A Phase 2/3, Open-Label, Multi-Cohort Switch Study to Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on a 2-NRTI-Containing Regimen
Phase: PHASE2
Conditions: HIV-1
Sponsor: Gilead Sciences

Study Title: 
Sponsor: 
IND Number: 
EudraCT Number: 
Clinical Trials.gov 
Identifier: 
Indication: 
Protocol ID: 
Gilead Clinical Program 
Manager: 
Gilead Medical Monitor: 
Clinical Study Director: 
Protocol Version/Date: 
[!'J GI LEAU 
CLINICAL STUDY PROTOCOL 
A Phase 2/3, Open-Label, Multi-Cohort Switch Study to Evaluate 
Emtricitabine/f enofovir Alafenamide (F/f AF) in HIV-1 Infected 
Children and Adolescents Virologically Suppressed on a 
2-NRTI-Containing Regimen 
Gilead Sciences, Inc. 
333 Lakeside Drive 
Foster City, CA 94404 
111851 
2015-001339-19 
NCT02285114 
HIV-1 
GS-US-311-1269 
Name: 
Telephone: 
Fax: 
Name: 
Telephone: 
Fax: 
Name: 
Telephone: 
Mobile: 
Fax: 
Original: 
Amendment 1: 
Amendment 1.1 (South Africa): 
Amendment 2: 
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23 June 2014 
20 November 2014 
04 March 2015 
02 August 2017 
CONFIDENTIALITY STATEMENT 
The information contained in this document, particularly unpublished data, is the property or 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 information is only to be used by you in 
connection with authorized clinical studies of the investigational drug described in the protocol. 
You will not disclose any of the information to others without written authorization from 
Gilead Sciences, Inc., except to the extent necessary to obtain informed consent from those 
persons to whom the drug may be administered. 

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TABLE OF CONTENTS
TABLE OF CONTENTS ..............................................................................................................................................2
LIST OF IN-TEXT TABLES........................................................................................................................................5
LIST OF IN-TEXT FIGURES ......................................................................................................................................5
PROTOCOL SYNOPSIS ..............................................................................................................................................6
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS....................................................................15
1.
INTRODUCTION ..............................................................................................................................................19
1.1.
Background ............................................................................................................................................19
1.2.
Tenofovir Alafenamide (TAF, GS-7340)...............................................................................................21
1.2.1.
General Information .............................................................................................................21
1.2.2.
Preclinical Pharmacology and Toxicology...........................................................................22
1.2.3.
Nonclinical Pharmacokinetics..............................................................................................22
1.2.4.
Clinical Trials of Single Agent Tenofovir Alafenamide (TAF, GS-7340) 
or Fixed-Dose Combination (FDC) emtricitabine/tenofovir alafenamide 
(F/TAF)................................................................................................................................22
1.3.
Emtricitabine (FTC, Emtriva®) ..............................................................................................................23
1.4.
Rationale for This Study ........................................................................................................................24
1.5.
Rationale for Dose Selection..................................................................................................................24
1.5.1.
F/TAF Dose in Adolescents 12 to < 18 years of Age Weighing ≥ 35 kg.............................24
1.5.2.
F/TAF Dose in Children 6 to < 12 Years of Age Weighing ≥ 25 kg and 
2 to < 12 Years of Age Weighing 17 to < 25 kg ..................................................................25
1.5.3.
Dosing in Cohorts 3 (2 to < 6 Years) and 4 (1 Month to < 2 Years)....................................28
1.6.
Risk/Benefit Assessment for the Study..................................................................................................28
1.7.
Compliance ............................................................................................................................................28
2.
OBJECTIVES.....................................................................................................................................................29
3.
STUDY DESIGN................................................................................................................................................30
3.1.
Primary Endpoints..................................................................................................................................30
3.1.1.
Secondary Endpoints............................................................................................................30
3.2.
Study Design..........................................................................................................................................30
3.2.1.
Cohort 1 (Adolescents 12 to < 18 years, ≥ 35 kg)................................................................31
3.2.2.
Cohorts 2, 3, and 4 ...............................................................................................................31
3.2.3.
Study Procedures and Frequency for All Subjects (All Cohorts and 
Parts A and B)......................................................................................................................32
3.3.
Study Treatments ...................................................................................................................................34
3.4.
Duration of Treatment............................................................................................................................35
3.5.
Criteria for Discontinuation of Study Treatment....................................................................................35
4.
SUBJECT POPULATION..................................................................................................................................37
4.1.
Number of Subjects and Subject Selection ............................................................................................37
4.2.
Inclusion Criteria....................................................................................................................................37
4.3.
Exclusion Criteria...................................................................................................................................39
5.
INVESTIGATIONAL MEDICINAL PRODUCTS ...........................................................................................41
5.1.
Enrollment..............................................................................................................................................41
5.2.
Description and Handling.......................................................................................................................41
5.2.1.
Formulations.........................................................................................................................41
5.2.2.
Packaging and Labeling .......................................................................................................42
C

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5.2.3.
Storage and Handling...........................................................................................................42
5.3.
Dosage and Administration....................................................................................................................43
5.3.1.
Cohort 1 (12 years to < 18 years, ≥ 35 kg)...........................................................................43
5.3.2.
Cohorts 2, 3, and 4 ...............................................................................................................43
5.4.
Prior and Concomitant Medications.......................................................................................................44
5.5.
Accountability........................................................................................................................................45
5.6.
Investigational Medicinal Product Return or Disposal...........................................................................45
6.
STUDY PROCEDURES ....................................................................................................................................46
6.1.
Subject Enrollment and Treatment Assignment.....................................................................................46
6.2.
Pretreatment Assessments......................................................................................................................46
6.2.1.
Screening Visit .....................................................................................................................46
6.2.2.
Baseline/Day 1 Assessments................................................................................................48
6.3.
Treatment Assessments through 48 Weeks (Weeks 1 (Day 7) − 48).....................................................50
6.4.
Early Study Drug Discontinuation (ESDD) ...........................................................................................55
6.5.
30-Day Follow-Up Visit.........................................................................................................................56
6.6.
Post Week 48 Assessments (every 12 weeks)........................................................................................58
6.7.
Bone Evaluations ...................................................................................................................................60
6.8.
Bone and Renal Safety Evaluations .......................................................................................................60
6.10.
Virologic Failure and Management of Virologic Rebound....................................................................61
6.10.1.
Subjects with ≥ 400 copies/mL of HIV-1 in Absence of Confirmed 
Virologic Failure..................................................................................................................62
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT...............................................................................63
7.1.
Definitions of Adverse Events, Adverse Reactions, and Serious Adverse Events.................................63
7.1.1.
Adverse Events.....................................................................................................................63
7.1.2.
Serious Adverse Events........................................................................................................63
7.1.3.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events .........................................................................64
7.2.
Assessment of Adverse Events and Serious Adverse Events.................................................................64
7.2.1.
Assessment of Causality for Study Drugs and Procedures...................................................64
7.2.2.
Assessment of Severity ........................................................................................................65
7.3.
Investigator Requirements and Instructions for Reporting Adverse Events and Serious 
Adverse Events to Gilead.......................................................................................................................65
7.4.
Gilead Reporting Requirements.............................................................................................................67
7.5.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events..........................................................................................................................68
7.5.1.
Toxicity Management...........................................................................................................68
7.5.2.
Grades 1 and 2 Laboratory Abnormality or Clinical Event..................................................68
7.5.3.
Grades 3 Laboratory Abnormality or Clinical Event ...........................................................68
7.5.4.
Grade 4 Laboratory Abnormality or Clinical Event.............................................................69
7.5.5.
Management of Hyperbilirubinemia in Patients Receiving Ritonavir 
Boosted Atazanavir ..............................................................................................................69
7.6.
Special Situations Reports......................................................................................................................70
7.6.1.
Definitions of Special Situations..........................................................................................70
7.6.2.
Instructions for Reporting Special Situations.......................................................................70
8.
STATISTICAL CONSIDERATIONS................................................................................................................72
8.1.
Analysis Objectives and Endpoints........................................................................................................72
8.1.1.
Analysis Objectives..............................................................................................................72
8.1.2.
Primary Endpoints................................................................................................................72
8.1.3.
Secondary Endpoints............................................................................................................72
CCI
CCI

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8.2.
Analysis Conventions.............................................................................................................................73
8.2.1.
Analysis Sets ........................................................................................................................73
8.3.
Data Handling Conventions ...................................................................................................................74
8.4.
Demographic Data and Baseline Characteristics ...................................................................................74
8.5.
Efficacy Analysis ...................................................................................................................................74
8.5.1.
Primary Analysis..................................................................................................................74
8.5.2.
Secondary Analyses .............................................................................................................75
8.6.
Safety Analysis.......................................................................................................................................75
8.6.1.
Extent of Exposure...............................................................................................................75
8.6.2.
Adverse Events.....................................................................................................................75
8.6.3.
Laboratory Evaluations ........................................................................................................76
8.6.4.
Bone Mineral Density ..........................................................................................................76
8.6.5.
Bone and Renal Safety Evaluations .....................................................................................76
8.6.6.
Tanner Stage Assessment.....................................................................................................76
8.6.7.
Acceptability and Palatability ..............................................................................................76
8.6.8.
Other Safety Evaluations......................................................................................................77
8.7.
Pharmacokinetic Analysis......................................................................................................................77
8.8.
Acceptability and Palatability ................................................................................................................77
8.9.
Sample Size............................................................................................................................................77
8.10.
Data Monitoring Committee ..................................................................................................................78
8.11.
Analysis Schedule ..................................................................................................................................79
8.12.
Endpoint Adjudication Committee.........................................................................................................79
9.
RESPONSIBILITIES..........................................................................................................................................80
9.1.
Investigator Responsibilities ..................................................................................................................80
9.1.1.
Good Clinical Practice..........................................................................................................80
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
Review and Approval...........................................................................................................80
9.1.3.
Informed Consent.................................................................................................................80
9.1.4.
Confidentiality......................................................................................................................81
9.1.5.
Study Files and Retention of Records ..................................................................................81
9.1.6.
Case Report Forms...............................................................................................................82
9.1.7.
Investigational Medicinal Product Accountability and Return.............................................83
9.1.8.
Inspections............................................................................................................................83
9.1.9.
Protocol Compliance............................................................................................................83
9.2.
Sponsor Responsibilities ........................................................................................................................84
9.2.1.
Protocol Modifications.........................................................................................................84
9.2.2.
Study Report and Publications .............................................................................................84
9.3.
Joint Investigator/Sponsor Responsibilities ...........................................................................................84
9.3.1.
Payment Reporting...............................................................................................................84
9.3.2.
Access to Information for Monitoring..................................................................................85
9.3.3.
Access to Information for Auditing or Inspections ..............................................................85
9.3.4.
Study Discontinuation..........................................................................................................85
10.
REFERENCES ...................................................................................................................................................86
11.
APPENDICES ....................................................................................................................................................88
Appendix 1.
Investigator Signature Page....................................................................................................89
Appendix 2.
Study Procedures Table..........................................................................................................90
Appendix 3.
Management of Clinical and Laboratory Adverse Events......................................................94
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities...............95
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements.................................................................................................115

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Appendix 6.
Definitions of HIV-1 Related Disease..................................................................................118
Appendix 7.
Tanner Stages .......................................................................................................................120
LIST OF IN-TEXT TABLES
Table 1-1.
TAF AUC upon Co-administration of TAF (10 or 25 mg) with 3rd Agent in Adults.............23
Table 1-2.
Pediatric F/TAF Dosing and Tablet Strength by Body Weight..............................................25
Table 4-1.
Prohibited Medication while on Study ...................................................................................40
Table 5-1.
Cohort 1 Dosing Recommendation for F/TAF in combination with 3rd ARV Agents ...........43
Table 5-2.
Cohorts 2, 3, and 4 Dosing Recommendations for F/TAF .....................................................44
Table 5-3.
List of Prohibited Medications and Medications That Are To Be Used With Caution ..........44
Table 5-4.
List of Prohibited Medications with Adverse Skeletal Effects...............................................45
LIST OF IN-TEXT FIGURES
Figure 1-1.
Predicted TAF AUC in Children Following Administration of F/TAF 200/25 mg or 
120/15 mga,b,c..........................................................................................................................26
Figure 1-2.
Predicted TFV AUC in Children Following Administration of F/TAF 200/25 mg or 
120/15 mga,b,c..........................................................................................................................27
Figure 3-1.
Study Schema.........................................................................................................................34
Figure 6-1.
Virologic Rebound Schema....................................................................................................62

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PROTOCOL SYNOPSIS
Gilead Sciences, Inc. 
333 Lakeside Drive
Foster City, CA 94404
Study Title: 
A Phase 2/3, Open-Label, Multi-Cohort Switch Study to Evaluate 
Emtricitabine/Tenofovir Alafenamide (F/TAF) in HIV-1 Infected 
Children and Adolescents Virologically Suppressed on a 
2-NRTI-Containing Regimen
IND Number:
EudraCT Number:
Clinical Trials.gov 
Identifier:
111851
2015-001339-19
NCT02285114
Study Centers Planned:
Approximately 25 centers globally.
Objectives:
The primary objectives of this study are:

To evaluate the pharmacokinetics (PK) of tenofovir alafenamide 
(TAF) and confirm the TAF dose in HIV-1 infected children and 
adolescents virologically suppressed on a 2-NRTI-containing 
regimen

To evaluate the safety and tolerability of emtricitabine/tenofovir 
alafenamide (F/TAF) through Week 24
The secondary objectives of this study are: 

To evaluate the PK of tenofovir (TFV) and emtricitabine (FTC)

To evaluate the safety, tolerability, and efficacy of F/TAF 
through Week 48
Study Design:
Open-label, multi-cohort switch study to evaluate the PK, safety, and 
efficacy of F/TAF in HIV-1 infected children (1 month to < 12 years) 
and adolescents (12 to <18 years) who are virologically suppressed 
(HIV-1 RNA < 50 copies/mL for at least 6 consecutive months) on a
stable 2-NRTI-containing regimen.
A minimum of 100 subjects aged 1 month to < 18 years of either sex 
will be enrolled as follows:
Cohort 1 (adolescents 12 to < 18 years, ≥ 35 kg):
All subjects in Cohort 1 (n = 25) will switch their current 
2-NRTI-containing regimen to F/TAF while continuing their
3rd antiretroviral (ARV) agent through 48 weeks. 

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An intensive PK (IPK) evaluation will be conducted at the Week 2
visit. TAF dose confirmation will be established if the exposure is 
comparable to that associated with efficacy in adults.
All subjects in Cohort 1 will continue to receive F/TAF plus their 
3rd ARV agent and return for study visits through Week 48.
Cohorts 2, 3, and 4
Cohorts 2, 3, and 4 will be enrolled by cohort into two parts 
(Parts A and B). Cohort 2 consists of 2 groups: Group 1 weighing 
≥25 kg and Group 2 weighing 17 kg to < 25 kg.
All subjects in Cohort 2 Group 1 must be on a boosted protease 
inhibitor (PI) as their 3rd ARV agent and will switch their current 
2-NRTI-containing regimen to open-label F/TAF while continuing 
their boosted PI through 48 weeks. 
All subjects in Cohort 2, Group 2 and Cohorts 3 and 4 will be on a 
boosted PI or other protocol-specified 3rd agents and will switch their 
current 2-NRTI-containing regimen to open-label F/TAF while 
continuing their 3rd agents through 48 weeks. 
A minimum of 10 subjects who are on boosted-ATV as their 
3rd ARV agent will be enrolled into Part A of each group of Cohort 2, 
as well as Cohorts 3 and 4. 
Cohorts 2, 3, and 4 will be enrolled as follows: 
Part A
Cohort
Age Range
Weight 
Range
Number of Subjects
ATV + 
F/TAF
LPV or 
DRV 
+ F/TAF
Other 3rd
ARV Agents 
+ F/TAF
2, Group 1
6 to < 12 years
≥ 25 kg
n ≥ 10
n ≥6
n/a
2, Group 2 
(subjects able
to swallow a 
tablet)
2 to < 12 years
17 kg to 
< 25 kg 
n ≥ 10
n ≥7
3b (subjects 
unable to 
swallow a
tablet)
2 to < 6 years
TBD
n ≥ 10
n ≥7
4a,b
1 month to 
< 2 years
TBD
n ≥ 10
n ≥7
a
DRV is not approved for Cohort 4
b
Formulation, dosing, and population specific details for Cohorts 3 and 4 will be added 
via a protocol amendment after data is obtained from Cohort 2.
All subjects in Part A will undergo an IPK evaluation at either the 
Week 2 or Week 4 visit (+7 days) to confirm the dose of TAF.

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Part B
Screening will be initiated for Part B following confirmation of TAF 
dose in Part A for each group of Cohort 2 and Cohorts 3 and 4. 
Approximately 10 additional total subjects will be enrolled in Part B 
and will receive F/TAF while continuing their 3rd ARV agent
through 48 weeks.
Number of Subjects 
Planned:
A minimum of 100 subjects will be enrolled. 
Target Population:
HIV-1 infected adolescents and children who have been virologically 
suppressed for ≥6 consecutive months prior to screening on a stable 
2-NRTI-containing regimen.
Duration of 
Treatment:
Subjects will receive study treatment for at least 48 weeks. 
After completion of 48 weeks of treatment in the study, all eligible
subjects will be given the option to participate in an extension phase 
of the study in which visits will occur every 12 weeks. Gilead will 
provide F/TAF until: 
a) the subject turns 18 years old and F/TAF is commercially available 
for use in adults in the country in which the subject is enrolled, or
b) F/TAF becomes commercially available for pediatric use in the 
country in which the subject is enrolled, or 
c) Gilead Sciences elects to terminate development of F/TAF in the 
applicable country.
Diagnosis and Main 
Eligibility Criteria:
HIV-1 infected pediatric patients at Baseline/Day 1. 
Currently on a stable 2-NRTI-containing regimen that includes a 
3rd ARV agent for ≥6 consecutive months prior to screening.
Body weight and age at screening for all cohorts is as follows:
Cohort
Age Range
Weight
1
12 years to < 18 years
≥ 35 kg
2 (Group 1)
6 years to < 12 years
≥ 25 kg
2 (Group 2) (subjects able to 
swallow a tablet)
2 years to < 12 years
17 kg to < 25 kg
3 (subjects unable to swallow a tablet)
2 years to < 6 years
TBDa
4
1 month to < 2 years
TBDb
a
Body weight cutoff at screening to be determined based upon analysis of short-term
safety and PK data from Cohort 2 Part A before initiating Cohort 3 Part A
b
Body weight cutoff at screening to be determined based upon analysis of short-term
safety and PK data from Cohort 2 Part A & Cohort 3 Part A

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No documented or suspected resistance to TFV or FTC, including, 
but not limited to, the presence of reverse transcriptase mutations 
K65R, K70E, M184V/I, or 3 or more thymidine analog-associated 
mutations (TAMs) that include M41L or L210W (TAMs are M41L, 
D67N, K70R, L210W, T215Y/F, K219Q/E/N/R).
No laboratory evidence of current active HBV or HCV infection.
Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 consecutive 
months.
Estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73 m2 by 
(Schwartz) formula.
Study Procedures/
Frequency:
At the Screening, Baseline/Day 1, and all subsequent study visits,
laboratory analyses (hematology, chemistry, and urinalysis), 
HIV-1 RNA, CD4+ cell count, complete or symptom directed 
physical examinations, and eGFR using the Schwartz formula will be 
performed. Serum (screening) or urine (all other visits) pregnancy 
tests will be performed on female subjects of childbearing potential.
At screening, HBV and HCV serology will be analyzed.
Subjects will return for study visits at Weeks 1, 2, 4, 8, 12, 24, 36,
and 48. After completion of 48 weeks of treatment in the study, all 
eligible subjects will be given the option to participate in an 
extension phase of the study in which visits will occur every 
12 weeks.
Adverse events and concomitant medications will be assessed at each 
visit.
Serum will be collected for bone safety tests (collected fasted):

Cohort 1 only: Baseline/Day 1, Weeks 4, 12, 24, and 48 and 
every 24 weeks thereafter.

Cohorts 2, 3, and 4: Baseline/Day 1, Weeks 8, 12, 24, 48, and 
every 24 weeks thereafter
For all Cohorts, urine will be collected for urine chemistry and 
selected renal safety tests, including retinol binding protein and 
beta-2-microglobulin, at Baseline/Day 1, Weeks 2, 4, 8, 12, 24, 48,
and every 12 weeks thereafter.
For Cohorts 1 and 2 (all groups), metabolic assessments will be 
collected for fasting glucose and lipid panel (total cholesterol, HDL, 
direct LDL, and triglycerides) at Baseline/Day 1, Weeks 24, 48, and 
every 24 weeks (±10 days) thereafter. The fasting requirement for 
Cohorts 3 and 4 will be specified in a future protocol amendment.

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Tanner stage assessment (Appendix 7) will be performed for subjects 
≥6 years of age at the time of the visit at Baseline/Day 1, 
Weeks 24, 48, and every 12 weeks thereafter, or until subjects reach 
Tanner Stage 5, after which point Tanner assessments will no longer 
be performed.
For all Cohorts, dual energy x-ray absorptiometry (DXA) scans of 
the lumbar spine and total body will be performed at Baseline/Day 1, 
Weeks 24, 48, and every 24 weeks thereafter to measure spine bone 
mineral density (BMD) and total body BMD.
PK sampling:
Single PK samples will be collected at the following visits for all 
cohorts:

Weeks 1 and 24: a single random PK sample.

