 mEq/L
6.0 to 6.5 mEq/L
6.5 to 7.0 mEq/L
7.0 mEq/L
5.6 to 6.0 mmol/L
6.0 to 6.5 mmol/L
6.5 to 7.0 mmol/L
7.0 mmol/L
Hypoglycemia
Adult and Pediatric
1 Month
55 to 64 mg/dL
40 to 55 mg/dL
30 to 40 mg/dL
30 mg/dL
3.03 to 3.58 mmol/L
2.20 to 3.03 mmol/L
1.64 to 2.20 mmol/L
1.64 mmol/L
Infant, 1 Month
50 to 54 mg/dL
2.8 to 3.0 mmol/L
40 to 50 mg/dL
2.2 to 2.8 mmol/L
30 to 40 mg/dL
1.7 to 2.2 mmol/L
30 mg/dL
1.7 mmol/L
Hyperglycemia, Nonfasting 
116 to 160 mg/dL
160 to 250 mg/dL
250 to 500 mg/dL
500 mg/dL
6.42 to 8.91 mmol/L
8.91 to 13.90 mmol/L
13.90 to 27.79 mmol/L
27.79 mmol/L
Hyperglycemia, Fasting
110 to 125 mg/dL
6.08 to 6.96 mmol/L
>125 to 250 mg/dL
>6.96 to 13.90 mmol/L
>250 to 500 mg/dL
>13.90 to 27.79 mmol/L
>500 mg/dL
>27.79 mmol/L
Hypocalcemia 
(corrected for albumin if 
appropriate*)
Adult and Pediatric
7 Days
7.8 to 8.4  mg/dL
7.0 to 7.8 mg/dL
6.1 to 7.0 mg/dL
6.1 mg/dL
1.94 to 2.10 mmol/L
1.74 to 1.94 mmol/L
1.51 to 1.74 mmol/L
1.51 mmol/L
Infant, 7 Days
6.5 to 7.5 mg/dL
1.61 to 1.88  mmol/L
6.0 to 6.5 mg/dL
1.49 to < 1.61 mmol/L
5.5 to 6.0 mg/dL
1.36 to < 1.49 mmol/L 
5.5 mg/dL
< 1.36 mmol/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 86
21 October 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hypercalcemia (corrected 
for albumin if appropriate*)
Adult and Pediatric 
7 Days
>ULN to 11.5 mg/dL
11.5 to 12.5 mg/dL
12.5 to 13.5 mg/dL
13.5 mg/dL
>ULN to 2.88 mmol/L
2.88 to 3.13 mmol/L
3.13 to 3.38 mmol/L
3.38 mmol/L
Infant, 7 Days
11.5 to 12.4 mg/dL
2.86 to 3.10  mmol/L
12.4 to 12.9 mg/dL
> 3.10 to 3.23  mmol/L
12.9 to 13.5 mg/dL
> 3.23 to 3.38  mmol/L
13.5 mg/dL
> 3.38 mmol/L
Hypocalcemia (ionized)
3.0 mg/dL to LLN
2.5 to < 3.0 mg/dL
2.0 to 2.5 mg/dL
2.0 mg/dL
0.74 mmol/L to LLN
0.62 to 0.74 mmol/L
0.49 to 0.62 mmol/L
0.49 mmol/L
Hypercalcemia (ionized)
ULN to 6.0 mg/dL
6.0 to 6.5 mg/dL
6.5 to 7.0 mg/dL
7.0 mg/dL
ULN to 1.50 mmol/L
1.50 to 1.63 mmol/L
1.63 to 1.75 mmol/L
1.75 mmol/L
Hypomagnesemia
1.40 to  <LLN mg/dL
1.2 to <LLN mEq/L
1.04 to 1.40 mg/dL
0.9 to 1.2 mEq/L
0.67 to 1.04 mg/dL
0.6 to 0.9 mEq/L
0.67 mg/dL
0.6 mEq/L
0.58 to <LLN mmol/L
0.43 to 0.58 mmol/L
0.28 to 0.43 mmol/L
0.28 mmol/L
Hypophosphatemia
Adult and Pediatric
14 Years
2.0 to < LLN mg/dL
1.5 to 2.0 mg/dL
1.0 to 1.5 mg/dL
1.0 mg/dL
0.63  to LLN mmol/L
0.47 to 0.63 mmol/L
0.31 to 0.47 mmol/L
0.31 mmol/L
Pediatric 1 Year–14 Years 
3.0 to 3.5 mg/dL
0.96 to 1.12 mmol/L
2.5 to 3.0 mg/dL
0.80 to < 0.96 mmol/L
1.5 to 2.5 mg/dL
0.47 to < 0.80 mmol/L
1.5 mg/dL
< 0.47 mmol/L
Pediatric 1 Year
3.5 to 4.5 mg/dL
1.12 to 1.46 mmol/L
2.5 to 3.5 mg/dL
0.80 to < 1.12 mmol/L
1.5 to 2.5 mg/dL
0.47 to < 0.80 mmol/L
1.5 mg/dL
< 0.47 mmol/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 87
21 October 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hyperbilirubinemia 
Adult and Pediatric 
> 14 Days
1.0 to 1.5 ULN 
1.5 to 2.5 ULN
2.5 to 5.0 ULN 
5.0 ULN 
Infant, 14 Days
(non-hemolytic)
NA
20.0 to 25.0 mg/dL
342 to 428 μmol/L
25.0 to 30.0 mg/dL
> 428 to 513 μmol/L
30.0 mg/dL
> 513 μmol/L
Infant, 14 Days
(hemolytic)
NA
NA
20.0 to 25.0 mg/dL
342 to 428 μmol/L
25.0 mg/dL
> 428 μmol/L
Blood Urea Nitrogen
1.25 to 2.50 ULN 
2.50 to 5.00 ULN 
5.00 to 10.00 ULN 
10.00 ULN
Hyperuricemia
>ULN to 10.0 mg/dL 
10.0 to 12.0 mg/dL 
12.0 to 15.0 mg/dL 
15.0 mg/dL
>ULN to 597 μmol/L
597 to 716 μmol/L
716 to 895 μmol/L
895 μmol/L
Hypouricemia
1.5 mg/dL to LLN
1.0 to 1.5 mg/dL
0.5 to 1.0 mg/dL
0.5 mg/dL
87 μmol/L to LLN
57 to 87 μmol/L
27 to 57 μmol/L
27 μmol/L
Creatinine 
1.50 to 2.00 mg/dL
2.00 to 3.00 mg/dL
3.00 to 6.00 mg/dL 
6.00 mg/dL
133 to 177 μmol/L
177 to 265 μmol/L
265 to 530 μmol/L
530 μmol/L
Bicarbonate
16.0 mEq/L to LLN 
11.0 to 16.0 mEq/L
8.0 to 11.0 mEq/L
8.0 mEq/L
16.0 mmol/L to LLN
11.0 to 16.0 mmol/L
8.0 to 11.0 mmol/L
8.0 mmol/L
Triglycerides
(Fasting)
NA
500 to 750 mg/dL
750 to 1200 mg/dL
1200 mg/dL
5.64–8.47 mmol/L
8.47–13.55 mmol/L
13.55 mmol/L


