A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children
Phase: PHASE2
Conditions: Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Sponsor: Gilead Sciences

CLINICAL STUDY PROTOCOL
Study Title:
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral 
Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide 
(E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral 
Treatment-Naive Adolescents and Virologically Suppressed Children
Sponsor:
Gilead Sciences, Inc.
333 Lakeside Drive 
Foster City, CA 94404
IND No.:
EudraCT Number:
Clinicaltrials.gov 
Identifier:
111007
2013-002780-26
NCT01854775
Indication:
Human immunodeficiency virus type 1 (HIV-1) infection
Protocol ID:
GS-US-292-0106
Contact 
Information: 
The medical monitor name and contact information will be provided on the 
Key Study Team Contact List.
Protocol 
Version/Date:
Original:
04 February 2013
Amendment 1:
22 March 2013
Amendment 2:
09 January 2015
Amendment 3:
11 August 2016
Amendment 4:
11 June 2018
Amendment 5:
17 August 2018
Amendment 6:
21 February 2020
Amendment 7:
01 June 2021
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The information contained in this document, particularly unpublished data, is the property or 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.
(rJ GILEAU 

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Amendment 7
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TABLE OF CONTENTS
TABLE OF CONTENTS................................................................................................................................................2
LIST OF IN-TEXT TABLES .........................................................................................................................................4
LIST OF IN-TEXT FIGURES........................................................................................................................................4
PROTOCOL SYNOPSIS................................................................................................................................................5
GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS ....................................................................17
1.
INTRODUCTION................................................................................................................................................21
1.1.
Background..............................................................................................................................................21
1.1.1.
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide 
(E/C/F/TAF)..........................................................................................................................23
1.2.
Rationale for the Current Study...............................................................................................................28
1.3.
Rationale for Dose Selection...................................................................................................................29
2.
OBJECTIVES.......................................................................................................................................................34
3.
STUDY DESIGN .................................................................................................................................................36
3.1.
Treatment Plan and Regimen ..................................................................................................................36
4.
SUBJECT POPULATION...................................................................................................................................39
4.1.
Number of Subjects and Subject Selection .............................................................................................39
4.2.
Inclusion Criteria.....................................................................................................................................39
4.3.
Exclusion Criteria....................................................................................................................................42
5.
INVESTIGATIONAL MEDICINAL PRODUCTS..............................................................................................44
5.1.
Randomization and Blinding...................................................................................................................44
5.2.
Description and Handling of E/C/F/TAF STR........................................................................................44
5.2.1.
Formulation ...........................................................................................................................44
5.2.2.
Packaging and Labeling ........................................................................................................45
5.2.3.
Storage and Handling ............................................................................................................45
5.3.
Dosage and Administration of E/C/F/TAF STR .....................................................................................45
5.4.
Prior and Concomitant Medications........................................................................................................46
5.5.
Study Drug Return or Disposal ...............................................................................................................50
6.
STUDY PROCEDURES......................................................................................................................................52
6.1.
Subject Enrollment and Treatment Assignment......................................................................................52
6.2.
Screening Visit ........................................................................................................................................52
6.3.
Treatment Assessments ...........................................................................................................................54
6.3.1.
Baseline/Day 1 Assessments .................................................................................................54
6.3.2.
Treatment Assessments through 48 Weeks (Weeks 1 (Day 7) – 48)....................................56
6.3.3.
Intensive PK Evaluation (Part A subjects only, inclusive of Cohort 3) ................................59
6.3.5.
Post-Week 48 Assessments ...................................................................................................60
6.3.6.
Early Study Drug Discontinuation (ESDD) ..........................................................................63
6.3.7.
30-Day Follow-Up Visit........................................................................................................64
6.4.
Bone Evaluations.....................................................................................................................................65
6.5.
Bone and Renal Safety ............................................................................................................................66
6.6.
Plasma and Urine Storage .......................................................................................................................66
6.7.
Criteria for Discontinuation of Study Treatment.....................................................................................66
6.8.
Virologic Failure .....................................................................................................................................67
6.8.1.
Management of Suboptimal Virologic Response (Cohort 1 only)........................................67
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6.8.2.
Management of Virologic Rebound ......................................................................................68
6.8.3.
Subjects with ≥ 400 copies/mL of HIV-1 in Absence of SVR or VR...................................70
7.
ADVERSE EVENTS AND TOXICITY MANAGEMENT.................................................................................71
7.1.
Adverse Events........................................................................................................................................71
7.2.
Assessment of Adverse Events................................................................................................................72
7.3.
Serious Adverse Events...........................................................................................................................72
7.4.
Special Situations ....................................................................................................................................74
7.4.1.
Definitions of Special Situations...........................................................................................74
7.4.2.
Instructions for Reporting Special Situations........................................................................75
7.5.
Serious Adverse Event Reporting Requirements ....................................................................................76
7.5.1.
All Serious Adverse Events...................................................................................................76
7.5.2.
Investigator and Sponsor Reporting Requirements for SAEs ...............................................77
7.5.3.
Post-Study Reporting Requirements .....................................................................................77
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or 
Serious Adverse Events...........................................................................................................................78
7.7.
Toxicity Management..............................................................................................................................78
7.7.1.
Management of Changes in Estimated Glomerular Filtration Rate.......................................79
7.7.2.
Management of Posterior Uveitis Cases................................................................................79
7.7.3.
Grades 1 and 2 Laboratory Abnormality or Clinical Event ..................................................79
7.7.4.
Grade 3 Laboratory Abnormality or Clinical Event..............................................................79
7.7.5.
Grade 4 Laboratory Abnormality or Clinical Event..............................................................80
8.
STATISTICAL CONSIDERATIONS ..................................................................................................................81
8.1.
Analysis Objectives and Endpoints.........................................................................................................81
8.1.1.
Analysis Objectives...............................................................................................................81
8.1.2.
Primary Endpoints.................................................................................................................82
8.1.3.
Secondary Endpoints.............................................................................................................83
8.2.
Analysis Conventions..............................................................................................................................84
8.2.1.
Analysis Sets .........................................................................................................................84
8.2.2.
Data Handling Conventions ..................................................................................................85
8.3.
Demographic Data and Baseline Characteristics ....................................................................................85
8.4.
Efficacy Analysis.....................................................................................................................................85
8.5.
Safety Analysis........................................................................................................................................86
8.5.1.
Extent of Exposure ................................................................................................................86
8.5.2.
Adverse Events......................................................................................................................86
8.5.3.
Laboratory Evaluations .........................................................................................................87
8.5.4.
Bone Safety ...........................................................................................................................87
8.5.5.
Renal Safety...........................................................................................................................87
8.5.6.
Spine and Total Body Less Head Bone Mineral Density......................................................87
8.5.7.
Tanner Stage Assessment......................................................................................................87
8.5.8.
Palatability.............................................................................................................................87
8.5.9.
Acceptability..........................................................................................................................87
8.6.
Pharmacokinetic Analysis .......................................................................................................................88
8.7.
Independent Data Monitoring Committee...............................................................................................88
8.8.
Analysis Schedule ...................................................................................................................................88
8.9.
Sample Size and Power ...........................................................................................................................89
9.
RESPONSIBILITIES...........................................................................................................................................91
9.1.
Investigator Responsibilities ...................................................................................................................91
9.1.1.
Good Clinical Practice...........................................................................................................91
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee 
(IEC)/Research Ethics Board (REB) Approval.....................................................................91
9.1.3.
Informed Consent ..................................................................................................................92

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9.1.4.
Confidentiality.......................................................................................................................92
9.1.5.
Study Files and Retention of Records ...................................................................................92
9.1.6.
Electronic Case Report Forms (eCRFs) ................................................................................94
9.1.7.
Drug Accountability ..............................................................................................................94
9.1.8.
Inspections.............................................................................................................................95
9.1.9.
Protocol Compliance .............................................................................................................95
9.2.
Sponsor Responsibilities .........................................................................................................................95
9.2.1.
Protocol Modifications ..........................................................................................................95
9.2.2.
Study Report and Publications ..............................................................................................95
9.3.
Joint Investigator/Sponsor Responsibilities ............................................................................................96
9.3.1.
Payment Reporting ................................................................................................................96
9.3.2.
Access to Information for Monitoring...................................................................................96
9.3.3.
Access to Information for Auditing or Inspections ...............................................................96
9.3.4.
Study Discontinuation ...........................................................................................................96
10.
REFERENCES.....................................................................................................................................................97
11.
APPENDICES......................................................................................................................................................99
Appendix 1.
Investigator Signature Page...................................................................................................100
Appendix 2.
Study Procedures Table.........................................................................................................101
Appendix 3.
Management of Clinical and Laboratory Adverse Events.....................................................105
Appendix 4.
GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities .............106
Appendix 5.
Pregnancy Precautions, Definition for Female of Childbearing Potential, and 
Contraceptive Requirements..................................................................................................127
Appendix 6.
Stage-3-Defining Opportunistic Illnesses in HIV Infection..................................................129
Appendix 7.
Tanner Stages ........................................................................................................................130
LIST OF IN-TEXT TABLES
Table 1-1.
Pooled Virologic Outcomes of Studies 104 and 111 at Weeks 48a and 144b.........................24
Table 1-2.
Measures of Bone Mineral Density in Studies 104 and 111 (Week 144 Analysis).................26
Table 1-3.
Change from Baseline in Renal Laboratory Tests in Studies 104 and 111 (Week 144 
analysis)...................................................................................................................................26
LIST OF IN-TEXT FIGURES
Figure 1-1.
Predicted EVG AUC in Children Following Administration of E/C/F/TAF 
90/90/120/6 mg........................................................................................................................31
Figure 1-2.
Predicted COBI AUC in Children Following Administration of E/C/F/TAF 
90/90/120/6 mg........................................................................................................................32
Figure 1-3.
Predicted FTC AUC in Children Following Administration of E/C/F/TAF 
90/90/120/6 mg........................................................................................................................32
Figure 1-4.
Predicted TAF AUC in Children Following Administration of E/C/F/TAF 
90/90/120/6 mg........................................................................................................................33
Figure 1-5.
Predicted TFV AUC in Children Following Administration of E/C/F/TAF 
90/90/120/6 mg........................................................................................................................33
Figure 3-1.
Study Schema ..........................................................................................................................37
Figure 6-1.
Suboptimal Virologic Response Schema (Cohort 1 only).......................................................68
Figure 6-2.
Virologic Rebound Schema.....................................................................................................69

EVG/COBI/FfC/TAF 
Protocol GS-US-292-0106 
Gilead Sciences, Inc. 
Study Title: 
IND Number: 
EudraCT Number: 
ClinicalTrials.gov 
Number: 
Study Centers 
Planned: 
Objectives: 
CONFIDENTIAL 
PROTOCOL SYNOPSIS 
Gilead Sciences, Inc. 
333 Lakeside Drive 
Foster City, CA 94404 
Final 
Amendment 7 
A Phase 2/3, Open-Label Study of the Phaim acokinetics, Safety, 
and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/ 
Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) 
in HIV-I Infected Antiretrnviral Treatment-Naive Adolescents and 
Virologically Suppressed Children 
111007 
2013-002780-26 
NCT01854775 
Approximately 15 centers in No1th America, Africa, and Thailand 
Cohort 1 
The prima1y objectives of this study ai·e: 
Part A: 
• 
To evaluate the steady state phaim acokinetics (PK) for 
elvitegravir (EVG) and tenofovir alafenamide (T AF) and 
confom the dose of the elvitegravir/cobicistat/emtricitabine/ 
tenofovir alafenamide (E/C/F/TAF) single tablet regimen (STR) 
in HIV-I infected, antiretroviral (ARV) treatment-naive 
adolescents 
Part B: 
• 
To evaluate the safety and tolerability of the E/C/FffAF STR 
through Week 24 in HIV-I infected, ARV treatment-naive 
adolescents 
The secondaiy objectives of this study are: 
• 
To evaluate the safety and tolerability of the E/C/FffAF STR 
through Week 48 in HIV-I infected, ARV treatment-naive 
adolescents 
• 
To evaluate the antiviral activity of the E/C/F/TAF STR through 
Week 48 in HIV-I infected, ARV treatment-naive adolescents 
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Cohort 2
The primary objectives of this study are:
Part A:

To evaluate the PK of EVG and TAF in virologically suppressed 
HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg 
administered E/C/F/TAF STR
Part B:

To evaluate the safety and tolerability of E/C/F/TAF STR 
through Week 24 in virologically suppressed HIV-1 infected 
children 6 to < 12 years of age weighing ≥ 25 kg
The secondary objectives of this study are:

To evaluate the antiviral activity of switching to E/C/F/TAF 
STR through Week 48 in virologically suppressed HIV-1 
infected children 6 to < 12 years of age weighing ≥ 25 kg

To evaluate the safety and tolerability of E/C/F/TAF STR 
through Week 48 in virologically suppressed HIV-1 infected 
children 6 to < 12 years of age, weighing ≥ 25 kg
Cohort 3
The primary objectives of this study are:

To evaluate the PK of EVG and TAF and confirm the dose of 
the STR in virologically suppressed HIV-1 infected children 
≥ 2 years of age weighing ≥ 14 to < 25 kg administered 
E/C/F/TAF low dose (LD) (90/90/120/6 mg) STR

To evaluate the safety and tolerability of E/C/F/TAF LD STR 
through Week 24 in virologically suppressed HIV-1 infected 
children ≥ 2 years of age and weighing ≥ 14 to < 25 kg
The secondary objectives of this study are:

To evaluate the antiviral activity of switching to E/C/F/TAF LD 
STR through Week 48 in virologically suppressed HIV-1 
infected children ≥ 2 years of age and weighing ≥ 14 to < 25 kg

To evaluate the safety and tolerability of E/C/F/TAF LD STR 
through Week 48 in virologically suppressed HIV-1 infected 
children ≥ 2 years of age and weighing ≥ 14 to < 25 kg

EVG/COBI/FfC/TAF 
Protocol GS-US-292-0106 
Gilead Sciences, Inc. 
Study Design: 
CONFIDENTIAL 
-
Final 
Amendment 7 
Open-label, multicenter, multi-coho1t, single-aim study of the 
phaim acokinetics, safety, tolerability, and antiviral activity of the 
E/C/F/TAF STR in HIV-1 infected ARV treatment-naive 
adolescents and virologically suppressed children. 
A total of 50 adolescents (12 to < 18 years of age), and upto 
75 children (2 to < 12 years of age) of either sex will be enrolled to 
receive the E/C/F/TAF STR once daily with food as follows: 
Part A 
Intensive PK samples will be analyzed once they ai·e available from 
18 subjects regai·dless of age distribution (Coho1ts 1 and 2 only). 
Coho1t 1, Pait A: EVG, TAF and COBI exposures will be compai·ed 
to historical data from adult HIV-1 infected subjects. T AF data will 
also be compared to HIV-negative subjects from GS-US-292-0103 
study. FTC and TFV exposures will be compai·ed to historical data 
in HIV-infected adults and available data in adolescent subjects. 
Coho1t 2 Pait A and Coho1t 3: EVG, TAF, COBI, FTC and TFV 
exposures will be compai·ed to historical adult data. 
EVG and TAF dose confnmation will be established if the 90% CI 
of geometric mean ratios for AUC in adolescents and children 
(respectively) versus those in adults ai·e within the equivalency 
bounds of 70-143%. 
Following completion of the Intensive PK visit, subjects will 
continue to receive the E/C/F IT AF STR and return for scheduled 
study visits through Week 48. 
Cohort 1 (Adolescents 12 to < 18 years of age) 
• 
Eighteen to 24 eligible subjects will be initially enrolled to 
evaluate the steady state phannacokinetics, and confnm the dose 
of the E/C/F/TAF STR. 
• 
Part A will aim to enroll at least 6 subjects 12 to < 15 years of 
age and at least 6 subjects 15 to < 18 years of age. 
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
If at least 6 subjects ages 12 to < 15 years and 6 subjects ages 
15 to < 18 have not been enrolled at the time of the Intensive PK 
analysis, Part A enrollment will remain open in order to enroll 
sufficient subjects to meet the minimum enrollment of the 2 age 
subgroups.

Subjects enrolled in Part A will participate in an Intensive PK 
evaluation at Week 4. Samples will be collected at 0 (pre-dose, 
≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 
5, 8, and 24 hours post-dose.
Cohort 2 (Children 6 to < 12 years of age and weighing ≥ 25 kg)

Eighteen to 24 eligible subjects will be initially enrolled to 
evaluate the EVG and TAF plasma PK and confirm the dose of 
EVG and TAF.

Subjects enrolled in Part A will participate in an Intensive PK 
evaluation at Week 4. Samples will be collected at 0 (pre-dose, 
≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 
24 hours post-dose.
Cohort 3 (Children ≥ 2 years of age and weighing ≥ 14 to 
< 25 kg)

Approximately 25 eligible subjects will be initially enrolled to 
evaluate the EVG and TAF plasma PK and confirm the dose of 
EVG and TAF.

Subjects enrolled in Part A will participate in an Intensive PK 
evaluation at Week 2. Samples will be collected at 0 (pre-dose, 
≤ 30 minutes prior to dosing), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 
8 hours post-dose.
Part B
Cohort 1 (Adolescents 12 to < 18 years of age)
Screening will be initiated into Cohort 1, Part B following 
confirmation of EVG and TAF exposure in at least 18 subjects from 
Cohort 1, Part A. The additional 26 – 32 subjects will be enrolled in 
Cohort 1, Part B to evaluate the safety, tolerability and antiviral 
activity of the E/C/F/TAF STR in at least 50 patients, including all 
subjects enrolled in Cohort 1 (Parts A and B combined).