Weeks 4 and 12: a single observed dosing PK sample at any time 
between 15 min to 4 hours post dose. (Note: Single observed 
dosing PK sample does not need to be collected at Week 4 if 
Intensive PK is also collected at the Week 4 visit)

Week 8: a trough sample at 0 hours (pre-dose, ≤ 30 minutes prior 
to dosing) at Week 8.
Intensive PK sampling:

Cohort 1 will participate in an Intensive PK (IPK) evaluation at 
the Week 2 visit as detailed in the PK manual.

Cohort 2 Part A will participate in an IPK evaluation during
either the Week 2 or Week 4 visit or within 7 days after the 
completion of Week 2 or Week 4 visit as detailed in the PK 
manual. The IPK collection schedule and fasting requirement for 
Cohorts 3 and 4 will be specified in a future protocol amendment.
PBMC collection:

PBMC collection will be performed at study sites that can 
perform PBMC processing. 

Cohorts 1 and 2: PBMC collection will be performed at the 
Week 8 visit. 

Cohort 3, and 4: PBMC collection schedule will be specified in a
future protocol amendment.

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Palatability and Acceptability Assessment:

Cohort 1: At the Week 2 visit, palatability and acceptability will 
be assessed 30 - 60 minutes after study drug dosing for all 
subjects undergoing IPK sampling. Acceptability will also be 
assessed 30 - 60 minutes after study drug dosing for active 
subjects at the next study visit immediately following approval of 
this protocol at the site.

Cohort 2 Part A: Palatability and acceptability will be assessed at 
the Week 2 or Week 4 visit, or within 7 days after the completion 
of the Week 2 or Week 4 visit, 30 - 60 minutes after study drug 
dosing for all subjects undergoing IPK sampling.

Cohorts 3 and 4 Part A: Palatability and acceptability will be 
assessed for subjects undergoing IPK sampling. Assessment 
schedule will be specified in a future protocol amendment.
Subjects who prematurely discontinue from the study or do not 
participate in the extension phase will be required to return to the 
clinic for a 30-Day Follow-up Visit.
Test Product, Dose, and 
Mode of 
Administration:
F/TAF tablets administered orally QD in combination with a 
3rd ARV agent, with or without food (as determined by the 3rd ARV 
agent), dosed as follows:
Cohort
Age and body weight
F/TAF dose (mg) with 3rd agent
1
12 to <18 years, ≥35 kg
200/25 for unboosted 3rd agent
200/10 for boosted 3rd agent
2, Group 1
6 to < 12 years, ≥25 kg
200/25
2, Group 2
(subjects able to 
swallow a tablet)
2 to < 12 years,
≥17 to < 25 kg
120/15 
3 (subjects unable 
to swallow a 
tablet)
2 to < 6 years, TBD
TBDa
4
1 month to < 2 years, TBD
TBDa
a
Dose, formulation, and population specific details will be specified by protocol 
amendment after clinical safety, efficacy, and PK data from Cohorts 1 and 2 are 
available to guide dose and formulation selection of F/TAF to be administered in 
Cohorts 3 and 4.

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Criteria for Evaluation:
Safety:
Adverse events and clinical laboratory tests, including selected renal
and bone safety tests and BMD (assessed by DXA)
Efficacy:
The efficacy endpoints are:

The percentage of subjects with HIV-1 RNA < 50 copies/mL at 
Weeks 24 and 48 as defined by the US FDA-defined snapshot 
algorithm 

The change from baseline in CD4+ cell count (cells/μL) and 
CD4+ percentage at Weeks 24 and 48
Pharmacokinetics:
The following plasma PK parameters will be calculated for TAF, 
TFV and FTC (as applicable): AUCtau, AUClast, Ctau, Cmax, Clast, Tmax, 
Tlast, λz, apparent CL, apparent Vz, and T½.
 
Statistical Methods:
Plasma concentration and parameters of TAF, TFV, and FTC will be 
summarized using descriptive statistics by cohort, dose level and 
type of boosted PI (eg, ATV/r or other PIs/r) if applicable. The 
AUCtau of TAF obtained in subjects from Cohort 1 or Part A of 
Cohort 2 Groups 1 and 2, Cohort 3, and Cohort 4, respectively, will 
be compared to historical adult data (ie, Study GS-US-311-1089). 
The comparisons will be conducted within each cohort and by dose 
level (ie. 200/25 mg vs 200/10 mg), when applicable. TAF dose 
confirmation will be established if the lower bound of the 
90% confidence interval (CI) of the geometric mean ratio (pediatric 
subjects vs adult subjects) is above 70% for TAF AUCtau. The 
95% CI of the geometric mean estimates of Cl/F and Vz /F will also 
be constructed for TAF. 
For efficacy and safety endpoints, results from each group or cohort
will be descriptive in nature. F/TAF results from each cohort will 
also be combined to describe the overall efficacy and safety profile 
of F/TAF in pediatric subjects. 
The percentage of subjects with HIV-1 RNA < 50 copies/mL at 
Weeks 24 and 48 as defined by the US FDA-defined snapshot 
algorithm will be summarized by group or cohort. The 95% CI for 
the point estimate for F/TAF will be constructed. 
CCI

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The change from baseline in CD4+ cell count and CD4+ percentage 
will be summarized by visit, group, and coho1i using descriptive 
statistics. 
Bone and renal safety test data will be summarized by visit, group, 
and coho1i. The incidences of treatment-emergent adverse events and 
treatment-emergent laborato1y abno1malities will be summarized by 
group, coho1i, and overall. 
Cohort 1: Twenty-five subjects in Coho1i 1 will provide at least 
90% power to target a 95% confidence interval within 60% and 
140% of the geometric mean estimate of apparent CL and apparent 
V2 of TAF, respectively, assuming a standard deviation of 0.60 for 
CL and 0.58 for V2 (natural log scale) estimated from 
Study GS-US-292-0106 Cohort 1 Pait A. 
Cohort 2 (Group 1) Part A: At least 10 subjects on boosted 
ATV+ F/TAF and 6 subjects on boosted LPV or DRV + F/TAF, 
compared with the population PK data from 44 adult subjects on 
boosted ATV+ F/TAF and 87 adult subjects on boosted LPV or 
DRV + F/TAF in Study GS-US-311-1089, respectively, will each 
provide at least 80% power to show the lower bound of a 90% CI of 
geometric mean ratio (pediatric subjects vs. adult subjects) greater 
than 70% for AUC1au of TAF, assuming that the expected geometric 
mean ratios of TAF AUC1au between pediatric subjects and adult 
subjects are equal to 1 and the standai·d deviations are 0.40 
(with boosted ATV + F/TAF) and 0.33 (with boosted LPV or 
DRV + F/TAF) ng*hr/mL for TAF AUCiau (natural log scale) 
estimated from the population PK data in Study GS-US-311-1089. 
Cohorts 2 (Group 2), 3, and 4, Part A: At least 10 subjects on 
boosted ATV+F/TAF and at least 7 subjects on any other 
3rd agent + F/TAF in each group or cohort, compai·ed with the 
population PK data from 292 adult subjects on any 3rd agent + F/TAF 
in Study GS-US-311-1089, will provide 90% power to show the 
lower bound of a 90% CI of geometric mean ratio (pediatric subjects 
vs. adult subjects) greater than 70% for AUCiau ofTAF, assuming 
that the expected geometric mean ratio ofTAF AUCtau between 
pediatric subjects and adult subjects is equal to 1 and the standard 
deviation is 0.48 ng*hr/mL for TAF AUCiau (natural log scale) 
estimated from the population PK data in Study GS-US-311-1089. 
Page 13 
02 August 2017 

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A total of at least 100 subjects receiving F/TAF from Cohort 1, 
Parts A and B of Cohort 2 (Groups 1 and 2), Cohort 3, and Cohort 4 
combined will provide reasonable assessment of safety through 
Week 48 in pediatric subjects.
This study will be conducted in accordance with the guidelines of Good Clinical Practice (GCP) 
including archiving of essential documents. 

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GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS
° C 
degrees Celsius
° F
degrees Fahrenheit
AE
adverse event
AIDS
Acquired Immune Deficiency Syndrome
AK
adenylate kinase
ALT
alanine aminotransferase
ARV
Antiretroviral
AST
aspartate aminotransferase
ATV/r
ritonavir boosted atazanavir 
AUC
area under the plasma/serum/peripheral blood mononuclear cell concentration versus time 
curve
AUCtau
area under the concentration verses time curve over the dosing interval
BsAP
Bone specific alkaline phosphatase
BMD
bone mineral density
BUN
blood urea nitrogen
CBC
complete blood count
Clast
the last observed quantifiable plasma concentration of drug
CL/F
the apparent oral clearance after administration of the drug: 
CL/F Dose/AUCinf
where “Dose” is the dose of the drug
Cmax
the maximum observed serum/plasma/peripheral blood mononuclear (PBMC) 
concentration of drug
CNS
central nervous system
COBI, /co
cobicistat 
Ctau
the observed drug concentration at the end of the dosing interval
CPK
creatine phosphokinase
CRF
case report form(s)
CRO
contract (or clinical) research organization 
CSR
Clinical Study Report
CTX
type 1 collagen crosslinked C-telopeptide
DXA
Dual-energy X-ray absorptiometry
DHHS
Department of Health and Human Services
DNA
deoxyribonucleic acid
DRV/r
ritonavir boosted darunavir
DSPH
Drug Safety and Public Health
DTG
Dolutegravir
D2000006
Gilead pre-clinical study: “A cardiovascular profile study following a single oral 
administration of GS-7340 in the unrestrained conscious beagle dog”
ECG
Electrocardiogram
EDC
electronic data capture

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eCRF
electronic case report form(s)
eGFR
estimated glomerular filtration rate
EFV
Efavirenz
EVG
elvitegravir 
E/C/F/TAF
elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 
200 mg/tenofovir alafenamide (TAF) 10 mg single tablet regimen
ESDD
Early Study Drug Discontinuation
FAS
full analysis set
FDA
(United States) Food and Drug Administration
FDC
Fixed-Dose Combination
FTC
Emtricitabine
F/TAF
emtricitabine/tenofovir alafenamide
GCP
Good Clinical Practice (Guidelines)
GSI
Gilead Sciences, Inc.
GS-7340
tenofovir alafenamide, TAF, L-Alanine, N-[(S)-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-
methylethoxy]methyl]/ phenoxyphosphinyl]-, 1-methylethyl ester
HAART
highly active antiretroviral therapy
HBsAg
hepatitis B virus surface antigen serology
HBV
hepatitis B virus
HCV
hepatitis C virus
HCVAb
hepatitis C virus serology
HDPE
high-density polyethylene
HIV
human immunodeficiency virus
HLGT
high-level group term
HLT
high-level term
HSP
Hysterosalpingogram
IB
investigator’s brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonisation
IDMC
Independent Data Monitoring Committee
IEC
Indpendent Ethics Committee
IND
Investigational New Drug (Application)
INSTI
integrase strand transfer inhibitor
IMP
Investigational Medicinal Product
IRB
institutional review board
IUD
intrauterine device
IWRS
interactive web response system
KS
Kaposi’s sarcoma
LLN
lower limit of the normal range
LLOQ
lower limit of quantification

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LLT
low-level term
LPV/r
ritonavir boosted lopinavir
MedDRA
Medical Dictionary for Regulatory Activities
mg
Milligram
min
Minute
mmHg
millimeters mercury
NNRTI
non-nucleoside reverse transcriptase inhibitor
NtRTI
nucleotide reverse transcriptase inhibitor
NRTI
nucleoside/nucleotide reverse transcriptase inhibitor
NVP
Nevirapine
P1NP
procollagen Type 1 N-terminal propeptide
PBMC
peripheral blood mononuclear cell
PC-120-2005
Gilead pre-clinical study: “Effect of GS-7340-03 on Cloned hERG Potassium Channels 
Expressed in Human Embryonic Kidney Cells”
PI
protease inhibitor
PK
Pharmacokinetic
PTH
parathyroid hormone
QD
once daily 
R990186
Gilead pre-clinical study: “A pharmacologic assessment of the effect of GS-7340-02 on 
the renal system of the rat”
R990187
Gilead pre-clinical study: “A pharmacologic assessment of the effect of GS-7340-02 on 
the gastrointestinal motility in the rat”
R990188
Gilead pre-clinical study: “A pharmacologic assessment of the effect of GS-7340-02 on 
the central nervous system of the rat”
RAL
Raltegravir
RBC
Red blood cells
RNA
ribonucleic acid
RPV
Rilpivirine
SAE
serious adverse event
SOC
system organ class
SOP
Standard Operating Procedure
STB
Stribild®, EVG/COBI/FTC/TDF (E/C/F/TDF) STR
SUSAR
Suspected Unexpected Serious Adverse Reaction
TAF
tenofovir alafenamide (GS-7340)
TAF fumarate
tenofovir alafenamide fumarate (GS-7340-03)
TAM
thymidine analog-associated mutations
TBD
to be determined
TDF
tenofovir disoproxil fumarate
TFV
Tenofovir
TFV-DP
tenofovir diphosphate (TFVpp)
Tmax
the time (observed time point) of Cmax

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UGT
uridine glucuronosyltransferase
ULN
upper limit of the normal range
US
United States
Vz /F
apparent volume of distribution during the terminal phase
z
terminal elimination rate constant, estimated by linear regression of the terminal 
elimination phase of the serum, plasma concentration of drug versus time curve

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1.
INTRODUCTION
1.1.
Background
Human immunodeficiency virus-1 (HIV-1) infection is a life-threatening and serious disease that 
is of major public health interest around the world. There are approximately 2.1 million people in 
North America and Western and Central Europe living with HIV-1 and 36.7 million people 
worldwide {Joint United Nations Programme on HIV/AIDS (UNAIDS) 2016}, including 
2.1 million children under 15 years of age {Joint United Nations Programme on HIV/AIDS 
(UNAIDS) 2016}. This figure is likely to underestimate the HIV disease burden in the pediatric 
population using the European Medicines Agency (EMA) categorization of adolescence as from 
12 to 16 or 18 years, depending on the region (EMA, Note for Guidance CPMP/ICH/2711/99).
The infection, if left untreated or suboptimally treated, is characterized by deterioration in 
immune function, ultimately resulting in death. Therapeutic strategies for the treatment of HIV-1 
disease have been significantly advanced by the availability of highly active antiretroviral 
therapy (HAART); the introduction of HAART was associated with a dramatic decrease in 
acquired immune deficiency syndrome (AIDS)-related morbidity and mortality {Mocroft 1998, 
Palella 1998, Sterne 2005}.
Disease Pathophysiology
The pathogenesis of HIV-1 infection and the general virologic and immunologic principles 
underlying the use of ARV therapy are similar between HIV-1 infected adult and pediatric 
patients. However, there are some important and unique issues for HIV-1 infected infants, 
children, and adolescents, including the following {Panel on Antiretroviral Therapy and Medical 
Management of HIV-infected Children 2011}:

Acquisition of infection through perinatal exposure for many infected children

In utero, intrapartum, and/or postpartum neonatal exposure to zidovudine and other ARV
medications in most perinatally infected children

Age-specific differences in CD4+ cell counts and percentages

Changes in pharmacokinetic parameters with age caused by the continuing development and 
maturation of organ systems involved in drug metabolism and clearance

Differences in the clinical and virologic manifestations of perinatal HIV-1 infection secondary 
to the occurrence of primary infection in growing, immunologically immature persons

Special considerations associated with adherence to ARV treatment for infants, children, and 
adolescents

Need for longer duration of therapy, with potentially greater implications than in adults for 
long-term toxicity and development of resistance

Differences in physiological development of certain body systems, including the skeletal 
system, where peak bone mass is not achieved until early adulthood

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Additional issues that may need to be considered include the fact that the processes involved in 
growth and development during childhood and adolescence can affect the adverse event profile 
of drugs, and that developmental changes associated with aging and growth are often not linear 
{Ginsberg 2004, McCarver 2004}.
Treatment
The goal of ARV therapy for HIV-1 infection is to delay disease progression, improve immune 
function, and increase the duration of survival by achieving maximal and prolonged suppression 
of HIV-1 replication. The availability of highly active antiretroviral therapy (HAART) 
combinations for the treatment of HIV-1 infection has resulted in a dramatic reduction in 
Acquired Immunodeficiency Syndrome (AIDS) related morbidity and mortality in the US and 
Europe {Mocroft 1998, Palella 1998, Sterne 2005}. However, eradication of the virus is not 
possible with therapies that are currently available. These therapies have several distinct adverse 
events such as mitochondrial dysfunction, metabolic abnormalities, hematologic toxicities, and 
allergic reactions.
The 2017 Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection generally 
recommend the use of 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in 
combination with a 3rd agent (a non-nucleoside reverse transcriptase inhibitor [NNRTI], a 
boosted protease inhibitor [PI] or an integrase strand transfer inhibitor [INSTI]) for treatment of 
children and adolescents with HIV infection. The choice of a regimen, including the 3rd agent, is 
individualized based on a number of factors including characteristics of the proposed regimen, 
patient characteristics and results of resistance testing {HHS Panel on Antiretroviral Therapy and 
Medical Management of HIV-Infected Children with HIV 2017, Welch 2009}.
Tenofovir (TFV) is a nucleotide analog that inhibits HIV-1 reverse transcription. While tenofovir 
disoproxil fumarate (TDF), an oral prodrug of TFV, is a preferred NtRTI for initial therapy, 
nephrotoxicity is an identified risk, and reductions in bone mineral density (BMD) have been 
shown that are larger than those seen with other NRTIs. Tenofovir alafenamide (TAF) is also an 
oral prodrug of TFV. TAF is more stable in plasma than TDF, provides higher intracellular levels 
of the active phosphorylated metabolite tenofovir diphosphate (TFV-DP), and approximately 90% 
lower circulating levels of TFV relative to TDF at the clinical doses. The distinct metabolism of 
TAF offers the potential for an improved clinical profile compared with TDF. TAF is 
coformulated with the integrase strand transfer inhibitor elvitegravir (EVG), cobicistat (COBI), 
and emtricitabine (FTC) as Genvoya® (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 
[E/C/F/TAF]) and with FTC as Descovy® (emtricitabine/tenofovir alafenamide [F/TAF]). The
fixed-dose combination (FDC) Genvoya® has been approved by the FDA and EMA for the 
treatment of HIV infection in ARV-naive individuals aged ≥12 years with estimated creatinine 
clearance ≥30 mL/min. The FDC Descovy® has also been approved in combination with other 
antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years 
of age and older weighing at least 35 kg.
Development of F/TAF increases the options available for the construction of ARV regimens for 
HIV-1 infected pediatric patients, and simplifies dosing of the NRTI/NtRTI backbone. The small 
F/TAF tablet size due to the low predicted mg dose of TAF in combination with FTC should 
improve acceptability for children who can swallow tablets.

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1.2.
Tenofovir Alafenamide (TAF, GS-7340)
1.2.1.
General Information
Tenofovir alafenamide (GS-7340, TAF, or L-Alanine, N-[(S)-[[(1R)-2-(6-amino-9H-purin-9-yl)-
1-methylethoxy]methyl]/phenoxyphosphinyl]-, 1-methylethyl ester) is a second generation oral 
prodrug of TFV, a nucleotide analog that inhibits HIV-1 reverse transcription. Tenofovir is 
metabolized intracellularly to the active metabolite, TFV-DP, a competitive inhibitor of HIV-1 
reverse transcriptase (RT) that terminates the elongation of the viral DNA chain. 
The intracellular metabolism of TAF and TFV are consistent with the 600-fold enhancement in 
anti-HIV activity in cell culture of TAF over TFV.
TAF has been evaluated in a broad range of patients (e.g. treatment-naïve, virologically 
suppressed, etc) as part of Genvoya® (E/C/F/TAF), Descovy® (F/TAF), or Odefsey®
(rilpivirine/emtricitabine/tenofovir alafenamide [F/R/TAF]). Specifically, Study GS-US-292-0106 
evaluated E/C/F/TAF (adult dose) in treatment-naïve adolescents. The conclusions for Cohort 1 
(ART-naive adolescents treated with E/C/F/TAF) in this study are as follows:

High virologic success was achieved (as assessed using the FDA-defined snapshot algorithm 
with HIV-1 RNA < 50 copies/mL) in ART-naive adolescents (90.0% and 92.0% virologic 
success at Weeks 24 and 48, respectively), demonstrating efficacy of the E/C/F/TAF FDC in 
this age group. These results are in accordance with pharmacokinetic (PK) data (presented in 
an earlier CSR) that confirmed the E/C/F/TAF 150/150/200/10 mg doses for each component.

There was evidence of a robust immunological response to E/C/F/TAF in ART-naive 
adolescents. The mean (SD) increase from baseline in CD4 cell count was 
191 (175.2) cells/μL at Week 24 and 224 (170.3) cells/μL at Week 48. The mean (SD) 
increase from baseline in CD4% was 7.7% (4.77%) at Week 24 and 9.3% (5.19%) at 
Week 48.

E/C/F/TAF was well tolerated, as evidenced by the low incidence of study-drug-related 
SAEs and the absence of AEs leading to discontinuation of study drug.

The lack of notable changes from baseline in height-age spine and TBLH BMD Z-scores at 
Weeks 24 and 48 indicates that subjects mineralized bone at rates consistent with those of the 
reference population. Few subjects experienced a clinically relevant decrease from baseline 
in BMD.