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 88
21 October 2014
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
LDL
(Fasting)
130 to 160 mg/dL
>160 to 190 mg/dL
> 190 mg/dL
NA
3.35 to 4.15 mmol/L
>4.15 to 4.92 mmol/L
>4.92 mmol/L
Pediatric >2 to <18 years
110 to 130 mg/dL
>130 to 190 mg/dL
> 190 mg/dL
NA
2.84 to 3.37 mmol/L
>3.37 to  4.92 mmol/L
>4.92 mmol/L
Hypercholesterolemia
(Fasting)
200 to 239 mg/dL
239 to 300 mg/dL
300 mg/dL
NA
5.16 to 6.19 mmol/L
6.19 to 7.77 mmol/L
7.77 mmol/L
Pediatric 18 Years
170 to 199 mg/dL
4.39 to 5.15 mmol/L
199 to 300 mg/dL
5.15 to 7.77 mmol/L
300 mg/dL
7.77 mmol/L
NA
Creatine Kinase
3.0 to 6.0 ULN
6.0 to 10.0 ULN
10.0 to 20.0 ULN
20.0 ULN
*Calcium should be corrected for albumin if albumin is < 4.0 g/dL


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 89
21 October 2014
ENZYMES
Grade 1
Grade 2
Grade 3
Grade 4
AST (SGOT) 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
ALT (SGPT) 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
GGT
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
Alkaline Phosphatase 
1.25 to 2.50 ULN
2.50 to 5.00 ULN
5.00 to 10.00 ULN
10.00 ULN
Total Amylase
1.0 to 1.5 ULN
1.5 to 2.0 ULN
2.0 to 5.0 ULN
5.0 ULN
Pancreatic Amylase
1.0 to 1.5 ULN
1.5 to 2.0 ULN
2.0 to 5.0 ULN
5.0 ULN
Lipase 
1.0 to 1.5 ULN
1.5 to 3.0 ULN
3.0 to 5.0 ULN
5.0 ULN
Albumin
3.0 g/dL to LLN
30 g/L to LLN
2.0 to 3.0 g/dL
20 to 30 g/L
2.0 g/dL
20 g/L
NA


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 90
21 October 2014
URINALYSIS
Grade 1
Grade 2
Grade 3
Grade 4
Hematuria (Dipstick) 
1
2
3-4+
NA
Hematuria (Quantitative) 
See Note below
                              Females
>ULN - 10 RBC/HPF
10-75 RBC/HPF
> 75 RBC/HPF
NA
                              Males
6-10 RBC/HPF
10-75 RBC/HPF
> 75 RBC/HPF
NA
Proteinuria (Dipstick)
1
2–3
4
NA
Proteinuria, 24 Hour Collection
Adult and Pediatric 
10 Years
200 to 999 mg/24 h
>999 to 1999 mg/24 h
>1999 to 3500 mg/24 h
3500 mg/24 h
Pediatric 3 Mo to 
< 10 Years
201 to 499 mg/m2/24 h
>499 to 799 mg/m2/24 h
>799 to 1000 mg/m2/24 h
1000 mg/ m2/24 h
Glycosuria (Dipstick)
1+
2-3
4
NA
Notes: 

Toxicity grades for Quantitative and Dipstick Hematuria will be assigned by Covance Laboratory, however for other laboratories, toxicity grades will only be assigned to 
Dipstick Hematuria.

With the exception of lipid tests, any graded laboratory test with a result that is between the LLN and ULN should be assigned Grade 0.

If the severity of a clinical AE could fall under either one of two grades (eg, the severity of an AE could be either Grade 2 or Grade 3), select the higher of the two grades for 
the AE.