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Cohort 2 (Children 6 to < 12 years of age and weighing ≥ 25 kg)
Screening will be initiated into Cohort 2, Part B based on exposure 
data from at least 18 subjects from Cohort 2, Part A. The additional 
26 – 32 subjects will be enrolled in Cohort 2, Part B to evaluate the 
safety, tolerability and antiviral activity of the E/C/F/TAF STR in at 
least 50 patients, including all subjects enrolled in Cohort 2 (Parts A 
and B combined).
Cohort 3 (Children ≥ 2 years of age and weighing ≥ 14 to 
< 25 kg)

No Part B for this cohort. All subjects will be enrolled in Part A 
and will complete an Intensive PK evaluation.
Number of Subjects 
Planned:
Cohort 1
50 subjects
Part A: Eighteen to 24 subjects representing 2 age subgroups 
(at least 6 subjects must be 12 to <15 years of age and at least 
6 subjects must be 15 to < 18 years of age)
Part B: Twenty-six to 32 subjects between 12 to < 18 years of age 
(dependent upon enrollment in Part A)
Cohort 2
50 subjects
Part A: Eighteen to 24 subjects between 6 to < 12 years of age 
weighing ≥ 25 kg
Part B: Twenty-six to 32 subjects must be 6 to < 12 years of age 
and weighing ≥ 25 kg (dependent upon enrollment in Part A)
Cohort 3
Approximately 25 subjects ≥ 2 years of age and weighing ≥ 14 to 
< 25 kg
Target Population:
Cohort 1
Antiretroviral treatment-naive, HIV-1 infected adolescents (12 to 
< 18 years of age) of either sex with plasma HIV-1 RNA levels 
≥ 1,000 copies/mL
Cohort 2
Virologically suppressed, HIV-1 infected children (6 to < 12 years 
of age and screening weight ≥ 25 kg) of either sex with plasma 
HIV-1 RNA levels < 50 copies/mL for ≥ 6 consecutive months prior 
to screening on a stable antiretroviral regimen, with no documented 
history of resistance to any component of E/C/F/TAF STR.

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Cohort 3
Virologically suppressed, HIV-1 infected children (≥ 2 years of age 
and screening weight of ≥ 14 to < 25 kg) of either sex with plasma 
HIV-1 RNA levels < 50 copies/mL for ≥ 6 consecutive months prior 
to screening on a stable antiretroviral regimen, with no documented 
history of resistance to any component of E/C/F/TAF STR.
Duration of 
Treatment:
48 weeks
After completion of Week 48, all subjects receiving the E/C/F/TAF 
STR who complete 48 weeks of study treatment will be given the 
option to participate in an extension phase of the study where Gilead 
will provide E/C/F/TAF STR until:
a) the relevant E/C/F/TAF STR formulation is available for use, 
other than through the study, in the country in which the subject 
is enrolled, or 
b) Gilead Sciences elects to terminate development of E/C/F/TAF 
STR in the applicable country.
Diagnosis and Main 
Eligibility Criteria:
HIV-1 infected subjects who meet the following criteria:
Cohort 1

Age at Baseline: 12 to < 18 years old

Weight at Screening: ≥ 35 kg (77 lbs)

Plasma HIV-1 RNA ≥ 1,000 copies/mL at Screening 
(Roche COBAS TaqMan v2.0)

Screening genotype report shows sensitivity to EVG, FTC and 
TFV (Monogram Biosciences, Inc.)

Subjects with HIV subtype AE who meet all inclusion/exclusion 
criteria and who have a non-reportable integrase genotype result 
may proceed with study enrollment. (For Thailand only)

No prior use of any approved or experimental anti-HIV-1 drug 
for any length of time (other than that given for prevention of 
mother-to-child transmission)
Cohort 2

Age at Baseline: 6 to < 12 years old

Weight at Screening: ≥ 25 kg (55 lbs)

Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 
RNA level according to the local assay being used if the limit of 
detection is > 50 copies/mL) for ≥ 6 months prior to Screening 
on a stable antiretroviral regimen, without documented history 
of resistance to any component of E/C/F/TAF STR

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
Unconfirmed HIV-1 RNA ≥ 50 copies/mL after previously 
reaching virologic suppression (transient detectable viremia, or 
“blip”) and prior to screening is acceptable

Currently receiving an antiretroviral regimen that has been stable 
for at least 6 months or has been newly initiated within 6 months 
for reasons other than virologic failure.
Cohort 3

Age at Baseline: ≥ 2 years old

Weight at Screening: ≥ 14 kg (31 lbs) to < 25 kg (55 lbs)

Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 
RNA level according to the local assay being used if the limit of 
detection is > 50 copies/mL) for ≥ 6 months prior to Screening 
on a stable antiretroviral regimen, without documented history 
of resistance to any component of E/C/F/TAF STR
Unconfirmed HIV-1 RNA ≥ 50 copies/mL after previously 
reaching virologic suppression (transient detectable viremia, 
or “blip”) and prior to screening is acceptable

Currently receiving an antiretroviral regimen that has been stable 
for at least 6 months or has been newly initiated within 6 months 
for reasons other than virologic failure.
Study Procedures/ 
Frequency:
All Subjects (All Cohorts unless specified):
At the Screening, Baseline/Day 1, and all subsequent study visits 
laboratory analyses (hematology, chemistry and urinalysis), HIV-1 
RNA, vital signs, and complete or symptom-directed physical 
examinations and estimated GFR using the Schwartz formula will 
be performed.
At Screening, HIV-1 protease, reverse transcriptase and integrase 
genotype will be analyzed (for Cohort 1 only).
HBV and HCV serologies will be analyzed and supine ECG will be 
performed.
Blood samples will be collected for full flow cytometry panel testing 
at Screening, Baseline and Weeks 2 - 48.
Adverse events and concomitant medications will be assessed at 
each visit.
Subjects will return for study visits at Weeks 1 (Day 7), 2, 4, 8, 12, 
16, and then every 8 weeks through Week 48.
Subjects enrolled in Part A will participate in an Intensive PK 
Evaluation at Week 2 (Cohort 3, all subjects) or Week 4 (Cohorts 1 
and 2). Subject diary cards will be provided to all Part A subjects to 
record administration of study drugs prior to the Intensive PK visit.

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For subjects in Cohorts 1 and 2, a trough PK sample (20 to 24 hours 
post-dose) will be collected at Weeks 1, 2, and 24. For Cohort 1, a 
trough PK sample will also be collected at Week 48. For subjects in 
Cohort 3, a trough sample will be collected at Weeks 4 and 24.
For subjects in Cohort 1, a timed random PK sample will be 
collected between 0.25 to 4 hours post-dose at Week 4 (Cohort 1 
Part B subjects only) and at Week 12 (all Cohort 1). For subjects in 
Cohort 2, a timed random PK sample will be collected between 0.25 
to 4 hours post-dose at Week 12 and a random single PK sample 
will be collected at Week 8 and Week 16. For subjects in Cohort 3, a 
timed single PK sample will be collected between 0.25 to 4 hours 
post-dose at Weeks 8, 12, and 16.
Fasting glucose and lipid panel (total cholesterol, high-density 
lipoprotein, direct low-density lipoprotein, and triglycerides) will be 
collected at Baseline, Week 24, and Week 48.
The following serum bone safety parameters will be collected at 
Screening (Cohort 3), Baseline (Cohorts 1 and 2), Week 8 (Cohort 1 
only), and Weeks 12, 24, and 48:

Cohorts 1 and 2: bicarbonate, N-telopeptide, C-telopeptide, 
osteocalcin, and procollagen type 1 N-terminal propeptide 
(P1NP).

For all cohorts: bone specific alkaline phosphatase, parathyroid 
hormone, 25OH Vitamin D, and 1,25OH Vitamin D.
The following urine bone safety parameters will be collected at 
Baseline, Weeks 8, 12, 24, and 48:

Cohorts 1 and 2: bicarbonate and N-telopeptide.
Urine will be collected for renal safety parameters at Screening 
(Cohort 3), Baseline (Cohorts 1 and 2), Weeks 8, 12, 24, and 48.

For all cohorts: urine chemistry, retinol binding protein, and 
beta-2-microglobulin.
Tanner stage will be assessed for subjects ≥ 6 years of age at 
Baseline, Weeks 24 and 48 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, 
Weeks 24 and 48 to measure spine bone mineral density (BMD) and 
total body BMD.

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Resistance testing will be performed using the RT/PR PhenoSense 
GT assay, the IN GeneSeq assay, and the IN PhenoSense assay 
(Monogram Biosciences, Inc.) in subjects who experience 
suboptimal virologic response or virologic rebound, if HIV-1 RNA 
is ≥ 400 copies/mL.
Palatability and Acceptability assessment will be performed at 
Baseline and Week 4 for Cohort 2 subjects, and Baseline, Week 4, 
Week 24, and Week 48 for Cohort 3 subjects. For Cohort 1 subjects 
currently on study, it will be performed at their next scheduled visit.
Subjects who are permanently discontinued from the study before 
Week 48 and subjects who do not wish to continue on the study 
after completing Week 48 will be required to return to the clinic 
30 days after the completion of study drug for a 30-Day Follow-Up 
Visit.
After Week 48, all subjects receiving E/C/F/TAF STR who 
complete 48 weeks of study treatment will be given the option to 
participate in an extension phase of the study. 
Test Product, Dose, 
and Mode of 
Administration:
Cohorts 1 and 2:
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ 
tenofovir alafenamide 10 mg STR administered orally once daily 
with food
Cohort 3:
Elvitegravir 90 mg/cobicistat 90 mg/emtricitabine 120 mg/ tenofovir 
alafenamide 6 mg STR low dose tablet administered orally 
once daily with food
Reference Therapy, 
Dose, and Mode of 
Administration:
None
Criteria for 
Evaluation:
Safety:
Adverse events, clinical laboratory tests, Tanner stage assessment 
(subjects ≥ 6 years of age), selected bone biomarkers, renal safety, 
and BMD to evaluate the safety and tolerability of the treatment 
regimen.

EVG/COBI/FfC/TAF 
Protocol GS-US-292-0106 
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Efficacy: 
PK: 
Statistical Methods: 
CONFIDENTIAL 
Cohort 1 
The efficacy endpoints are: 
• 
The percentage of subjects with plasma HIV-1 RNA 
Final 
Amendment 7 
< 50 copies/mL at Weeks 24 and 48 as defined by the FDA 
snapshot analysis 
• 
The percentage of subjects with plasma HIV-1 RNA 
< 400 copies/mL at Weeks 24 and 48 as defined by the FDA 
snapshot analysis 
• 
The change from baseline in plasma log10 HIV-1 RNA 
( copies/mL) and in CD4 + cell count ( cells/ µL) and percentage at 
Weeks 24 and 48 
Cohorts 2 and 3 
• 
The percentage of subjects with plasma HIV-1 RNA 
< 50 copies/mL at Weeks 24 and 48 by the FDA snapshot 
analysis 
• 
The change from baseline in CD4+ cell count (cells/µL) and 
percentage at Weeks 24 and 48 
The following plasma phannacokinetic parameters will be 
calculated for EVG, COBI, FTC, TAF and TFV, as applicable: 
AUCtau, AUC1ast, Ciau, Cmax, C1ast, Tmax, T1ast, Az, CL/F, VJF, and T½ 
(where possible) 
PK Analyses 
PK parameters (AUCtau, Ciau, and Cmax) of EVG and PK parameters 
(AUC and Cmax) ofTAF will be summarized and compared to 
historical adult data. Plasma concentration and parameter data of 
EVG, COBI, FTC, TAF, and TFV will be summarized using 
descriptive statistics. 
An analysis of variance (ANOV A) using a mixed-effects model for 
appropriate parallel group design will be fitted to natural-logarithm 
trnnsfo1med AUC for TAF and AUC1au for EVG to evaluate whether 
the exposures of these two analytes achieved in adolescent 
(Cohort 1) or children (Cohorts 2 and 3) are similar to the exposure 
achieved in adult subjects. An appropriate adult comparator 
database will be identified and integrated as historical control data. 
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For each cohort, two one-sided tests with each performed at an alpha 
level of 0.05 and a boundary of 70% to 143% will be used for 
exposure equivalence assessment.
Efficacy Analyses
The percentage of subjects who achieve HIV-1 RNA < 50 copies/mL 
and < 400 copies/mL at Weeks 24 and 48 as defined by the FDA 
snapshot analysis algorithm will be summarized by cohort. The 95% 
confidence intervals will also be presented.
The change from baseline in log10 HIV-1 RNA (Cohort 1 only) and 
CD4+ cell count and percentage at Weeks 24 and 48 will be 
summarized by cohort using descriptive statistics.
Sample Size and Power 
Cohorts 1 and 2
A minimum of 18 Part A subjects from each cohort compared to 51 
HIV-infected adult subjects in GS-US-292-0102 and HIV-negative 
adult subjects in GS-US-292-0103 combined, will provide 92% 
power to conclude exposure equivalence of TAF AUClast in 
adolescent subjects and children, respectively vs in adult subjects, 
assuming the expected geometric mean ratio is 1, equivalency 
boundary is 70% to 143%, two one-sided tests are each performed at 
an alpha level of 0.05, and the standard deviation of AUClast is 
0.37 ng•hr/mL (natural log scale).
A minimum of 18 Part A subjects from each cohort will also provide 
> 99% power to target a 95% confidence interval within 60% and 
140% of the geometric mean estimate of clearance and volume of 
distribution of TAF respectively, assuming a coefficient of variation 
(CV) of 38% for clearance and 42% for volume of distribution 
(GS-US-292-0102 and GS-US-292-0103 combined).
For each cohort, with a total of 50 subjects from Parts A and B 
combined, the chance to observe at least 1 SAE is 92%, assuming 
the SAE incidence rate is 5% (observed in GS-US-292-0102). After 
amendment 2 of the study protocol was finalized, the adult data 
included in E/C/F/TAF (Genvoya®) label have become available and 
will be used as historical control for comparison for Cohort 2 
(ie, intensive PK data from 19 HIV-1 infected adults in Study 
GS-US-292-0102 for EVG AUCtau and population PK data from 
539 HIV-1 infected adults in Studies GS-US-292-0104 and 
GS-US-292-0111 combined for TAF AUClast). Given the actual 
number of enrollments in Cohort 2 Part A was 23, a total of 
23 subjects would provide 90% power for EVG AUCtau and 88% 
power for TAF AUClast to conclude exposure equivalence between 

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children and adults, assuming the expected geometric mean ratios 
was 1, equivalency boundary was 70% to 143%, two one-sided tests 
were each performed at an alpha level of 0.05, and the intersubject 
standard deviation (natural log scale) of EVG AUCtau and TAF 
AUClast was 0.34 ng•hr/mL and 0.52 ng•hr/mL, respectively.
A total of 23 subjects from Cohort 2 Part A would also provide 86% 
power to target a 95% confidence interval within 60% and 140% of 
the geometric mean estimate of clearance and volume of distribution 
of TAF respectively, assuming a CV of 53% for clearance and 76% 
for volume of distribution (based on population PK data from 
GS US-292-0104 and GS-US-292-0111 combined).
Cohort 3
Twenty-five evaluable subjects compared to historical adult data 
will provide 90% power for each of EVG AUCtau and TAF AUCtau 
to conclude exposure equivalence between children and adults. In 
this power analysis, it is assumed that the expected geometric mean 
ratios is 1, equivalency boundary is 70% to 143%, two one-sided 
tests are each performed at an alpha level of 0.05, and the 
intersubject standard deviations (natural log scale) of EVG AUCtau 
and TAF AUCtau are 0.34 ng•hr/mL and 0.52 ng•hr/mL. For 
historical adult data, we used intensive PK data from 19 HIV-1 
infected adults in Study GS-US-292-0102 for EVG AUCtau and 
population PK data from Studies GS-US-292-0104 and 
GS-US-292-0111 combined for TAF AUCtau.
Twenty-five evaluable subjects will also provide > 99% power to 
target a 95% confidence interval within 60% and 140% of the 
geometric mean estimate of apparent clearance and volume of 
distribution of TAF respectively, assuming the standard deviation 
natural log scale is 0.51 for CL and 0.54 for Vz (based on population 
PK data from Studies GS-US-292-0104 and GS-US-292-0111 
combined).
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
λz
terminal elimination rate constant, estimated by linear regression of the terminal 
elimination phase of the plasma concentration of drug versus time curve
AE
adverse event
AIDS
acquired immunodeficiency syndrome
ALT
alanine aminotransferase
ANC
absolute neutrophil counts
ARV
antiretroviral
AST
aspartate aminotransferase
AUC
area under the plasma/serum/peripheral blood mononuclear cell concentration 
versus time curve
AUClast
area under the concentration versus time curve from time zero to the last 
quantifiable concentration
AUCtau
area under the concentration versus time curve over the dosing interval 
BMD
bone mineral density
BUN
blood urea nitrogen
CBC
complete blood count
CDC
Centers for Disease Control and Prevention
CI
confidence interval
CFR
Code of Federal Regulations
CLcr
creatinine clearance
Cmax
maximum observed serum/plasma/peripheral blood mononuclear concentration of 
drug
Clast
last observed quantifiable concentration of the drug in plasma
CNS
central nervous system
COBI
cobicistat (GS-9350)
CPK
creatine phosphokinase
CRF
case report form
CRO
contract (or clinical) research organization
Ctau
observed drug concentration at the end of the dosing interval
CTX
C-telopeptide
CV
coefficient of variation
CYP
cytochrome P450
DAVG
average area under the dosing interval
DHHS
Department of Health and Human Services
DNA
deoxyribonucleic acid
DRV
darunavir

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DXA
dual energy x-ray absorptiometry
E/C/F/TDF
single tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 
200 mg/ tenofovir disoproxil fumarate 300 mg
EC
Ethics Committee
ECG
electrocardiogram
eCRF
electronic case report form
EFV
efavirenz, Sustiva®
EFV/FTC/TDF
single tablet regimen of efavirenz 600 mg/emtricitabine 200 mg/tenofovir 
disoproxil fumarate 300 mg, Atripla®
EU
European Union
EVG
elvitegravir (GS-9137)
EVG/COBI/FTC/TAF, 
E/C/F/TAF
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 
FDA
Food and Drug Administration
FTC
emtricitabine, Emtriva®
FTC/RPV/TDF
emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg, 
Complera® FTC/TDF
GCP
Good Clinical Practice (Guidelines)
GFR
glomerular filtration rate
GGT
gamma glutamyl transferase
GLP
Good Laboratory Practices
GLPS
Global Patient Safety
GSI
Gilead Sciences, Inc.
GS-9137
elvitegravir, EVG, 6-(3-Chloro-2-fluorobenzyl)-1-[(2S)-1-hydroxy-3-methylbutan-
2-yl]-7-methoxy-4-oxo-1, 4-dihydroquinoline-3-carboxylic acid
GS-9350
cobicistat, COBI, 1,3-Thiazol-5-ylmethyl (2R,5R)-(5-(((2S)-2-((methyl((2-(propan-
2-yl)-1,3-thiazol-4-yl(methyl(carbamoyl)amino((-4-(morpholin-4-yl)butanamido
HAART
highly active antiretroviral therapy
HBV
hepatitis B virus
HCV
hepatitis C virus
HDL
high-density lipoprotein
HDPE
high-density polyethylene
HIV
human immunodeficiency virus
HMG-CoA
5-hydroxy-3-methylglutaryl-coenzyme A
ICH
International Council for Harmonisation (of Technical Requirements for 
Pharmaceuticals for Human Use)
ID
identification
IDMC
Independent Data Monitoring Committee
IEC
independent ethics committee
Ig
immunoglobulin