Changes from baseline in serum creatinine and eGFR were consistent with the inhibitory 
effect of COBI on renal tubular secretion of creatinine, and are not considered reflective of 
changes in actual glomerular filtration. There were decreases from baseline in proteinuria, as 
assessed by UPCR (urine protein to creatinine ratio).

E/C/F/TAF has been approved in adults and pediatric patients 12 years of age and older in 
the US and EU {Gilead Sciences Inc 2016, Gilead Sciences International Limited 2016}.
Please refer to the respective Investigator’s Brochure for further information, including data from 
adult studies.

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1.2.2.
Preclinical Pharmacology and Toxicology
1.2.2.1.
Primary Pharmacodynamics
TAF, like TDF, is an orally bioavailable prodrug of TFV. Following oral administration, TAF is 
metabolized to TFV, a nucleotide analog (i.e., a nucleoside monophosphate analog) which is not 
dependent on an intracellular nucleoside kinase activity for the first step in the conversion to the 
active metabolite, TFV-DP. The cellular enzymes responsible for TFV metabolism to the active 
diphosphorylated form are adenylate kinase (AK) {Robbins 1995} and nucleotide diphosphate 
kinase, which are highly active and ubiquitous. AK exists as multiple isozymes (AK1 to AK4), 
with the phosphorylation of TFV mediated most efficiently by AK2.
The intracellular metabolism of TAF and TFV are consistent with the 600-fold enhancement in 
anti-HIV activity in cell culture of TAF over TFV. Metabolism of TAF was also studied in 
different human blood lymphocyte subpopulations, CD4+ and CD8+ T-cells, NK cells, B-cells 
and macrophages/monocytes. TAF is metabolized inside host cells to the active metabolite 
TFV-DP. Concentration of the active metabolite TFV-DP was substantial in all cell populations.
1.2.2.2.
Safety Pharmacology
TAF monofumarate (GS-7430-02) has been evaluated to determine potential effects on the 
central nervous system (Study R990188), renal system (Study R990186), cardiovascular system 
(Study D2000006) and gastrointestinal systems (Study R990187). Single doses did not induce 
pharmacologic effects on the central nervous system of the rat (1000 mg/kg), the renal system of 
the rat (1000 mg/kg), or the cardiovascular system of the dog (100 mg/kg). TAF monofumarate 
(at 1000 mg/kg) reduced distal transit and increased stomach weights starting 2 hours postdosing 
with reversibility beginning by 6 hours after dosing. The NOEL for gastrointestinal motility was 
100 mg/kg. The IC50 for the inhibitory effect of TAF fumarate (GS-7340-03) on hERG 
potassium current was estimated to be greater than 10 μM (Study PC-120-2005).
1.2.3.
Nonclinical Pharmacokinetics
Information regarding the TAF nonclinical PK is available in the current F/TAF IB.
1.2.4.
Clinical Trials of Single Agent Tenofovir Alafenamide (TAF, GS-7340) or 
Fixed-Dose Combination (FDC) emtricitabine/tenofovir alafenamide 
(F/TAF)
Clinical trials entailing the use of TAF or F/TAF FDC are included in the F/TAF IB.
Drug Interaction Studies with TAF and 3rd ARV Agents
TAF systemic exposure was found to be increased by COBI via P-glycoprotein inhibition. This 
led to the selection of TAF 10 mg in the E/C/F/TAF FDC tablet, which achieved TAF exposure 
bioequivalent to that achieved with TAF 25 mg (Study GS-US-292-0103), which is considered 
the reference exposure.

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Three drug-drug interaction studies (GS-US-311-0101, GS-US-120-0117, and GS-US-120-0118) 
have been conducted to determine the drug interaction potential of commonly used 3rd agents 
with TAF. In combination, Studies GS-US-311-0101, GS-US-120-0117, and GS-US-120-0118 
provide drug interaction data between TAF and boosted protease inhibitors (DRV/r, ATV/r, 
LPV/r), non-nucleoside reverse transcriptase inhibitors (EFV and RPV), and the integrase strand 
transfer (INSTI) inhibitor dolutegravir (DTG), and the effect of these 3rd agents on TAF 
exposure is shown in Table 1-1. 
While no clinical drug-drug interaction studies of TAF were conducted with RAL, MVC and 
NVP, no clinically relevant drug-drug interaction is expected based upon preclinical and clinical 
information.
Table 1-1.
TAF AUC upon Co-administration of TAF (10 or 25 mg) with 
3rd Agent in Adults
Study 
Co-administered 
3rd agent
TAF dose evaluated in the 
DDI study (mg)
Effect of 3rd agent on 
TAF AUClast
GS-US-120-0118
ATV/r
10
↑ 91%
LPV/r
10
↑47%
DRV/r
10
↑ 6%
DTG
10
↑19%
GS-US-120-0117
RPV
25
↓ 4%
GS-US-311-0101
EFV
40
↓ 14%
Study GS-US-311-1089 is an ongoing 48-week, randomized, double-blinded, switch study to 
evaluate F/TAF in HIV-1 infected, virologically suppressed adults on regimens containing 
FTC/TDF. Safety and efficacy of F/TAF 200/10 or 200/25 mg in combination with the 
appropriate 3rd agent is being evaluated in addition to TAF and TFV PK.
1.3.
Emtricitabine (FTC, Emtriva®)
Emtricitabine (5-fluoro-1-[(2R, 5S)-2-(hydroxymethyl)-[1, 3]-oxathiolan-5-yl] cytosine, FTC) is 
an NRTI that has demonstrated potent and selective inhibition of HIV. In HIV-infected adults,
FTC is administered as a 200 mg QD dose concurrently with other ARV drugs. The 200 mg FTC
capsule formulation was approved by the US Food and Drug Administration (FDA) for
marketing on 02 July 2003 and is available under the name Emtriva®. In the European Union
(EU), marketing authorization was granted for both the 200 mg Emtriva® capsule formulation
and a 10 mg/mL Emtriva® oral solution formulation on 24 October 2003, with indications for the
treatment of HIV infection concurrently with other antiretroviral drugs in both adult and
pediatric patients. Further information is available in the current Prescribing Information for 
Emtriva®.

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1.4.
Rationale for This Study
The success of HAART and the apparent benefits of maximally suppressed viremia have shifted
clinical attention towards ARV agents that optimize long-term safety and tolerability. Young, 
newly infected patients are diagnosed earlier, initiate therapy earlier and look ahead towards 
lifelong therapy {Prejean 2011}. Renal and bone health, in both of these contexts are 
increasingly important {Capeau 2011}
Although more than 20 different ARV agents in five classes are available for the treatment of 
HIV infection in adults, adolescents have limited treatment options for effective, safe and well 
tolerated once daily therapy. Adolescents with HIV infection are in need of ARV regimens for 
which therapeutic dosing has been validated by pharmacokinetic data. Many adolescents with 
HIV infection would benefit from the availability of a simplified, fixed dose combination of 
F/TAF that combines potent efficacy, tolerability, a favorable toxicity profile, and practical, 
convenient dosing.
Gilead has developed the FDC product F/TAF. Children ages 2 to < 12 years old will benefit 
from the availability of an NRTI/NtRTI backbone in a single formulation to be administered with 
other ARV agents. 
Switching from a 2-NRTI-containing ARV regimen to a TAF-containing ARV regimen may lead 
to improvement in renal and bone safety parameters due to lower plasma TFV exposure. 
HIV-infected pediatric subjects may benefit from a fixed dose tablet or age appropriate 
formulation of F/TAF, which has the potential for an improved renal and bone safety profile 
relative to TDF, an important consideration for a population in which peak bone mass has not yet 
been achieved and for whom HIV treatment is anticipated to be life-long. 
1.5.
Rationale for Dose Selection
The proposed F/TAF doses for this study are expected to provide plasma exposures in the 
pediatric population that are comparable to those associated with safety and efficacy in adults. 
1.5.1.
F/TAF Dose in Adolescents 12 to < 18 years of Age Weighing ≥35 kg
The recommended F/TAF dose in adolescents 12 to < 18 years is 200/10 mg or 200/25 mg based 
on the coadministered 3rd agent. Exposures of TAF, TAF-metabolite TFV, and FTC observed 
following administration of F/TAF 200/10 mg or 200/25 mg in adolescents are consistent with 
exposures observed in adults.
For boosted regimens, such as LPV/r, DRV/r and ATV/r, the recommended F/TAF dose is the 
adult strength tablet, 200/10 mg. For unboosted regimens, such as EFV, NVP, RAL and DTG, 
the recommended F/TAF dose is the adult strength tablet, 200/25 mg. 

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1.5.2.
F/TAF Dose in Children 6 to < 12 Years of Age Weighing ≥25 kg and 
2 to < 12 Years of Age Weighing 17 to < 25 kg
In the US, F/TAF 200/25 mg is approved for use in adults and adolescents (greater than 12 years 
of age and weighing ≥ 35 kg) when used with unboosted or boosted 3rd agents.
For children 6 to < 12 years old weighing ≥25 kg, the proposed F/TAF dose for evaluation is
200/25 mg (Table 1-2).
For children 2 to < 12 years old weighing 17 to ˂ 25 kg, a reduced F/TAF dose of 120/15 mg is 
proposed for evaluation (Table 1-2).
Table 1-2.
Pediatric F/TAF Dosing and Tablet Strength by Body Weight
Weight Band in (kg)
Strength F/TAFa (mg)
≥25 to < 35
200/25b
≥17 to < 25
120/15
a
These doses are regardless of 3rd agent.
b
This group will enroll only boosted PIs and this is the dose that will be used.
The dosing nomogram is structured to simplify dosing and formulations and to avoid 
subtherapeutic dosing in a population requiring lifelong therapy from a young age, in which the 
implications of virologic failure may be greater than in adults. The predicted exposures following 
administration of F/TAF 200/25 mg in children weighing ≥25 kg or F/TAF 120/15 mg in 
children weighing 17 to ˂ 25 kg are generally within the range of those observed in adults and 
simulations of TAF and TFV (TAF-metabolite) exposures for these doses are shown in 
Figure 1-1 and Figure 1-2 below.
Rationale for TAF Doses in Children 6 to < 12 Years of Age Weighing ≥25 kg and 
Children 2 to 12 Years of Age Weighing 17 to < 25 kg
TAF and TFV exposures were predicted by allometric scaling of adult exposures considering 
correlations between body weight and clearance (CL) capacity. Model-predicted systemic 
exposures of TAF and TFV in children 6 to < 12 years old and weighing ≥ 25 kg administered 
F/TAF 200/25 mg or children 2 to < 12 years weighing 17 to < 25 kg with unboosted or boosted 
3rd agents are presented in Figure 1-1 and Figure 1-2 respectively. These simulations indicate 
similar predicted ranges of TAF and TFV exposure in children 6 to < 12 years weighing ≥25 kg 
and children 2 to < 12 years weighing 17 to < 25 kg following administration of F/TAF 
200/25 mg or 120/15 mg respectively with unboosted or boosted 3rd agents. Additionally, the 
range of expected TAF and TFV exposures are generally within the range of those observed in 
the adult Phase 2/3 population, with TFV exposures that are generally less than median TFV 
exposures (median AUC: 2360 h*ng/mL) observed in children 6 to < 12 years old with TDF 
(Study GS-US-104-0352).

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Figure 1-1.
Predicted TAF AUC in Children Following Administration of 
F/TAF 200/25 mg or 120/15 mga,b,c
a
The adult exposures for TAF were the population PK predicted exposures from GEN Phase 3 studies
(Genvoya NDA 207561, m5.3.3.5, Population PK Analysis of TAF and TFV following Administration of E/C/F/TAF STR)
b
The observed AUC values for TAF in children ≥ 25 kg are from Study GS-US-292-0106.
c
For boosted agents, predicted exposures of TAF upon administration of TAF 25 mg with ATV/r are shown and are expected 
to encompass exposures of TAF upon coadministration with other boosted 3rd agents (LPV/r or DRV/r) (Table 1-1).
 
 
 
 
 
 
                                                                                         
 
 
 
 
 
 
 
 
  
  
 
  
 
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                                                         
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 

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Figure 1-2.
Predicted TFV AUC in Children Following Administration of 
F/TAF 200/25 mg or 120/15 mga,b,c
a
The adult exposures for TFV were the population PK predicted exposures from GEN Phase 3 studies
(Genvoya NDA 207561, m5.3.3.5, Population PK Analysis of TAF and TFV following Administration of E/C/F/TAF STR)
b
The observed AUC values for TFV in children ≥ 25 kg are from Study GS-US-292-0106.
c
For boosted agents, predicted exposures of TFV upon administration of TAF 25 mg with ATV/r are shown and are expected 
to encompass exposures of TFV upon coadministration with other boosted 3rd agents (LPV/r or DRV/r) (Table 1-1).
Rationale for FTC Doses in Children 6 to < 12 Years of Age Weighing ≥25 kg and 
Children 2 to < 12 Years of Age Weighing 17 to < 25 kg
Emtricitabine is approved to be dosed at ≤6.1 mg/kg in children as either a capsule or oral 
solution formulation {EMTRIVA® 2012}. Per the current Emtriva label, the approved dose of 
200 mg FTC can be administered in adults with normal renal function and those with mild renal 
impairment (50-80 mL/min), in whom FTC exposures were shown to be approximately 70% 
higher than adults with normal renal function {EMTRIVA® 2012}. In addition, a proposal for 
FTC/TDF low-dose tablets from the WHO Paediatric Antiretroviral Working Group 
{World Health Organization (WHO) 2011} allows FTC doses up to 8.57 mg/kg (corresponding 
to a 40% increase over 6.1 mg/kg) for use in children. Given the approved doses for FTC and its 
dose-proportional pharmacokinetics, the proposed FTC doses for evaluation in children 
6 to < 12 years weighing ≥25 kg or 2 to < 6 years weighing 17 to < 25 kg are expected to result 
in exposures in the range of those providing a favorable risk:benefit profile.
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
                                              
 
 
 
 
 
 
 
   
 
 
 
 
 
                                                                                         
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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The F/TAF FDC tablets for use in patients 6 to < 12 years weighing ≥25 kg or 2 to < 6 years 
weighing 17 to < 25 kg provide a range of FTC doses comparable to the approved doses which 
do not exceed 8.57 mg/kg.
1.5.3.
Dosing in Cohorts 3 (2 to < 6 Years) and 4 (1 Month to < 2 Years)
The protocol will be amended to add dosing and formulation and specific inclusion/exclusion for 
Cohorts 3 and 4 once dose confirmation is established in Cohort 2.
1.6.
Risk/Benefit Assessment for the Study
All patients with HIV-1 infection should receive effective antiretroviral therapy. Potential risks 
associated with all classes of ARVs include immune reconstitution syndrome, lipodystrophy, and 
lactic acidosis with steatosis. The risk of class effects is considered to be low. Important 
identified risks will be appropriately managed by study inclusion/exclusion criteria as well as 
through close clinical and laboratory monitoring during the study. Interim data will also be 
reviewed by an independent data monitoring committee. Potential benefits may include provision 
of a new antiretroviral therapy that is not currently available and which may have fewer side
effects than alternative therapies. Other potential benefits include the knowledge that patient 
participation will contribute to the body of knowledge of HIV therapies. 
Potential toxicity is appropriately managed by study inclusion/exclusion criteria, close clinical 
and laboratory monitoring, as well as specific toxicity management guidance to investigators 
(refer to Section 7.5.1). 
The overall benefit-risk assessment for F/TAF administered orally once-daily with food, in 
combination with boosted-PI or any other 3rd ARV agent, is favorable at this time.
1.7.
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 objectives of this study are:

To evaluate the PK of TAF and confirm the TAF dose in HIV-1 infected children and 
adolescents virologically suppressed on a 2 NRTI-containing regimen.

To evaluate the safety and tolerability of F/TAF through Week 24.
The secondary objectives of this study are: 

To evaluate the PK of TFV and FTC.

To evaluate the safety, tolerability, and efficacy of F/TAF through Week 48.

F!TAF 
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3_ 
STUDY DESIGN 
3.1. 
Primary Endpoints 
The prima1y endpoints are: 
• 
The PK parameter AUCtau for TAF 
Final 
Amendment2 
• 
fucidence of treatment-emergent SAEs and all treatment-emergent adverse events through 
Week24 
3.1.1. 
Secondary Endpoints 
The secondaiy endpoints are: 
• 
PK parameters of Cmax, C1ast, Cl/F, and V2 IF for TAF, AUCtau, Cma.x, and Ctau for FTC and 
TFV 
• 
fucidence of treatment-emergent SAEs and all treatment-emergent adverse events through 
Week48 
• 
The percentage of subjects with HIV-I RNA < 50 copies/mL at Weeks 24 and 48 as defined 
by the US FDA-defined snapshot algorithm 
• 
The change from baseline in CD4+ cell count (cells/µL) and CD4+ percentage at 
Weeks 24 and 48 
• 
The palatability and acceptability of the age-appropriate F/TAF fo1mulation 
I 
I 
I 
3.2. 
Study Design 
This protocol describes an open-label, multi-coho1t switch study to evaluate the PK, safety, and 
efficacy of FIT AF in HIV-I infected children (1 month to < 12 yeai·s) and adolescents 
(12 to <18 yeai·s) who are virologically suppressed while on a stable 2-NRTI-containing regimen. 
A minimum of 100 children and adolescent subjects, 1 month to < 18 years of age of either sex, 
will be emolled to receive F/TAF. The study will proceed in sequential cohorts as follows: 
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3.2.1.
Cohort 1 (Adolescents 12 to < 18 years, ≥ 35 kg)
All subjects in Cohort 1 (n = 25) will switch their current 2-NRTI-containing regimen to 
open-label F/TAF while continuing on their 3rd ARV agent through 48 weeks.
Subjects will be enrolled to evaluate the steady state PK and confirm the dose of TAF. 
An intensive PK (IPK) evaluation will be conducted at the Week 2 visit to confirm the dose of 
TAF and to characterize TFV and FTC exposures as appropriate. Samples will be collected over 
24 hours (pre and post dose) and will be analyzed once they are available from all subjects.
Replacement subjects may be enrolled if subjects do not complete all IPK procedures or if IPK 
data is incomplete. Replacement subjects will not be enrolled in Cohort 1 for subjects who 
discontinue the study due to treatment-related toxicity.
Following completion of the Week 2 IPK visit, all subjects will continue to receive F/TAF plus 
their 3rd ARV agent and return for study visits through Week 48. 
3.2.2.
Cohorts 2, 3, and 4
Subjects in Cohorts 2, 3, and 4 must be on a boosted protease inhibitor (PI) (Cohort 2 only) or 
any other 3rd ARV agent and will switch their current 2-NRTI-containing regimen to open-label 
F/TAF while continuing their boosted PI or 3rd agent through 48 weeks. A minimum of 
10 subjects each in Groups 1 and 2 of Cohort 2, and Cohorts 3 and 4, who are on boosted-ATV
as their 3rd ARV agent will be enrolled. Cohorts 2, 3, and 4 will be enrolled by cohort into a 
two-part study (Parts A and B) as follows: 
Part A
A minimum of 67 subjects will be enrolled to evaluate the steady state PK and confirm the dose 
of TAF with boosted ATV, LPV, DRV or other agents. 
Cohort #
Age Range
ATV + F/TAF
LPV or DRV 
+ F/TAF
Other 3rd ARV Agents
+ F/TAF
2, Group 1a
6 to < 12 years
n ≥ 10
n ≥6
n/a
2, Group 2b
2 to < 12 years
n ≥ 10
n ≥7
3
2 to < 6 years
n ≥ 10
n ≥7
4
1 month to < 2 years
n ≥ 10
n ≥7c
a
Cohort 2, Group 1 subjects must weigh ≥ 25 kg at screening
b
Cohort 2, Group 2 subjects must weigh 17 to < 25 kg at screening
c
DRV is not approved for Cohort 4
All subjects in Cohort 2 Part A will undergo an IPK evaluation at either the Week 2 or Week 4 
visit or within 7 days after the completion of the Week 2 or Week 4 visit to confirm the dose of 
TAF and to characterize the exposure of TFV. TAF dose confirmation will be established if the 
exposure is comparable to that associated with efficacy in adults. Samples will be collected over 
8 hours (pre and post dose) and will be analyzed once they are available from all subjects. 