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 91
21 October 2014
CARDIOVASCULAR
Grade 1
Grade 2
Grade 3
Grade 4
Cardiac Arrhythmia (general)
(By ECG or physical exam)
Asymptomatic AND No 
intervention indicated
Asymptomatic AND Non-
urgent medical intervention 
indicated
Symptomatic, non-life-
threatening AND Non-
urgent medical intervention 
indicated 
Life-threatening arrhythmia 
OR Urgent intervention 
indicated
Cardiac-ischemia/Infarction
NA
NA
Symptomatic ischemia 
(stable angina) OR Testing 
consistent with ischemia 
Unstable angina OR Acute 
myocardial infarction
Hemorrhage (significant acute 
blood loss)
NA
Symptomatic AND No 
transfusion indicated
Symptomatic AND 
Transfusion of 2 units 
packed RBCs (for children 
10 cc/kg) indicated 
Life-threatening hypotension 
OR Transfusion of 2 units 
packed RBCs indicated (for 
children 10 cc/kg) indicated
Hypertension (with repeat 
testing at same visit)
140–159 mmHg systolic 
OR 
90–99 mmHg diastolic
159–179 mmHg systolic 
OR 
99–109 mmHg diastolic
179 mmHg systolic 
OR 
109 mmHg diastolic
Life-threatening consequences 
(eg, malignant hypertension) 
OR Hospitalization (other than 
ER visit) indicated
Pediatric 17 Years (with 
repeat testing at same visit)
NA
91st–94th percentile adjusted 
for age, height, and gender 
(systolic and/or diastolic)
≥95th percentile adjusted 
for age, height, and gender 
(systolic and/or diastolic)
Life-threatening consequences 
(eg, malignant hypertension) 
OR Hospitalization indicated 
(other than emergency room 
visit)
Hypotension
NA
Symptomatic, corrected with 
oral fluid replacement
Symptomatic, IV fluids 
indicated
Shock requiring use of 
vasopressors or mechanical 
assistance to maintain blood 
pressure
Pericardial Effusion
Asymptomatic, small 
effusion requiring no 
intervention
Asymptomatic, moderate or 
larger effusion requiring no 
intervention
Effusion with non-life-
threatening physiologic 
consequences OR Effusion 
with nonurgent intervention 
indicated
Life-threatening consequences 
(eg, tamponade) OR Urgent 
intervention indicated


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 92
21 October 2014
CARDIOVASCULAR
Grade 1
Grade 2
Grade 3
Grade 4
Prolonged PR Interval
PR interval 
0.21 to 0.25 sec
PR interval
0.25 sec
Type II 2nd degree AV 
block OR Ventricular pause 
3.0 sec
Complete AV block 
Pediatric 16 Years
1st degree AV block
(PR > normal for age and 
rate)
Type I 2nd degree AV block 
Type II 2nd degree AV 
block 
Complete AV block
Prolonged QTc
Asymptomatic, QTc interval 
0.45 to 0.47 sec OR Increase 
interval 0.03 sec above 
baseline
Asymptomatic, QTc interval 
0.48 to 0.49 sec OR Increase 
in interval 0.03 to 0.05 sec 
above baseline
Asymptomatic, QTc interval 
0.50 sec OR Increase in 
interval 0.06 sec above 
baseline
Life-threatening 
consequences, eg, Torsade de 
pointes or other associated 
serious ventricular 
dysrhythmia
Pediatric 16 Years
Asymptomatic, QTc interval 
0.450 to 0.464 sec 
Asymptomatic, QTc interval 
0.465 to 0.479 sec 
Asymptomatic, QTc interval 
0.480 sec 
Life-threatening 
consequences, eg, Torsade de 
pointes or other associated 
serious ventricular 
dysrhythmia
Thrombosis/Embolism
NA
Deep vein thrombosis AND 
No intervention indicated (eg, 
anticoagulation, lysis filter, 
invasive procedure) 
Deep vein thrombosis AND 
Intervention indicated (eg, 
anticoagulation, lysis filter, 
invasive procedure) 
Embolic event (eg, pulmonary 
embolism, life-threatening 
thrombus) 
Vasovagal Episode (associated 
with a procedure of any kind)
Present without loss of 
consciousness 
Present with transient loss of 
consciousness
NA 
NA
Ventricular Dysfunction 
(congestive heart failure, 
CHF)
NA
Asymptomatic diagnostic 
finding AND intervention 
indicated
New onset with symptoms 
OR Worsening symptomatic 
CHF
Life-threatening CHF


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 93
21 October 2014
RESPIRATORY
Grade 1
Grade 2
Grade 3
Grade 4
Bronchospasm (acute)
FEV1 or peak flow reduced to 
70% to 80%
FEV1 or peak flow 50% to 69%
FEV1 or peak flow 25% to 
49% 
Cyanosis OR FEV1 or peak flow 
25% OR Intubation
Dyspnea or Respiratory 
Distress
Dyspnea on exertion with no 
or minimal interference with 
usual social & functional 
activities 
Dyspnea on exertion causing 
greater than minimal interference 
with usual social & functional 
activities 
Dyspnea at rest causing 
inability to perform usual 
social & functional activities 
Respiratory failure with 
ventilatory support indicated
Pediatric 14 Years
Wheezing OR minimal 
increase in respiratory rate for 
age
Nasal flaring OR Intercostal 
retractions OR Pulse oximetry 
90% to 95%
Dyspnea at rest causing 
inability to perform usual 
social & functional activities 
OR Pulse oximetry 90%
Respiratory failure with 
ventilatory support indicated
OCULAR/VISUAL
Grade 1
Grade 2
Grade 3
Grade 4
Uveitis
Asymptomatic but detectable 
on exam
Symptomatic anterior uveitis OR 
Medical intervention indicated
Posterior or pan-uveitis OR 
Operative intervention 
indicated
Disabling visual loss in affected 
eye(s) 
Visual Changes (from 
Baseline)
Visual changes causing no or 
minimal interference with 
usual social & functional 
activities
Visual changes causing greater 
than minimal interference with 
usual social & functional 
activities
Visual changes causing 
inability to perform usual 
social & functional activities
Disabling visual loss in affected 
eye(s)