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IND
investigational new drug 
INH
isonicotinylhydrazine, Isoniazid (Laniazid, Nydrazid)
INSTI
integrase strand transfer inhibitor
IRB
institutional review board
ITT
intent to treat (analysis or subset)
IV
intravenous
KS
Kaposi’s sarcoma
LD
low dose
LDL
low-density lipoprotein
LLN
lower limit of the normal range
MedDRA
Medical Dictionary for Regulatory Activities
NNRTI
non-nucleoside reverse transcriptase inhibitor
NRTI
nucleoside/nucleotide reverse transcriptase inhibitor
OTC
over the counter
PAH
pulmonary arterial hypertension
PBMC
peripheral blood mononuclear cell
PI
protease inhibitor
PI/r
ritonavir boosted-protease inhibitor
PK
pharmacokinetic
PR
pulse rate
PT
preferred term (in Section 8)
PT
prothrombin time (in Appendix 4)
PTH
parathyroid hormone
QTc
corrected QT
RAL
raltegravir
RBP
retinol-binding protein
REB
Research Ethics Board
RNA
ribonucleic acid
RPV
rilpivirine
RTV
ritonavir, Norvir®
SAE
serious adverse event
Scr
serum creatinine
SOC
System Organ Class
SOP
standard operating procedure
Spo4
serum phosphate concentration

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STR
Single Tablet Regimen
SUSAR
suspected unexpected serious adverse reaction
SVR
suboptimal virologic response
T½
half life
TAF
tenofovir alafenamide (GS-7340)
TBLH
total body less head
TDF
tenofovir disoproxil fumarate, Viread®
TFV
tenofovir
TFV-DP
tenofovir diphosphate
TLOVR
time to loss of virologic response
tmax
time (observed time point) of Cmax
TPV/r
ritonavir-boosted tipranavir
UACR
Urine Albumin to Creatinine Ratio
ULN
upper limit of the normal range
UPCR
Urine Protein to Creatinine Ratio
US
United States
Upo4
urine phosphate concentration
VR
virologic rebound

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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

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
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
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 2018 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 depending on age and sexual maturity rating for 
adolescents (DHHS guidelines May 2018). 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 {Department of Health and Human 
Services (DHHS) 2018}.
Studies have shown that a once-daily STR significantly improved adherence, treatment 
satisfaction, and virologic outcomes for patients infected with HIV-1 {Airoldi 2010, Bangsberg 
2010, Dejesus 2009, Hodder 2010, Sax 2015}. Due to a longer duration of high adherence, 
patients taking STRs also have better clinical outcomes, such as fewer hospitalizations, 
compared with multiple-tablet regimens {Sax 2010}. The following STRs are currently approved 
for once-daily administration in the treatment of HIV-1 infection in adolescents and/or children: 
EFV/FTC/TDF (Atripla®), FTC/RPV/TDF (Complera®/Eviplera®), EVG/COBI/FTC/TDF 
(Stribild®), EVG/COBI/FTC/TAF (Genvoya®), BIC/FTC/TAF (Biktarvy®), R/F/TAF (Odefsey®) 
and Triumeq®.
Tenofovir disoproxil fumarate (TDF) is a preferred NRTI among recommended regimens for 
treatment-naive HIV-infected adults and adolescents, but is associated with nephrotoxicity and 
reduced bone mineral density {Panel on Antiretroviral Guidelines for Adults and Adolescents 
2012}. Lifelong antiretroviral treatment and the increasing comorbidities being recognized and 
treated in HIV-infected patients creates an urgent need to improve the safety profile of regimens 
that most effectively suppress HIV replication.

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Tenofovir alafenamide (TAF, also known as GS-7340) is an oral prodrug of tenofovir (TFV), a 
nucleotide analog that inhibits HIV-1 reverse transcription. Gilead has coformulated TAF with 
the integrase strand transfer inhibitor EVG, cobicistat (COBI, GS-9350), and FTC into a STR. 
Compared to TDF, the use of TAF in the E/C/F/TAF STR provides enhanced lymphatic delivery 
of TFV, resulting in higher intracellular levels of the active phosphorylated moiety 
tenofovir-diphosphate (TFV-DP), and lower systemic circulating levels of TFV. These features 
are hypothesized to translate into more effective suppression of viral replication, and an 
improved tolerability and safety profile. FTC/TAF (Descovy), Genvoya, R/F/TAF (Odefsey), 
and GS-9883/Emtricitabine/Tenofovir Alafenamide (Biktarvy) are all FDC’s containing TAF 
that have been approved in adolescents (US and EU) and children 6 to <12 years of age weighing 
≥ 25 kg (Genvoya in the US and EU and Descovy in the US only).
EVG can be dosed once daily when used with a pharmacoenhancing (boosting) agent like 
ritonavir 100 mg or COBI. COBI is devoid of anti-HIV activity, may have less adverse 
biochemical effects (e.g., effect on adipocyte functions such as lipid accumulation) relative to 
ritonavir, and can be coformulated as a tablet with other ARV agents that require boosting. 
Gilead Sciences has coformulated a single tablet regimen of COBI with EVG, FTC and TAF. 
This STR may be an attractive option for adolescents and children with HIV-1 infection.
This study represents the first use of the E/C/F/TAF STR in adolescents and children 6 to 
< 12 years of age. E/C/F/TAF was approved in adults and pediatric patients 12 years of age and 
older in the US and EU in 2016 and most recently for 6 to < 12 year olds and weighing ≥ 25 kg. 
Please refer to the E/C/F/TAF local labeling and the Investigator’s Brochure for 
contraindications, warnings and precautions, and interactions.
1.1.1.
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF)
A brief summary of the clinical trials of E/C/F/TAF STR for the treatment of HIV-1 infection are 
below. Please refer to the E/C/F/TAF Investigator’s Brochure for additional details:
The efficacy and safety of E/C/F/TAF (Genvoya) in HIV-1 infected, treatment-naïve adults are 
based on 144-week data from two randomized, double-blind, active-controlled studies, 
GS-US-292-0104 (“Study 104”) and GS-US-292-0111 (“Study 111”) (N=1733).
The efficacy and safety of Genvoya in virologically-suppressed HIV-1 infected adults are based 
on 96-week data from a randomized, open-label, active-controlled study, GS-US-292-0109 
(“Study 109”) (N=1436).
The efficacy and safety of Genvoya in HIV-1 infected, virologically-suppressed patients with 
mild to moderate renal impairment is based on 144-week data from an open-label study, 
GS-US-292-0112 (“Study 112”) (N = 242).
The efficacy and safety of Genvoya in HIV-1 infected pediatric patients are based on 48-week 
data in treatment-naïve patients between the ages of 12 to < 18 years (weighing ≥ 35 kg) (N=50) 
and 24-week data in virologically suppressed patients between the ages of 6 to < 12 years 
(weighing ≥ 25 kg) (N = 23) from Cohorts 1 and 2, respectively, of this study 
(GS-US-292-0106).

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Treatment-Naïve Patients
In both Study 104 and Study 111, patients were randomized in a 1:1 ratio to receive either 
Genvoya (N = 866) once daily or Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 
200 mg/tenofovir disoproxil fumarate 300 mg; N = 867) once daily.
In Studies 104 and 111, the mean age was 36 years (range 18-76), 85% were male, 57% were 
White, 25% were Black, and 10% were Asian. Nineteen percent of patients identified as 
Hispanic/Latino. The mean baseline plasma HIV-1 RNA was 4.5 log10 copies/mL 
(range 1.3-7.0). The mean baseline CD4+ cell count was 427 cells/mm3 (range 0-1360) and 13% 
had CD4+ cell counts less than 200 cells/mm3. Twenty-three percent of patients had baseline 
viral loads greater than 100,000 copies/mL.
In both studies, patients were stratified by baseline HIV-1 RNA (less than or equal to 
100,000 copies/mL, greater than 100,000 copies/mL to less than or equal to 400,000 copies/mL, 
or greater than 400,000 copies/mL), by CD4 count (less than 50 cells/μL, 50-199 cells/μL, or 
greater than or equal to 200 cells/μL), and by region (US or ex-US).
Treatment outcomes of Studies 104 and 111 through 48 and 144 weeks are presented in 
Table 1-1.
Table 1-1.
Pooled Virologic Outcomes of Studies 104 and 111 at Weeks 48a and 
144b
Week 48
Week 144
Genvoya
(N = 866)
Stribild
(N = 867)
Genvoya
(N = 866)
Stribild
(N = 867)
HIV-1 RNA < 50 copies/mL
92%
90%
84%
80%
Treatment Difference
2.0% (95% CI = −0.7% to 4.7%)
4.2% (95% CI = 0.6% to 7.8%)
HIV-1 RNA ≥ 50 copies/mLc
4%
4%
5%
4%
No Virologic Data at Week 48 or 144 
Window
4%
6%
11%
16%
Discontinued Study Drug Due to 
AE or Deathd
1%
2%
1%
3%
Discontinued Study Drug Due to 
Other Reasons and Last Available 
HIV-1 RNA < 50 copies/mLe
2%
4%
9%
11%
Missing Data During Window but 
on Study Drug
1%
<1%
1%
1%

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Week 48
Week 144
Genvoya
(N = 866)
Stribild
(N = 867)
Genvoya
(N = 866)
Stribild
(N = 867)
Proportion (%) of Patients with HIV-1 RNA <50 copies/mL by Subgroup
Age
< 50 years
≥ 50 years
716/777 (92%)
84/89 (94%)
680/753 (90%)
104/114 (91%)
647/777 (83%)
82/89 (92%)
602/753 (80%)
92/114 (81%)
Sex
Male
Female
674/733 (92%)
126/133 (95%)
673/740 (91%)
111/127 (87%)
616/733 (84%)
113/133 (85%)
603/740 (81%)
91/127 (72%)
Race
Black
Nonblack
197/223 (88%)
603/643 (94%)
177/213 (83%)
607/654 (93%)
168/223 (75%)
561/643 (87%)
152/213 (71%)
542/654 (83%)
Baseline Viral Load
≤ 100,000 copies/mL
100,000 copies/mL
629/670 (94%)
171/196 (87%)
610/672 (91%)
174/195 (89%)
567/670 (85%)
162/196 (83%)
537/672 (80%)
157/195 (81%)
Baseline CD4+ cell count
< 200 cells/mm3
≥ 200 cells/mm3
96/112 (86%)
703/753 (93%)
104/117 (89%)
680/750 (91%)
93/112 (83%)
635/753 (84%)
94/117 (80%)
600/750 (80%)
a
Week 48 window was between Day 294 and 377 (inclusive).
b
Week 144 window was between Day 966 and 1049 (inclusive).
c
Includes patients who had ≥ 50 copies/mL in the Week 48 or 144 window; patients who discontinued early due to lack or 
loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and 
at the time of discontinuation had a viral value of ≥ 50 copies/mL.
d
Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted 
in no virologic data on treatment during the specified window.
e
Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy, e.g., withdrew consent, 
loss to follow-up, etc.
At Week 144, Genvoya demonstrated statistical superiority (P = 0.021) in achieving HIV-1 RNA 
< 50 copies/mL when compared to Stribild.
In Studies 104 and 111, the mean increase from baseline in CD4+ cell count at Week 144 was 
326 cells/mm3 in Genvoya-treated patients and 305 cells/mm3 in Stribild-treated patients 
(P = 0.06).
Bone Mineral Density: In a pooled analysis of Studies 104 and 111, the effects of Genvoya 
compared to that of Stribild on bone mineral density (BMD) change from baseline to Week 144 
were assessed by dual-energy X-ray absorptiometry (DXA). As shown in Table 1-2, in patients 
who had both baseline and Week 144 measurements (N = 690 and 702 in the Genvoya group and 
N = 683 and 686 in the STRIBLD group, for hip and spine, respectively) there were smaller 
decreases in BMD in the Genvoya group as compared to Stribild.

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Table 1-2.
Measures of Bone Mineral Density in Studies 104 and 111 (Week 144 
Analysis)
Genvoya
Stribild
Treatment Difference
Hip DXA Analysis
N = 690
N = 683
Mean Percent Change in BMD
−0.8%
−3.4%
2.6%
P < 0.001
Patients with Categorical Change:
3% Decrease in BMD
3% Increase in BMD
28%
13%
55%
6%
--
Patients with No Decrease (≥ zero % change) in BMD
40%
19%
--
Lumbar Spine DXA Analysis
N=702
N=686
Mean Percent Change in BMD
−0.9%
−3.0%
2.0%
P < 0.001
Patients with Categorical Change:
3% Decrease in BMD
3% Increase in BMD
30%
13%
49%
7%
--
Patients with No Decrease (≥ zero % change) in BMD
39%
22%
--
Changes in Renal Laboratory Tests: Laboratory tests were performed in Studies 104 and 111 to 
compare the effect of TAF, administered as a component of Genvoya, to that of TDF, 
administered as a component of Stribild, on renal laboratory parameters. As shown in Table 1-3, 
statistically significant differences were observed between treatment groups that favored 
Genvoya. In these studies, there were statistically significant differences between treatment 
groups for increases in serum creatinine and changes in proteinuria, including Urine Protein to 
Creatinine Ratio (UPCR), Urine Albumin to Creatinine Ratio (UACR), urine retinol-binding 
protein (RBP) to creatinine ratio, and urine beta-2-microglobulin to creatinine ratio that favored 
Genvoya.
Table 1-3.
Change from Baseline in Renal Laboratory Tests in Studies 104 and 
111 (Week 144 analysis)
Genvoya N = 866
Stribild N = 867
Treatment Difference
Serum Creatinine (mg/dL)a
0.04 ± 0.12
0.07 ± 0.13
−0.04
P < 0.001
Proteinuria by Urine Dipstickb
40%
45%
P = 0.027
Urine Protein to Creatinine Ratio [UPCR]c
−10.5%
25.2%
P < 0.001
Urine Albumin to Creatinine Ratio [UACR]c,d
−5.2%
5.2%
P < 0.001
Urine RBP to Creatinine Ratioc
34.8%
111%
P < 0.001
Urine Beta-2-Microglobulin to Creatinine Ratioc
−25.7%
53.8%
P < 0.001
a
Mean change ± standard deviation
b
Includes all severity grades (1-3).
c
Median percent change.
d
Week 96 analysis.

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Virologically Suppressed Patients
In Study 109, the efficacy and safety of switching from either ATRIPLA, TRUVADA plus 
atazanavir (boosted by either cobicistat or ritonavir), or Stribild to Genvoya were evaluated in a 
randomized, open-label study of virologically-suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 
infected adults (N = 1436). Patients must have been stably suppressed (HIV-1 RNA 
< 50 copies/mL) on their baseline regimen for at least 6 months and had no resistance mutations 
to any of the components of Genvoya prior to study entry. Patients were randomized in a 2:1 
ratio to either switch to Genvoya at baseline (N = 959), or stay on their baseline antiretroviral 
regimen (N = 477). Patients had a mean age of 41 years (range 1-77), 89% were male, 67% were 
White, and 19% were Black. The mean baseline CD4+ cell count was 697 cells/mm3 
(range 79-1951)
Patients were stratified by prior treatment regimen. At screening, 42% of patients were receiving 
TRUVADA plus atazanavir (boosted by either cobicistat or ritonavir), 32% of patients were 
receiving Stribild, and 26% of patients were receiving ATRIPLA.
Pediatric Patients
In this study (GS-US-292-0106), the efficacy, safety, and pharmacokinetics of Genvoya in 
HIV-1-infected patients were evaluated in open-label studies in treatment-naïve patients between 
the ages of 12 to < 18 years (weighing ≥ 35 kg) (N = 50), in virologically suppressed patients 
between the ages of 6 to < 12 years (weighing ≥ 25 kg) (N = 52), and in virologically suppressed 
patients at least 2 years of age (weighing at least 14 to < 25 kg) (N = 27).
Cohort 1: Treatment-naïve adolescents (12 to < 18 years; weighing ≥ 35 kg), Week 48 Analysis
Patients in Cohort 1 had a mean age of 15 years (range: 12 to 17), 44% were male, 12% were 
Asian, and 88% were black. At baseline, mean plasma HIV-1 RNA was 4.6 log10 copies/mL, 
median CD4+ cell count was 456 cells/mm3 (range: 95 to 1110), and median CD4% was 23% 
(range: 7% to 45%). 22% had baseline plasma HIV-1 RNA > 100,000 copies/mL.
Among the patients in Cohort 1 treated with Genvoya, 92% (46/50) achieved HIV-1 RNA 
< 50 copies/mL at Week 48. The mean increase from baseline in CD4+ cell count at Week 48 
was 224 cells/mm3. Three of 50 patients had virologic failure at Week 48; no emergent resistance 
to Genvoya was detected through Week 48.
Among the patients in Cohort 1 who had both baseline and Week 48 measurements (N=47 and 
44 for the lumbar spine and total body less head [TBLH], respectively), mean BMD increased 
from baseline to Week 48, +4.2% at the lumbar spine and +1.3% for TBLH.