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Replacement subjects may be enrolled if subjects do not complete all IPK procedures or if the 
IPK data is incomplete but will not be enrolled for subjects who discontinue the study due to 
treatment-related toxicity.
Following completion of the IPK, all subjects will continue to receive F/TAF plus their 
3rd ARV agent and return for study visits through Week 48.
The IPK collection schedule and fasting requirement for Cohorts 3 and 4 will be specified in a 
future protocol amendment.
Part B
After confirmation of TAF dose in Part A (IDMC review required) for each cohort (and group
for Cohort 2), approximately 10 additional total subjects will receive F/TAF while continuing
their 3rd ARV agent through 48 weeks in Part B to evaluate the safety, tolerability and efficacy of 
the treatment regimen.
3.2.3.
Study Procedures and Frequency for All Subjects (All Cohorts and 
Parts A and B)
At the Screening, Baseline/Day 1, and all subsequent study visits laboratory analyses 
(hematology, chemistry, and urinalysis), HIV-1 RNA, CD4+ cell count, eGFR using the 
Schwartz formula, and a complete or symptom directed physical examinations will be 
performed. Serum (screening) or urine (all other visits) pregnancy tests will be performed on 
female subjects of childbearing potential.
At screening HBV and HCV serology will be analyzed.
Subjects will return for study visits at Weeks 1, 2, 4, 8, 12, 24, 36, and 48. After completion of 
48 weeks of treatment in the study, all eligible subjects will be given the option to participate in 
an extension phase of the study in which visits will occur every 12 weeks. Adverse events and 
concomitant medications will be assessed at each visit.
Tanner stage assessment will be performed at Baseline/Day 1, Weeks 24 and 48, and every 
12 weeks thereafter or until subjects reach Tanner Stage 5, after which point Tanner assessments 
will no longer be performed.
Dual energy x-ray absorptiometry (DXA) scans of the lumbar spine and total body will be 
performed at Baseline/Day 1, Weeks 24 and 48, and every 24 weeks thereafter to measure spine 
bone mineral density (BMD) and total body BMD.
For all subjects, single PK samples will be collected: A single random PK sample will be 
collected at Weeks 1 and 24, and a single observed dosing PK sample will be collected at any 
time between 15 min to 4 hours post dose during Weeks 4 and 12 (Note: For subjects in Cohort 2
Part A, a single observed dosing PK sample does not need to be collected at Week 4 if Intensive 
PK is also collected at the Week 4 visit). A trough sample will be collected at 0 hours (pre-dose, 
≤ 30 minutes prior to dosing) during Week 8.

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PBMC collection will be performed at sites that have PBMC processing capability. For subjects 
in Cohorts 1 and 2, PBMC collection will be performed at the Week 8 visit. PBMC collection 
schedule for Cohorts 3 and 4 will be addressed in a future protocol amendment. For PK profiling 
in PBMCs, blood samples will be collected at 0 hours (≤ 30 minutes pre-dose). Details of PBMC 
collection and processing will be documented in the Pharmacokinetic Sample Collection, 
Processing, Storage, and Shipment Manual (PK manual).
Palatability and acceptability will be assessed in Cohort 1 subjects 30 - 60 minutes after study 
drug dosing for all subjects undergoing IPK sampling. For Cohort 1 subjects that are currently on 
study and are beyond the Week 2 visit, an acceptability assessment is required once, preferably 
at the next clinic visit following the approval of this protocol amendment at the site. Palatability
and acceptability will be assessed 30 - 60 minutes after study drug dosing for all subjects 
undergoing IPK sampling in Part A of Cohorts 2, 3, and 4. 
Serum will be collected for bone safety tests (collected fasted), including bone specific alkaline 
phosphatase (BsAP), serum phosphorous, procollagen type 1-N-terminal propeptide (P1NP), 
C-type collagen sequence (CTX), parathyroid hormone (PTH), 1,25-OH vitamin D, and 25-OH 
vitamin D (for Cohort 1: Baseline and Weeks 4, 12, 24, and 48 (±6 days) and every 24 weeks 
thereafter; for Cohorts 2,3, and 4: Baseline and Weeks 8, 12, 24, and 48 (±6 days) and every 24 
weeks thereafter).
For all cohorts and groups, urine will be collected for urine chemistry, and selected renal safety 
tests, including retinol binding protein, and beta-2-microglobulin at Baseline/Day 1, 
Weeks 2, 4, 8, 12, 24, 48, and every 12 weeks thereafter. 
For Cohorts 1 and 2 (all groups), metabolic assessments will be collected for fasting glucose and 
lipid panel (total cholesterol, HDL, direct LDL, and triglycerides) at Baseline/Day 1, 
Weeks 24, 48, and every 24 weeks (±10 days) thereafter.
Tanner stage assessment will be performed at Baseline/Day 1, Weeks 24 and 48, and every 
12 weeks thereafter, or until subjects reach Tanner Stage 5, after which point Tanner assessments 
will no longer be performed.
Dual energy x-ray absorptiometry (DXA) scans of the lumbar spine and total body will be 
performed at Baseline/Day 1, Weeks 24 and 48, and every 24 weeks thereafter to measure spine 
bone mineral density (BMD) and total body BMD.
Subjects who prematurely discontinue the study or do not participate in the extension phase, as 
well as subjects who prematurely discontinue prior to Week 48, will be required to return to the 
clinic 30 days after the completion of the study drug for a 30 Day Follow up visit. 

F!TAF 
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Final 
Amendment2 
Subjects will receive their assigned tr·eatment for 48 weeks. After completion of 48 weeks, all 
subjects will be given the option to paiiicipate in an extension phase of the study. Gilead will 
provide F/TAF until a) the subject turns 18 and F/TAF is commercially available for use in 
adults in the country in which the subject is emolled or, b) F/TAF becomes commercially 
available for pediatr·ic use in the country in which the subject is emolled or, c) Gilead Sciences 
elects to tenninate development of F/TAF in the applicable country. 
In the extension phase of the study, subjects will return for study visits eve1y 12 weeks. During 
these visits, subjects will be assessed at vaiying intervals for AEs and concomitant medications, 
Tanner Stage assessments, physical exams, vital signs, height measurements, 12-lead ECGs, 
urine collection, blood sampling, eGFR, CD4+ cell count and percentage, plasma HIV-I RNA, 
DXA scans, and study dmg dispensation and accountability. Refer to Section 6.6 for precise 
timing of the post Week 48 assessments. 
Figure 3-1. 
Screening 
$ 35 days prior 
to Day 1 
Screening 
Study Schema 
Baseline/ 
Dayl 
COHORT 1 
12 to < 18YR 
IPK 
(Week 2) 
PART A 
COHORT 2, 6 to < 12 YR 
GROUP 1, <! 25 kg 
COHORT 2, 2 to < 12 YR 
GROUP 2, 17 to< 25 kg 
Week48 
30 Day 
Follow-Up 
Extension 
Phase 
30 Day 
Follow-Up 
-or-
Extension 
Phase 
$ 35 days prior 
Baseline/ 
IPK 
Week48 
to Day 1 
Day 1 
(Week 2 or 4) 
Acceptable Week 4 
b 
PK & Safety Data 
a 
Screening 
PARTB 
COHORT 2, 6 to < 12 YR 
GROUP 1, <! 25 kg 
COHORT 2, 2 to < 12 YR 
GROUP 2, 17 to< 25 kg 
$ 35 days prior 
Baseline/ 
to Day 1 
Day 1 
Week48 
a 
Patt B screening will initiate after analysis of intensive PK samples and confumation ofTAF dose in corresponding age 
cohott in Patt A. 
b 
TI1e screening schema for Cohotts 3 and 4 will be specified in a future protocol amendment. 
3.3. 
Study Treatments 
In Coho1i 1, F/TAF will be administered orally, dosed once-daily in combination with their 
3rd ARV agent, at approximately the saine time each day, either with or without food, as 
determined by the subject's 3rd ARV agent. 
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In Cohorts 2, 3, and 4, F/TAF will be administered orally, dosed once-daily in combination with 
their 3rd ARV agent, at approximately the same time each day, either with or without food, as 
determined by the subject’s 3rd ARV agent. The F/TAF dose will be based on the subject’s 
weight and 3rd ARV agent.
On the morning of the IPK visit, subjects in Cohort 1 and in Part A of Cohorts 2, 3, and 4 will be 
administered their dose of study medication in combination with their 3rd ARV agent in the 
clinic, along with food, prior to IPK sampling. To prepare for the in-clinic dosing, subjects 
should begin taking study drug and their 3rd ARV agent in the morning starting at least 1 week 
prior to the IPK visit.
At the single observed dosing PK sampling visit, subjects will be administered their dose of 
study drug medication in combination with their 3rd ARV agent in the clinic. Prior to the single 
observed dosing PK sampling visit, subjects should take study drug at approximately the same 
time each day, regardless of the time of day, for at least 1 week prior to the PK sampling. 
Subjects will be required to report the time of the last dose during the visit. 
Prior to the single random PK sampling visit, subjects should take study drug in combination 
with their 3rd ARV agent at approximately the same time each day, regardless of the time of day, 
for at least 1 week prior to the PK sampling. Subjects will be required to report the time of the 
last dose at the time of the visit.
3.4.
Duration of Treatment
Subjects will receive their assigned treatment for 48 weeks. All subjects that complete 48 weeks
of treatment will be given the option to participate in an extension phase of the study where 
Gilead will provide F/TAF until a) the subject turns 18 years old and F/TAF is commercially 
available for use in adults in the country in which the subject is enrolled or b) F/TAF becomes 
commercially available for pediatric use in the country in which the subject is enrolled or 
c) Gilead Sciences elects to terminate development of F/TAF in the applicable country.
3.5.
Criteria for Discontinuation of Study Treatment
Study medication may be discontinued in the following instances:

Intercurrent illness that would, in the judgment of the investigator, affect assessments of 
clinical status to a significant degree. Following resolution of intercurrent illness, the subject 
may resume study dosing at the discretion of the investigator.

Unacceptable toxicity or toxicity that, in the judgment of the investigator, compromises the 
ability to continue study-specific procedures or is considered to not be in the subject’s best 
interest.

Therapeutic failure (i.e., virologic failure as per Section 6.10).

Subject request to discontinue for any reason.

Subject noncompliance.

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
Pregnancy during the study; refer to Appendix 5.

Discontinuation of the study at the request of Gilead, a regulatory agency or an institutional 
review board or independent ethics committee (IRB/IEC).

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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
A minimum of 100 subjects who meet the eligibility criteria will be enrolled.
4.2.
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for participation in this 
study.
1) HIV-1 infected male and female pediatric patients aged 1 month to < 18 years at 
Baseline/Day 1 (according to requirements of the enrolling cohort)
2) Subject able to give written assent prior to any screening evaluations if they have the ability 
to read and write
3) Parent or guardian able to give written informed consent prior to any screening evaluations 
and willing to comply with study requirements 
4) A negative serum β-HCG pregnancy test is required for female subjects of childbearing 
potential only (as defined in Appendix 5)
5) Body weight at screening as follows:
Age Range
Weight
Cohort 1
12 years to < 18 years
≥ 35 kg
Cohort 2: Group 1
6 years to < 12 years
≥ 25 kg
Cohort 2: Group 2 (able to swallow a tablet)
2 years to < 12 years
17 kg to < 25 kg
Cohort 3 (unable to swallow a tablet)
2 years to < 6 years
TBDa
Cohort 4
1 month to < 2 years
TBDb
a
Body weight cutoff at screening to be determined based upon analysis of short-term safety and PK data from Cohort 2 
Part A before initiating Cohort 3 Part A
b
Body weight cutoff at screening to be determined based upon analysis of short-term safety and PK data from Cohort 2 
Part A & Cohort 3 Part A
6) Currently on a stable 2-NRTI-containing regimen that includes a 3rd ARV agent for 
≥6 consecutive months prior to screening.
7) Plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 consecutive months preceding the 
screening visit (measured at least twice using the same assay) and not experienced 
two consecutive HIV-1 RNA above detectable levels after achieving a confirmed 
(two consecutive) HIV-1 RNA below detectable levels on the current regimen in the past year. 
a) To determine virologic suppression in the preceding 6 months prior to screening, the 
lower limit of quantification (LLOQ) by the local HIV-1 RNA assay may be used, only if 
its LLOQ is greater than 50 copies/mL (e.g. LLOQ of 75 copies/mL).

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8) Estimated glomerular filtration rate (eGFR) 90 mL/min/1.73m2 by (Schwartz) formula
9) All male subjects and those female subjects of childbearing potential or those who reach 
childbearing potential during study participation (as defined in Appendix 5) must agree to 
utilize highly effective contraception methods while on study treatment or agree to abstain 
from heterosexual intercourse throughout the study period and for 30 days following the last 
dose of study drug; highly effective methods normally utilize two separate forms of 
contraception, one of which must be an effective barrier contraceptive method. Pre-pubertal 
females (Tanner stages 1 and 2) are not considered to be of childbearing potential, unless 
onset of menarche has occurred. See Appendix 5 for definition of females of childbearing 
potential.
10) Female subjects who utilize hormonal contraceptive as one of their birth control methods 
must have used the same method for at least three months prior to study dosing. 
11) Adequate hematologic function defined as:
a) Absolute neutrophil count ≥500 cells/mm3 (Subjects with neutrophil count of < 500/mm3
documented at least twice within 6 months of screening, and in who, according to the 
investigator, there is no evidence of immunosuppression associated with low neutrophil
count, can enroll in the study contingent upon approval from the Gilead study Medical 
Monitor.)
b) Hemoglobin > 8.5 g/dL
c) Platelets ≥50,000/mm3
12) Hepatic transaminases (AST and ALT) 5 × upper limit of normal (ULN)
13) For subjects on all 3rd ARV agents except ATV, total bilirubin ≤1.5 mg/dL or normal direct 
bilirubin
14) For subjects on ATV, total bilirubin ≤ 3.0 mg/dL or normal direct bilirubin
15) Normal ECG (or if abnormal, determined by the investigator to be not clinically significant)
16) Must be willing and able to comply with all study requirements 
17) No opportunistic infection within 30 days of study entry (at Baseline/Day 1)
18) Subject is able to swallow a tablet

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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. 
1) An acquired immunodeficiency syndrome (AIDS)-defining condition with onset within 
30 days prior to screening 
2) Life expectancy of < 2 years.
3) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or 
antifungal therapy within 30 days prior to Baseline/Day 1
4) Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of 
the screening visit 
5) Anticipated requirement for rifamycin treatment while participating in the study. 
Note: prophylactic isoniazid therapy for latent tuberculosis is allowed.
6) Active HCV infection defined as positive for HCV antibody and having detectable 
HCV RNA.
a) Note: subjects with positive HCV antibody and without detectable HCV RNA are 
permitted to enroll.
7) Positive hepatitis B surface antigen or other evidence of active HBV infection. 
a) Note: Subjects with positive HBV surface antibody and no evidence of active HBV
infection are permitted to enroll. 
8) Subjects with a historical genotype that have documented or suspected resistance to TFV or 
FTC, including, but not limited to, the presence of reverse transcriptase mutations K65R, 
K70E, M184V/I, or 3 or more thymidine analog-associated mutations (TAMs) that include 
M41L or L210W (TAMs are M41L, D67N, K70R, L210W, T215Y/F, K219Q/E/N/R).
9) Have any serious or active medical or psychiatric illness which, in the opinion of the 
Investigator, would interfere with subject treatment, assessment, or compliance with the 
protocol. This would include uncontrolled renal, cardiac, hematological, hepatic, pulmonary 
(including chronic asthma or active tuberculosis), endocrine (e.g., diabetes), central nervous, 
gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), 
immunodeficiency disorders, active infection, or malignancy that are clinically significant or 
requiring treatment (within 30 days prior to Baseline/Day 1).
10) Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy).

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11) A history or ongoing malignancy other than cutaneous Kaposi’s sarcoma (KS), basal cell 
carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with 
biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic 
therapy for KS within 30 days of screening and are not anticipated to require systemic 
therapy during the study.
12) Pregnant or lactating subjects
13) Current alcohol or substance abuse judged by the Investigator to potentially interfere with 
subject compliance.
14) Have history of significant drug sensitivity or drug allergy.
15) Known hypersensitivity to the investigational medicinal product (IMP), the metabolites, or 
formulation excipient.
16) Have previously participated in an investigational trial involving administration of any 
investigational agent, other than TDF, within 30 days prior to the study dosing.
17) Participation in any other clinical trial without prior approval from sponsor is prohibited 
while participating in this trial.
18) Subjects receiving ongoing therapy with any of the following medications in the table below, 
including drugs not to be used with FTC, TAF or their 3rd ARV agent (refer to the individual 
agents Prescribing Information).
Table 4-1.
Prohibited Medication while on Study
Medication Class
Prohibited Medications
Anticonvulsants
carbamazepine, oxcarbazepine, phenobarbital, phenytoin
Antimycobacterials
rifapentine, rifabutin, rifampin
Antivirals
cidofovir, ganciclovir, valganciclovir
Herbal/Natural Supplements
St. John’s Wort, Echinacea, Milk thistle (i.e., silymarin), 
Chinese herb sho-saiko-to (or Xiao-Shai-Hu-Tang)
Other
probenecid
*
Administration of any of the above prohibited medications must be discontinued at least 30 days prior to the Baseline/Day 1 
visit and for the duration of the study.

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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Enrollment 
This is an open-label study. 
It is the responsibility of the Investigator to ensure that the subject is eligible for the study prior
to enrollment.
Subjects will be assigned a screening number at the time of consent. 
The enrollment and Baseline/Day 1 visit cannot occur until subject eligibility has been 
confirmed. Once eligibility is confirmed, the study site will use the IWRS to assign a unique 
subject enrollment number. Once a subject number has been assigned to a subject it will not be 
reassigned to any other subject.
The subject number assignment and enrollment may be performed up to 7 days prior to the 
Baseline/Day1 visit provided that all screening procedures have been completed and subject 
eligibility has been confirmed by the Sponsor.
All subjects will switch their current 2-NRTI-containing regimen to F/TAF while continuing 
their protocol-specified 3rd ARV agent.
IWRS will assign study drug bottle numbers for dispensing study drug at study visits. Initiation 
of treatment with the study drug must take place within 24 hours after the Baseline/Day 1 visit.
5.2.
Description and Handling 
5.2.1.
Formulations
5.2.1.1.
Emtricitabine/Tenofovir Alafenamide (F/TAF)
5.2.1.1.1.
Emtricitabine 200 mg/Tenofovir Alafenamide 25 mg tablets
Emtricitabine 200 mg/Tenofovir Alafenamide 25 mg tablets are rectangular-shaped, film-coated 
blue tablets that are debossed with "GSI" on one side of the tablet and "225" on the other side of 
the tablet. The F/TAF tablet cores contain 200 mg of emtricitabine and 25 mg of tenofovir 
alafenamide. In addition to the active ingredients, the F/TAF tablets contain croscarmellose 
sodium, magnesium stearate, and microcrystalline cellulose. The tablet cores are film coated 
with FD&C Blue #2/indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, 
and titanium dioxide.

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5.2.1.1.2.
Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg tablets
Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg tablets are rectangular-shaped, film-coated 
gray tablets that are debossed with "GSI" on one side of the tablet and "210" on the other side of 
the tablet. The F/TAF tablet cores contain 200 mg of emtricitabine and 10 mg of tenofovir 
alafenamide. In addition to the active ingredients, the F/TAF tablets contain croscarmellose 
sodium, magnesium stearate, and microcrystalline cellulose. The tablet cores are film coated 
with iron oxide black, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
5.2.1.1.3.
Emtricitabine 120 mg/Tenofovir Alafenamide 15 mg tablets
Emtricitabine 120 mg/Tenofovir Alafenamide 15 mg tablets are round, plain faced, film-coated 
white tablets. Alternatively F/TAF 120/15 mg tablets are round, debossed with “GSI” on one 
side of the tablet and “15” on the other side, film-coated white tablets. The F/TAF tablet cores 
contain 120 mg of emtricitabine and 15 mg of tenofovir alafenamide. In addition to the active 
ingredients, the F/TAF tablets contain croscarmellose sodium, magnesium stearate, and 
microcrystalline cellulose. The tablet cores are film coated with polyethylene glycol, polyvinyl 
alcohol, talc, and titanium dioxide.
5.2.2.
Packaging and Labeling
Emtricitabine/Tenofovir Alafenamide (F/TAF) tablets are packaged in a white high density 
polyethylene (HDPE) bottle. Each bottle contains 30 tablets, silica gel desiccant, and polyester 
packing material. Each bottle is capped with a white, continuous thread, child-resistant, 
polypropylene screw cap fitted with an induction-sealed, aluminum-faced liner.
Study drug(s) to be distributed to centers in the US and other participating countries shall be 
labeled to meet applicable requirements of the United States Food and Drug Administration 
(FDA), EU Guideline to Good Manufacturing Practice - Annex 13 (Investigational Medicinal 
Products), and/or other local regulations. All labels for study drug bottles to be distributed to 
centers in the US, EU and the rest of the countries will meet all applicable requirements of the 
US Food and Drug Administration (FDA) and Annex 13 of Good Manufacturing Practices: 
Manufacture of investigational medicinal products (February 2010) and/or other local regulations 
as applicable.
5.2.3.
Storage and Handling
Emtricitabine/Tenofovir Alafenamide (F/TAF) should be stored at a 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 study 
drugs should be stored in a securely locked area, accessible only to authorized site personnel.
To ensure the stability and proper identification, study drug(s) should not be stored in a container 
other than the container in which they were supplied. Consideration should be given to handling, 
preparation, and disposal through measures that minimize drug contact with the body. 
Appropriate precautions should be followed to avoid direct eye contact or exposure through 
inhalation when handling.