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 94
21 October 2014
SKIN
Grade 1
Grade 2
Grade 3
Grade 4
Alopecia
Thinning detectable by 
study participant or  
caregiver (for disabled 
adults)
Thinning or patchy hair loss 
detectable by health care 
provider
Complete hair loss
NA
Cutaneous Reaction – Rash
Localized macular rash 
Diffuse macular, 
maculopapular, or 
morbilliform rash OR Target 
lesions 
Diffuse macular, 
maculopapular, or morbilliform 
rash with vesicles or limited 
number of bullae OR 
Superficial ulcerations of 
mucous membrane limited to 
one site
Extensive or generalized 
bullous lesions OR 
Stevens-Johnson syndrome 
OR Ulceration of mucous 
membrane involving two 
or more distinct mucosal 
sites OR Toxic epidermal 
necrolysis (TEN)
Hyperpigmentation
Slight or localized
Marked or generalized
NA
NA
Hypopigmentation
Slight or localized 
Marked or generalized
NA
NA
Pruritis (itching – no skin 
lesions) 
(See also Injection Site 
Reactions: Pruritis associated 
with injection)
Itching causing no or 
minimal interference with 
usual social & functional 
activities
Itching causing greater than 
minimal interference with 
usual social & functional 
activities
Itching causing inability to 
perform usual social & 
functional activities 
NA


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 95
21 October 2014
GASTROINTESTINAL
Grade 1
Grade 2
Grade 3
Grade 4
Anorexia
Loss of appetite without 
decreased oral intake
Loss of appetite associated with 
decreased oral intake without 
significant weight loss 
Loss of appetite associated 
with significant weight loss 
Life-threatening consequences 
OR Aggressive intervention 
indicated [eg, tube feeding or 
total parenteral nutrition]
Ascites
Asymptomatic
Symptomatic AND Intervention 
indicated (eg, diuretics or 
therapeutic paracentesis)
Symptomatic despite 
intervention
Life-threatening consequences
Cholecystitis
NA
Symptomatic AND Medical 
intervention indicated
Radiologic, endoscopic, or 
operative intervention 
indicated
Life-threatening consequences 
(eg, sepsis or perforation) 
Constipation 
NA
Persistent constipation requiring 
regular use of dietary 
modifications, laxatives, or 
enemas 
Obstipation with manual 
evacuation indicated
Life-threatening consequences 
(eg, obstruction)
Diarrhea 
Adult and Pediatric 
1 Year
Transient or intermittent 
episodes of unformed stools 
OR Increase of 3 stools 
over baseline/24 hr
Persistent episodes of unformed 
to watery stools OR Increase of 
4–6 stools over baseline per 
24 hrs. 
Bloody diarrhea OR Increase 
of 7 stools per 24-hour 
period OR IV fluid 
replacement indicated
Life-threatening consequences 
(eg, hypotensive shock)
Pediatric 1 Year
Liquid stools (more 
unformed than usual) but 
usual number of stools
Liquid stools with increased 
number of stools OR Mild 
dehydration
Liquid stools with moderate 
dehydration
Liquid stools resulting in 
severe dehydration with 
aggressive rehydration 
indicated OR Hypotensive 
shock
Dysphagia-Odynophagia 
Symptomatic but able to eat 
usual diet
Symptoms causing altered 
dietary intake without medical 
intervention indicated
Symptoms causing severely 
altered dietary intake with 
medical intervention indicated
Life-threatening reduction in 
oral intake


GS-5806
Protocol GS-US-218-1502
Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 96
21 October 2014
GASTROINTESTINAL
Grade 1
Grade 2
Grade 3
Grade 4
Mucositis/Stomatitis 
(clinical exam)
See also Proctitis, 
Dysphagia-Odynophagia
Erythema of the mucosa
Patchy pseudomembranes or 
ulcerations 
Confluent pseudomembranes 
or ulcerations OR Mucosal 
bleeding with minor trauma
Tissue necrosis OR Diffuse 
spontaneous mucosal bleeding 
OR Life-threatening 
consequences (eg, aspiration, 
choking)
Nausea 
Transient (24 hours) or 
intermittent nausea with no 
or minimal interference with 
oral intake
Persistent nausea resulting in 
decreased oral intake for 24–48 
hours
Persistent nausea resulting in 
minimal oral intake for 48 
hours OR Aggressive 
rehydration indicated (eg, 
IV fluids)
Life-threatening consequences 
(eg, hypotensive shock)
Pancreatitis
NA
Symptomatic AND 
Hospitalization not indicated 
(other than ER visit)
Symptomatic AND 
Hospitalization indicated 
(other than ER visit)
Life-threatening consequences 
(eg, sepsis, circulatory failure, 
hemorrhage)
Proctitis (functional-
symptomatic)
Also see Mucositis/ 
Stomatitis for Clinical 
Exam
Rectal discomfort AND No 
intervention indicated
Symptoms causing greater than 
minimal interference with usual 
social & functional activities OR 
Medical intervention indicated 
Symptoms causing inability to 
perform usual social/ 
functional activities OR 
Operative intervention 
indicated 
Life-threatening consequences 
(eg, perforation)
Vomiting
Transient or intermittent 
vomiting with no or 
minimal interference with 
oral intake
Frequent episodes of vomiting 
with no or mild dehydration
Persistent vomiting resulting 
in orthostatic hypotension OR 
Aggressive rehydration 
indicated
Life-threatening consequences 
(eg, hypotensive shock)