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Cohort 2: Virologically suppressed children (6 to < 12 years; weighing ≥ 25 kg), Week 48 
Analysis
Patients in Cohort 2 had a mean age of 10 years (range: 7 to 11), a mean baseline weight of 32 kg 
(range: 26 to 58), 42% were male, 25% were Asian, and 71% were black. At baseline, median 
CD4+ cell count was 926 cells/mm3 (range: 336 to 1611) and median CD4% was 38% 
(range: 23% to 51%).
After switching to Genvoya, 98% (51/52) of patients in Cohort 2 remained suppressed (HIV-1 
RNA < 50 copies/mL) at Week 48. The mean change from baseline in CD4+ cell count was 
-66 cells/mm3 and the mean change in CD4% was -0.6% at Week 48. One of 52 patients met the 
criteria for inclusion in the resistance analysis population through Week 48; no emergent 
resistance to Genvoya was detected through Week 48.
Among the patients in Cohort 2 who had both baseline and Week 48 measurements (N=49 and 
51, for lumbar spine and TBLH, respectively), mean BMD increased from baseline to Week 48, 
+3.9% at the lumbar spine and +4.2% for TBLH.
Cohort 3: Virologically suppressed children (≥ 2 years; weighing 14 to < 25 kg), Week 48 
Analysis
Patients in Cohort 3 had a mean age of 6 years (range: 3 to 9), a mean baseline weight of 19 kg 
(range: 15 to 24), 37% were male, 11% were Asian, and 89% were black. At baseline, median 
CD4+ cell count was 1061 cells/mm3 (range: 383 to 2401) and median CD4% was 37% 
(range: 24% to 53%). 
After switching to Genvoya, 96.3% (26 of 27) of patients in Cohort 3 remained suppressed 
(HIV-1 RNA < 50 copies/mL) at Week 48. The mean change from baseline in CD4+ cell count 
was -179 cells/mm3 and the mean change in CD4% was 0.2% at Week 48. One of 27 patients 
(3.7%) qualified for viral resistance testing at Week 48; no resistance to study drug was detected 
and the patient resuppressed HIV-1 RNA to < 50 copies/mL while remaining on study drug. 
Among the patients in Cohort 3, mean BMD increased from baseline to Week 48, +5.3% at the 
lumbar spine and +7.2% for TBLH. 
For further information, including the results of studies of Genvoya in adults and adolescents, 
please refer to the current Genvoya Investigator’s Brochure.
1.2.
Rationale for the Current Study
The success of HAART and the apparent benefits of maximally suppressed viremia has shifted 
clinical attention towards antiretroviral agents that optimize long-term safety and tolerability. 
Young, newly infected patients are diagnosed earlier, initiate therapy earlier, and look ahead 
towards lifelong therapy, often greater than fifty years {Prejean 2011}. Renal and bone health, in 
both of these contexts, are increasingly important {Capeau 2011}.

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Based on the data from this study and extrapolation to adult efficacy and safety data, Genvoya 
was approved in adults and pediatric patients 12 years of age and older in the US and EU in 2016 
and approved in 2017 for use in pediatric patients 6 to < 12 year of age weighing ≥ 25 kg.
HIV-infected children ages ≥ 2 years of age will benefit from the availability of an 
age-appropriate formulation containing 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.
The objective of this study is to characterize the pharmacokinetics (PK), and confirm the dose of 
E/C/F/TAF and to evaluate the safety, tolerability and antiviral activity of E/C/F/TAF as an STR 
in treatment-naive HIV-1 infected adolescents 12 to less than 18 years of age and in virologically 
suppressed HIV-1 infected children 2 to < 12 years of age.
1.3.
Rationale for Dose Selection
The proposed E/C/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.
E/C/F/TAF Dose in Adolescents 12 to < 18 years old, weighing ≥ 35 kg
The FDA-approved dose of E/C/F/TAF in adolescents 12 to < 18 years and weighing ≥ 35 kg is 
the adult strength STR (150/150/200/10 mg).
E/C/F/TAF Dose in Children ≥ 2 years old weighing ≥ 25 kg, and weighing ≥ 14 to < 25 kg
The FDA-approved dose of E/C/F/TAF in children weighing ≥ 25 kg is the adult strength STR 
(150/150/200/10 mg). For children weighing ≥ 14 to ˂ 25 kg, a low dose E/C/F/TAF 
(E/C/F/TAF LD) tablet of 90/90/120/6 mg is proposed for evaluation. The observed exposures 
following administration of E/C/F/TAF 150/150/200/10 mg in children weighing ≥ 25 kg or 
predicted exposures of E/C/F/TAF 90/90/120/6 mg in children weighing ≥ 14 to ˂ 25 kg are 
comparable to those observed in adults for all analytes (EVG, COBI, FTC, TAF and 
TAF-metabolite TFV). The dosing nomogram is structured 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.
Rationale for E/C/F/TAF Dose in Children weighing ≥ 25 kg 
EVG:
EVG is differentially dosed in adults in order to achieve comparable EVG exposures depending 
on the co-administered regimen: 85 mg with LPV/r or ATV/r; EVG 150 mg with COBI and 
other boosted PIs.

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Preliminary data are available in treatment-experienced children 6 to < 12 years old on a regimen 
containing LPV/r or ATV/r from Study GS-US-183-0160. Of 14 participants who completed the 
PK substudy, 6 were taking the adult strength EVG 85 mg (body weight ≥ 30 kg) and 8 were 
taking a reduced strength EVG 50 mg (body weight 17 to < 30 kg). Plasma exposures of EVG 
were similar to those previously observed in adolescents, and higher than in adults 
(GMR AUC 1.36; GMR Ctrough 1.29) with all participants having an EVG Ctrough above the 
protein-binding adjusted IC95 of 44.5 ng/mL. Plasma exposures support using the adult EVG 
dose in 6 to < 12 years olds weighing ≥ 30 kg. Simulation for children with a body weight 
between 25 and < 30 kg demonstrated that when combined with LPV/r, administration of the 
higher dose (85 mg) would result in slightly higher, but acceptable EVG exposures. EVG was 
well-tolerated in this study, with no related SAEs or AEs leading to EVG discontinuation 
(with one related AE of mild dizziness). Therefore, the adult 150 mg dose of EVG is proposed 
for use in children 6 to < 12 years old weighing ≥ 25 kg.
COBI:
The 150 mg dose of COBI is the adult dose, selected for its efficacy in boosting EVG exposures. 
COBI dose selection was guided by dose/data available for ritonavir boosting in various pediatric 
weight bands and similarities in observed dose-dependent pharmacodynamic effects (CYP3A 
inhibition) for COBI versus ritonavir (RTV) in adults. Comparison of RTV and COBI 
dose-ranging PK and pharmacodynamic (Studies GS-US-183-0113, GS-US-216-0101, 
GS-US-216-0110, and GS-US-236-0101) indicate comparable CYP inhibition/boosting of 
probe/other substrates, including ARVs. The proposed COBI doses generally represent a higher 
dose on a mg/kg basis relative to the adult dose, and are expected to provide sufficient boosting 
activity within the context of E/C/F/TAF STR. The adult 150 mg dose of COBI is proposed for 
administration to pediatric subjects weighing ≥ 25 kg.
FTC:
Emtricitabine is approved to be dosed at ≤ 6.1 mg/kg in children with 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 in dose over 6.1 mg/kg) for use in children. Given the approved doses for FTC and its 
dose-proportional pharmacokinetics, a modest increase of FTC dose in children is expected to 
result in exposures in the range of those providing a favorable risk:benefit profile. The E/C/F/TAF 
(150/150/200/10 mg) adult-strength STR for use in patients 6 to < 12 years of age weighing 
≥ 25 kg provides a range of FTC doses comparable to the approved doses, and does not exceed 
8.57 mg/kg.

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TAF:
The TAF dose selection in children 6 to < 12 years of age is based on the established TDF dose 
to exposure relationship in children and adults, where it has been shown that administration of 
TDF doses at approximately twice the average adult dose (on a mg/kg basis) result in TFV 
exposures in children within the range observed in adults {Gilead Sciences Inc 2012}.
The TAF dose proposed for a 75 kg adult is 0.13 mg/kg when used with boosted regimens such 
as E/C/F/TAF STR. For a subject weighing ≥ 25 kg to < 35 kg, administration of TAF 10 mg 
(in the context of E/C/F/TAF STR) corresponds to a range of TAF dose per body weight of 0.29 
to 0.40 mg/kg (approximately 2 to 3 times the adult dose). This is predicted to result in TAF 
exposures in children within the range observed in adults and to yield maximum exposures in the 
lowest weight ranges of each band less than 2-fold above mean TAF exposure in adults.
Rationale for E/C/F/TAF Dose in Children weighing ≥ 14 to < 25 kg
For dose selection in children weighing ≥ 14 to < 25 kg, EVG, COBI, FTC, 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 EVG, 
COBI, FTC, TAF and TFV in children weighing ≥ 14 to < 25 kg administered the E/C/F/TAF 
LD STR (90/90/120/6 mg) are presented in Figure 1-1, Figure 1-2, Figure 1-3, Figure 1-4 and 
Figure 1-5, respectively. These simulations indicate that the predicted exposure ranges of EVG, 
COBI, FTC, TAF and TFV in children 2 to < 12 years weighing ≥ 14 to < 25 kg following 
administration of E/C/F/TAF 90/90/120/6 mg are comparable to those observed in the adult 
Phase 2/3 population, and in children 6 to < 12 years weighing ≥ 25 kg who received the adult 
strength STR.
Figure 1-1.
Predicted EVG AUC in Children Following Administration of 
E/C/F/TAF 90/90/120/6 mg
The adult exposures for EVG were the population PK predicted exposures from the STB Phase 2/3 program 
(Stribild NDA 203100 SN 0000, m5.3.3.5, COBI-boosted EVG Population PK report)
::r 
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Predicted AUC: 
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Median 
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5th/95th percentile 

EVG/COBI/FTC/TAF
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Amendment 7
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Figure 1-2.
Predicted COBI AUC in Children Following Administration of 
E/C/F/TAF 90/90/120/6 mg
The adult exposures for COBI were the population PK predicted exposures from Phase 2/3 studies with Stribild (STB) or 
ATV/co + Truvada (ATV/co + TVD) (Studies GS-US-236-0102, GS-US-236-0103, GS-US-236-0104, GS-US-216-0105, and 
GS-US-216-0114)
Figure 1-3.
Predicted FTC AUC in Children Following Administration of 
E/C/F/TAF 90/90/120/6 mg
The adult exposures for FTC were the exposures from Phase 2/3 studies with STB (Studies GS-US-236-0101, GS-US-236-0102, 
GS-US-236-0103, GS-US-236-0104, and GS-US-236-0110)
E/C/F/TAF 90/90/120/6 mg 
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Predicted AUC: -
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E/C/F/TAF 90/90/120/6 mg 
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• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • -- • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Ph2/3 Adult Max 
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Predicted AUC: -
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5th/95th percentile 

EVG/COBI/FTC/TAF
Protocol GS-US-292-0106
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
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01 June 2021
Figure 1-4.
Predicted TAF AUC in Children Following Administration of 
E/C/F/TAF 90/90/120/6 mg
The adult exposures for TAF were the population PK predicted exposures from the GEN Phase 2/3 program
(Genvoya NDA 207561, m5.3.3.5, Population PK Analysis of TAF and TFV following Administration of E/C/F/TAF STR)
Figure 1-5.
Predicted TFV AUC in Children Following Administration of 
E/C/F/TAF 90/90/120/6 mg
The adult exposures for TFV were the population PK predicted exposures from the GEN Phase 2/3 program
(Genvoya NDA 207561, m5.3.3.5, Population PK Analysis of TAF and TFV following Administration of E/C/F/TAF STR)
EJC/F/TAF 90/90/120/6 mg 
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~ 
------
E 
---------------
~ 
-----~ 
Cl 
C 
.. .c -
(.) 
::::> 
<( 
~ 
.... 
Ph2/3 Adult 95th % 
• -~-"" ·• · .. - · - ·• ·:.; ·.;. ·:.; • .. ;;;.: ·:_· • • • • • • • • • • • • • .. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • .. • • • • Ph2/3 Adult Median 
-----------------------
• • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • .... • • • • • • .. • • • • .. • .. • • • • • • • • • • • • • • • • • Ph 2/3 Adult 5th % 
.. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • .. • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Ph2/3 Adult Min 
100+-----------~-------.-----------+ 
14 
15 
16 
17 
Predicted AUC: -
Median 
18 
19 
20 
21 
Weight (kg) 
22 
- • 5th/95th percentile 
23 
24 
25 

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2.
OBJECTIVES
Cohort 1
The primary objectives of this study are:
Part A:

To evaluate the steady state pharmacokinetics (PK) for elvitegravir (EVG) and tenofovir 
alafenamide (TAF) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir 
alafenamide (E/C/F/TAF) single tablet regimen (STR) in HIV-1 infected, antiretroviral 
(ARV) treatment-naive adolescents
Part B:

To evaluate the safety and tolerability of the E/C/F/TAF STR through Week 24 in HIV-1 
infected, ARV treatment-naive adolescents
The secondary objectives for Cohort 1 for this study are:

To evaluate the safety and tolerability of the E/C/F/TAF STR through Week 48 in HIV-1 
infected, ARV treatment-naive adolescents

To evaluate the antiviral activity of the E/C/F/TAF STR through Week 48 in HIV-1 infected, 
ARV treatment-naive adolescents
Cohort 2
The primary objectives of this study are:
Part A:

To evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 
6 to < 12 years of age, weighing ≥ 25 kg, administered E/C/F/TAF STR
Part B:

To evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in HIV-1 
infected children 6 to < 12 years of age
The secondary objectives for this study are:

To evaluate the antiviral activity of switching to E/C/F/TAF STR through Week 48 in 
virologically suppressed HIV-1 infected children 6 to < 12 years of age weighing ≥ 25 kg.

To evaluate the safety and tolerability of E/C/F/TAF STR through Week 48 in virologically 
suppressed HIV-1 infected children 6 to < 12 years of age, weighing ≥ 25 kg

EVG/COBI/FfC/TAF 
Protocol GS-US-292-0106 
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Cohort 3 
The prirmuy objectives of this study are: 
Final 
Amendment 7 
• 
To evaluate the PK ofEVG and TAF and confnm the dose of the STR in virologically 
suppressed HIV-1 infected children~ 2 years of age weighing ~ 14 to < 25 kg administered 
E/C/F IT AF LD STR 
• 
To evaluate the safety and tolerability ofE/C/F/TAF LD STR through Week 24 in 
virologically suppressed HIV-1 infected children ~ 2 years of age and weighing ~ 14 to 
< 25 kg 
The secondaiy objectives of this study are: 
• 
To evaluate the antiviral activity of switching to E/C/F/TAF LD STR through Week 48 in 
virologically suppressed HIV-1 infected children ~ 2 yeai·s of age and weighing ~ 14 to 
< 25 kg 
• 
To evaluate the safety and tolerability ofE/C/F/TAF LD STR through Week 48 in 
virologically suppressed HIV-1 infected children ~ 2 yeai·s of age and weighing ~ 14 to 
< 25 kg 
• 
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3.
STUDY DESIGN
3.1.
Treatment Plan and Regimen
This protocol describes an open-label, multicenter, multi-cohort, single-arm study of the 
pharmacokinetics (PK), safety, tolerability, and antiviral activity of the E/C/F/TAF STR in 
HIV-1 infected ARV treatment-naive adolescents and virologically suppressed children.
A total of 50 adolescents (12 to < 18 years of age) and up to 75 children (6 to < 12 years of age) 
of either sex will be enrolled to receive the STR of E/C/F/TAF once daily with food as follows:
Part A
Intensive PK samples will be analyzed for Cohorts 1 and 2 once they are available from 
18 subjects regardless of age distribution and for all Cohort 3 subjects.
Cohort 1, Part A: EVG, TAF and COBI exposures will be compared to historical data from adult 
HIV-1 infected subjects. TAF data will also be compared to HIV-negative subjects from 
292-0103 study. FTC and TFV exposures will be compared to historical data in HIV-infected 
adults and available data in adolescent subjects. Cohort 2, Part A: EVG, TAF, COBI, FTC and 
TFV exposures will be compared to historical adult data.
EVG and TAF dose confirmation will be established if the 90% confidence intervals of 
geometric mean ratios for AUC in adolescents and children (respectively) versus those in adults 
are within the equivalency bounds of 70-143%.
Following completion of the Intensive PK visit, subjects will continue to receive E/C/F/TAF 
STR and return for scheduled study visits through Week 48.
Cohort 1 (Adolescents 12 to < 18 years of age)

Eighteen to 24 eligible subjects will be initially enrolled to evaluate the steady state PK, and 
confirm the dose of the E/C/F/TAF STR.

Part A will aim to enroll at least 6 subjects 12 to < 15 years of age and at least 6 subjects 
15 to < 18 years of age.

If at least 6 subjects ages 12 to < 15 years and 6 subjects ages 15 to < 18 have not been 
enrolled at the time of the Intensive PK analysis, Part A enrollment will remain open in order 
to enroll sufficient subjects to meet the minimum enrollment of the 2 age subgroups.

Subjects enrolled in Part A will participate in an Intensive PK evaluation on Week 4. 
Samples will be collected at 0 (pre-dose, ≤ 30 minutes prior to dosing), 5 minutes, 0.25, 0.5, 
1, 1.5, 2, 4, 5, 8 and 24 hours post-dose.

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Cohort 2 (Children 6 to < 12 years of age and weighing ≥ 25 kg)

Eighteen to 24 eligible subjects will be enrolled to evaluate the EVG and TAF plasma PK 
and confirm the dose of EVG and TAF.

Subjects will participate in an Intensive PK evaluation on Week 4.
Cohort 3 (Children ≥ 2 years of age and weighing ≥ 14 to < 25 kg)

Up to 25 eligible subjects will be enrolled to evaluate the EVG and TAF plasma PK and 
confirm the dose of EVG and TAF.