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5.3.
Dosage and Administration
All subjects in Cohort 1 will switch their current 2-NRTI-containing regimen to F/TAF while
continuing their 3rd ARV agent. All subjects in Cohorts 2, 3, and 4 will switch their current 
2-NRTI-containing regimen to F/TAF and must be on a boosted-PI or other agent as their 
3rd ARV agent as applicable per cohort.
5.3.1.
Cohort 1 (12 years to < 18 years, ≥ 35 kg)
F/TAF fixed-dose combination tablets will be provided by Gilead Sciences and will be 
administered orally, once daily as noted below in Table 5-1. The 3rd ARV agent will be 
prescribed by the Investigator and the subject will be responsible for obtaining the 3rd ARV agent 
prior to Baseline/Day 1 visit. 
During the study, investigators wishing to change a subject’s 3rd ARV agent for reasons other 
than virologic failure must discuss this change with the Gilead Medical Monitor. Refer to 
Section 6.10 for more information.
At the IPK and at the single observed dosing PK sampling visits at Weeks 4 and 12, subjects will 
be administered their dose of study medication and their 3rd ARV agent in the clinic with food 
prior to the PK sampling.
Subjects will receive their assigned treatment for 48 weeks. After completion of 48 weeks, all 
subjects will be given the option to participate in an extension phase of the study. Gilead will 
provide F/TAF until a) The subject turns 18 years old and F/TAF is commercially available for 
use in adults in the country in which the subject is enrolled or b), F/TAF becomes commercially 
available for pediatric use in the country in which the subject is enrolled or c), Gilead Sciences 
elects to terminate development of F/TAF in the applicable country. 
Table 5-1.
Cohort 1 Dosing Recommendation for F/TAF in combination with 
3rd ARV Agents
Cohort
Age and body weight
F/TAF dose (mg) with 3rd agent
1
12 to < 18 years, ≥ 35 kg
200/25 for unboosted 3rd agent
200/10 for boosted 3rd agent
5.3.2.
Cohorts 2, 3, and 4
F/TAF fixed-dose combination tablets will be provided by Gilead Sciences and will be 
administered orally, once daily as noted above in Table 5-1. The subject’s 3rd ARV agent will be 
prescribed by the Investigator and the subject will be responsible for obtaining the 3rd ARV agent 
prior to Baseline/Day 1 visit. 
For subjects in Part A of Cohorts 2, 3, and 4, at the IPK visit and at the single observed dosing 
PK sampling visits, subjects will be administered their dose of study medication and their 
3rd ARV agent in the clinic with food prior to the PK sampling.

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Table 5-2.
Cohorts 2, 3, and 4 Dosing Recommendations for F/TAF
Cohort
Age and body weight
F/TAF dose (mg) 
2, Group 1
6 to < 12 years, ≥ 25 kg
200/25
2, Group 2 (able to swallow a tablet)
2 to < 12 years, ≥ 17 to < 25 kg
120/15 
3 (unable to swallow a tablet)
2 to < 6 years, TBD
TBDa
4
1 month to < 2 years, TBD
TBDa
a
Dosage, using weight appropriate F/TAF dispersible tablets prepared as an oral suspension, will be specified by protocol 
amendment after clinical safety, efficacy, and PK data from Cohorts 1 and 2 are available to guide dose selection of F/TAF 
to be administered in Cohorts 3 and 4. Subjects under 6 years of age who cannot swallow tablets will be allowed to choose 
this formulation for treatment as well.
5.4.
Prior and Concomitant Medications
The use of medications for the treatment of HIV, other than the study treatment (i.e., F/TAF) and 
baseline 3rd ARV agent, is prohibited. Medications listed in Table 5-3 and use of herbal/natural 
supplements are excluded or should be used with caution while subjects are participating in the 
study due to potential drug-drug interactions with the study drugs. 
Should subjects have a need to initiate treatment with any excluded or prohibited concomitant 
medication, the Gilead Sciences Medical Monitor must be consulted prior to initiation of the new 
medication. In instances where a prohibited medication is initiated prior to discussion with the 
Sponsor, the Investigator must notify Gilead Sciences as soon as he/she is aware of the use of the 
prohibited medication.
Table 5-3.
List of Prohibited Medications and Medications That Are To Be Used 
With Caution
Medication Class
Prohibited Medications 
Medications To Be Used With Caution
Antiarrhythmics
amiodarone, quinidine: May increase 
concentration of TAF and/or TFV
Anticonvulsants
carbazepine, oxcarbazepine, 
phenobarbital, pheynytoin
Antimycobacterials
rifapentine, rifabutin, rifampin 
clarithromycin: may increase concentration of 
TAF and/or TFV
Antifungals
itraconazole, ketoconazole, voriconazole: may 
increase concentration of TAF and/or TFV
Antivirals
cidofovir, ganciclovir, valganciclovir 
acyclovir, valacyclovir
Calcium channel 
blockers
diltiazem, felodipine, verapamil: may increase 
concentration of TAF and/or TFV
Digoxin
Concomitant use may result in an increased or 
decreased digoxin concentration; use with 
caution and with appropriate monitoring of 
serum digoxin concentrations.
Herbal/Natural 
Supplements
St. John’s wort, Echinaccea, Milk thistle 
(i.e. silymarin), Chinese herb sho-saiko-to 
(or Xiao-Shai-Hu-Tang
Others
Probenecid

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Medications listed in Table 5-4 are prohibited and should be discussed with the GSI Medical 
Monitor while subjects are participating in the study due to potential adverse skeletal effects. 
Table 5-4.
List of Prohibited Medications with Adverse Skeletal Effects
Medication Class
Prohibited Medications
Cyclophosphamides / Cytophosphanes
cytoxan, endoxan, neosar, procytox, revimmune
Ciclosporins
cyclosporine A, B, C, D, E, F, and G
Glucocorticoids
Chronic, systemic glucocorticoids
Medroxyprogesterones
Depo-Provera
Additionally, Investigators should refer to the product/package inserts of the other ARV
medications for age-related recommendations or contraindications related to their use.
5.5.
Accountability
The investigator is responsible for ensuring adequate accountability of all used and unused IMP. 
This includes acknowledgement of receipt of each shipment of IMP (quantity and condition). All 
used and unused IMP dispensed to subjects must be returned to the site.
F/TAF accountability records will be provided to each study site to:

Record the date received and quantity of IMP kits

Record the date, subject number, subject initials, the IMP kit number dispensed

Record the date, quantity of used and unused IMP returned, along with the initials of the 
person recording the information.
5.6.
Investigational Medicinal Product Return or Disposal
Refer to Section 9.1.7 for detailed instructions. 

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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 also described in the text that follows.
Any deviation from protocol procedures should be noted in the subject’s clinical chart and
electronic Case Report Forms (eCRFs). In addition, the Sponsor or Contract Research 
Organization (CRO) should be promptly notified of any important protocol deviations.
6.1.
Subject Enrollment and Treatment Assignment
It is the responsibility of the Investigator to ensure that each subject is eligible for the study 
before enrollment.
Please refer to Section 5.1 for details about subject number and treatment assignment for each 
Cohort.
6.2.
Pretreatment Assessments
6.2.1.
Screening Visit
Subjects will be screened within 35 days before Baseline/Day 1 to determine eligibility for 
participation in the study. The following activities will be performed and documented during
screening: 

Obtain written informed assent/consent
Each subject must sign an assent if they have the ability to read and write (and parent or legal 
guardian sign an informed consent form) prior to the conduct of any screening procedures. 
Subjects will be assigned a screening number at the time of assent/consent. Screening 
evaluations are used to determine the eligibility of each candidate for study enrollment. 

Obtain medical and medication history, including history of: 
Review of Concomitant Medications
■
Any ongoing medications within 30 days of the Screening visit
HIV-1 disease-related events 
Historical genotypes should be collected, if available.

Complete physical examination (urogenital/anorectal examination will be performed at the 
discretion of the investigator)

Vital signs (blood pressure, pulse, respiration rate, and temperature)

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
Weight and height/length

12-lead ECG performed supine 

Urine collection for the following laboratory procedures:
Urinalysis 

Blood sample collection for the following laboratory analyses:
Serum pregnancy test (for females of childbearing potential in Cohorts 1 & 2 only). If 
the test is positive, the subject will not be enrolled.
Chemistry profile: alkaline phosphatase, AST, ALT, total bilirubin, direct and indirect 
bilirubin, total protein, albumin, CPK, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, phosphorus, magnesium, potassium, sodium, uric acid, and amylase 
(reflex lipase testing is performed in subjects with total amylase > 1.5 × ULN)
Hematology profile: complete blood count (CBC) with differential and platelet count
Estimated Glomerular Filtration Rate (eGFR) using Schwartz Formula:
■
(mL/min/1.73 m2) = k × L/SCr (k is a proportionality constant, L is height in 
centimeters (cm) and SCr is serum creatinine (mg/dL)). 
○
The value of k is 0.55 for children (≥ 2 to < 12) and adolescent girls 
(≥12 years old) and 0.7 for adolescent boys (≥ 12 years old).
Plasma HIV-1 RNA 
CD4cell count and percentage
Hepatitis B virus (HBV) surface antigen serology (HBsAg)
Hepatitis C virus antibody (HCVAb) serology
■
Note: If the antibody test result is positive, HCV RNA test will be performed to 
confirm HCV viremia.

Record any serious adverse events and all adverse events related to protocol mandated 
procedures occurring after signing of the consent form.

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6.2.2.
Baseline/Day 1 Assessments
Subjects meeting all of the inclusion criteria and none of the exclusion criteria will return to the 
clinic within 35 days after the Screening visit for the Baseline/Day 1visit.
Subjects with exclusionary screening laboratory results due to an acute clinical condition which 
resolves can be re-screened within 3 months of initial Screening. The decision to re-screen the 
subject will be made in consultation with the Medical Monitor, and written notice of eligibility 
from the Sponsor is required before a re-screened subject can be enrolled.
From the time of obtaining informed consent and subject assent through the first administration 
of investigational medicinal product, record all serious adverse events (SAEs), as well as any 
non-serious adverse events related to protocol-mandated procedures on the adverse events case 
report form (CRF/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 CRF/eCRF. Refer to Section 7, Adverse Events and Toxicity Management, for additional 
details. 
The following items and evaluations are to be completed at the Baseline/Day 1 Visit. The subject 
must complete all Baseline/Day 1 procedures before being dispensed the study drug. Initiation of 
treatment with the study drug must take place within 24 hours after the Baseline/Day 1 visit.

Review of AEs and changes in concomitant medications

Complete physical examination (urogenital/anorectal exams will be performed at the 
discretion of the Investigator) 

Vital signs measurement (blood pressure, pulse, respiration rate, and temperature)

Weight and height/length

Tanner Stage assessment

DXA Scan of the lumbar spine and of the total body for BMD:
The DXA scan will be performed on subjects once eligibility is confirmed and prior to 
study drug administration at the Baseline/Day 1 Visit. The scan may be performed on the 
morning of the Baseline/Day 1 Visit as long as it occurs before dosing.

Urine collection for the following laboratory procedures:
Urinalysis
Urine Chemistry

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Urine renal safety test ( collected fasted for Coho1is 1 and 2) including retinol binding 
protein and beta-2-microglobulin. If the subject has not fasted prior to the visit, the visit 
may continue; however, the subject must return within 72 hours in a fasted state to 
provide a urine sample for renal safety test. The fasting requirement for Cohorts 3 and 4 
will be specified in a future protocol amendment. 
-
Urine pregnancy test (females of childbearing potential in Cohorts 1 & 2 only). If the 
urine pregnancy test is positive at Baseline/Day 1, study dmg will not be dispensed. The 
positive result will be confomed with a sennn pregnancy test. If the semm pregnancy test 
is positive the subject will not be able to participate. 
• 
Blood sample collection for the following laborato1y analyses: 
-
Chemistiy profile: alkaline phosphatase, AST, ALT, total bilimbin, direct and indirect 
bilimbin, total protein, albumin, CPK, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, phosphoms, magnesium, potassium, sodium, uric acid, and amylase 
(reflex lipase testing is perfo1med in subjects with total amylase > 1.5 x ULN). 
-
Metabolic assessments: Fasting (no food or drinks, except water, at least 5 hours prior to 
blood collection) glucose and lipid panel (total cholesterol, HDL, direct LDL, and 
ti·iglycerides) for Coho1is 1 and 2 (all groups). If the subject has not fasted prior to the 
visit, the visit may continue; however, the subject must return within 72 hours in a fasted 
state to draw blood for the metabolic assessments. The fasting requirement for 
Coho1is 3 and 4 will be specified in a future protocol amendment. 
-
Hematology profile: complete blood count (CBC) with differential and platelet count 
-
Plasma HIV-1 RNA 
-
CD4+ cell count and percentage 
-
Whole blood sample storage for virology testing 
-
Semm will be collected for bone safety tests ( collected fasted), including bone specific 
alkaline phosphatase (BsAP), sennn phosphorous, PlNP, CTX, PTH, 1,25-0 H 
vitamin D, and 25-0H vitamin D. If the subject has not fasted prior to the visit, the visit 
may continue; however, the subject must return within 72 hours in a fasted state to draw 
blood for bone safety tests. 
-
eGFR using Schwa1iz Fo1mula 
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
Assign subject number:
The subject’s enrollment number can be assigned via IWRS up to 7 days prior to the 
Baseline/Day 1 visit provided that all screening procedures have been completed and subject 
eligibility has been confirmed.

Study drug dispensation:
Study drug will be dispensed in an open-label fashion. Subjects and/or parent/guardian will 
be dispensed F/TAF based on cohort, their weight and their 3rd agent. Subjects should initiate 
dosing of study drug within 24 hours after the Baseline/Day 1 visit. Investigators will provide 
prescriptions to the subjects and/or parent/guardian for their 3rd ARV agent. The subjects
and/or parent/guardian are responsible for obtaining their 3rd ARV agent prior to the 
Baseline/Day 1 visit.
Subjects and/or parent/guardian should be instructed to take study drug along with the
subject’s 3rd ARV agent once daily with or without food as determined by the 3rd ARV agent
and at approximately the same time each day. The subject and/or parent/guardian should be 
counseled regarding the importance of adherence and taking all their ARV study medication 
at approximately the same time each day. Sites should consider individual subject study drug 
dosing schedules while scheduling study visits requiring collection of PK samples.

Study drug accountability:
Subjects and/or parent/guardian should be reminded to bring their drug bottles of the F/TAF
and their 3rd ARV agent with them for drug accountability at Week 1.
6.3.
Treatment Assessments through 48 Weeks (Weeks 1 (Day 7) −48)
The following evaluations are to be completed at the end of Weeks 1 (Day 7), 2, 4, 8, 12, 24, 36, 
and 48 unless otherwise specified.
All study visits are to be scheduled relative to when the Baseline/Day 1 visit was completed.
Thereafter all study visits through Week 8 are to be completed within ± 2 days of the protocol
specified visit date. Visits between Week 12 through Week 48 are to be completed within 
± 4 days of the protocol specified visit date, unless otherwise specified.
Regularly scheduled evaluations will be made on all subjects whether or not they continue to
receive study drug.

Review of AEs and changes in concomitant medications

Complete physical examination (Weeks 24 and 48) (urogenital/anorectal exams will be 
performed at the discretion of the Investigator) or symptom-directed physical examination as 
needed (Week(s) 1 (on Day 7), 2, 4, 8, 12, and 36)

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Vital signs (blood pressure, pulse, respiration rate, and temperature) 
• 
Weight and height/length 
Final 
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• 
Tanner Stage assessment (\Veeks 24 and 48 - except for subjects documented to have 
achieved Tanner Stage 5) 
• 
DXA Scan of the lumbar spine and the total body for BMD at Weeks 24 and 48 (± 10 days) 
• 
Urine collection for the following laborato1y procedures: 
-
Urinalysis 
-
Urine chemistry (\Veeks 2, 4, 8, 12, 24, and 48) 
-
Selected renal safety test ( collected fasted for Coho1is 1 and 2) including retinol binding 
protein and beta-2-microglobulin. If the subject has not fasted prior to the visit, the visit 
may continue; however, the subject must return within 72 hours in a fasted state to 
provide a urine sample for renal safety test (\Veeks 2, 4, 8, 12, 24, and 48). 
-
Urine pregnancy test (females of child bearing potential in Cohorts 1 & 2 only). If the 
urine pregnancy test is positive, study dmg will not be dispensed. The positive result will 
be confnmed with a sernm pregnancy test. If the sernm pregnancy test is positive the 
subject will be discontinued. 
• 
Blood collection for the following laborato1y procedures: 
-
Chemistiy profile: alkaline phosphatase, AST, ALT, total bilimbin, direct and indirect 
bilirnbin, total protein, albumin, CPK, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, phosphorns, magnesium, potassium, sodium, uric acid, and amylase 
(reflex lipase testing is perfo1med in subjects with total amylase > 1.5 x ULN). 
-
Metabolic assessments: Fasting (no food or drinks, except water, at least 5 hours prior to 
blood collection) glucose and lipid panel (total cholesterol, HDL, direct LDL, and 
ti·iglycerides) for Coho1is 1 and 2. If the subject has not fasted prior to the visit, the visit 
may continue; however, the subject must return within 72 hours in a fasted state to draw 
blood for the metabolic assessments. Fasting requirement for Coho1is 3 and 4 will be 
specified in a future protocol amendment (\Veeks 24 and 48). 
-
Hematology profile: complete blood count (CBC) with differential and platelet count 
-
Plasma HIV-I RNA 
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CD4+ cell count and percentage 
I 
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-
Sernm for bone safety tests ( collected fasted), including bone specific alkaline 
phosphatase (BsAP), sernm phosphorous, PlNP, CTX, PTH, 1,25-OH vitamin D, and 
25-OH vitamin D. If the subject has not fasted prior to the visit, the visit may continue; 
however, the subject must return within 72 hours in a fasted state to draw blood for bone 
safety tests (for Cohort 1: Weeks 4, 12, 24, and 48 (±6 days); for Cohorts 2,3, and 4: 
Weeks 8, 12, 24, and 48 (±6 days)) 
-
eGFR according to Schwaiiz fo1mula 
• 
Diaiy cai·d dispensation: 
-
Coho1i 1: Dispense subject diaiy cai·ds for subject to record administration of study mugs 
and their 3rd ARV agent for at least 3 days prior to the IPK visit (Week 2). 
-
Coho1is 2, 3, and 4, Paii A: Dispense subject diaiy cards for subject and/or 
pai·ent/guai·dian to record amninistration of study mugs and their 3rd ARV agent for at 
least 3 days prior to the IPK visit (Week 2 or 4). 
• 
Study mug dispensation: 
-
In-clinic dosing will occur at Weeks 2, 4, 8, and 12 
-
Document study mug dispensation for all study mugs dispensed (Weeks 4, 8, 12, 24, 36, 
and 48 [Week 48 study drug dispensing is for subjects that will continue post 
Week 48]). 
-
The subject should be counseled regai·ding the importance of adherence and taking their 
study medication and their 3rd ARV agent, once daily, at approximately the same time 
each day as directed by the Investigator. Sites should consider individual subject study 
mug dosing schedules while scheduling study visits requiring collection of PK samples. 
• 
Study mug accountability: 
-
Subjects and/or pai·ent/guai·dian should be reminded to bring their mug bottles of the 
F/TAF and their 3rd ARV agent with them to each visit for mug accountability 
(Weeks 1, 2, 4, 8, 12, 24, 36, and 48). 
• 
Subjects who meet the criteria for rebound should be managed according to Management 
Virologic Failure Section 6.10. 
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
PK Blood Collection:
Intensive PK: 
■
IPK samples will be collected for IPK evaluation for fasted subjects in Cohort 1
during the Week 2 visit and for fasted subjects in Cohort 2 Part A during either the 
Week 2 or the Week 4 visit or within 7 days after the completion of Week 2 or the 
Week 4 visit, as detailed in the PK manual. The protocol will be amended prior to 
Cohorts 3 and 4 screening. The IPK collection schedule and fasting requirement for 
Cohorts 3 and 4 will be specified in a future protocol amendment. 
■
Details of the IPK blood sampling procedures, and sample management will be 
documented in the Pharmacokinetic Sample Collection, Processing, Storage, and 
Shipment Manual (PK manual). Subject diary cards will be provided to subjects
and/or parent/guardian to record administration of study drugs and their
3rd ARV agent for at least 3 days prior to the PK visit. 
■
Subjects and/or parent/guardian should be instructed prior to the IPK visit that on the 
day of IPK evaluations they should be fasted and that their dose of F/TAF and their 
3rd ARV agent must not be taken prior to the visit. This is not applicable to the visits 
when the random PK sample is drawn.
■
If the subject has already dosed prior to the IPK evaluation visit or is not in a fasted 
state, the IPK assessments must not be completed. The subject should be instructed to 
return in a fasted state anytime within 7 days and to return completed Diary Cards.
■
If dosing non-compliance not related to AEs is identified on or prior to the IPK 
evaluation visit, the IPK assessments must not be completed. The subject should be 
counseled regarding proper dosing and be scheduled to return for the IPK evaluation 
visit no sooner than 3 days following compliant dosing and within 7 days and to 
return completed Diary Cards.
■
In both scenarios described above the subject and/or parent/guardian should be 
reminded again to be fasted and to not take the F/TAF or their 3rd ARV agent prior to 
arriving at the clinic on the day of the re-scheduled Intensive PK visit. 
■
Subject dosing diaries will be collected and reviewed on the day of the IPK study 
visit.

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Single PK: 
■
Cohort 1: A single random PK sample will be collected at Weeks 1 and 24, and a 
single observed PK dosing sample will be collected at any time between 15 min to 
4 hours post dose during Weeks 4 and 12 and a trough PK sample at 0 hours
(pre-dose, ≤ 30 minutes prior to dosing) during the Week 8 visit.
■
Cohorts 2, 3, and 4: A single random PK sample will be collected at Weeks 1 and 24,
and a single observed PK dosing sample will be collected at any time between 15 min 
to 4 hours post dose during Weeks 4 and 12 (Note: Single observed dosing PK 
sample does not need to be collected at Week 4 if Intensive PK is also collected at the 
Week 4 visit). Trough PK sampling will be performed at the Week 8 visit at 0 hours 
(pre-dose, ≤ 30 minutes prior to dosing).