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Amendment 3
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NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Alteration in Personality-
Behavior or in Mood (eg, 
agitation, anxiety, 
depression, mania, 
psychosis)
Alteration causing no or 
minimal interference with 
usual social & functional 
activities 
Alteration causing greater than 
minimal interference with 
usual social & functional 
activities 
Alteration causing inability to 
perform usual social & 
functional activities 
Behavior potentially harmful 
to self or others (eg, 
suicidal/homicidal ideation or 
attempt, acute psychosis) OR 
Causing inability to perform 
basic self-care functions
Altered Mental Status 
For Dementia, see Cognitive 
and Behavioral/Attentional 
Disturbance (including 
dementia and ADD)
Changes causing no or 
minimal interference with 
usual social & functional 
activities
Mild lethargy or somnolence 
causing greater than minimal 
interference with usual social 
& functional activities
Confusion, memory 
impairment, lethargy, or 
somnolence causing inability 
to perform usual social & 
functional activities
Delirium OR obtundation, OR 
coma
Ataxia 
Asymptomatic ataxia 
detectable on exam OR 
Minimal ataxia causing no 
or minimal interference with 
usual social & functional 
activities
Symptomatic ataxia causing 
greater than minimal 
interference with usual social 
& functional activities
Symptomatic ataxia causing 
inability to perform usual 
social & functional activities 
Disabling ataxia causing 
inability to perform basic 
self-care functions
Cognitive and 
Behavioral/Attentional 
Disturbance (including 
dementia and Attention 
Deficit Disorder) 
Disability causing no or 
minimal interference with 
usual social & functional 
activities OR Specialized 
resources not indicated
Disability causing greater than 
minimal interference with 
usual social & functional 
activities OR Specialized 
resources on part-time basis 
indicated
Disability causing inability to 
perform usual social & 
functional activities OR 
Specialized resources on a 
full-time basis indicated
Disability causing inability to 
perform basic self-care 
functions OR 
Institutionalization indicated
CNS Ischemia
(acute)
NA
NA
Transient ischemic attack
Cerebral vascular accident 
(CVA, stroke) with 
neurological deficit 


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Protocol GS-US-218-1502
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Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
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21 October 2014
NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Developmental delay –
Pediatric 16 Years
Mild developmental delay, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate 
for the setting 
Moderate developmental 
delay, either motor or 
cognitive, as determined by 
comparison with a 
developmental screening tool 
appropriate for the setting 
Severe developmental delay, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate for 
the setting 
Developmental regression, 
either motor or cognitive, as 
determined by comparison 
with a developmental 
screening tool appropriate for 
the setting
Headache 
Symptoms causing no or 
minimal interference with 
usual social & functional 
activities
Symptoms causing greater 
than minimal interference with 
usual social & functional 
activities
Symptoms causing inability to 
perform usual social & 
functional activities
Symptoms causing inability to 
perform basic self-care 
functions OR Hospitalization 
indicated (other than ER visit) 
OR Headache with significant 
impairment of alertness or
other neurologic function 
Insomnia
NA
Difficulty sleeping causing 
greater than minimal 
interference with usual 
social/functional activities
Difficulty sleeping causing 
inability to perform usual 
social & functional activities
Disabling insomnia causing 
inability to perform basic 
self-care functions
Neuromuscular Weakness 
(including myopathy & 
neuropathy) 
Asymptomatic with 
decreased strength on exam 
OR Minimal muscle weak-
ness causing no or minimal 
interference with usual 
social & functional activities
Muscle weakness causing 
greater than minimal 
interference with usual social 
& functional activities
Muscle weakness causing 
inability to perform usual 
social & functional activities 
Disabling muscle weakness 
causing inability to perform 
basic self-care functions OR 
Respiratory muscle weakness 
impairing ventilation
Neurosensory Alteration 
(including paresthesia and 
painful neuropathy)
Asymptomatic with sensory 
alteration on exam or 
minimal paresthesia causing 
no or minimal interference 
with usual social &
functional activities 
Sensory alteration or 
paresthesia causing greater 
than minimal interference with 
usual social & functional 
activities 
Sensory alteration or 
paresthesia causing inability to 
perform usual social & 
functional activities
Disabling sensory alteration or 
paresthesia causing inability to 
perform basic self-care 
functions