Subjects will participate in an Intensive PK evaluation on Week 2.
Part B 
Cohort 1
Screening will be initiated into Cohort 1, Part B following confirmation of EVG and TAF 
exposure in at least 18 subjects from Cohort 1, Part A. The additional 26 to 32 subjects will be 
enrolled in Cohort 1, Part B to evaluate the safety, tolerability and antiviral activity of the 
E/C/F/TAF STR in at least 50 patients, including all subjects enrolled in Cohort 1 (Parts A and 
Part B combined).
Cohort 2
Screening will be initiated in subjects 6 to < 12 years of age into Cohort 2, Part B based on 
exposure data from at least 18 subjects from Cohort 2, Part A. The additional 26 to 32 subjects 
will be enrolled in Cohort 2, Part B to evaluate the safety, tolerability and antiviral activity of the 
E/C/F/TAF STR in at least 50 patients, including all subjects enrolled in Cohort 2 (Parts A and B 
combined).
Cohort 3
No Part B for this cohort. All subjects will be enrolled in Part A and will complete an Intensive 
PK evaluation.
Figure 3-1.
Study Schema
Cohort 1:
a
Screening for Part B will commence after the PK data from Part A confirms the adolescent dose of the E/C/F/TAF STR
( ScreeningH._ __ P_an_·_A_:_E_J,._~_i_241T
_ A_F Q_D _ _.._ .............. ~ 
:'.: 35 days p1ior 
Baselme 
PK 
to Baseline 
(Day ]) 
\Veek24 
\Veek 4S 
30 Day f 
( Screening~ 
Part B:E!C/F AF QD ~
I 
N=26-3_ 
~
. 
:'.: 35 days prior 
Baselme 
Week24 
Week 48 
30 Day F/U 
to Baseline 
(Day I) 

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Cohort 2:
Cohort 3:
::= 35 d>.ys prior 
B~ 
PK 
\Veek 24 
Week48 
30 Dayf • 
to Baseline 
(Day I) 
( ScreeoingHL.. __ 
P_art
_· _B_:_E/
.:.;Nal
~C/F
;.:.0-.:.;32:.._A_FQ_D_...i._:.:.::.:..:..a.;...:, 
::= 35 clays prior 
B.isehne 
\Veek 24 
30 DayF/U 
to Baseline 
(D,ay l) 
( Screening) -,1.. ___ 
El
,::,N=.:.~= "':::-=
·AF
=·::.;!:.:.1;;;.~ __ 
....i;.~~~LL,J~ 
::= 35 clays prior 
Baselim, 
fo Baseline 
(Day I) 
PK 
\Veek 24 
\Veek 48 
30 Dayf • 

EVG/COBI/FTC/TAF
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Amendment 7
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4.
SUBJECT POPULATION
4.1.
Number of Subjects and Subject Selection
A total of 50 adolescents (12 to < 18 years of age) and up to 75 children (2 to < 12 years of age) 
who meet the eligibility criteria will be enrolled into this study.
Replacement subjects may be enrolled if subjects do not complete all Intensive PK procedures or 
if PK data are incomplete. Replacement subjects will not be enrolled in Part A for subjects who 
discontinue the study due to treatment-related toxicity.
Cohort 1:
Part A
Eighteen to 24 subjects representing two age strata (at least 6 subjects must be 12 to < 15 years 
of age and at least 6 subjects must be 15 to < 18 years of age).
Part B
Twenty-six to 32 subjects between 12 to < 18 years of age (dependent upon enrollment in 
Part A).
Cohort 2:
Part A
Eighteen to 24 subjects 6 to < 12 years of age and weighing ≥ 25 kg.
Part B
Twenty-six to 32 subjects 6 to < 12 years of age and weighing ≥ 25 kg.
Cohort 3:
Approximately 25 subjects ≥ 2 years of age and weighing ≥ 14 to < 25 kg.
4.2.
Inclusion Criteria
All Cohorts
Subjects must meet all of the following inclusion criteria, as well as the Cohort specific criteria 
listed below, to be eligible for participation in this study. Subjects with screening results that do 
not meet eligibility criteria will not be allowed to rescreen:

CD4+ cell count ≥ 400 cells/μL and CD4+ percentage of 20%

Adequate renal function: estimated glomerular filtration rate ≥ 90 mL/min/1.73 m2
Estimated Glomerular Filtration Rate (eGFR) using Schwartz Formula (mL/min/1.73 m2) 
= k  L/Scr [(k is a proportionality constant, for females ≥ 2 years old is 0.55; and for 
males ≥ 12 years old is 0.70) and males and females 2 to ≤ 11 years old is 0.55; L is 
height in centimeters (cm); and Scr is serum creatinine (mg/dL)]

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
Clinically normal ECG (or if abnormal, determined by the investigator to be not clinically 
significant)

Documented screening for active pulmonary tuberculosis per local standard of care within 
6 months of a Screening visit.

Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)

Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

Adequate hematologic function:

Absolute neutrophil count ≥ 500/mm3

Platelets ≥ 50,000/mm3
Hemoglobin ≥ 8.5 g/dL

Note that subjects with chronic neutropenia, defined as having an ANC of < 500/mm3 
documented at least twice within 6 months of screening, and in whom, according to the 
investigator, there is no evidence of active opportunistic or serious infection can enroll in the 
study contingent upon approval from the Gilead study Medical Monitor.

Negative serum pregnancy test for all female subjects

Females of childbearing potential (as defined in Appendix 5) must have a negative serum 
pregnancy test at screening and Baseline/Day 1

Male subjects and female subjects of childbearing potential who engage in heterosexual 
intercourse must agree to use protocol specified method(s) of contraception as described in 
Appendix 5

Subjects able to give written assent prior to any screening evaluations

Parent or guardian able to give written informed consent prior to any screening evaluations 
and willing to comply with study requirements

Able to swallow oral tablets

Must be willing and able to comply with all study requirements

Life expectancy > 1 year
Cohort 1

12 to < 18 years of age at Baseline

Weight ≥ 35 kg (77 lbs) at Screening

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
Plasma HIV-1 RNA levels of > 1,000 copies/mL at Screening (Roche COBAS TaqMan v2.0)

Screening genotype report shows sensitivity to EVG, FTC and TFV (Monogram Biosciences, 
Inc.)
Subjects with HIV subtype AE who meet all inclusion/exclusion criteria and who have a 
non-reportable integrase genotype result may proceed with study enrollment 
(Thailand only)

No prior use of any approved or experimental anti-HIV-1 drug for any length of time 
(other than that given for prevention of mother-to-child transmission)
Cohort 2

6 to < 12 years of age at Baseline

Weight ≥ 25 kg (55 lbs) at Screening

Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the 
local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days 
(6 months) prior to Screening on a stable antiretroviral regimen, without documented history 
of resistance to any component of E/C/F/TAF STR
Unconfirmed HIV-1 RNA ≥ 50 copies/mL after previously reaching virologic 
suppression (transient detectable viremia, or “blip”) prior to Screening is acceptable
Currently receiving an antiretroviral regimen that has been stable for at least 
180 consecutive days (6 months) or has been newly initiated within 6 months for reasons 
other than virologic failure.
Cohort 3

≥ 2 years of age at Baseline

Weight ≥ 14 to < 25 kg (≥ 31 to < 55 lbs) at Screening

Plasma HIV-1 RNA: < 50 copies/mL (or undetectable HIV-1 RNA level according to the 
local assay being used if the limit of detection is > 50 copies/mL) for ≥ 180 consecutive days 
(6 months) prior to Screening on a stable antiretroviral regimen, without documented history 
of resistance to any component of E/C/F/TAF STR
Unconfirmed HIV-1 RNA ≥ 50 copies/mL after previously reaching virologic 
suppression (transient detectable viremia, or “blip”) prior to Screening is acceptable
Currently receiving an antiretroviral regimen that has been stable for at least 
180 consecutive days (6 months) or has been newly initiated within 6 months for reasons 
other than virologic failure.

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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.

A new AIDS-defining condition diagnosed within the 30 days prior to Screening (Refer to 
Appendix 6).

Positive Hepatitis C antibody. Note: Subjects with false positive hepatitis antibody confirmed 
by negative Hepatitis C PCR are permitted to enroll.

Positive Hepatitis B surface antigen or other evidence of active HBV infection. 
Note: Subjects with positive HBV surface antibody and no evidence of active HBV infection 
are permitted to enroll.

Prior treatment with any approved or investigational or experimental anti-HIV-1 drug for any 
length of time (other than that given for prevention of mother-to-child transmission) 
(Cohort 1 only)

Evidence of active pulmonary or extra-pulmonary tuberculosis disease within 3 months of 
the Screening visit.

Anticipated to require rifamycin treatment for mycobacterial infection while participating in 
the study. Note: prophylactic INH therapy for latent TB treatment is allowed.

Subjects experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)

Pregnant or lactating subjects

Have an implanted defibrillator or pacemaker

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), 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 the study dosing.

Current alcohol or substance abuse judged by the investigator to potentially interfere with 
subject compliance.

Have history of significant drug sensitivity or drug allergy.

Known hypersensitivity to the study drugs, the metabolites or formulation excipients 
(see Section 5.2)

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
Have been treated with immunosuppressant therapies or chemotherapeutic agents within 
3 months of study Screening or expected to receive these agents during the study 
(e.g., immunoglobulins, and other immune- or cytokine-based therapies).

A history of malignancy within the past 5 years (prior to Screening) or ongoing malignancy 
other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive 
cutaneous squamous carcinoma. Subjects with cutaneous KS are eligible, but must not have 
received any systemic therapy for KS within 30 days of Baseline and must not be anticipated 
to require systemic therapy during the study.

Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or 
antifungal therapy within 30 days prior to Baseline.

Have previously participated in an investigational trial involving administration of any 
investigational agent within 30 days prior to the study dosing.

Participation in any other clinical trial (including observational trials) without prior approval 
from sponsor is prohibited while participating in this trial.

Subjects receiving ongoing therapy with any of the medications in the table below, including 
drugs not to be used with EVG, COBI, FTC, TDF and TAF (For EVG, COBI, and FTC refer 
to the individual agents Prescribing Information; for EVG, and TAF refer to the E/C/F/TAF 
STR Investigator’s Brochure); or subjects with any known allergies to the excipients of 
E/C/F/TAF STR tablets.
Drug Class
Agents Disallowed*
Alpha Adrenergic Receptor Antagonists
Alfuzosin
Antibacterials
Telithromycin
Anticonvulsants
Phenobarbital, Phenytoin, Carbamazepine, Oxcarbazepine
Antihistamines
Astemizole, Terfenadine
Antimycobacterials
Rifampin, Rifapentine, Rifabutin
Antiplatelets
Clopidogrel
Endothelin Receptor Antagonists
Bosentan
Calcium Channel Blockers
Bepridil
Ergot Derivatives
Ergotamine, Ergonovine Dihydroergotamine Methylergonovine 
Ergometrine
Direct Acting Anticoagulants
Apixaban, Rivaroxaban
GI Motility Agents
Cisapride
Herbal Supplements
St. John’s Wort, Echinacea
HMG-CoA Reductase Inhibitors
Simvastatin, Lovastatin
Neuroleptics
Pimozide
Sedatives/Hypnotics
Midazolam, Triazolam
Systemic** Corticosteroids with the exception of short-term (≤ 
1 week) use of prednisone as a steroid burst
All agents, including dexamethasone
*
Administration of any of the above medications must be discontinued at least 21 days prior to the Baseline/Day 1 visit and 
for the duration of the study.
**
Systemic use defined as intravenously or orally administered corticosteroid.

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5.
INVESTIGATIONAL MEDICINAL PRODUCTS
5.1.
Randomization and Blinding
This is an open-label, non-blinded study. All eligible subjects will receive open-label E/C/F/TAF 
STR.
Once eligibility is confirmed, the Sponsor will assign a unique subject number for each eligible 
subject and provide the subject number information to the study site.
The subject number assignment may be performed up to 7 days prior to the in-clinic Baseline 
visit provided that all screening procedures have been completed and subject eligibility has been 
confirmed. Once a subject number has been assigned, it will not be reassigned to any other 
subject.
All Baseline tests and procedures must be completed and eligibility confirmed prior to the 
administration of the first dose of study drug.
It is the responsibility of the investigator to ensure that the subject is eligible for the study prior 
to enrollment.
5.2.
Description and Handling of E/C/F/TAF STR
5.2.1.
Formulation
E/C/F/TAF 150/150/200/10 mg
E/C/F/TAF 150/150/200/10 mg STR tablets are capsule-shaped, film-coated green tablets and 
are debossed with “GSI” on one side of the tablet and “510” on the other side of the tablet. 
E/C/F/TAF STR tablets contain 150 mg of EVG, 150 mg of COBI, 200 mg of FTC, and 10 mg 
of TAF (as 11.2 mg of TAF fumarate). The E/C/F/TAF 150/150/200/10 mg STR tablet cores 
contain silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, 
magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate as inactive ingredients 
and are film-coated with indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, 
talc, titanium dioxide, and yellow iron oxide.
E/C/F/TAF 90/90/120/6 mg (Low Dose)
E/C/F/TAF LD STR tablets are capsule-shaped, film-coated green tablets and are debossed with 
“GSI” on one side of the tablet and “306” on the other side of the tablet. E/C/F/TAF LD STR 
tablets contain 90 mg of EVG, 90 mg of COBI, 120 mg of FTC, and 6 mg of TAF (as 6.7 mg of 
TAF fumarate). The E/C/F/TAF LD STR tablet cores contain silicon dioxide, croscarmellose 
sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline 
cellulose, and sodium lauryl sulfate as inactive ingredients and are film-coated with polyethylene 
glycol, polyvinyl alcohol, talc, titanium dioxide, black iron oxide, and yellow iron oxide.

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If clinical supply is discontinued, sites will be able to use both clinical and commercial supplies 
of E/C/F/TAF STR. Low dose tablets intended for commercial use are similar in appearance and 
the same in composition as tablets provided via the clinical supply chain. Clinical and 
commercial E/C/F/TAF LD tablets are debossed with "GSI" on one side of the tablet; the other 
side of the tablet is debossed with "306" for clinical E/C/F/TAF LD tablets while the commercial 
E/C/F/TAF LD tablets are scored.
5.2.2.
Packaging and Labeling
E/C/F/TAF 150/150/200/10 mg tablets are packaged in white, high density polyethylene (HDPE) 
bottles. Each bottle contains 30 tablets, a silica gel desiccant canister and polyester coil fiber. 
Each bottle is enclosed with a white, continuous thread, child-resistant polypropylene screw cap 
fitted with an induction-sealed, aluminum-faced liner.
E/C/F/TAF 90/90/120/6 mg LD tablets are packaged in white, HDPE bottles. Each bottle 
contains 30 tablets, a silica gel desiccant canister and polyester coil fiber. Each bottle is enclosed 
with a white, continuous thread, child-resistant polypropylene screw cap fitted with an 
induction-sealed, aluminum-faced liner.
All labels for study drug bottles to be distributed to centers in all countries will meet all 
applicable requirements of the FDA and Annex 13 of Good Manufacturing Practices: 
Manufacture of investigational medicinal products (July 2010) and/or other local regulations as 
applicable.
5.2.3.
Storage and Handling
The E/C/F/TAF STR tablets 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). To ensure the stability of the 
tablets, the drug product should not be dispensed into a container other than the container in 
which it is supplied. Measures that minimize drug contact with the body should always be 
considered during handling, preparation, and disposal procedures.
All study medications should not be stored in any containers other than the container in which it 
is supplied.
5.3.
Dosage and Administration of E/C/F/TAF STR
The E/C/F/TAF STR tablets will be provided by Gilead Sciences and will be administered orally, 
once daily with food at approximately the same time each day.
In-clinic dosing will be performed at Baseline/Day 1 and Weeks 1, 2, 4, 12, 24, and 48. For 
those subjects that take their medication in the evening, the in-clinic dosing will not be 
performed.
Subjects in Part A (inclusive of Cohort 3) will be administered their dose of study 
medication in the clinic with food during the Intensive PK visit, at Week 4 (Cohorts 1 and 2) 
or Week 2 (Cohort 3). In order to allow for ease of PK sampling over a 24-hour period, subjects 
should be instructed to take their dose of E/C/F/TAF STR together with food at the same time 
every day in the morning (breakfast), during the days leading up to Intensive PK assessments.

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Prior to the scheduled trough and Intensive PK visits, subjects should fast overnight (a minimum 
of 8 hours).
After Week 48, all subjects receiving E/C/F/TAF STR who complete 48 weeks of study 
treatment will be given the option to participate in an extension phase of the study. Subjects will 
return for study visits every 12 weeks in the extension phase. After Week 240 in Cohorts 1 and 2 
and after Week 96 in Cohort 3, subjects will return for study visits every 24 weeks for the 
duration of the extension phase.
Subjects will be instructed to bring all study medication in the original container at each study 
visit for drug accountability (unless otherwise specified in Section 6). The investigator will be 
responsible for maintaining accurate records for all study drug bottles dispensed and tablets 
returned. The inventory and dispensing logs must be available for inspection by the study 
monitor. Study medication supplies, including partially used or empty bottles, must be accounted 
for by the study monitor prior to destruction or return. Remote drug accountability will be 
permitted in instances where on-site drug accountability is not possible and will require prior 
Gilead approval.
After collection of intensive PK samples at Week 2, dose adjustments are permitted for subjects 
in Cohort 3 due to weight changes, including during the extension phase. A subject whose 
weight has increased to ≥ 25 kg when measured at a study visit may have their dose increased to 
E/C/F/TAF 150/150/200/10 mg at that visit. If the subject’s weight is < 25 kg at a subsequent 
visit, dose reduction back to E/C/F/TAF 90/90/120/6 mg may be implemented at the 
investigator’s discretion.
For subjects in Cohort 3 unable to swallow the tablet whole, it is acceptable to split the tablet in 
two and administer both parts sequentially.
5.4.
Prior and Concomitant Medications

Concentrations of ethinyl estradiol may decrease and progestin level may increase on 
coadministration of hormonal contraceptives with study drug. Please see the table below and 
refer to Appendix 5 for guidance on the use of contraception methods.

Coadministration of Genvoya with drugs that have active metabolite(s) formed by CYP3A 
may result in reduced plasma concentrations of the active metabolite(s).

Drugs that induce CYP3A activity are expected to increase the clearance of EVG and COBI, 
resulting in decreased plasma concentration of COBI, and thus that of EVG, which may lead 
to loss of therapeutic effect of Genvoya, and development of resistance.

Medications listed in the following table 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 drug. Inclusion of medications in this list does not 
imply approval for use in pediatric populations.

The list below should be utilized in jurisdictions in which E/C/F/TAF has NOT been 
approved.