Palatability and Acceptability Assessment:
Cohort 1: At the Week 2 visit palatability will be assessed 30 - 60 minutes after study 
drug dosing for all subjects undergoing IPK sampling. Acceptability will be assessed 
30 - 60 minutes after study drug dosing for active subjects at the next study visit 
immediately following approval of this protocol at the site.
Cohorts 2 Part A: Palatability and acceptability will be assessed at the Week 2 or Week 4 
visit, or within 7 days after the completion of the Week 2 or Week 4 visit,
30 - 60 minutes after study drug dosing for all subjects undergoing IPK sampling. 
Cohorts 3 and 4 Part A: Palatability and acceptability will be assessed for subjects 
undergoing IPK sampling. Assessment schedule will be specified in a future protocol
amendment.

PBMC Collection (at centers that have PBMC processing capability):
Cohorts 1 and 2: PBMC collection will be performed during the Week 8 visit only at 
study sites that can perform PBMC processing.
Cohorts 3 and 4: PBMC collection schedule will be specified in a future protocol
amendment.
For PK profiling in PBMCs, blood samples will be collected at 0 hours (≤30 minutes
pre-dose). Details of PBMC collection and processing will be documented in the PK 
manual.

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6.4. 
Early Study Drug Discontinuation (ESDD) 
Final 
Amendment2 
If a subject discontinues study drng prior to Week 48, the subject will be asked to return to the 
clinic within 72 hours of stopping study drngs for an ESDD Visit. Subjects will then be asked to 
continue attending all scheduled study visits. Subjects who are no longer taking study chug at 
Week 48 are not eligible to participate in the study extension. 
At the ESDD Visit, any evaluations showing abnormal results for which there is a possible 
or probable causal relationship with the study drug, should be repeated weekly ( or as often 
as deemed prudent by the investigator) until the abnormality is resolved, returns to 
baseline, or is otherwise explained. 
The following evaluations are to be completed at the ESDD visit: 
• 
Review of AEs and concomitant medications 
• 
Complete physical examination (urogenital/anorectal exams will be perfo1med at the 
discretion of the Investigator) 
• 
Vital signs (blood pressure, pulse, respiration rate, and temperature) 
• 
Weight and height/length 
• 
12-lead ECG perfo1med supine 
• 
Urine collection for the following procedures: 
-
Urinalysis and urine chemistiy 
-
Urine pregnancy test (for females of childbearing potential in Coho1is 1 and 2 only). The 
positive result will be confomed with a sennn pregnancy test. 
-
Selected renal safety test, including retinol binding protein and beta-2-microglobulin 
(renal safety tests required if last test was acquired > 12 weeks from the date of the 
ESDD Visit (collected fasted for Coho1is 1 and 2). If the subject has not fasted prior to 
the visit, the visit may continue; however, the subject must return within 72 hours in a 
fasted state to provide a urine sample for renal safety test). 
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
Blood sample collection for the following laboratory analyses:
Chemistry profile: alkaline phosphatase, AST, ALT, total bilirubin, direct and indirect 
bilirubin, total protein, albumin, CPK, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, phosphorus, magnesium, potassium, sodium, uric acid, and amylase 
(reflex lipase testing is performed in subjects with total amylase > 1.5 × ULN)
eGFR according to Schwartz formula
Hematology profile: complete blood count (CBC) with differential and platelet count
CD4cell count and percentage
Plasma HIV-1 RNA 
Serum storage sample for possible additional testing
Serum will be collected for bone safety tests (collected fasted), including bone specific 
alkaline phosphatase (BsAP), serum phosphorous, P1NP, CTX, PTH, 1,25-OH vitamin 
D, and 25-OH vitamin D. If the subject has not fasted prior to the visit, the visit may 
continue, however the subject must return within 72 hours in a fasted state to draw blood 
for bone safety tests.

DXA scan (lumbar spine and total body) required if last scan was acquired > 12 weeks from 
the date of the ESDD Visit. DXA scan can occur up to 10 days after the ESDD Visit. 

Drug accountability
6.5.
30-Day Follow-Up Visit
Subjects who discontinue study drug prior to Week 48 will be required to return to the clinic 
30 days after completion of an ESDD visit for a 30-Day Follow-up visit. Those subjects who 
permanently discontinue study drug and continue in the study through at least one subsequent 
visit after the Early Study Drug Discontinuation Visit will not be required to complete the 
30-Day Follow-Up visit.
Subjects who complete 48 weeks on study drug and do not enroll in the extension phase of the 
study will be required to return to the clinic 30 days after completion of the Week 48 visit for a 
30-Day Follow-up visit.
For the purpose of scheduling a 30-Day Follow-Up visit, a ± 6 days window may be used.
CCI

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The following evaluations are to be completed at the 30-Day Follow-Up visit: 
• 
Review of AEs and concomitant medications 
• 
Symptom-directed physical examination 
• 
Vital signs (blood pressure, pulse, respiration rate, and temperature) 
• 
Weight and height/length 
• 
Urine collection for the following procedures: 
-
Urinalysis 
Final 
Amendment2 
-
Urine pregnancy test (for females of childbearing potential only for Coho1is 1 and 2). 
A positive result will be confnmed with a sernm pregnancy test. 
I 
• 
DXA scan (lumbar spine and total body) required if last scan was acquired > 12 weeks from 
the date of the 30 day follow-up Visit. DXA scan can occur up to 10 days after the 30 day 
follow-up Visit. 
• 
Blood sample collection for the following laborato1y analyses: 
-
Chemistiy profile: alkaline phosphatase, AST, ALT, total bilirnbin, direct and indirect 
bilirnbin, total protein, albumin, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, phosphorns, magnesium, potassium, and sodium, CPK, and uric acid 
-
eGFR according to Schwaiiz fo1mula 
-
Hematology profile: complete blood count (CBC) with differential and platelet count 
-
CD4+ cell count and percentage 
-
Plasma HIV-1 RNA 
-
Sernm storage sample for possible additional testing 
At the 30-Day Follow-Up visit, any evaluations showing abno1m al results for which there is a 
possible or probable causal relationship with the study diug. should be repeated weekly ( or as 
often as deemed prndent by the investigator) until the abno1mality is resolved, returns to 
baseline, or is othe1wise explained. 
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6.6.
Post Week 48 Assessments (every 12 weeks)
Subjects will receive their assigned treatment for 48 weeks. After completion of 48 weeks of 
study treatment, all subjects will be given the option to participate in an extension phase of the 
study. Gilead will provide F/TAF until a) the subject turns 18 years old and F/TAF is 
commercially available for use in adults in the country in which the subject is enrolled or
b) F/TAF becomes commercially available for pediatric use in the country in which the subject is 
enrolled or c) Gilead Sciences elects to terminate development of F/TAF in the applicable 
country. Subjects who are no longer taking study drug at Week 48 are not eligible to participate 
in the study extension. 
Subjects who choose to participate in the extension phase will return for study visits 
every 12 weeks (± 10 days).
The following evaluations are to be completed at each study visit unless otherwise specified:

Review of AEs and concomitant medications

Tanner Stage assessment (every 12 weeks except for subjects documented to have 
achieved Tanner Stage 5)

Either a symptom-directed physical examination every 12 weeks or a complete physical 
examination at every 48 weeks (urogenital/anorectal exams will be performed at the 
discretion of the Investigator).

Vital signs (blood pressure, pulse, respiration rate, and temperature) 

Weight and height/length

12 lead ECG performed supine every 48 weeks 

Urine collection for the following procedures:
Urinalysis Urine Chemistry (every 12 Weeks)
Urine pregnancy test (females of child bearing potential only). If the urine pregnancy test 
is positive, study drug will not be dispensed. The positive result will be confirmed with a 
serum pregnancy test. If the serum pregnancy test is positive the subject will be 
discontinued from the study.
Urine sample storage for possible additional testing (urine chemistry including urine 
phosphorus and urine creatinine)
Selected renal safety tests (collected fasted for Cohorts 1 and 2), including retinol binding 
protein and beta-2-microglobulin. If the subject has not fasted prior to the visit, the visit 
may continue; however, the subject must return within 72 hours in a fasted state to 
provide a urine sample for renal safety test (every 12 Weeks).

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
Blood sample collection for the following laboratory analyses:
Chemistry profile: alkaline phosphatase, AST, ALT, total bilirubin, direct and indirect 
bilirubin, total protein, albumin, CPK, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, phosphorus, magnesium, potassium, sodium, uric acid, and amylase 
(reflex lipase testing is performed in subjects with total amylase > 1.5 × ULN).
Metabolic assessments: Fasting (no food or drinks, except water, at least 5 hours prior to 
blood collection) glucose and lipid panel (total cholesterol, HDL, direct LDL, and 
triglycerides) for Cohorts 1 and 2. If the subject has not fasted prior to the visit, the visit 
may continue; however, the subject must return within 72 hours in a fasted state to draw 
blood for the metabolic assessments (every 24 Weeks). Note that glucose analysis will be 
done as part of the fasting metabolic assessments and not as part of the chemistry profile, 
every 24 weeks post week 96
Serum will be collected for bone safety tests (collected fasted), including bone specific 
alkaline phosphatase (BsAP), serum phosphorous, P1NP, CTX, PTH, 1,25-OH vitamin 
D, and 25-OH vitamin D will be performed at every 12 weeks (±10 days) thereafter. If 
the subject has not fasted prior to the visit, the visit may continue; however, the subject 
must return within 72 hours in a fasted state to draw blood for bone safety tests
(every 24 Weeks)
Plasma sample storage for virology, safety, and/or PK testing (every 12 weeks)
eGFR according to Schwartz formula
Hematology profile: complete blood count (CBC) with differential and platelet count
CD4cell count and percentage
Plasma HIV-1 RNA 

DXA scans of the lumbar spine and of the total body for BMD (every 24 Weeks ± 10 days)

Study drug dispensation:
Subjects and/or parent/guardian should be instructed to take study drugs with or without 
food as determined by their 3rd ARV agent. The subject and/or parent/guardian should be 
counseled regarding the importance of adherence and taking their study medication at 
approximately the same time each day as directed by the Investigator.

Study drug accountability:
Subjects and/or parent/guardian should be reminded to bring the required drug bottles of 
the F/TAF and their 3rd ARV agent with them for drug accountability.

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6.7. 
Bone Evaluations 
Final 
Amendment 2 
For all subjects DXA scans will be perfo1med prior to study diug adininistration at the 
Baseline/Day 1, at Weeks 24 and 48 (::1:10 days), followed by eve1y 24 weeks post Week 48 
(::1:10 days), and the Early Study Drng Discontinuation Visit (if applicable) up to 10 days after the 
ESDD visit date. Scans will cover the lumbar spine and total body to measure changes in bone 
mineral density (BMD). DXA scan results will be provided to study sites. 
A complete description of the procedures perfo1med for the DXA scans will be provided in a 
DXAmanual. 
6.8. 
Bone and Renal Safety Evaluations 
For subjects in Coho1i 1, the following bone safety tests will be collected (fasted) at 
Baseline/Day 1 and Weeks 4, 12, 24, and 48 (±6 days), followed by eve1y 24 weeks post 
Week 48 (::1:10 days): BsAP, PlNP, CTX, PTH, 1,25-OH vitamin D, and 25-OH vitamin. 
For subjects in Coho1i 2, 3, and 4, the following bone safety tests will be collected (fasted) at 
Baseline/Day 1 and Weeks 8, 12, 24, and 48 (±6 days), followed by eve1y 24 weeks post 
Week 48 (::1:10 days): BsAP, PlNP, CTX, PTH, 1,25-OH vitamin D, and 25-OH vitamin. 
For all subjects, urine will also be collected for selected renal safety tests, including urine 
chemistiy, retinol binding protein, and beta-2-inicroglobulin at the Baseline/Day 1 Visit, 
Weeks 2, 4, 8, 12, 24, and 48, followed by eve1y 12 weeks post Week 48 (::1:10 days). 
Bone and renal safety test assessments will be collected fasted. If the subject has not fasted prior 
to the visit, the visit may continue; however, the subject must return within 72 hours in a fasted 
state to di·aw blood for bone safety tests and provide a urine sample for renal safety tests. 
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6.10.
Virologic Failure and Management of Virologic Rebound
Subjects who experience virologic rebound (VR), as defined below, will be considered to have 
virologic failure. 
If the viral load is ≥ 50 copies/mL, HIV-1 RNA should be repeated at a scheduled or 
unscheduled visit (2-4 weeks after the date of the original test with HIV-1 RNA 
≥50 copies/mL).
Subjects will be considered to have virologic rebound if they have confirmed HIV-1 RNA 
≥50 copies/mL (two consecutive tests) at scheduled or unscheduled visits.
Upon confirmation of HIV-1 RNA ≥ 50 copies/mL, potential causes of virologic failure should 
be documented. Assessments should include:

Review treatment adherence with subject and/or parent/guardian

Review of AEs and concomitant medications

Comorbidities (eg, active substance abuse, depression, other intercurrent illnesses)
If virologic rebound is confirmed at the scheduled or unscheduled visit, and the HIV-1 RNA 
value is ≥ 400 copies/mL, the blood samples from the confirmation visit will be used for HIV-1 
genotype/phenotype testing.
If genotype/phenotype resistance to study drug is documented, study drugs should be 
discontinued. 
If no resistance is detected from genotype/phenotype testing, subject may remain on study drug 
and the HIV-1 RNA testing should be repeated (2-4 weeks from the date of confirmed test with 
viral load ≥ 50 copies/mL) until <50 copies/mL is achieved or the subject discontinues. 
Subjects experiencing virologic failure due to emergent resistance on study, but whose virus
remains sensitive to FTC and TFV will be permitted to switch to a new fully active 
3rd ARV agent and remain on their F/TAF-containing regimen. Subjects unable to tolerate 
current 3rd agents due to clinically significant toxicities will be permitted to switch after 
consultation with the medical monitor to a new fully active 3rd ARV agent and remain on their 
F/TAF-containing regimen.
Investigators should carefully evaluate the benefits and risks of remaining on study drug for each 
individual subject and document this assessment in the on site medical record. Investigators who 
opt to discontinue study drugs for an individual subject must discuss with the 
Gilead Medical Monitor prior to study drug discontinuation. 
Please refer to Figure 6-1 for the management of subjects who meet the criteria for virologic 
rebound.

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Figure 6-1.
Virologic Rebound Schema
a
If virologic rebound is not confirmed, the subject will remain on their current regimen
b
If virologic rebound is confirmed, and the HIV-1 RNA is ≥ 400 copies/mL, the HIV-1 genotype and phenotype 
(reverse transcriptase and protease) will be analyzed
c
Based on the results of the genotype/phenotype assays, the subject will remain on study drugs, or study drugs will be 
discontinued. If genotyping/phenotyping fails, a new ARV regimen may be configured at the discretion of the Investigator
d
If no resistance detected, HIV-1 RNA will be repeated (2-4 weeks later) until < 50 copies/mL is achieved or the subject 
discontinues. Investigator is to review and discuss study drug continuation/discontinuation options with Medical Monitor 
prior to study drug discontinuation
e
A new ARV regimen will be configured, at the Investigator’s discretion, and the subject will remain in the study
6.10.1.
Subjects with ≥ 400 copies/mL of HIV-1 in Absence of Confirmed Virologic 
Failure
Subjects may also be analyzed for resistance that does not meet the virologic failure criteria. 
Subjects who have HIV-1 RNA ≥400 copies/mL at Weeks 24 or 48 or the last visit while 
receiving study drugs (within 72 hours of discontinuation of study treatment) will be analyzed 
for resistance.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 

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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 pharmaceutical 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 (e.g., hospitalization for 
elective surgery, social and/or convenience admissions)

Overdose without clinical sequelae (see Section 7.6.1)

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. 
7.1.3.
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 (e.g., 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 (e.g., 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 (e.g., anemia), not the 
laboratory result (i.e., decreased hemoglobin).
For specific information on handling of clinical laboratory abnormalities in this study, please 
refer to Appendix 3.
7.2.
Assessment of Adverse Events and Serious Adverse Events
The Investigator or qualified Sub-investigator 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 Study Drugs and Procedures
The investigator or qualified sub-investigator 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 (e.g., 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.

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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 (e.g., 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 (e.g., 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 (Appendix 4). For adverse events 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 Study Drug Initiation
After informed consent, but prior to initiation of study medication, the following types of events 
should be reported on the case report form (CRF/eCRF): 

all serious adverse events (SAEs) 

adverse events related to protocol-mandated procedures.
Adverse Events
Following initiation of study medication, collect all AEs, regardless of cause or relationship, 
until 4 weeks after last administration of study IMP must be reported to the CRF/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.
Serious Adverse Events
All SAEs, regardless of cause or relationship, that occurs after the subject first consents to 
participate in the study (i.e., 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 
CRF/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 of the last dose of study IMP, regardless of causality, should also be reported. 

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All SAEs should be followed up until resolution if possible. If by the last day on study (including 
the off-study medication follow-up period) the SAE has not resolved, then the SAE will be 
followed up until the investigator and/or Gilead Sciences determine that the subject's condition is 
stable. However, Gilead Sciences may request that certain SAEs be followed until resolution.
Investigators are not obligated to actively seek SAEs after the follow up 30-day period. 
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.

All AEs and SAEs will be recorded in the CRF/eCRF database within the timelines 
outlined in the CRF/eCRF completion guideline. 

At the time of study start, SAEs will be reported using an electronic SAE (eSAE) system
using the Electronic Serious Adverse Event Reporting Process detailed below. Gilead will 
provide training and account information prior to implementing an eSAE system.

The Serious Adverse Event Paper Reporting Process is to be used only if the EDC System is 
not available.
Electronic Serious Adverse Event (eSAE) Reporting Process

Site personnel will 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, 
i.e., the eCRF database is not functioning, record the SAE on the paper serious adverse event 
reporting form and submit within 24 hours as described above.
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.

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, i.e., the 
eCRF database is not functioning, record the SAE on the paper serious adverse event 
reporting form and submit within 24 hours as described above.

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.

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• 
If an SAE has been reported via a paper fonn because the eCRF database has been locked, no 
further action is necessa1y. 
• 
For fatal or life-threatening events, copies of hospital case repo1ts, autopsy repo1ts, 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 trnceability of a document to the subject identifiers. 
• 
Additional infonnation may be requested to ensure the timely completion of accurate safety 
repo1ts. 
• 
Any medications necessaiy 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 
fo1m. 
Serious Adverse Event Paper Repo1ting Process 
SAEs will be recorded on the serious adverse event paper report fo1m and submitted by faxing or 
emailing the repo1t fo1m within 24 hours of the Investigator's knowledge of the event to the 
attention of Gilead DSPH and the medical monitor: 
Gilead Sciences Drng Safety 
Public Health (DSPH): 
Gilead Sciences Medical Monitor: 
Fax: 
E-mail: 
Name: 
Telephone: 
Mobile Phone: 
Fax: 
E-mail: 
7.4. 
Gilead Reporting Requirements 
IPIPD 
IPIPD 
IPIPD 
IPIPD 
IPIPD 
IPIPD 
IPIPD 
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 countiy-specific legislation or regulations, Gilead may be required to expedite to 
worldwide regulato1y agencies reports of SAEs, serious adverse drng 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 regulato1y 
agencies and the relevant IEC in concerned Member States of applicable SUSARs as outlined in 
cmTent regulations. 
Assessment of expectedness for SAEs will be dete1mined by Gilead using reference safety 
info1mation specified in the investigator's brochure or relevant local label as applicable. 
All investigators will receive a safety letter notifying them of relevant SUSAR repo1ts. The 
investigator should notify the IRB or IEC of SUSAR reports as soon as is practical, where this is 
required by local regulato1y 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
7.5.1.
Toxicity Management
All clinical and clinically significant laboratory toxicities will be managed according to uniform 
guidelines detailed in Appendix 3 as outlined below.

All clinically significant Grade 3 and 4 laboratory abnormalities should be repeated
immediately to confirm toxicity grade. Confirmation of toxicity grade is required prior to the 
next dose of investigational medicinal product for any Grade 3 and 4 laboratory abnormality 
that in the opinion of the Investigator is clinically significant and may pose a risk to the 
subject’s safety.

Clinical events and clinically significant laboratory abnormalities will be graded according to 
the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
(Refer to Appendix 4).

Any questions regarding toxicity management should be directed to the 
Gilead Medical Monitor.
7.5.1.1.
Management of Bone Toxicity
As there is uncertainty surrounding the clinical significance and management of decreases in 
bone mineral density for HIV-1 infected children and adolescents, Gilead recommends that any 
subject who has a DXA scan that demonstrates a decrease from baseline or from the previous 
visit of ≥ 4% to have a repeat DXA within 7 calendar days to confirm the decrease. If the DXA 
is confirmed the investigator in consultation with the Gilead medical monitor may decide to 
discontinue the study drug but keep the subject on the study if feasible. 
7.5.2.
Grades 1 and 2 Laboratory Abnormality or Clinical Event
Continue investigational medicinal product at the discretion of the Investigator.
7.5.3.
Grades 3 Laboratory Abnormality or Clinical Event
For Grade 3 clinically significant laboratory abnormality or clinical event, investigational 
medicinal product may be continued if the event is considered to be unrelated to investigational 
medicinal product.
For a Grade 3 clinical event, or clinically significant laboratory abnormality confirmed by repeat 
testing, that is considered to be related to investigational medicinal product, investigational 
medicinal product should be withheld until the toxicity returns to ≤Grade 2.