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Protocol GS-US-218-1502
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Gilead Sciences, Inc.
Amendment 3
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21 October 2014
NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Seizure: (new onset) 
NA
1 seizure 
2–4 seizures 
Seizures of any kind that are 
prolonged, repetitive (eg, 
status epilepticus), or difficult 
to control (eg, refractory 
epilepsy)
Seizure: (pre-existing) 
For Worsening of Existing 
Epilepsy the Grades Should 
Be Based on an Increase 
from Previous Level of 
Control to Any of These 
Levels
NA
Increased frequency of pre-
existing seizures (non-
repetitive) without change in 
seizure character OR 
infrequent breakthrough 
seizures while on stable meds 
in a previously controlled 
seizure disorder
Change in seizure character 
from baseline either in 
duration or quality (eg, 
severity or focality) 
Seizures of any kind that are 
prolonged, repetitive (eg, 
status epilepticus), or difficult 
to control (eg, refractory 
epilepsy)
Seizure 
– Pediatric 18 Years
Seizure, generalized onset 
with or without secondary 
generalization, lasting 
< 5 minutes with < 24 hours 
post ictal state
Seizure, generalized onset 
with or without secondary 
generalization, lasting 5–20 
minutes with 
< 24 hours post ictal state
Seizure, generalized onset 
with or without secondary 
generalization, lasting 
> 20 minutes 
Seizure, generalized onset 
with or without secondary 
generalization, requiring 
intubation and sedation
Syncope (not associated 
with a procedure)
NA
Present
NA
NA
Vertigo
Vertigo causing no or 
minimal interference with 
usual social & functional 
activities
Vertigo causing greater than 
minimal interference with 
usual social & functional 
activities 
Vertigo causing inability to 
perform usual social & 
functional activities
Disabling vertigo causing 
inability to perform basic self-
care functions


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Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
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MUSCULOSKELETAL
Grade 1
Grade 2
Grade 3
Grade 4
Arthralgia
See also Arthritis
Joint pain causing no or 
minimal interference with 
usual social & functional 
activities
Joint pain causing greater than 
minimal interference with usual 
social & functional activities
Joint pain causing inability 
to perform usual social & 
functional activities
Disabling joint pain causing 
inability to perform basic self-
care functions
Arthritis
See also Arthralgia
Stiffness or joint swelling 
causing no or minimal 
interference with usual 
social & functional activities
Stiffness or joint swelling causing 
greater than minimal interference 
with usual social & functional 
activities
Stiffness or joint swelling 
causing inability to perform 
usual social & functional 
activities
Disabling joint stiffness or 
swelling causing inability to 
perform basic self-care 
functions
Bone Mineral Loss
BMD t-score or z-score
–2.5 to –1.0 
BMD t-score or z-score –2.5
Pathological fracture 
(including loss of vertebral 
height)
Pathologic fracture causing 
life-threatening consequences 
Pediatric 21 Years
BMD z-score 
–2.5 to –1.0
BMD z-score < –2.5
Pathological fracture 
(including loss of vertebral 
height)
Pathologic fracture causing 
life-threatening consequences 
Myalgia
(non-injection site)
Muscle pain causing no or 
minimal interference with 
usual social & functional 
activities
Muscle pain causing greater than 
minimal interference with usual 
social & functional activities
Muscle pain causing 
inability to perform usual 
social & functional activities
Disabling muscle pain causing 
inability to perform basic self-
care functions
Osteonecrosis
NA
Asymptomatic with radiographic 
findings AND No operative 
intervention indicated
Symptomatic bone pain with 
radiographic findings OR 
Operative intervention 
indicated
Disabling bone pain with 
radiographic findings causing 
inability to perform basic self-
care functions


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Gilead Sciences, Inc.
Amendment 3
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SYSTEMIC
Grade 1
Grade 2
Grade 3
Grade 4
Acute Systemic Allergic 
Reaction 
Localized urticaria 
(wheals) with no medical 
intervention indicated
Localized urticaria with medical 
intervention indicated OR Mild 
angioedema with no medical 
intervention indicated
Generalized urticaria OR 
Angioedema with medical 
intervention indicated OR 
Symptomatic mild 
bronchospasm
Acute anaphylaxis OR Life-
threatening bronchospasm OR 
laryngeal edema
Chills
Symptoms causing no or 
minimal interference with 
usual social & functional 
activities
Symptoms causing greater than 
minimal interference with usual 
social & functional activities 
Symptoms causing inability to 
perform usual social & 
functional activities
NA
Fatigue
Malaise
Symptoms causing no or 
minimal interference with 
usual social & functional 
activities
Symptoms causing greater than 
minimal interference with usual 
social & functional activities
Symptoms causing inability to 
perform usual social & 
functional activities
Incapacitating fatigue/malaise 
symptoms causing inability to 
perform basic self-care 
functions
Fever (nonaxillary)
37.7C to 38.6C
99.8F to 101.5F
38.7C to 39.3C
101.6F to 102.8F
39.4C to 40.5C
102.9F to 104.9F
40.5C 
104.9F
Pain- Indicate Body Site
See also Injection Site 
Pain, Headache, 
Arthralgia, and Myalgia
Pain causing no or 
minimal interference with 
usual social & functional 
activities
Pain causing greater than minimal 
interference with usual social & 
functional activities
Pain causing inability to 
perform usual social & 
functional activities
Disabling pain causing 
inability to perform basic self-
care functions OR 
Hospitalization (other than ER 
visit) indicated
Unintentional Weight 
Loss
NA
5% to 9% loss in body weight from 
baseline
10% to 19% loss in body 
weight from baseline
20% loss in body weight 
from baseline OR  Aggressive 
intervention indicated [eg, 
tube feeding or total parenteral 
nutrition]