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Drug Class
Agents Disallowed
Use Discouraged and To Be Used With Caution
Acid Reducing Agents 
Antacids
Elvitegravir plasma concentrations are lower with antacids due to 
local complexation in the GI tract and not to changes in gastric pH. 
It is recommended to separate E/C/F/TAF STR and antacid 
administration by at least 2 hours.
Alpha-1 Adrenoreceptor 
Antagonist
Alfuzosin
Antiarrhythmics
Amiodarone, Bepridil, Digoxin, Disopyramide, Flecainide, 
systemic Lidocaine, Mexiletine, Propafenone, Quinidine:
Concentrations of these antiarrhythmics may increase when 
coadministered with Cobicistat. Caution is warranted and clinical 
monitoring is recommended upon coadministration of these agents 
with E/C/F/TAF STR.
Antibacterials
Telithromycin
Clarithromycin and Telithromycin:
Concentrations of Clarithromycin and/or Cobicistat may be altered 
when Clarithromycin is coadministered with E/C/F/TAF STR.
Patients with CLcr greater than or equal to 60 mL/min: No dose 
adjustment of Clarithromycin is required.
Patients with CLcr between 30 mL/min and 60 mL/min: The dose 
of Clarithromycin should be reduced by 50%. Concentrations of 
Telithromycin and/or Cobicistat may be increased when 
Telithromycin is coadministered with E/C/F/TAF STR. Clinical 
monitoring is recommended
upon coadministration with E/C/F/TAF STR.
Anticoagulants
Concentrations of Warfarin may be affected upon coadministration 
with E/C/F/TAF STR. It is recommended that the international 
normalized ratio (INR) be monitored upon coadministration with 
E/C/F/TAF STR.
Direct Oral Anticoagulants 
(DOACs)
Apixaban, Rivaroxaban
Dabigatran, Edoxaban: Concentrations may increase with study 
drug(s). Clinical monitoring and/or dose adjustment is 
recommended
Anticonvulsants
Carbamazepine, Phenobarbital, Phenytoin,
Ethosuximide, Oxcarbazepine,
Coadministration of Oxcarbazepine, a CYP3A inducer, may 
decrease Cobicistat and Elvitegravir plasma concentrations, which 
may result in loss of therapeutic effect and development of 
resistance. Alternative anticonvulsants should be considered.
Concentrations of Ethosuximide may be increased when 
coadministered with Cobicistat. Clinical monitoring is 
recommended upon coadministration with E/C/F/TAF
STR.
Antidepressants
Bupropion:
Concentrations may increase or decrease with study drug. Subjects 
receiving bupropion should be monitored for adequate clinical 
response.
SSRI dosing should be titrated in conjunction with clinical 
monitoring.
SSRIs except Sertraline, and Trazodone, tricyclic antidepressants 
(TCAs):
Concentrations may increase when coadministered with Cobicistat.
Concentrations of Sertraline are not affected upon coadministration 
with study drug. No dose adjustment is required upon 
coadministration.
Concentrations of other antidepressant agents may be increased when 
coadministered with Cobicistat. Dose titration may be required for 
most drugs of the SSRI class. Concentrations of Trazodone may 
increase upon coadministration with Cobicistat. Dose reduction 
should be considered when Trazodone is coadministered with
E/C/F/TAF STR.

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Drug Class
Agents Disallowed
Use Discouraged and To Be Used With Caution
Antifungals
Concentrations of ketoconazole, itraconazole and/or cobicistat may 
increase with coadministration of E/C/F/TAF STR. When 
administering with E/C/F/TAF STR, the maximum daily dose of 
ketoconazole and itraconazole should not exceed 200 mg per day.
Concentrations of voriconazole may be increased when 
coadministered with cobicistat. Clinical monitoring may be needed 
upon coadministration with E/C/F/TAF STR.
Antigout
Colchicine:
Concentrations may increase with study drug(s). Dose reductions 
of colchicine may be required. Should not be coadministered in 
patients with renal or hepatic impairment.
Dose reductions of colchicine may be required. E/C/F/TAF STR 
should not be coadministered with colchicine in patients with renal 
or hepatic impairment.
Treatment of familial Mediterranean fever:
Maximum daily dose of 0.6 mg (may be given as 0.3 mg twice a 
day)
Antihistamines
Astemizole, Terfenadine:
Concentrations of Astemizole and Terfenadine may be increased 
when coadministered with Cobicistat. Clinical monitoring is 
recommended when these agents are coadministered with 
E/C/F/TAF STR.
Antimycobacterials
Coadministration of rifampin, rifabutin, and 
rifapentine, potent CYP3A inducers, may 
significantly decrease cobicistat and 
elvitegravir plasma concentrations, which 
may result in loss of therapeutic effect and 
development of resistance.
Coadministration of E/C/F/TAF STR with 
rifampin is contraindicated.
Coadministration of E/C/F/TAF STR with 
rifabutin or rifapentine is not recommended.
Antiplatelets
Coadministration of clopidogrel with 
cobicistat is expected to decrease clopidogrel 
active metabolite plasma concentrations, 
which may reduce the antiplatelet activity of 
clopidogrel. Coadministration of clopidogrel 
with Genvoya is not recommended.
Genvoya is not expected to have a clinically 
relevant effect on plasma concentrations of 
the active metabolite of prasugrel.
Benzodiazepines
Orally administered Midazolam and 
Triazolam
Diazepam: Concentrations of other benzodiazepines, including 
Diazepam and parenterally administered Midazolam, may be 
increased when administered with E/C/F/TAF STR. 
Coadministration should be done in a setting that ensures close 
clinical monitoring and appropriate medical management in case of 
respiratory depression and/or prolonged sedation. Dose reduction 
may be necessary.
Based on non-CYP-mediated elimination pathways for Lorazepam, 
no effect on plasma concentrations is expected upon 
coadministration with E/C/F/TAF STR.
β-Blockers
Concentrations of beta-blockers may be increased when 
coadministered with Cobicistat. Clinical monitoring is 
recommended and a dose decrease may be necessary when these 
agents are coadministered with E/C/F/TAF STR.

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Drug Class
Agents Disallowed
Use Discouraged and To Be Used With Caution
Calcium Channel Blockers
Amlodipine, Diltiazem, Felodipine, Nicardipine, Nifedipine, 
Verapamil:
Concentrations of calcium channel blockers may be increased when 
coadministered with Cobicistat. Caution is warranted and clinical 
monitoring is recommended upon coadministration with 
E/C/F/TAF STR.
Corticosteroids
Betamethasone, Budesonide, Dexamethasone (oral), Fluticasone, 
Mometasone, Triamcinolone:
Coadministration of dexamethasone, a CYP3A inducer, may 
decrease cobicistat and elvitegravir plasma concentrations, which 
may result in loss of therapeutic effect and development of 
resistance.
Alternative corticosteroids should be considered.
Coadministration with corticosteroids that are sensitive to CYP3A 
inhibition can increase the risk for Cushing’s syndrome and adrenal 
suppression, which have been reported during postmarketing use of 
cobicistat-containing products. Consider the risk of systemic 
corticosteroid effects if E/C/F/TAF STR is coadministered with 
corticosteroids that are sensitive to CYP3A inhibition.
Alternative corticosteroids should be considered, particularly for 
long-term use.
For coadministration of cutaneously-administered corticosteroids 
sensitive to CYP3A inhibition, refer to the prescribing information 
of the corticosteroid for conditions or uses that augment its 
systemic absorption.
Endothelin Receptor 
Antagonists
Coadministration of Bosentan with study drug may lead to 
decreased Elvitegravir and/or Cobicistat exposures and loss of 
therapeutic effect and development of resistance. Alternative 
endothelin receptor antagonists may be considered.
Ergot Derivatives
Ergotamine, Ergonovine (known as 
ergometrine in some regions), 
Dihydroergotamine Methylergonovine
GI Motility Agents
Cisapride
Hepatitis C Virus Antiviral 
Agents
Concentrations of Cobicistat, Ledipasvir, Sofosbuvir, and 
GS-331007 (the predominant circulating metabolite of sofosbuvir) 
are increased when ledipasvir/sofosbuvir is coadministered with 
Elvitegravir and Cobicistat. The effect of coadministration of 
ledipasvir/sofosbuvir and E/C/F/TAF STR on concentrations of all 
components of these fixed-dose combinations is unknown. There 
are insufficient data to make a dosing recommendation for 
coadministration of E/C/F/TAF STR with ledipasvir/sofosbuvir.
Herbal/Natural Supplements
St. John’s Wort
HMG-CoA Reductase 
Inhibitors
Simvastatin, Lovastatin
Concentrations of Atorvastatin may be increased when 
coadministered with Elvitegravir and Cobicistat. Start with the 
lowest possible dose of Atorvastatin with careful monitoring upon 
coadministration with E/C/F/TAF STR.
Concentrations of Rosuvastatin are transiently increased when 
coadministered with Elvitegravir and Cobicistat. Dose 
modifications are not necessary when Rosuvastatin is administered 
in combination with E/C/F/TAF STR.
Hormonal Contraceptives
Drospirenone: Plasma concentrations may be increased when 
administered with E/C/F/TAF STR. Clinical monitoring is 
recommended due to the potential for hyperkalemia.
Coadministration of study drug and a norgestimate/ethinyl 
estradiol-containing hormonal oral contraceptive is expected to 
decrease plasma concentrations of ethinyl estradiol and increase 
norgestimate.
Use caution when coadministering study drug and a hormonal 
contraceptive. The hormonal contraceptive should contain at least 
30 mcg of ethinyl estradiol..

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Drug Class
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The long-term effects of substantial increases in progesterone 
exposure are unknown. The effect of coadministration of 
E/C/F/TAF STR with oral contraceptives or hormonal 
contraceptives containing progestogens other than drospirenone, 
norgestimate, or less than 25 mcg of ethinyl estradiol, is not known
Immunosuppressants
Cyclosporine, Rapamycin, Sirolimus, Tacrolimus: Concentrations 
may increase when coadministered with Cobicistat. Therapeutic 
monitoring is recommended upon coadministration with 
E/C/F/TAF STR.
Inhaled Beta Agonist
Salmeterol:
Coadministration with study drug may result in increased plasma 
concentrations of Salmeterol, which is associated with the potential 
for serious and/or life-threatening reactions. Coadministration of 
Salmeterol and E/C/F/TAF STR is not recommended.
Neuroleptics
Pimozide
Perphenazine, Risperidone, Thioridazine, Quetiapine:
Consider reducing the dose of the neuroleptic upon 
coadministration with E/C/F/TAF STR.
Phosphodiesterase-5 Inhibitors
Coadministration of E/C/F/TAF STR with 
Sildenafil for the treatment of pulmonary 
arterial hypertension (PAH) is 
contraindicated.
PDE5 inhibitors are primarily metabolized by CYP3A. 
Coadministration with E/C/F/TAF STR may result in increased 
plasma concentrations of Sildenafil and Tadalafil, which may result 
in PDE5 inhibitor-associated adverse reactions.
Caution should be exercised, including consideration of dose 
reduction, when coadministering E/C/F/TAF STR with Tadalafil 
for the treatment of pulmonary arterial hypertension.
For the treatment of erectile dysfunction, it is recommended that a 
single dose of sildenafil no more than 25 mg in 48 hours, vardenafil 
no more than 2.5 mg in 72 hours, or tadalafil no more than 10 mg 
in 72 hours be coadministered with E/C/F/TAF STR.
Sedatives/Hypnotics
Midazolam, Triazolam
Buspirone, orally administered Zolpidem:
With sedative/hypnotics, dose reduction may be necessary upon 
coadministration with E/C/F/TAF STR and clinical monitoring is 
recommended.
In jurisdictions in which E/C/F/TAF has been approved, consult the local prescribing 
information for E/C/F/TAF dose recommendations with concomitant medications.
Should subjects have a need to initiate treatment with any excluded concomitant medication, the 
Gilead Science Medical Monitor must be consulted prior to initiation of the new medication. In 
instances where an excluded 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 excluded 
medication.
5.5.
Study Drug Return or Disposal
Gilead recommends that used and unused study drug supplies be destroyed at the site. If the site 
has an appropriate standard operating procedure (SOP) for drug destruction as determined by 
Gilead, the site may destroy used (empty or partially empty) and unused study drug supplies in 
accordance with that site’s approved SOP. A copy of the site’s approved SOP will be obtained 
for the electronic trial master file. If study drug is destroyed on site, the investigator must 
maintain accurate records for all study drugs destroyed. Records must show the identification 
and quantity of each unit destroyed, the method of destruction, and the person who disposed of 

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the study drug. Upon study completion, copies of the study drug accountability records must be 
filed at the site. Another copy will be returned to Gilead. 
If the site does not have an appropriate SOP for drug destruction, used and unused study drug 
supplies are to be sent to the designated disposal facility for destruction. The study monitor will 
provide instructions for return.
The study monitor will review study drug supplies and associated records at periodic intervals.
For both disposal options listed above, the study monitor must first perform drug accountability 
during a monitoring visit prior to disposal or return of study drug. Performing drug 
accountability at an on-site monitoring visit is preferred; however, if necessary, remote drug 
accountability can be performed with prior approval from Gilead.

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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.
All subjects will participate in all study visits and assessments. Additionally, subjects in Part A 
(inclusive of Cohort 3) will complete the Intensive PK visit at Week 4 (Cohorts 1 and 2) or 
Week 2 (Cohort 3).
Any deviation from protocol procedures should be noted and the Sponsor or Contract Research 
Organization (CRO) should be notified.
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 assignment.
6.2.
Screening Visit
Each subject must sign an assent (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.
The following evaluations are to be completed at the Screening visit:

Obtain medical and medication history, including history of HIV-1 disease-related events, 
and any other ongoing medications within 30 days of the Screening visit

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)

Height and weight

12-lead ECG performed supine

Urine collection for the following laboratory procedures:
Urinalysis
For Cohort 3, urine renal safety including: urine chemistry, retinol binding protein and 
beta-2-microglobulin. 

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
Blood sample collection for the following laboratory analyses:
Serum pregnancy test (females of childbearing potential 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, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, phosphorus, magnesium, potassium, sodium, CPK, and uric acid
For Cohort 3, metabolic assessments: Fasting (no food or drinks, except water, at least 
8 hours prior to blood collection) glucose and lipid panel (total cholesterol, high-density 
lipoprotein [HDL], direct low-density lipoprotein [LDL], and triglycerides). If the subject 
has not fasted prior to the visit, the visit may proceed, but the subject must return within 
72 hours in a fasted state to draw blood for the metabolic assessments.
Hematology profile: complete blood count (CBC) with differential and platelet count
Estimated Glomerular Filtration Rate (GFR) using Schwartz Formula (mL/min/1.73 m2) 
= k  L/Scr
Plasma HIV-1 RNA (Roche COBAS TaqMan® v2.0)
Whole blood sample (Cohort 3 only)
Full flow cytometry panel testing
HIV-1 genotype (protease, reverse transcriptase and integrase) testing (Cohort 1 only). 
The HIV-1 genotype may not be performed for subjects that fail to meet other screening 
laboratory criteria.
Hepatitis B virus (HBV) surface antigen serology (HBsAg)
Hepatitis C virus (HCV) serology (HCVAb)
For Cohort 3, serum bone safety including: Bone specific alkaline phosphatase, 
parathyroid hormone (PTH), 25OH Vitamin D, and 1,25OH Vitamin D

Review of Adverse Events (AEs) and Concomitant Medications

Historical genotype report(s) should be collected, if available (Cohorts 2 and 3 only)
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 1 assessments. For Cohort 1, 
the Screening window may be extended to 42 days for subjects who require repeat testing of the 
HIV-1 genotype.

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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.
For each screened subject, complete an eligibility worksheet and submit to Sponsor for review 
prior to assignment of subject number. The subject number assignment may be performed up to 
7 days prior to the in-clinic Baseline visit provided that all other Screening procedures have been 
completed and subject eligibility has been confirmed.
6.3.
Treatment Assessments
6.3.1.
Baseline/Day 1 Assessments
The following evaluations are to be completed at the Baseline/Day 1 visit. The subject must 
complete all Baseline procedures before being dispensed the study drug. Initiation of treatment 
with the study drug must take place within 24 hours after the Baseline visit. For Cohort 1, the 
investigator must have received the results from the screening genotype report before proceeding 
with 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)

Height and weight

Tanner Stage assessments (≥ 6 years of age)

DXA Scan (lumbar spine and total body)
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
For Cohorts 1 and 2, urine renal safety including: urine chemistry, retinol binding protein 
and beta-2-microglobulin. 
For Cohorts 1 and 2, urine bone safety including: bicarbonate, N-telopeptide

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Urine pregnancy test (females of childbearing potential only). If the urine pregnancy test 
is positive at Baseline, 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 not be able to participate.
Urine sample storage for possible additional testing (Urine chemistry including urine 
phosphorus and urine creatinine)

Blood sample collection for the following laboratory analyses:
Chemistry profile: alkaline phosphatase, AST, ALT, total bilirubin, direct and indirect 
bilirubin, cystatin C for Cohorts 1 and 2, total protein, albumin, bicarbonate, BUN, 
calcium, chloride, creatinine, phosphorus, magnesium, potassium, sodium, CPK, and uric 
acid
For Cohorts 1 and 2, metabolic assessments: Fasting (no food or drinks, except water, at 
least 8 hours prior to blood collection) glucose and lipid panel (total cholesterol, HDL, 
direct LDL, and triglycerides). If the subject has not fasted prior to the visit, the visit may 
proceed, but the subject must return within 72 hours in a fasted state to draw blood for the 
metabolic assessments.
Hematology profile: CBC with differential and platelet count
Plasma HIV-1 RNA (Roche COBAS TaqMan® v2.0)
Full flow cytometry panel testing
Plasma storage sample for possible additional testing (virology analysis, safety, 
pharmacokinetic analysis) (Cohorts 1 and 2)
For Cohorts 1 and 2, serum bone safety including: Bicarbonate, N-telopeptide, 
C-telopeptide (CTX), osteocalcin, procollagen type 1 N-terminal propeptide (P1NP), 
bone specific alkaline phosphatase, parathyroid hormone (PTH), 25OH Vitamin D, and 
1,25OH Vitamin D
Estimated glomerular filtration rate according to Schwartz formula

Study drug dispensation. Subjects should initiate dosing of study drug along with food 
in-clinic the day of the Baseline visit.

Subjects should be instructed to take study drugs with food. The subject 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. Sites should consider individual 
subject study drug dosing schedule while scheduling study visits requiring collection of 
trough PK samples.

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The PK study of Part A (inclusive of Cohort 3) is designed to assess the PK of and 
confirm the doses of E/C/F/TAF STR. Therefore, all subjects must take their dose of 
study medication with food at approximately the same time every morning at all visits 
prior to the Intensive PK visit.