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If a laboratory abnormality recurs to ≥Grade 3 following rechallenge with investigational 
medicinal product and is considered related to investigational medicinal product, then 
investigational medicinal product should be permanently discontinued and the subject managed 
according to local practice. Recurrence of laboratory abnormalities considered unrelated to 
investigational medicinal product may not require permanent discontinuation.
7.5.4.
Grade 4 Laboratory Abnormality or Clinical Event
For a Grade 4 clinical event or clinically significant Grade 4 laboratory abnormality confirmed 
by repeat testing that is considered related to investigational medicinal product, investigational 
medicinal product should be permanently discontinued and the subject managed according to 
local practice. The subject should be followed as clinically indicated until the laboratory 
abnormality returns to baseline or is otherwise explained, whichever occurs first. A clinically 
significant Grade 4 laboratory abnormality that is not confirmed by repeat testing should be 
managed according to the algorithm for the new toxicity grade.
Investigational medicinal product may be continued without dose interruption for a clinically 
non-significant Grade 3-4 laboratory abnormality (e.g., CK elevation after strenuous exercise, or 
triglyceride elevation that is non-fasting or that can be medically managed) or a Grade 3-4 
clinical event considered unrelated to investigational medicinal product.
7.5.5.
Management of Hyperbilirubinemia in Patients Receiving Ritonavir Boosted 
Atazanavir
Most patients taking atazanavir sulfate experience asymptomatic elevations in indirect 
(unconjugated) bilirubin related to inhibition of UDP-glucuronyl transferase (UGT). In pediatric 
clinical trials, 58% of patients experienced Grade 3 to 4 elevations (≥ 3.2 mg/dL) in total 
bilirubin (Reyataz US Prescribing Information 2013). As subjects in this study who are taking 
ATV/r as their 3rd ARV agent may frequently have atazanavir-associated hyperbilirubinemia, the 
management of graded laboratory abnormalities described above in Section 7.5 is not applicable 
for the management of graded hyperbilirubinemia in these subjects.
However, repeat testing should be done and alternative etiologies (e.g. acute hepatitis B or C) 
should be sought in the following subjects:
1) In those with elevation in conjugated (direct) bilirubin > 1.5 × ULN (i.e. direct 
hyperbilirubinemia), regardless of the hyperbilirubinemia grade, liver labs (total bilirubin, 
direct bilirubin, AST, ALT) should be repeated within 7 days of the Investigator being 
notified of the elevated bilirubin level and be discussed with the Medical Monitor. 
Thereafter, the management of a subject who continues to have direct bilirubin > 1.5 × ULN, 
which is deemed as clinically not significant, should be followed according to the clinical 
judgment of the Investigator.
2) In those with hepatic transaminase elevation, the graded AST or ALT abnormalities should 
be managed according to Section 7.5

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Dose modification of atazanavir sulfate is not permitted. Subjects who experience unacceptable 
jaundice/scleral icterus due to atazanavir-associated hyperbilirubinemia can be discontinued 
from the study at the discretion of the Investigator.
7.6.
Special Situations Reports
7.6.1.
Definitions of Special Situations
Special situation reports include all reports of medication error, abuse, misuse, overdose, and 
pregnancy reports regardless of an associated AE. Also includes reports of adverse reactions in 
infants following exposure from breastfeeding, and reports of adverse reactions associated with 
product complaints and reports arising from occupational exposure.
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 labeling (as it applies to the daily dose of the subject in 
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. 
7.6.2.
Instructions for Reporting Special Situations
7.6.2.1.
Instructions for Reporting Pregnancies
The Investigator should report all pregnancies in the female subjects that are identified after 
initiation of study medication and throughout the study, including the post study drug follow-up 
period, to Gilead DSPH using the pregnancy report form within 24 hours of becoming aware of 
the pregnancy. Refer to Section 7.6.2 and 7.3 and the CRF/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.

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Any premature termination of pregnancy (e.g., 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 as follows: Email: 
and Fax: 
Pregnancies of female partners of male study subjects exposed to Gilead or other study drugs 
must also be reported and relevant information should be submitted to 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, fax number 
 or email 
Refer to Appendix 5 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Recommendations.
7.6.2.2.
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 on the AE form. 
Any inappropriate use of medications prohibited by this protocol should not be reported as 
“misuse,” but may be more appropriately documented as a protocol deviation.
Refer to Section 7.6.2 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.
PPD
PPD
PPD
PPD

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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
The primary objectives of this study are:

To evaluate the PK of TAF in HIV-1 infected children and adolescents virologically 
suppressed on 2-NRTI-containing regimen,

To evaluate the safety and tolerability of F/TAF through Week 24
The secondary objectives of this study are:

To evaluate the PK of TFV and FTC 

To evaluate the safety, tolerability, and efficacy of F/TAF through Week 48.
8.1.2.
Primary Endpoints
The primary endpoints are:

The PK parameter AUCtau for TAF

Incidence of treatment-emergent SAEs and all treatment-emergent adverse events through 
Week 24 
8.1.3.
Secondary Endpoints
The secondary endpoints are:

PK parameters of Cmax, Clast, Cl/F, and Vz /F for TAF, AUCtau, Cmax, and Ctau for FTC and 
TFV

Incidence of treatment-emergent SAEs and all treatment-emergent adverse events through 
Week 48 

The percentage of subjects with HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 as defined 
by the US FDA-defined snapshot algorithm 

The change from baseline in CD4+ cell count (cells/μL) and CD4+ percentage at 
Weeks 24 and 48

The palatability and acceptability of the age-appropriate F/TAF formulation

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8.2. 
8.2.1. 
8.2.1.1. 
Analysis Conventions 
Analysis Sets 
All Enrolled 
The all enrolled analysis set includes all subjects who are enrolled into the study. 
All enrolled analysis set is the primaiy analysis set for by-subject listings. 
8.2.1.2. 
8.2.1.2.1. 
Efficacy 
Full Analysis Set 
Final 
Amendment2 
The full analysis set (FAS) will include all subjects who ai·e enrolled in the study and have 
received at least one dose of study medication. 
8.2.1.3. 
8.2.1.3.1. 
Safety 
Safety Analysis Set 
The safety analysis set will include all subjects who are enrolled in the study and have received 
at least one dose of study medication. 
8.2.1.4. 
8.2.1.4.1. 
DXA 
Total Body Less Head DXA Analysis Set 
The total body less head DXA analysis set will include all subjects who (1) are enrolled in the 
study, (2) have received at least one dose of study medication, and (3) have non-missing total 
body less head BMD value for the baseline visit. 
8.2.1.4.2. 
Spine DXA Analysis Set 
The spine DXA analysis set will include all subjects who (1) are enrolled in the study, 
(2) have received at least one dose of study medication and (3) have non-missing spine BMD 
value for the baseline visit. 
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8.2.1.5.
Pharmacokinetics
8.2.1.5.1.
IPK Analysis Set
The IPK analysis set will include all subjects who (1) are enrolled in Cohort 1 or Part A of 
Cohorts 2 (each group), 3, and 4 for IPK evaluation, (2) have received at least one dose of study 
medication and (3) have at least 1 non-missing PK concentration data for any analyte of interest 
(e.g., FTC, TAF, and TFV). The IPK analysis set will be used for analyses of intensive PK 
analytes of TAF, TFV, and FTC.
8.2.1.5.2.
PK Analysis Set
The PK analysis set will include all subjects who (1) are enrolled into the study, 
(2) have received at least one dose of study medication and (3) have at least 1 non-missing PK 
concentration data for any analyte of interest (e.g., FTC, TAF, and TFV). The PK analysis set 
will be used for analyses of general pharmacokinetics.
8.2.1.5.3.
PBMC PK Analysis Set
The PBMC PK analysis set will include all subjects who (1) are enrolled into the study, 
(2) have received at least one dose of study medication and (3) have at least 1 non-missing 
concentration data of TFV-DP. The PBMC PK analysis set will be used for pharmacokinetic 
analyses of TFV-DP.
8.3.
Data Handling Conventions
Natural logarithm transformation for PK parameters, such as Cmax, Clast, Ctau, AUClast, and 
AUCtau, will be applied for pharmacokinetic analysis.
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, and age.
Baseline data including body weight, height/length, body mass index, HIV-1 infection, and 
enrollment distribution will be summarized.
8.5.
Efficacy Analysis
Efficacy endpoints results from each group or cohort will be descriptive in nature. 
8.5.1.
Primary Analysis
The primary efficacy endpoint is the proportion of subjects with HIV-1 RNA < 50 copies/mL at 
Week 24 as defined by the US FDA-defined snapshot algorithm using the full analysis set (FAS).
Virologic outcomes will be summarized using frequency counts and percentages. The 95% CI
for the percentage estimate for each group or cohort will be constructed using the Exact method. 

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8.5.2.
Secondary Analyses
The percentage of subjects with HIV-1 RNA < 50 copies/mL at Week 48 as defined by the US 
FDA-defined snapshot algorithm will be summarized in the same manner as the primary efficacy 
endpoint.
The change from baseline in CD4+ cell count and CD4+ percentage will be summarized by visit, 
group, and cohort using descriptive statistics. 
8.6.
Safety Analysis
All safety analyses will be performed using the safety analysis set.
All safety data collected on or after the date that the study drug was first administered up to the 
date of last dose of study drug plus 30 days, unless specified otherwise, will be summarized by 
group and cohort. Data for the pretreatment period and the period post the date of last dose of 
study drug plus 30 days will be included in data listings.
Safety results from each group and cohort will be descriptive in nature. F/TAF results from all
cohorts will be combined to describe the overall safety profile of F/TAF in subjects 1 month to 
< 18 years of age. 
8.6.1.
Extent of Exposure
A subject’s extent of exposure to study drug will be generated from the study drug 
administration data. Duration of exposure to study drug will be expressed as the number of 
weeks between the first and last dose of the study regimen, inclusive, regardless of temporary 
interruptions in study regimen administration. Exposure data will be summarized by group, 
cohort, and overall. Dosing information for individual subjects will be listed.
8.6.2.
Adverse Events
Clinical and laboratory adverse events will be coded using 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 
attached to the clinical database.
Treatment-emergent AEs are events that meet one of the following criteria up to 30 days after the 
permanent discontinuation of the study drug:

Events with onset dates on or after the first dose date of study drug,

Events that result in permanent study drug discontinuation.
Summaries (number and percentage of subjects) of treatment-emergent adverse events (by SOC 
and PT) will be provided by group, cohort and overall. Additional summaries will include 
summaries for adverse events by grade, Investigator’s assessment of relationship to study drug, 
and effect on study drug dosing.

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On an ongoing basis adverse events will be reviewed for events that might meet the definition of 
Catego1y C events that are indicative of an AIDS-Defining Diagnoses. The Gilead medical 
personnel will review the possible Catego1y C events and approve the events that meet the 
definition. Those events that do meet the Catego1y C definition of an AIDS-Defining Diagnosis 
will be listed. A listing of Catego1y C, AIDS-Defining Diagnosis can be found in Appendix 6. 
8.6.3. 
Laboratory Evaluations 
Selected laborato1y data will be summarized using observed data. Absolute values and changes 
from baseline at all scheduled visits will be summarized. 
Graded laborato1y abnonnalities will be defined using the grading scheme defined in Grading of 
laborato1y abno1malities provided in Appendix 4. 
Incidence of treatment-emergent laborato1y abno1malities, defined as values that increase at least 
one toxicity grade from baseline at any time post baseline up to and including the date of last 
dose of study regimen plus 30 days, will be summarized by group, coho1t and overall. If baseline 
data are missing, then any graded abno1mality (i.e., at least a Grade 1) will be considered 
treatment emergent. The maximum toxicity grade will be summarized by laborato1y parameter. 
Laborato1y abno1malities that occm before the first dose of study regimen or after the subject has 
been discontinued from treatment plus 30 days will be included in a data listing. 
8.6.4. 
Bone Mineral Density 
Z-scores (standard Z-scores and adjusted Z-scores) for spine 
and total body less head BMD and change from baseline in Z-scores will also be summarized by 
visit, group and coho1t . The adjustment method will be specified in the Statistical Analysis Plan. 
8.6.5. 
Bone and Renal Safety Evaluations 
Selected bone safety tests, including BsAP, PlNP, CTX, PTH, 1,25-OH vitamin D, and 25-OH 
vitamin D, will be summarized by visit using descriptive statistics. 
For all subjects in all coho1ts, selected renal safety tests, including retinol binding protein, and 
beta-2-Inicroglobulin, will be summarized by visit, group, and coho1t using descriptive statistics. 
8.6.6. 
Tanner Stage Assessment 
The Tanner stage assessment score will be summarized by study visit, group, and coho1t . 
8.6.7. 
Acceptability and Palatability 
Acceptability and palatability will be summarized by study visit, group, and coho1t. 
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8.6.8. 
Other Safety Evaluations 
Final 
Amendment2 
Weight and height/length will be summarized by visit. Safety ECGs will be summarized. 
Number and percentage of subjects with abnonnal safety ECG will be summarized by visit, 
group, and cohort. 
8.7. 
Pharmacokinetic Analysis 
The concentrntion data ofTAF, FTC, and TFV (if applicable) over sampling time will be listed 
and SUilllllarized using descriptive statistics by group and cohort. PK parameters (e.g., AUC1au, 
AUC1ast, Cmax, Tmax, C1ast, T1ast, C1au, "-z., apparent CL, apparent V2, and T ½) will be listed and 
summarized for analytes TAF, FTC, and TFV (as applicable) using descriptive statistics 
(e.g., sample size, arithmetic mean, geometi·ic mean, coefficient of variation%, standard 
deviation, median, Ql , Q3, minimum, and maximum) by group and cohort. Plasma 
concenti·ations over time will be plotted in semilogarithmic and linear fo1mats as mean 
± standard deviation, and median (Ql , Q3). 
TAF exposure PK parameter (i.e., AUC1au) achieved in pediati·ic subjects from Cohort 1 and 
Pait A of Coho1is 2 (Groups 1 and 2), 3, 4 will be compared to historical adult data 
(ie, GS-US-311-1089). 
An analysis of variance will be canied out for log-ti·ansfonned TAF AUC1au as a prima1y 
pai·ameter while other pha1macokinetic pai·ameters such as Cmax will be explored. T AF data from 
each coho1i will be compai·ed to Study GS-US-311-1089 adult population PK T AF data by dose 
level and type of boosted PI ( eg, A TV /r or other Pis/r) if applicable. If the lower bound of the 
90% CI of the geometi·ic mean ratio (pediati·ic subjects vs adult subjects) is above 70% for TAF 
AUC1au, the TAF dose will be confnmed. 
In addition, the 95% CI of the geometi·ic mean estimate of apparent CL and apparent V z of T AF 
will be provided. 
8.8. 
Acceptability and Palatability 
Acceptability and palatability for the age-appropriate F/TAF FDC fo1mulation will be 
summarized. Treatinent adherence will also be summarized. 
8.9. 
Sample Size 
Cohort 1: Twenty-five subjects from Coho1i 1 in the TAF h'eatment aim will provide at least 
90% power to tai·get a 95% confidence interval within 60% and 140% of the geomeh'ic mean 
estimate of apparent CL and apparent V2 ofTAF, respectively, assuming a standai·d deviation of 
0.60 for CL and 0.58 for V2 (natural log scale) estimated from Study GS-US-292-0106 Coho1i 1 
PaiiA. 
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Cohort 2 (Group 1) Part A: At least 10 subjects on boosted ATV + F/TAF and 6 subjects on 
boosted LPV or DRV + F/TAF, compared with the population PK data from 44 adult subjects on 
boosted ATV + F/TAF and 87 adult subjects on boosted LPV or DRV + F/TAF in 
Study GS-US-311-1089, respectively, will each provide at least 80% power to show the lower 
bound of a 90% CI of geometric mean ratio (pediatric subjects vs. adult subjects) greater than 
70% for AUCtau of TAF, assuming that the expected geometric mean ratios of TAF AUCtau
between pediatric subjects and adult subjects are equal to 1 and the standard deviations are 0.40 
(with boosted ATV + F/TAF) and 0.33 (with boosted LPV or DRV + F/TAF) ng*hr/mL for TAF 
AUCtau (natural log scale) estimated from the population PK data in Study GS-US-311-1089.
Part A of Cohorts 2 (Group 2), 3, and 4: At least 10 subjects on boosted ATV + F/TAF and 
7 subjects on any other third agent + F/TAF in each group or cohort, compared with the 
population PK data from the 292 adults on any third agent + DVY in Study GS-US-311-1089, 
will provide 90% power to show the lower bound of a 90% CI of geometric mean ratio (pediatric 
subjects vs. adult subjects) greater than 70% for AUCtau of TAF, assuming that the expected 
geometric mean ratio of TAF AUCtau between pediatric subjects and adult subjects is equal to 1 
and the standard deviation is 0.48 ng*hr/mL for TAF AUCtau (natural log scale) estimated from 
the population PK data in Study GS-US-311-1089.
A total of at least 100 subjects receiving F/TAF from Cohort 1, and Parts A and B of Cohort 2 
(Groups 1 and 2), Cohort 3, and Cohort 4 combined will provide reasonable assessment of safety 
through Week 48 in pediatric subjects.
Sample size and power calculations were made using the statistical software package nQuery 
Advisor (Version 7.0) and R.
8.10.
Data Monitoring Committee
An external multidisciplinary independent data monitoring committee (IDMC) will review the 
progress of the study and perform interim reviews of safety, efficacy and PK data 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 IDMC’s specific activities will be defined in an approved charter, which will define the 
IDMC’s membership, conduct and meeting schedule.
While the IDMC 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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8.11.
Analysis Schedule
Cohort 1
The Week 48 analysis of efficacy and safety will be conducted after the last subject completes 
Week 48 visit or prematurely discontinue from the study drug. Efficacy and safety endpoints at 
Week 24 for Cohort 1 will also be analyzed at the Week 48 analysis. A PK analysis will also be 
performed at the Week 48 analysis. 
Cohorts 2, 3 and 4
A PK analysis will be performed after all the subjects enrolled in Part A complete the IPK 
evaluation within each group (Cohort 2) or each cohort (Cohorts 3 and 4). After the confirmation 
of TAF dose and TAF safety acceptance among the subjects in Part A, enrollment in Part B will 
be initiated. 
The Week 24 analysis of efficacy and safety will be conducted after the last subject completes
Week 24 visit or prematurely discontinue from the study drug within each group (Cohort 2) or 
cohort (Cohorts 3 and 4). The Week 48 analysis of efficacy and safety will be conducted after the 
last subject completes Week 48 visit or prematurely discontinue from the study drug within each 
group (Cohort 2) or cohort (Cohorts 3 and 4).
Final analysis will be performed after all subjects complete the study or prematurely discontinue 
from the study.
8.12.
Endpoint Adjudication Committee
No formal endpoint adjudication committee is planned for this 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 Part 312, Subpart D, “Responsibilities of Sponsors and Investigators,” 
21 CFR Part 50, and 21 CFR Part 56.
The investigator and all applicable subinvestigators will comply with 21 CFR, Part 54, 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 institutional review board or independent ethics committee. 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/ICE detailing 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 
investigator must use the most current or approved consent form for documenting written 

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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 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, or laboratory. Laboratory specimens must 
be labeled in such a way 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, 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, i.e., history, physical examination, and 
confirmation of diagnosis (to support inclusion and exclusion criteria);

Documentation of the reason(s) a consented subject is not enrolled

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
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 (i.e., 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. The eCRF should
capture the data required per the protocol schedule of events and procedures. All eCRFs 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 the 
audit trail of the system.

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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.
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 (e.g. 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.
Investigational Medicinal Product Accountability and Return
The study monitor will provide instructions for return to the designated disposal site. If return is 
not 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 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.
9.1.8.
Inspections
The investigator will make available all source documents and other records for this trial to 
Gilead’s appointed study monitors, or to regulatory authority or health authority inspectors.
9.1.9.
Protocol Compliance
The investigator is responsible for ensuring the study is conducted in accordance with the 
procedures and evaluations described in this protocol.

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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 in 
accordance with local requirements and receive documented 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 regulatory agency. 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).
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, e.g. 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.

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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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10.
REFERENCES
Capeau J. Premature Aging and Premature Age-Related Comorbidities in HIV-Infected Patients: 
Facts and Hypotheses. Clin Infect Dis 2011;53 (11):1127-9.
Department of Health and Human Services (DHHS). Guidelines for the Use of Antiretroviral 
Agents in Pediatric Infection. Available at http://aidsinfo.nih.gov/guidelines. 
Accessed: March 14 2014.
EMTRIVA®, Gilead Sciences Inc. EMTRIVA® (emtricitabine) capsule, for oral use. 
EMTRIVA® (emtricitabine) oral solution. US Prescribing Information. Foster 
City, CA. Revised November.  2012:
Gilead Sciences Inc. GENVOYA® (elvitegravir, cobicistat, emtricitabine, and tenofovir 
alafenamide) tablets, for oral use. US Prescribing Information. Foster City, CA 
Revised March.  2016:
Gilead Sciences International Limited. Genvoya 150mg/150mg/200mg/10mg film coated tablets. 
Summary of Product Characteristics.  Updated 07 March.  2016:
Ginsberg G, Hattis D, Miller R, Sonawane B. Pediatric pharmacokinetic data: implications for 
environmental risk assessment for children. Pediatrics 2004;113 (4 Suppl):973-83.
HHS Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children with 
HIV. Guidelines for the use of Antiretroviral Agents in Pediatric HIV Infection. 
Revised: 27 April.  2017.
Joint United Nations Programme on HIV/AIDS (UNAIDS). Fact Sheet 2016. Available at: 
http://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf
.  2016.
McCarver DG. Applicability of the principles of developmental pharmacology to the study of 
environmental toxicants. Pediatrics 2004;113 (4 Suppl):969-72.
Mocroft A, Vella S, Benfield TL, Chiesi A, Miller V, Gargalianos P, et al. Changing patterns of 
mortality across Europe in patients infected with HIV-1. EuroSIDA Study Group. 
Lancet 1998;352 (9142):1725-30.
Palella FJ, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, et al. Declining 
Morbidity and Mortality Among Patients With Advanced Human 
Immunodeficiency Virus Infection. N Eng J Med 1998;338 (13):853-60.