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Final
Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
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INJECTION SITE REACTION
Grade 1
Grade 2
Grade 3
Grade 4
Injection Site Pain (pain 
without touching)
Or Tenderness (pain when 
area is touched) 
Pain/tenderness causing no 
or minimal limitation of use 
of limb
Pain/tenderness limiting use of 
limb OR Pain/tenderness 
causing greater than minimal 
interference with usual social 
& functional activities
Pain/tenderness causing 
inability to perform usual 
social & functional activities
Pain/tenderness causing inability 
to perform basic self-care 
function OR Hospitalization 
(other than ER visit) indicated 
for management of 
pain/tenderness
Injection Site Reaction 
(Localized), 15 Years
Erythema OR Induration
of 5 5 cm to 9 9 cm (or 
2581 cm2)
Erythema OR Induration OR 
Edema 9 cm any diameter 
(or 81 cm2)
Ulceration OR Secondary 
infection OR Phlebitis OR 
Sterile abscess OR Drainage
Necrosis (involving dermis and 
deeper tissue)
Pediatric 15 Years
Erythema OR Induration 
OR Edema present but 
2.5 cm diameter
Erythema OR Induration 
OR Edema > 2.5 cm 
diameter but < 50% surface 
area of the extremity 
segment (eg, upper 
arm/thigh)
Erythema OR Induration 
OR Edema involving 
50% surface area of the 
extremity segment (eg, 
upper arm/thigh) OR 
Ulceration OR Secondary 
infection OR Phlebitis OR 
Sterile abscess OR 
Drainage
Necrosis (involving dermis and 
deeper tissue)
Pruritis Associated with 
Injection 
See also Skin: Pruritis 
(itching—no skin lesions)
Itching localized to injection 
site AND Relieved 
spontaneously or with 
48 h treatment 
Itching beyond the injection 
site but not generalized OR 
Itching localized to injection 
site requiring 48 h treatment 
Generalized itching causing 
inability to perform usual 
social & functional activities
NA


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Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
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21 October 2014
ENDOCRINE/METABOLIC
Grade 1
Grade 2
Grade 3
Grade 4
Lipodystrophy (eg, back 
of neck, breasts, 
abdomen)
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious 
changes on casual visual 
inspection
NA
Diabetes Mellitus
NA
New onset without need to initiate 
medication OR Modification of 
current meds to regain glucose 
control
New onset with initiation of 
indicated med OR Diabetes 
uncontrolled despite treatment 
modification
Life-threatening consequences 
(eg, ketoacidosis, 
hyperosmolar non-ketotic 
coma) 
Gynecomastia
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious on 
casual visual inspection
NA
Hyperthyroidism 
Asymptomatic
Symptomatic causing greater than 
minimal interference with usual 
social & functional activities OR 
Thyroid suppression therapy 
indicated
Symptoms causing inability to 
perform usual social & 
functional activities OR 
Uncontrolled despite treatment 
modification 
Life-threatening consequences 
(eg, thyroid storm)
Hypothyroidism
Asymptomatic
Symptomatic causing greater than 
minimal interference with usual 
social & functional activities OR 
Thyroid replacement therapy 
indicated
Symptoms causing inability to 
perform usual social & 
functional activities OR 
Uncontrolled despite treatment 
modification 
Life-threatening consequences 
(eg, myxedema coma)
Lipoatrophy (eg, fat loss 
from the face, extremities, 
buttocks)
Detectable by study 
participant or caregiver 
(for young children and 
disabled adults)
Detectable on physical exam by 
health care provider
Disfiguring OR Obvious on 
casual visual inspection
NA


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Gilead Sciences, Inc.
Amendment 3
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21 October 2014
GENITOURINARY
Grade 1
Grade 2
Grade 3
Grade 4
Intermenstrual Bleeding 
(IMB)
Spotting observed by participant 
OR Minimal blood observed 
during clinical or colposcopic 
exam
Intermenstrual bleeding not 
greater in duration or amount 
than usual menstrual cycle
Intermenstrual bleeding greater 
in duration or amount than usual 
menstrual cycle
Hemorrhage with life-
threatening hypotension OR 
Operative intervention 
indicated
Urinary Tract 
obstruction (eg, stone)
NA
Signs or symptoms of urinary 
tract obstruction without 
hydronephrosis or renal 
dysfunction
Signs or symptoms of urinary 
tract obstruction with 
hydronephrosis or renal 
dysfunction
Obstruction causing life-
threatening consequences
INFECTION
Grade 1
Grade 2
Grade 3
Grade 4
Infection (any other 
than HIV infection)
Localized, no systemic antiμbial 
treatment indicated AND 
Symptoms causing no or 
minimal interference with usual 
social & functional activities
Systemic antiμbial treatment 
indicated OR Symptoms 
causing greater than minimal 
interference with usual social 
& functional activities
Systemic antiμbial treatment 
indicated AND Symptoms 
causing inability to perform 
usual social & functional 
activities OR Operative 
intervention (other than simple 
incision and drainage) indicated
Life-threatening 
consequences (eg, septic 
shock)
Basic Self-care Functions: Activities such as bathing, dressing, toileting, transfer/movement, continence, and feeding.
Usual Social & Functional Activities: Adaptive tasks and desirable activities, such as going to work, shopping, cooking, use of transportation, pursuing a hobby, etc.