Palatability and Acceptability assessment (Cohorts 2 and 3)
The investigator will ask if the study drug was palatable and if the subject was able to 
take the dosage form.

Subjects should be reminded to bring the required drug bottles of the E/C/F/TAF STR with 
them for in-clinic dosing and drug accountability at the Week 1/(Day 7) visit.
6.3.2.
Treatment Assessments through 48 Weeks (Weeks 1 (Day 7) – 48)
The following evaluations are to be completed at the end of Weeks 1, 2, 4, 8, 12, 16, 24, 32, 40 
and 48 unless otherwise specified.
All study visits are to be scheduled relative to the Baseline/Day 1 visit date. The Week 1 
(Day 7) visit should occur on the protocol-specified visit date based on the Baseline/Day 1 visit. 
Study visits at Weeks 2 through 8 are to be completed within ± 2 days of the protocol-specified 
visit date based on the Baseline/Day 1 visit and completed within ± 4 days of the 
protocol-specified visit date at Weeks 12 through Week 48, 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 (all other visits)

Vital signs (blood pressure, pulse, respiration rate, and temperature)

Height and weight

Tanner Stage assessments for ≥ 6 years of age (Weeks 24 and 48 − except for subjects 
documented to have achieved Tanner Stage 5)

DXA scan (lumbar spine and total body) (Weeks 24 and 48 ± 10 days)

Urine collection for the following laboratory procedures:
Urinalysis and urine chemistry
Urine renal safety including: urine chemistry, retinol binding protein and 
beta-2-microglobulin (Weeks 8, 12, 24, and 48)

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For Cohorts 1 and 2, urine bone safety including: bicarbonate, N-telopeptide (Weeks 8, 
12, 24, and 48)
Urine pregnancy test (females of childbearing 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
Urine sample storage for possible additional testing (Urine chemistry including urine 
phosphorus and urine creatinine)

Blood sample collection for the following laboratory analyses:
Chemistry profile: alkaline phosphatase, AST, ALT, total bilirubin, direct and indirect 
bilirubin, cystatin C (Weeks 2 [Cohort 1 only], 4, 24, and 48 [Cohorts 1 and 2 only]. 
Cystatin C will not be done for Cohort 3 to reduce blood draw volumes), total protein, 
albumin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, phosphorus, 
magnesium, potassium, and sodium, CPK, and uric acid. At Weeks 24 and 48, analyses of 
glucose will be done as part of the fasting metabolic assessments and not as part of the 
chemistry profile.
Metabolic assessments: Fasting (no food or drinks, except water, at least 8 hours prior to 
blood collection) glucose and lipid panel (total cholesterol, HDL, direct LDL, and 
triglycerides). If the subject has not fasted prior to the visit, the visit may proceed, but the 
subject must return within 72 hours in a fasted state to draw blood for the metabolic 
assessments (Weeks 24 and 48 only).
Hematology profile: CBC with differential and platelet count
Plasma HIV-1 RNA (Roche COBAS TaqMan v2.0)
Full flow cytometry panel testing (Weeks 2 – 48)
Plasma storage sample for possible additional testing (virology analysis, safety, 
pharmacokinetic analysis) (Week 4 [Cohort 1 Part B subjects only], Weeks 8-48 
[all cohorts], and Week 32 [Cohorts 1 and 2 only])
Serum bone safety including:
Cohorts 1 and 2: bicarbonate, N-telopeptide, CTX, osteocalcin, P1NP
For all cohorts: bone specific alkaline phosphatase, PTH, 25OH Vitamin D, and 1,25OH 
Vitamin D (Weeks 8 [Cohort 1 only], 12, 24 and 48)
Estimated glomerular filtration rate according to Schwartz formula
HIV-1 genotype/phenotype testing for subjects with suboptimal virologic response or 
virologic rebound (as needed)

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
Pharmacokinetic (PK) blood collection:
Cohort 1
Trough PK sample (20 to 24 hours post-dose) (Weeks 1 (Day 7), 2, 24, and 48)*
Timed Single PK sample collected between 0.25 to 4 hours post-dose (Week 4 [Part B 
subjects only] and at Week 12 only)*
Random Single PK sample taken anytime in relationship to last dose of study drug 
(all other visits)*
Cohort 2
Trough PK sample (20 to 24 hours post-dose) (Weeks 1, 2, and 24)
Timed Single PK sample collected between 0.25 to 4 hours post-dose (Week 12 only)*
Random Single PK sample taken anytime in relationship to last dose of study drug 
(Weeks 8 and 16)
Cohort 3
Timed Single PK sample collected between 0.25 to 4 hours post-dose (Weeks 8, 12, 
and 16)*
Trough PK sample (20 to 24 hours post-dose). Subjects should be reminded not to take 
their study medication on the morning of these visits. The time of last dose prior to the 
PK draw should be documented. (Weeks 4 and 24)
*
For subjects who take their medication in the evening, a Random Single PK sample taken 
at any time in relationship to last dose of study drug will be collected in lieu of the 
Trough or Timed Single PK collected between 0.25 to 4 hours post-dose. The time of 
last dose prior to the PK draw should be documented. (For Uganda only)

Subjects who meet the criteria for suboptimal virologic response or rebound should be 
managed according to Management Virologic Failure Section 6.8.1.

Subjects should be reminded not to take their study medication on the morning of their 
Week 1 (Day 7), 2, 4, 12, 24, and 48 clinic visits and the visits during which PK trough or 
intensive samples will be collected.

Document study drug dispensation and accountability for all study drugs dispensed. No study 
drug will be dispensed at the Week 2 visit.

Subject dosing diaries should be dispensed at the Week 1 (Cohort 3) or Week 2 (Cohorts 1 
and 2) visit (depending upon the timing of the intensive PK visit) to subjects in Part A 
(inclusive of Cohort 3) to capture study drug information prior to the Intensive PK study visit.

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Amendment 7
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
Palatability and Acceptability Assessment
For Cohort 1, at the next scheduled visit, the investigator will ask if the study drug was 
palatable and if the subject was able to take the dosage form. If the subject has passed the 
Week 48 visit, the assessment will be performed during the next scheduled post Week 48 
visit. If the subject discontinues prior to the Week 48 visit, this assessment will be 
captured at the ESDD visit.
For Cohort 2, the same questions asked at Baseline will be asked at Week 4 or if the 
subject discontinues prior to the Week 4 visit, this assessment will be captured at the 
ESDD visit.
For Cohort 3, the same questions asked at Baseline will be asked at Week 4, Week 24, 
and Week 48. If the subject discontinues prior to the Week 4 visit, this assessment will be 
captured at the ESDD visit.
6.3.3.
Intensive PK Evaluation (Part A subjects only, inclusive of Cohort 3)
The Intensive PK evaluation will occur at the Week 4 (Cohorts 1 and 2) or Week 2 (Cohort 3) 
visit. For the purpose of scheduling the Intensive PK visit, a + 7 days window may be used.
Subjects should come in a fasted state (i.e. no food or drink except water at least 8 hours prior). 
Subjects should be instructed that on the day of the Intensive PK evaluation the dose of 
E/C/F/TAF STR must not be taken prior to the visit.
If the subject has already dosed prior to the Intensive PK evaluation visit or is not in a fasted 
state, the Intensive PK assessments must not be completed. The subject should be instructed to 
return in a fasted state within 7 days of their Week 4 (Cohorts 1 and 2) or Week 2 (Cohort 3) 
visit for the Intensive PK assessments.
If dosing non-compliance not related to AEs is identified on or prior to the Intensive PK 
evaluation visit, the Intensive PK assessments must not be completed. The subject should be 
counseled regarding proper dosing and be scheduled to return for the Intensive PK evaluation 
visit no sooner than three days following compliant dosing and no later than Week 4 (Cohorts 1 
and 2) + 7 days or Week 2 (Cohort 3) + 7 days.
In both scenarios described above, the subject should be reminded to not take the E/C/F/TAF 
STR prior to arriving at the clinic on the day of the re-scheduled Intensive PK visit. All Intensive 
PK assessments listed below should be completed when the subject returns:

Subject dosing diaries will be collected and reviewed.

For Cohort 1 subjects, blood samples will be collected at 0 (pre-dose, ≤ 30 minutes prior to 
dosing). After collection of the pre-dose sample, subjects will be provided a standardized 
meal. Within five minutes after consuming the standardized meal, subjects will be dosed 
with the E/C/F/TAF STR. Intensive PK sampling at the following time-points will occur: 
5 minutes, 0.25, 0.5, 1, 1.5, 2, 4, 5, 8 and 24 hours post-dose.

EVG/COBI/FfC/TAF 
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Final 
Amendment 7 
• 
For Coho1t 2 subjects, blood samples will be collected ::; 30 minutes prior to dosing. After 
collection of the pre-dose sample, subjects will be provided a meal. Within five minutes after 
consuming the meal, subjects will be dosed with the EICIF!TAF STR. Intensive PK sampling 
at the following time-points will occur: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 8, and 24 hours post-dose. 
Subjects will be restricted from finiher food intake until after the 4-hour PK blood draw. 
• 
For Cohort 3 subjects, blood samples will be collected ::; 30 minutes prior to dosing. After 
collection of the pre-dose sample, subjects will be provided a meal. Within five minutes 
after consuming the meal, subjects will be dosed with the EICIF!TAF STR. Intensive PK 
sampling at the following time-points will occur: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, and 8 hours 
post-dose. Subjects will be restricted from further food intake until after the 4-hour PK blood 
draw. 
6.3.5. 
Post-Week 48 Assessments 
Study subjects receiving EICIF!TAF STR who complete 48 weeks of study treatment will be 
given the option to participate in an extension phase of the study where Gilead will provide 
EICIFITAF STR until: a) the relevant E/C/F/TAF STR fo1mulation is available for use, other 
than through the study, in the countiy in which the subject is emolled, orb) Gilead Sciences 
elects to te1minate development ofE/C/F/TAF STR in the applicable countiy. Subjects who are 
no longer taking study dmg at Week 48 are not eligible to paiticipate in the study extension. 
6.3.5.1. 
Post-Week 48 through Week 240 for Coho1ts 1 and 2 and Post-Week 48 through 
Week 96 for Coho1t 3 
Subjects who choose to receive the EICIF!TAF STR or E/C/F/TAF LD STR in the extension 
phase will return for study visits eve1y 12 weeks through Week 240 for Coho1ts 1 and 2 and 
through Week 96 for Coho1t 3. Study visits are to be completed within ± 6 days of the 
protocol-specified visit date unless othe1wise specified. 
The following evaluations ai·e to be completed at visits eve1y 12 weeks unless othe1wise 
specified: 
• 
Review of AEs and concomitant medications 
• 
Tanner Stage assessments (subjects~ 6 yeai·s of age) (eve1y 48 weeks - except for subjects 
documented to have achieved Tanner Stage 5) 
• 
Symptom-directed physical examination as needed 
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01 June 2021 

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Amendment 7
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
Vital signs (blood pressure, pulse, respiration rate, and temperature)

Height and weight

Urine collection for the following procedures:
Urinalysis
Urine pregnancy test (females of childbearing 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.
Urine sample storage for possible additional testing

Blood sample collection for the following laboratory analyses:
Chemistry profile: alkaline phosphatase, AST, ALT, total bilirubin, direct and indirect 
bilirubin, total protein, albumin, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, phosphorus, magnesium, potassium, and sodium, CPK, and uric acid
Metabolic assessments: Fasting (no food or drinks, except water, at least 8 hours prior to 
blood collection) glucose and lipid panel (total cholesterol, HDL, direct LDL, and 
triglycerides). If the subject has not fasted prior to the visit, the visit may proceed, but the 
subject must return within 72 hours in a fasted state to draw blood for the metabolic 
assessments. (every 48 weeks)
Estimated glomerular filtration rate according to Schwartz formula
Hematology profile: CBC with differential and platelet count
Full flow cytometry panel testing
Plasma HIV-1 RNA (Roche COBAS TaqMan v2.0)
Plasma storage sample for possible additional testing (virology analysis, safety, 
pharmacokinetic analysis)
Serum bone safety (every 24 weeks) including:
Cohorts 1 and 2: bicarbonate, N-telopeptide, CTX, osteocalcin, P1NP
For all cohorts: bone specific alkaline phosphatase, PTH, 25OH Vitamin D, and 1,25OH 
Vitamin D

DXA scan (lumbar spine and total body) (every 48 weeks ± 10 days)

Study drug dispensation

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
Study drug accountability

Palatability and Acceptability assessment (Cohort 1 only)
At the next scheduled visit, the investigator will ask if the study drug was palatable and if 
the subject was able to take the dosage form.
6.3.5.2.
Post-Week 240 for Cohorts 1 and 2 and Post-Week 96 for Cohort 3
Subjects who choose to receive the E/C/F/TAF STR or E/C/F/TAF LD STR in the extension 
phase after Week 240 in Cohorts 1 and 2 and after Week 96 in Cohort 3 will return for study 
visits every 24 weeks for the duration of the extension phase. Study visits are to be completed 
within ± 6 days of the protocol-specified visit date unless otherwise specified. Subjects should be 
fasting (no food or drinks, except water, at least 8 hours prior to blood collection). 
The following evaluations are to be completed at visits every 24 weeks unless otherwise 
specified:

Review of AEs and concomitant medications

Tanner Stage assessments (subjects ≥ 6 years of age) (every 48 weeks - except for subjects 
documented to have achieved Tanner Stage 5)

Symptom-directed physical examination as needed

Vital signs (blood pressure, pulse, respiration rate, and temperature)

Height and weight

Urine collection for the following procedures:
Urinalysis
Urine pregnancy test (females of childbearing 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.

Blood sample collection for the following laboratory analyses:
Chemistry profile: alkaline phosphatase, AST, ALT, total bilirubin, direct and indirect 
bilirubin, total protein, albumin, bicarbonate, BUN, calcium, chloride, creatinine, fasting 
glucose, phosphorus, magnesium, potassium, and sodium, CPK, and uric acid 
Estimated glomerular filtration rate according to Schwartz formula
Hematology profile: CBC with differential and platelet count
CD4 cell count and percentage

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Plasma HIV-1 RNA (Roche COBAS TaqMan v2.0)
Plasma storage sample for possible additional testing (virology analysis, safety, 
pharmacokinetic analysis)
Serum bone safety including (Cohort 3): 
■
Bone specific alkaline phosphatase, PTH, 25OH Vitamin D, and 1,25OH Vitamin D. 
(every 48 weeks from Week 96 up to and including Week 240) 

DXA scan (lumbar spine and total body) (Cohort 3 only) (every 48 weeks ± 10 days up to 
and including Week 240)

Study drug dispensation

Study drug accountability
6.3.6.
Early Study Drug Discontinuation (ESDD)
If a subject in the treatment phase of the study discontinues study drug prior to Week 48, the 
subject will be asked to return to the clinic within 72 hours of stopping study drugs for an ESDD 
Visit. Subjects will then be asked to continue attending all scheduled study visits. Subjects who 
are no longer taking study drug 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 performed at the 
discretion of the investigator)

Vital signs (blood pressure, pulse, respiration rate, and temperature)

Height and weight

Urine collection for the following procedures:
Urinalysis
Urine pregnancy test (females of childbearing potential only). The positive result will be 
confirmed with a serum pregnancy test.
Urine sample storage for possible additional testing (Urine chemistry including urine 
phosphorus and urine creatinine)

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Amendment 7
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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, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, phosphorus, magnesium, potassium, and sodium, CPK, and uric acid
Estimated glomerular filtration rate according to Schwartz formula
Hematology profile: CBC with differential and platelet count
Full flow cytometry panel testing
Plasma HIV-1 RNA (Roche COBAS TaqMan v2.0)
Plasma storage samples for virology testing, safety or pharmacokinetic testing
Serum storage sample for possible additional testing
HIV-1 genotype/phenotype testing for subjects with suboptimal virologic response or 
virologic rebound
Single plasma PK sample taken anytime in relationship to last dose of study drug

Study drug accountability

Palatability and Acceptability assessment (if applicable)
6.3.7.
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 Early Study Drug Discontinuation 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 will be required to return to the clinic 30 days 
after completion of the Week 48 visit for a 30-Day Follow-Up Visit only if they do not wish to 
enroll in the extension phase of the study.
Subjects who complete 48 weeks and continue in the extension phase will be required to return 
to the clinic 30 days after discontinuation of study drug 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. The 
following evaluations are to be completed at the 30-Day Follow-Up Visit:

Review of AEs and concomitant medications

Symptom-directed physical examination, if indicated

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
Vital signs (blood pressure, pulse, respiration rate, and temperature)

Height and weight

Urine collection for the following procedures: 
Urinalysis
Urine pregnancy test (females of childbearing potential only). A positive result will be 
confirmed with a serum pregnancy test.
Urine sample storage for possible additional testing (Urine chemistry including urine 
phosphorus and urine creatinine)

Blood sample collection for the following laboratory analyses:
Chemistry profile: alkaline phosphatase, AST, ALT, total bilirubin, direct and indirect 
bilirubin, total protein, albumin, bicarbonate, BUN, calcium, chloride, creatinine, 
glucose, phosphorus, magnesium, potassium, and sodium, CPK, and uric acid
Estimated glomerular filtration rate according to Schwartz formula
Hematology profile: CBC with differential and platelet count
Full flow cytometry panel testing
Plasma HIV-1 RNA (Roche COBAS TaqMan v2.0)
Serum storage sample for possible additional testing

Palatability and Acceptability assessment (if applicable)
At the 30-Day Follow-Up 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.
6.4.
Bone Evaluations
Dual energy x-ray absorptiometry (DXA) scans of the lumbar spine and total body will be 
performed prior to study drug administration at the Baseline/Day 1, and Weeks 24, 48 and 
applicable post-Week 48 visits (±10 days). Scans will measure changes in lumbar spine bone 
mineral density (BMD) and total BMD. DXA scan results will be provided to study sites.
A complete description of the procedures performed for the DXA scans will be provided in a 
DXA manual.