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Panel on Antiretroviral Therapy and Medical Management of HIV-infected Children. Guidelines 
for the use of antiretroviral agents in pediatric HIV infection: Available at: 
http://aidsinfo.nih.gov/ContentFiles/PediactricGuidelines.pdf. Accessed 
September 9, 2012.  2011:1-279. 
Prejean J, Song R, Hernandez A, Ziebell R, Green T, Walker F, et al. Estimated HIV incidence 
in the United States, 2006-2009. PLoS ONE 2011;6 (8):e17502.
Robbins BL, Greenhaw JJ, Connelly MC, Fridland A. Metabolic pathways for activation of the 
antiviral agent 9-(2-phosphonylmethoxyethyl)adenine in human lymphoid cells. 
Antimicrob Agents Chemother 1995;39 (10):2304-8.
Sterne J, Hernán M, Ledergerber B, Tilling K, Weber R, Sendi P, et al. Long-term effectiveness 
of potent antiretroviral therapy in preventing AIDS and death: a prospective 
cohort study. Lancet 2005;366 (9483):378-84.
Welch S, Sharland M, Lyall EG, Tudor-Williams G, Niehues T, Wintergerst U, et al. PENTA 
2009 guidelines for the use of antiretroviral therapy in paediatric HIV-1 infection. 
HIV Med 2009;10 (10):591-613.
World Health Organization (WHO). Developing Dosing Guidance For New And Upcoming 
Formulations Of Paediatric Antiretrovirals In Line With Treatment 2.0 Priorities. 
Presented at: Paediatric Antiretroviral Working Group.; 2011 25-26 October; 
Geneva, Switzerland. 

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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
Appendix 6.
Definitions of HIV-1 Related Disease
Appendix 7.
Tanner Stages

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Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC. 
333 LAKESIDE DRIVE 
FOSTER CITY, CA 94404 
STUDY ACKNOWLEDGEMENT 
A Phase 2/3, Open-Label, Multi-Cohort Switch Study to Evaluate Emtricitabine/Tenofovir 
Alafenamide (F/TAF) in HIV-1 Infected Children and Adolescents Virologically Suppressed on 
a 2-NRTI-Containing Regimen 
GS-US-311-1269, Amendment 2, 02 August 2017 
This protocol has been approved by Gilead Sciences, Inc. The following signature documents 
this approval. 
PPD 
PPD 
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. 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 study personnel under my supervision copies of the protocol and access to all 
infoimation 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 89 
02August2017 

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Appendix 2.
Study Procedures Table
Study Procedure
Screenc
Baseline/ 
Day 1d
End of Weeka
Post Week 48b
30 Day 
Follow-upe
ESDDf
1
2
4
8
12
24
36
48
Every 
12 Wks
Every 
24 Wks
Informed Consent/Assent
X
Medical Historyg
X
Concomitant Medications
X
X
X
X
X
X
X
X
X
X
X
X
X
Adverse Events
X
X
X
X
X
X
X
X
X
X
X
X
X
Complete Physical Exam
X
X
X
X
Xh
X
Symptom-Directed Physical Exami
X
X
X
X
X
X
X
X
12-Lead ECG (performed supine)
X
Xj
X
Vital Signs 
X
X
X
X
X
X
X
X
X
X
X
X
X
Weight and Height/Length
X
X
X
X
X
X
X
X
X
X
X
X
X
Urinalysis
X
X
X
X
X
X
X
X
X
X
X
X
X
Urine Chemistry
X
X
X
X
X
X
X
X
X
Selected Renal Safety Testsk
X
X
X
X
X
X
X
X
Xl
Serum Pregnancy Testm
X
Urine Pregnancy Testn
X
X
X
X
X
X
X
X
X
X
X
X
Chemistry Profile
X
X
X
X
X
X
X
X
X
X
X
X
X
Metabolic Assessments
X
X
X
X
Estimated GFR
X
X
X
X
X
X
X
X
X
X
X
X
X
Hematology Profile
X
X
X
X
X
X
X
X
X
X
X
X
X
Plasma HIV-1 RNA
X
X
X
X
X
X
X
X
X
X
X
X
X
CCI

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Study Procedure
Screenc
Baseline/ 
Day 1d
End of Weeka
Post Week 48b
30 Day 
Follow-upe
ESDDf
1
2
4
8
12
24
36
48
Every 
12 Wks
Every 
24 Wks
CD4+ Cell Count
X
X
X
X
X
X
X
X
X
X
X
X
X
Whole Blood Sample Storage
X
Serum Storage Sample
X
X
HCV Serologyp
X
HBV Serology
X
Enrollmentq
X
Cohort 1 Dispense Diary Cards r
X
Cohorts 2, 3, & 4 Dispense Diary 
Cardsr
X
X
Single Random PK Samples
X
X
Cohorts 1 and 2 Fasted Prior to Visit
X
X
X
X
X
X
X
X
Cohort 1 IPK Samplingt
X
Cohort 2 Part A IPK Samplingt
Xt
Xt
Cohort 1 Palatability and 
Acceptability Assessmentu
X
Xu
Xu
Cohort 2 Part A Palatability and 
Acceptability Assessment
X
X
Single Observed Dosing PK Samplev
X
X
Trough PK Samples,w
X
PBMCs,x
X
DXA Scan (spine & total body)
X
X
X
X
Xy
Xy
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Study Procedure
Screenc
Baseline/ 
Day 1d
End of Weeka
Post Week 48b
30 Day 
Follow-upe
ESDDf
1
2
4
8
12
24
36
48
Every 
12 Wks
Every 
24 Wks
Cohort 1 Serum Bone Safety Testsz
X
X
X
X
X
X
Xaa
Cohorts 2, 3, and 4 Serum Bone 
Safety Testsz
X
X
X
X
X
X
Xaa
Tanner Stage Assessmentbb
X
X
X
X
In-Clinic Dosing 
X
X
X
X
Study Drug Dispensation 
X
X
X
X
X
X
X
Xcc
Study Drug Accountability
X
X
X
X
X
X
X
X
X
X
a
All study visits are to be scheduled relative to when the Baseline/Day 1 visit was completed. All study visits through Week 8 are to be completed within ± 2 days of the 
protocol-specified visit date. Visits between Week 12 through Week 48 are to be completed within ± 4 days of the protocol-specified visit date, unless otherwise specified.
b
Post Week 48 study visits are to be completed every 12 weeks (± 10 days) unless otherwise specified.
c
All screening evaluations are to be completed within 35 days prior to Baseline/Day 1 Visit.
d
Subjects will be dispensed study drug on the Baseline/Day 1 Visit. Initiation of treatment with the study drug must take place within 24 hours after the Baseline/Day 1 visit. 
F/TAF will be provided by the Sponsor unless prohibited by local regulations or upon request by the subject due to insurance restrictions.
e
30 Day Follow-Up only required for those subjects who do not wish to continue to participate after Week 48 or those subjects who permanently discontinue study drug and do 
not continue in the study through at least one subsequent visit after the Early Study Drug Discontinuation (ESDD) Visit. For the purpose of scheduling a 30-Day Follow-Up 
Visit, a ± 6 days window may be used.
f
Early Study Drug Discontinuation visit to occur within 72 hours of last dose of study drug. Subjects will be asked to continue attending the scheduled study visits through 
Week 48 even if the subject discontinues study drug.
g
Medical history should include a history of HIV-1 disease-related events, ongoing medications within 30 days of Screening, and all information available on historical 
genotypes.
h
Complete physical examination every 48 weeks post 48 weeks (urogenital/anorectal exams will be performed at the discretion of the Investigator).
i
Symptom-directed physical examination, as needed.
j
12-lead ECG performed supine every 48 weeks post week 48.
k
Renal safety tests assessments will be collected fasted for Cohorts 1 and 2. If the subject has not fasted prior to the visit the subject must return within 72 hours in a fasted 
state to collect urine for renal safety tests. 
l
Required for ESDD visit if last test was > 12 weeks from ESDD visit.
m
Females of childbearing potential in Cohorts 1 and 2 only. Performed at screening and anytime during the study to confirm a positive urine pregnancy test.
n
Females of childbearing potential in Cohorts 1 and 2 only. Positive urine pregnancy tests anytime during the study will be confirmed with a serum test. 
 
p
If the antibody test result is positive, HCV RNA test will be performed to confirm HCV viremia.
q
Assignment of the subject’s enrollment number may occur up to 7 days prior to the Baseline/Day 1 visit.
CCI

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r
Diary Cards will be dispensed at Week 1 for all subjects in Cohort 1 to record administration of study drugs and their 3rd ARV agent for at least 3 days prior to the IPK visit at
the Week 2 visit. Diary Cards will be dispensed at Week 1 or Week 2 for all subjects in Part A of Cohorts 2, 3, and 4 to record administration of study drugs and their 
3rd ARV agent for at least 3 days prior to the IPK visit that is to occur during the Week 2 or 4 visit, or within 7 after the completion of the Week 2 or Week 4 visit. Diary 
Cards are to be collected and reviewed for protocol compliance prior to in-clinic dosing and IPK sampling. If the subject has already dosed or is not fasted prior to the IPK 
evaluation visit refer IPK instructions in Section 6.3 for details on how to proceed.
s
Subjects are allowed to take study drug at approximately the same time each day however at the time of the single random PK, trough PK, or PBMC sampling they are 
required to report the time of the last dose.
t
IPK will occur during the Week 2 visit for subjects in Cohort 1 and at either the Week 2 or Week 4 visit, or within 7 days after the completion of Week 2 or Week 4 visits, for 
subjects in Cohort 2 Part A. For the purpose of scheduling the IPK visit, a +7 day window may be used. Subject dosing diary cards are to be collected and reviewed prior to 
in-clinic dosing and IPK sampling.
u
For Cohort 1, palatability will be assessed 30 - 60 minutes after study drug dosing for all subjects undergoing IPK sampling at Week 2. Acceptability will be assessed 
30 - 60 minutes after study drug dosing for active subjects at the next study visit immediately following approval of this protocol at the site.
v
A single observed dosing PK sample will be collected at Weeks 4 and 12 at any time between 15 min to 4 hours post observed in-clinic dose. For subjects in Cohort 2 Part A, 
a single observed dosing PK sample does not need to be collected at Week 4 if IPK is collected at the Week 4 visit.
w
For subjects in all Cohorts a trough PK sample will be collected during the Week 8 visit at 0 hours (pre-dose, ≤ 30 minutes prior to dosing) will be collected. 
x
For subjects in Cohorts 1 and 2, PBMC collection will be performed at the Week 8 visit only at study sites that can perform PBMC processing. For subjects in 
Cohorts 3 and 4, PBMC collection schedule will be specified in a future protocol amendment. All PBMC blood samples will be collected at 0 hours (≤30 minutes pre-dose).
y
DXA scan to be performed at the 30 Day Follow-up visit or the ESDD visit if the last scan was acquired > 12 weeks from the date of the ESDD Visit. DXA scan can occur up 
to 10 days after the ESDD visit date.
z
If the subject has not fasted prior to the blood draw for serum bone safety tests visit may continue however the subject must return within 72 hours after completion of the 
visit in a fasted state to draw blood for serum bone safety tests.
aa
Serum bone safety test is required at ESDD visit if last test was > 12 weeks from ESDD visit.
bb
Tanner assessments will be performed at Baseline/Day1, Weeks 24 and 48 and every 12 post week 48, or until subject reaches Tanner Stage 5
cc
Drug dispensation at Week 48 is only for subjects that are to continue in the study post Week 48.

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Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 94
02 August 2017
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
Repe t lab t  
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
 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
 
  
 
 
 
 
 
 
----l --
 
 
 
 
 
 
 
 
 

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Protocol GS-US-311-1269
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 95
02 August 2017
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities
Version: 18 June 2012
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
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

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Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 96
02 August 2017
HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
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
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%

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Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 97
02 August 2017
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
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

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Protocol GS-US-311-1269
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 98
02 August 2017
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
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
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

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Protocol GS-US-311-1269
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 99
02 August 2017
CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
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
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
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
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

F/TAF
Protocol GS-US-311-1269
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 100
02 August 2017
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 (e.g., the severity of an AE could be either Grade 2 or Grade 3), select the higher of the two grades for 
the AE.

F/TAF
Protocol GS-US-311-1269
Final
Gilead Sciences, Inc.
Amendment 2
CONFIDENTIAL
Page 101
02 August 2017
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 
(e.g., 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 
(e.g., 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 non-urgent intervention 
indicated
Life-threatening consequences 
(e.g., tamponade) OR Urgent 
intervention indicated

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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, e.g., 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, e.g., Torsade de 
pointes or other associated 
serious ventricular 
dysrhythmia
Thrombosis/Embolism
NA
Deep vein thrombosis AND 
No intervention indicated 
(e.g., anticoagulation, lysis 
filter, invasive procedure) 
Deep vein thrombosis AND 
Intervention indicated (e.g., 
anticoagulation, lysis filter, 
invasive procedure) 
Embolic event (e.g., 
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

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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)

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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

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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 [e.g., tube feeding or 
total parenteral nutrition]
Ascites
Asymptomatic
Symptomatic AND Intervention 
indicated (e.g., 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 
(e.g., sepsis or perforation) 
Constipation 
NA
Persistent constipation requiring 
regular use of dietary 
modifications, laxatives, or
enemas 
Obstipation with manual 
evacuation indicated
Life-threatening consequences 
(e.g., 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 
(e.g., 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

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GASTROINTESTINAL
Grade 1
Grade 2
Grade 3
Grade 4
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
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 (e.g., 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 (e.g., 
IV fluids)
Life-threatening consequences 
(e.g., hypotensive shock)
Pancreatitis
NA
Symptomatic AND 
Hospitalization not indicated 
(other than ER visit)
Symptomatic AND 
Hospitalization indicated 
(other than ER visit)
Life-threatening consequences 
(e.g., 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 
(e.g., 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 
(e.g., hypotensive shock)

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NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Alteration in Personality-
Behavior or in Mood (e.g., 
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 (e.g., 
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 
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

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NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
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
Seizure: (new onset) 
NA
1 seizure 
2–4 seizures 
Seizures of any kind that are 
prolonged, repetitive (e.g., 
status epilepticus), or difficult 
to control (e.g., refractory 
epilepsy)

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NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
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 (e.g., 
severity or focality) 
Seizures of any kind that are 
prolonged, repetitive (e.g., 
status epilepticus), or difficult 
to control (e.g., 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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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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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 [e.g., 
tube feeding or total parenteral 
nutrition]

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Amendment 2
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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 (e.g., upper 
arm/thigh)
Erythema OR Induration 
OR Edema involving 50% 
surface area of the extremity 
segment (e.g., 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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Amendment 2
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ENDOCRINE/METABOLIC
Grade 1
Grade 2
Grade 3
Grade 4
Lipodystrophy (e.g., 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 
(e.g., 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
(e.g., 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 
(e.g., myxedema coma)
Lipoatrophy (e.g., 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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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 (e.g., 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 (e.g., 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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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 
The risks of treatment with the study drug during pregnancy have not been evaluated. Pregnancy 
must be excluded before the start of treatment with study drug and prevented thereafter by 
reliable contraceptive methods. Pregnancy tests will be performed regularly throughout this 
study (Refer to Appendix 2). If females are using hormonal agents for contraception, the safety 
and/or efficacy may be affected by possible drug-drug interaction. However, it is recommended 
that the hormonal agent be continued and that a non-hormonal method (or methods) be used 
concurrently.
If females utilize hormonal agents as one of their contraceptive methods, it is required that the 
same hormonal method be used for at least 3 months before study dosing. Please refer to the 
latest version of the Investigator’s Brochure for additional information.
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. A woman who has had a tubal sterilization is considered to be of childbearing 
potential. This definition also includes a pubertal female who has not yet started menstruating. 
A female subject may be considered menopausal in either of the following conditions:

Surgical menopause: Appropriate medical documentation of prior complete bilateral 
oophorectomy (i.e., 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
3) Contraceptive Requirements 
Female subjects of childbearing potential who engage in intercourse must agree to utilize 
protocol specified methods of contraception from the screening visit throughout the study period 
and for 30 days following the last dose of study drug. Male subjects of childbearing potential 
who engage in intercourse must agree to utilize protocol specified methods of contraception from 
the 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 abstinence from heterosexual intercourse and regular pregnancy testing while taking 
any study medication. The investigator will counsel subjects on the protocol specified method(s) 
for avoiding pregnancy in case the subject chooses to engage in heterosexual intercourse.

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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; 
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. 
Female subjects must use either a hormonal method or a barrier method if the partner has a 
vasectomy. 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 serum pregnancy test at screening 
and a negative urine pregnancy test at Baseline/Day 1 prior to receiving the first dose of study 
drug. Lactating females must discontinue nursing before IMP administration.
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 (without 
spermicide)
Partner’s vasectomy must be used with a hormone or barrier method.

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The investigator will counsel all subjects on the most effective method(s) for avoiding pregnancy 
during the study.
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, except for lambskin, 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.
4) 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 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 seek the investigator’s advice regarding action 
required with the study drug immediately. 
Instructions for reporting pregnancy and pregnancy outcome are outlined in Section 7.6.2.1.

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Appendix 6.
Definitions of HIV-1 Related Disease
CDC Classification Systems, Category C: AIDS-Indicator Conditions

Bacterial pneumonia, recurrent (two or more episodes in 12 months)

Candidiasis of bronchi, trachea, or lungs

Candidiasis, esophageal

Cervical carcinoma, invasive, confirmed by biopsy

Coccidioidomycosis, disseminated or extrapulmonary

Cryptococcosis, extrapulmonary

Cryptosporidiosis, chronic intestinal (1 month duration)

Cytomegalovirus disease (other than liver, spleen or nodes)

Encephalopathy, HIV-related

Herpes simplex: chronic ulcers (1 month duration), or bronchitis, pneumonitis or 
esophagitis

Histoplasmosis, disseminated or extrapulmonary

Isosporiasis, chronic intestinal (1-month duration)

Kaposi’s sarcoma

Lymphoma, Burkitt, immunoblastic, or primary central nervous system

Mycobacterium avium complex (MAC) or Myobacterium kansasii, disseminated or 
extrapulmonary

Mycobacterium tuberculosis, pulmonary or extrapulmonary 

Mycobacterium, other species or unidentified species, disseminated or extrapulmonary

Pneumocystis jirovecii (formerly carinii) pneumonia (PCP)

Progressive multifocal leukoencephalopathy (PML)

Salmonella septicemia, recurrent (nontyphoid)

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
Toxoplasmosis of brain

Wasting syndrome caused by HIV (involuntary weight loss > 10% of baseline weight) 
associated with either chronic diarrhea (two or more loose stools per day for ≥1 month) or 
chronic weakness and documented fever for ≥ 1 month
U.S Department of Health and Human Services (DHHS). Guide for HIV/AIDS Clinical Care. -
2014 {Department of Health and Human Services (DHHS) 2014}

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Appendix 7.
Tanner Stages
1. Pubic hair (male and female)
Tanner I
no pubic hair at all (prepubertal Dominic state)
Tanner II
small amount of long, downy hair with slight pigmentation at the base of the penis and scrotum 
(males) or on the labia majora (females)
Tanner III
hair becomes more coarse and curly, and begins to extend laterally
Tanner IV
adult-like hair quality, extending across pubis but sparing medial thighs
Tanner V
hair extends to medial surface of the thighs
2. Genitals (male) (One standard deviation around mean age)
Tanner I
Testes, scrotum, and penis about same size and proportion as in early childhood
Tanner II
Enlargement of scrotum and testes; skin of scrotum reddens and changes in texture; little or no 
enlargement of penis (10.5-12.5)
Tanner III
Enlargement of penis, first mainly in length; further growth of testes and scrotum (11.5-14)
Tanner IV
Increased size of penis with growth in breadth and development of glans; further enlargement of 
testes and scrotum and increased darkening of scrotal skin (13.5-15)
Tanner V
Genitalia adult in size and shape
3. Breasts (female)
Tanner I
no glandular tissue: areola follows the skin contours of the chest
Tanner II
breast bud forms, with small area of surrounding glandular tissue; areola begins to widen
Tanner III
breast begins to become more elevated, and extends beyond the borders of the areola, which 
continues to widen but remains in contour with surrounding breast
Tanner IV
increased breast size and elevation; areola and papilla form a secondary mound projecting from 
the contour of the surrounding breast
Tanner V
breast reaches final adult size; areola returns to contour of the surrounding breast, with a 
projecting central papilla.