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Amendment 3
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Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing 
Potential, and Contraceptive Requirements
1) Pregnancy and Contraception Requirements for Males and Females of Childbearing 
Potential 
Pregnancy must be excluded before the start of treatment with study drug and prevented 
thereafter by reliable contraceptive methods. A urine or serum pregnancy test will be performed 
for all females of childbearing potential at the screening visit and at each dosing visit (Visits 2, 4, 
6, 7, and 8) prior to administration of study drug to ensure pregnant women are not included or 
treated with study drug in the trial. Please refer to the latest version of the investigator’s brochure 
for additional information about the effects of GS 5806. 
2) Definition of Female of Childbearing Potential
For the purposes of this study, a female subject of childbearing potential is a nonmenopausal 
female who has not had a hysterectomy, bilateral oophorectomy, or medically documented 
ovarian failure. This definition includes a pubertal female who has not yet started menstruating. 
A woman who has had a tubal sterilization is considered to be of childbearing potential.
A female subject may be considered menopausal in either of the following conditions:

Surgical menopause: Appropriate medical documentation of prior complete bilateral 
oophorectomy (ie, surgical removal of the ovaries and occurring at the age at which the 
procedure was performed)

Spontaneous menopause: Permanent cessation of previously occurring menses as a result of 
ovarian failure with documentation of hormonal deficiency by a certified health care 
provider. The worldwide mean age of spontaneous menopause is 49.24 (SD 1.73) years

A hormonal deficiency should be properly documented in the case of suspected spontaneous 
menopause as follows:
— If age 54 years and with the absence of normal menses: serum follicle stimulating 
hormone (FSH) level elevated to within the postmenopausal range based on the 
laboratory reference range where the hormonal assay is performed
— If age <54 years and with the absence of normal menses: negative serum or urine human 
chorionic gonadotropin (hCG) with concurrently elevated serum FSH level in the 
postmenopausal range, depressed estradiol (E2) level in the postmenopausal range, and 
absent serum progesterone level, based on the laboratory reference ranges where the 
hormonal assays are performed
3) Contraceptive Requirements 
Female subjects of childbearing potential and male subjects must agree to either continue 
abstinence from sexual intercourse or utilize protocol specified methods of contraception if they 
choose to engage in intercourse from the screening/enrollment visit throughout the study period 


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Amendment 3
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and for 30 days following the last dose of study drug (90 days for males). Female study subjects
of childbearing potential will undergo regular pregnancy testing while taking GS-5806. The 
investigator will counsel subjects on the protocol specified method(s) for avoiding pregnancy in 
case the subject chooses to engage in heterosexual intercourse.
Protocol specified contraceptive methods are as follows: (1) a combination of one hormonal 
method and one barrier method; or (2) use of an intrauterine device (IUD) or tubal sterilization; 
see Appendix Table 1 below. Acceptable hormonal methods include injectable progesterone, 
progesterone implants, combination oral contraceptives, transdermal contraceptive patch, and 
vaginal ring. Acceptable barrier methods include diaphragm with spermicide, cervical cap with 
spermicide, and the male condom with spermicide. Female subjects must use either a hormonal 
method or a barrier method if the partner has a vasectomy and the male partner should be the 
sole partner for that subject. For a vasectomy, appropriate post-vasectomy documentation of the 
absence of sperm in the ejaculate must be available. If a subject has undergone tubal sterilization 
or has had a Copper T 380A IUD or LNg 20 IUD inserted, no other contraception is needed.  
If tubal sterilization is via the Essure procedure, verification of tubal blockage by 
hysterosalpingogram (HSP) must be performed approximately 3 months after microinsertion. 
Prior to verification, Essure is not considered a reliable form of contraception and the 
contraception methods described below must be used. Female subjects who utilize hormonal 
contraceptives as one of their birth control methods must have used the same method for at least 
3 months before study dosing.
Female subjects of childbearing potential must have a negative urine or serum pregnancy test at 
screening and at each dosing visit (Visits 2, 4, 6, 7, and 8) prior to receiving study drug. 


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Gilead Sciences, Inc.
Amendment 3
CONFIDENTIAL
Page 107
21 October 2014
Appendix Table 1.
Protocol Specified Contraceptive Methods
Methods to Use by Themselves
Combination Methods
Hormone Methods
(choose one and use with a barrier 
method)
Barrier Methods
(choose one and use with a hormone 
method)
Intrauterine Devices (IUDs)

Copper T 380A IUD

LNg 20 IUD
Tubal Sterilization
Estrogen and Progesterone

Oral contraceptives

Transdermal patch

Vaginal ring
Progesterone

Injection

Implant

Diaphragm with spermicide

Cervical cap with spermicide

Male condom (with spermicide)
Partner’s vasectomy must be used with a hormone or barrier method and the
male partner should be the sole partner for that subject. For a vasectomy, 
appropriate post-vasectomy documentation of the absence of sperm in the 
ejaculate must be available.
The investigator will counsel all subjects on the most effective method(s) for avoiding pregnancy 
during the study.
4) Additional Requirements for Male Subjects
Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm 
donation while enrolled in the study and for at least 90 days after administration of the last dose 
of study medication.
Use of condoms, with spermicide, has been proven to decrease the risk of transmission of HIV 
and other sexually transmitted diseases. The use of spermicide is not recommended if the subject 
or subject’s partner is infected with HIV.
5) Procedures to be Followed in the Event of Pregnancy
Subjects will be instructed to notify the investigator if they become pregnant at any time during 
the study, or if they become pregnant within 30 days or 4 weeks of last study drug dose. Subjects 
who become pregnant or who suspect that they are pregnant during the study must report the 
information to the investigator and discontinue study drug immediately. Subjects whose partner 
has become pregnant or suspects she is pregnant during the study must report the information to 
the investigator. 
Instructions for reporting pregnancy, partner pregnancy, and pregnancy outcome are outlined in 
Section 7.7.2.1.