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6.5. 
Bone and Renal Safety 
Final 
Amendment 7 
The following sernm bone safety parameters will be collected at Screening (Cohort 3) or 
Baseline (Coho1is 1 and 2) and Weeks 8 (Cohort 1 only), 12, 24, and 48 and applicable 
post-Week 48 visits (±6 days): Senun: For Coho1is 1 and 2 only: bicarbonate, N-telopeptide, 
C-telopeptide (CTX), osteocalcin, and procollagen type 1 N-tenninal propeptide (PINP). For all 
coho1is: bone specific alkaline phosphatase, PTH, 250H Vitamin D, and 1,250H Vitamin D. 
For Cohorts 1 and 2, the following urine bone safety parameters will be collected at Baseline, 
Weeks 8, 12, 24, 48: Urine: bicarbonate, N-telopeptide. 
For all subjects, urine will also be collected for selected renal safety, including urine chemistiy, 
retinol binding protein, and beta-2-microglobulin at the Screening (Coho1i 3) or Baseline 
(Coho1is 1 and 2) visit, and Weeks 8, 12, 24, 48. 
6.6. 
Plasma and Urine Storage 
A portion of the blood and urine samples drawn at specific visits will be frozen and stored, as 
noted in Appendix 2, Study Procedures Table. These stored blood and urine samples may be 
used by the Sponsor or its research pa1iners for HIV-I genotyping/phenotyping assays or their 
development, for retestin the amount of HIV-I in the blood for measurement of antiviral diug 
levels in the blood, 
or cl' • al a o • to 
6.7. 
Criteria for Discontinuation of Study Treatment 
Study medication may be discontinued in the following instances: 
• 
Intercunent illness that would, in the judgment of the investigator, affect assessments of 
clinical sta.tus to a significant degree 
• 
Unacceptable toxicity, as defined in the toxicity management section of the protocol, 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 
• 
Lack of efficacy (virologic failure) 
• 
Subject request to discontinue for any reason 
• 
Subject noncompliance 
• 
Pregnancy during the study 
• 
Discontinuation of the study at the request of Gilead, a regulato1y agency, or an 
!RB/independent ethics committee (IEC) 
CONFIDENTIAL 
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Amendment 7
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6.8.
Virologic Failure
Subjects in Cohort 1 who experience suboptimal virologic response (SVR) or subjects in 
Cohorts 1, 2, or 3 who experience virologic rebound (VR), as defined below, will be considered 
to have virologic failure.
Upon confirmation of virologic failure, potential causes should be documented. Assessments 
should include:

Adherence

Concomitant medication

Comorbidities (eg active substance abuse, depression, other intercurrent illnesses)
If virologic failure is confirmed 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.
Genotype/phenotype resistance testing will be performed using the RT/PR PhenoSense GT 
assay, the IN GeneSeq assay, and the IN PhenoSense assay (Monogram Biosciences, Inc.) in 
subjects who experience suboptimal virologic response or virologic rebound, if HIV-1 RNA is 
≥ 400 copies/mL.
If genotype/phenotype resistance to study drug is documented, study drugs should be 
discontinued.
If no resistance is detected from genotype/phenotype testing, the subject may remain on study 
drug and an HIV-1 RNA test should be repeated (3-6 weeks after date of test with HIV-1 RNA 
≥ 50 copies/mL). 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 Medical Monitor prior to study drug discontinuation.
6.8.1.
Management of Suboptimal Virologic Response (Cohort 1 only)
Subjects who meet the criteria listed below will be considered to have suboptimal virologic 
response:

HIV-1 RNA is < 1 log10 reduction from Baseline and ≥ 50 copies/mL at the Week 8 visit, 
confirmed at Week 12 or Unscheduled visit following Week 8.
Following the unconfirmed suboptimal virologic response at Week 8, HIV-1 RNA should be 
repeated at a scheduled or Unscheduled visit (3-6 weeks after the date of the original test with 
HIV-1 RNA to ≥ 50 copies/mL). If suboptimal virologic response is confirmed, the samples from 
the confirmation visit will be used for HIV-1 genotype/phenotype testing if HIV-1 RNA is 
≥ 400 copies/mL.

EVG/COBI/FTC/TAF
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Amendment 7
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Please refer to Figure 6-1 for the management of subjects who meet the criteria for suboptimal 
virologic response.
Figure 6-1.
Suboptimal Virologic Response Schema (Cohort 1 only)
a
If suboptimal virologic response is confirmed and the HIV-1 RNA is ≥ 400 copies/mL, the HIV-1 genotype and phenotype 
(reverse transcriptase, protease and integrase) will be analyzed.
b
If genotype/phenotype results are not available by the Week 12 visit, an unscheduled visit should be performed when the 
laboratory results are available.
c
Based on the results of the genotype/phenotype assays, the subject will remain on study drug or study drug will be 
discontinued at the next scheduled or unscheduled visit, whichever occurs first. If genotyping/phenotyping fails, a repeat 
specimen will be sent for analysis. If repeat genotyping/phenotyping subsequently fails, study medications can be continued 
or a new ARV regimen can be configured at the discretion of the investigator, in consultation with the Medical Monitor.
d
If no resistance is detected, HIV-1 RNA will be repeated within 3-6 weeks. Investigator reviews and document study drug 
continuation/discontinuation options. Investigator must discuss with the 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.
6.8.2.
Management of Virologic Rebound
Subjects who meet the criteria listed below will be considered to have virologic rebound:

At any visit, after achieving HIV-1 RNA < 50 copies/mL, a rebound in HIV-1 RNA to

≥ 50 copies/mL, which is subsequently confirmed (two consecutive tests) at the following 
scheduled or Unscheduled visit (3-6 weeks after the date of the original test with HIV-1 RNA 
to ≥ 50 copies/mL) (Cohorts 1, 2, and 3); OR
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EVG/COBI/FTC/TAF
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Gilead Sciences, Inc.
Amendment 7
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
At any visit, a >1 log10 increase in HIV-1 RNA from the nadir which is subsequently 
confirmed (two consecutive tests) at the following scheduled or Unscheduled visit 
(3-6 weeks after the date of the original test with HIV-1 RNA to ≥ 50 copies/mL) (Cohort 1 
only)
Following the unconfirmed virologic rebound, HIV-1 RNA should be repeated at a scheduled or 
unscheduled visit (3-6 weeks after the date of the original test with VL ≥ 50 copies/mL). If 
virologic rebound is confirmed, the samples from the confirmation visit will be used for HIV-1 
genotype/phenotype testing if HIV-1 RNA is ≥ 400 copies/mL.
Please refer to Figure 6-2 for the management of subjects who meet the criteria for virologic 
rebound.
Figure 6-2.
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, protease and integrase) will be analyzed.
c
Based on the results of the genotype/phenotype assays, the subject will remain on study drug or study drug will be 
discontinued. If genotyping/phenotyping fails, a repeat specimen will be sent for analysis. If repeat genotyping/phenotyping 
subsequently fails, study medication can be continued or a new ARV regimen can be configured at the discretion of the 
investigator, in consultation with the Medical Monitor.
d
If no resistance is detected. Investigator reviews study drug continuation/discontinuation options and discuss with the 
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
Screening 
Treatment Beriod 
30-0ai• Follow-up 
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6.8.3.
Subjects with ≥ 400 copies/mL of HIV-1 in Absence of SVR or VR
Subjects may have an antiviral response that is sustained at ≥ 400 copies/mL but do not meet 
either SVR or VR criteria. Subjects in that category could have an antiviral response that was
1 log10 HIV-1 RNA reduction from baseline (and therefore did not meet SVR criteria), but did 
not show > 1 log10 increase from nadir. These subjects will be analyzed for resistance at Week 48 
or their last time point on study. Subjects who have achieved HIV-1 RNA < 50 copies/mL could 
subsequently experience unconfirmed blips ≥ 400 copies/mL of HIV-1 RNA. Such subjects will 
be analyzed for resistance if the unconfirmed rebound happens at Week 48 or last visit while 
receiving study drugs (or within 72 hours of discontinuation of study treatment). Subjects with 
≥ 400 copies/mL of HIV-1 RNA at study discontinuation (after Week 8) while receiving study 
drugs (or 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.
Adverse Events
An adverse event (AE) is any untoward medical occurrence in a clinical investigation subject 
administered a medicinal product and which does not necessarily have a causal relationship with 
this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or 
disease temporally associated with the use of a medicinal product, whether or not considered 
related to the medicinal product.
AEs also include the following:

Pre- or post-treatment complications that occur as a result of protocol mandated procedure 
(e.g. such as venipuncture, biopsy) during or after Screening (before the administration of 
study investigational medicinal product).

Any pre-existing condition that increases in severity, or changes in nature during or as a 
consequence of the study investigational medicinal product phase of a human clinical trial, 
will also be considered an AE.

Complications and termination of pregnancy (see Section 7.4 for additional information)

All AEs that occur from the Screening visit onwards and throughout the duration of the 
study, including the follow-up off study medication period should be recorded as an AE.
An AE does not include the following:

Medical or surgical procedures (e.g., surgery, endoscopy, tooth extraction, transfusion) 
performed; the condition that leads to the procedure is an adverse event

Pre-existing diseases or 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 7.4)

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 case 
report form (CRF).

Uncomplicated pregnancy.

An induced elective abortion to terminate a pregnancy without medical reason.

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7.2.
Assessment of Adverse Events
All AEs will be assessed by the investigator or qualified designee and recorded on the AE CRF 
page. The AE entry should indicate whether or not the AE was serious, the start date (AE onset), 
the stop date (date of AE resolution), whether or not the AE was related to investigational 
medicinal product or to a study procedure, the action taken with investigational medicinal 
product due to the AE, and the severity of the AE. The investigator is responsible for final 
review and confirmation of accuracy of events, relationship and severity confirmed by the 
signature on the CRF book. The relationship to investigational medicinal product therapy should 
be assessed using clinical judgment and the following considerations:

No: Evidence exists that the adverse event has an etiology other than the investigational 
medicinal product. For SAEs, an alternative causality must be provided (e.g., pre-existing 
condition, underlying disease, intercurrent illness, or concomitant medication).

Yes: A temporal relationship exists between the AE onset and administration of the 
investigational medicinal product that cannot be readily explained by the subject’s clinical 
state or concomitant therapies. Furthermore, the AE appears with some degree of certainty to 
be related, based on the known therapeutic and pharmacologic actions or adverse event 
profile of the investigational medicinal product. In case of cessation or reduction of the dose, 
the AE abates or resolves and reappears upon rechallenge.
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-mandated procedures such as 
venipuncture or biopsy.
7.3.
Serious Adverse Events
A serious adverse event (SAE) is defined as follows:
Any adverse drug experience occurring at any dose that results in any of the following outcomes:

Death

Life-threatening situation (subject is at immediate risk of death)

In-patient hospitalization or prolongation of existing hospitalization (excluding those for 
study therapy or placement of an indwelling catheter, unless associated with other SAEs)

Persistent or significant disability/incapacity

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
Congenital anomaly/birth defect in the offspring of a subject who received investigational 
medicinal product

Other: medically significant events that may not be immediately life-threatening or result in 
death or hospitalization, but based upon appropriate medical and scientific judgment, may 
jeopardize the subject or may require medical or surgical intervention to prevent one of the 
outcomes listed above
Examples of such events are as follows:
Intensive treatment in an emergency room or at home for allergic bronchospasm
Blood dyscrasias or convulsions that do not result in hospitalization
Development of drug dependency or drug abuse
Clarification of Serious Adverse Events

Death is an outcome of an AE, and not an adverse event in itself. In reports of death due to 
“Disease Progression,” where no other information is provided, the death will be assumed to 
have resulted from progression of the disease being treated with the investigational medicinal 
product(s).

The subject may not have been on investigational medicinal product at the occurrence of the 
event. Dosing may have been given as treatment cycles or interrupted temporarily before the 
onset of the SAE, but may have contributed to the event.

“Life-threatening” means that the subject was at immediate risk of death from the event as it 
occurred. This does not include an event that might have led to death if it had occurred with 
greater severity.

Complications that occur during hospitalizations are AEs. If a complication prolongs the 
hospitalization, it is a SAE.

“In-patient hospitalization” means the subject has been formally admitted to a hospital for 
medical reasons, for any length of time. This may or may not be overnight. It does not 
include presentation and care within an emergency department.

The investigator should attempt to establish a diagnosis of the event on the basis of signs, 
symptoms and/or other clinical information. In such cases, the diagnosis should be 
documented as the AE and/or SAE and not the individual signs/symptoms.
A distinction should be drawn between seriousness and severity of AEs. An AE that is assessed 
as Grade 4 (potentially life-threatening) should not be confused with an SAE. Severity is a 
category utilized for rating the intensity of an event; and both AEs and SAEs can be assessed as 
Grade 4. An event is defined as “serious” when it meets one of the predefined outcomes 
described above in Section 7.3.

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7.4.
Special Situations
7.4.1.
Definitions of Special Situations
Special situation reports include pregnancy reports, reports of medication error, abuse, misuse, 
occupational exposure, drug interactions, exposure via breastfeeding, unexpected benefit, 
transmission of infectious agents via the product, counterfeit or falsified medicine, pregnancy 
regardless of an associated AE, or overdose. 
Medication error is any unintentional error in the prescribing, dispensing, preparation for 
administration, or administration of a study drug while the medication is in the control of a 
health care professional, patient, or consumer. Medication errors may be classified as a 
medication error without an AE, which includes situations of missed dose, medication error with 
an AE, intercepted medication error, or potential medication error.
Abuse is defined as persistent, sporadic, or intentional excessive use of a medicinal product by a 
patient.
Misuse is defined as any use of a medicinal product in a way that the product is intentionally and 
inappropriately used not in accordance with the protocol instructions or the local prescribing 
information.
An overdose is defined as a dose taken (accidentally or intentionally) exceeding the dose as 
prescribed by the protocol or the maximal recommended daily dose as stated in the Product 
Labeling (as it applies to the daily dose for the subject/patient 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)
Occupational exposure is defined as exposure to a medicinal product as a result of one’s 
professional or non-professional occupation.
Drug interaction is defined as any drug/drug, drug/food, or drug/device interaction.
Unexpected benefit is defined as an unintended therapeutic effect where the results are judged to 
be desirable and beneficial. 
Transmission of infectious agents is defined as any suspected transmission of an infected agent 
through a Gilead study drug.
Counterfeit or falsified medicine: Any study drug with a false representation of (a) its identity, 
(b) its source, or (c) its history.

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7.4.2. 
7.4.2.1. 
Instructions for Reporting Special Situations 
Instrnctions for Repo1iing Pregnancies 
Final 
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The investigator should report all pregnancies occmTing in female subjects that are identified 
after the subject first consents to paiiicipate in the study (ie, signing the infonned consent) and 
throughout the study, including the post-study drng follow-up period, to Gilead Global Patient 
Safety (GLPS) (fo1merly Phaimacovigilance and Epidemiology) using the Pregnancy Repo1i 
fo1m within 24 hours of becoming awai·e of the pregnancy. 
Refer to Section 7.5 and the CRF/eCRF completion guidelines for full instrnctions on the 
mechanism of pregnancy repo1iing. 
The pregnancy itself is not considered an AE nor is an induced elective abo1iion to te1minate a 
pregnancy without medical reasons. 
Any premature te1mination of pregnancy ( eg, a spontaneous abo1iion, an induced therapeutic 
abo1iion due to complications or other medical reasons) must be repo1ied within 24 hours as an 
SAE. The underlying medical reason for this procedure should be recorded as the adverse event 
tenn. 
A spontaneous abo1iion is always considered to be an SAE and will be repo1ied as described in 
the Adverse and Serious Adverse Events section. Fmihe1more, any SAE occuning as an adverse 
pregnancy outcome post-study must be repo1ied to Gilead Sciences. 
The subject should receive appropriate monitoring and care until the conclusion of the 
pregnancy. If the conclusion of the pregnancy occurs after the post-study drng follow up period, 
then the outcome should be repo1ied to Gilead GLPS using the Pregnancy Outcome Repo1i f01m. 
Gilead GLPS contact info1mation is as follows: 
Email: 
and fax: 
Refer to Appendix 5 for Pregnancy Precautions, Definition for Female of Childbearing Potential, 
and Contraceptive Recommendations. 
7.4.2.2. 
Instrnctions for Repo1iing Other Special Situations 
All other Special Situation repo1is must be repo1ied on the Special Situations Repo1i Fo1m and 
fo1wai·ded to Gilead GLPS within 24 hours. 
These repo1is must consist of situations that involve study investigational medicinal products 
(IMPs) and Gilead concomitant medications, but do not apply to non-Gilead concomitant 
medications (i.e., except for situations that result in adverse events, special situations involving 
non-Gilead concomitant medications will not be repo1ied). Any inappropriate use of 
non-protocol approved medications should not be reported as "misuse" but may be more 
appropriately documented as a protocol deviation if applicable. 
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Refer to Section 7.5 and the CRF/eCRF completion guidelines for full instructions on the 
mechanism of special situations repo1iing. 
All clinical sequelae in relation to these special situation repo1is will be reported as AEs or SAEs 
at the same time using the AE eCRF and/or the SAE repo1i fonn. Details of the symptoms and 
signs, clinical management and outcome will be repo1ied, when available. 
7.5. 
7.5.1. 
Serious Adverse Event Reporting Requirements 
All Serious Adverse Events 
Gilead Sciences is required to expedite to worldwide regulato1y authorities repo1is of SAEs 
which may be in the fo1m of line listings, Serious Adverse Drng Reactions or Suspected 
Unexpected Serious Adverse Reactions (SUSARs); therefore, Gilead Sciences (or the CRO on 
the behalf of Gilead Sciences) must be notified immediately regarding the occmTence of any 
SAE that occurs after the subject consents to participate in the study, including SAEs resulting 
from protocol-associated procedures perfo1med from Screening onwards. The procedures for 
repo1iing all SAEs, regardless of causal relationship, are as follows: 
• 
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 staii, SAEs will be repo1ied using a paper serious adverse event 
repo1iing fo1m (see following bullet). During the study conduct sites may tI'ansition to an 
electI'onic SAE ( eSAE) system. Gilead will notify sites in writing and provide ti·aining and 
account infonnation prior to implementing an eSAE system. 
Serious Adverse Event Paper Reporting Process 
All SAEs will be recorded on the serious adverse event report fo1m and subinitted by faxing the 
repo1i fonn within 24 hours of the investigator's knowledge of the event to the attention of 
Gilead GLPS. Contact info1mation is as follows: 
Gilead GLPS: 
Gilead Sciences Medical Monitor: 
Fax: 
E-mail: 
IPIPD 
PPU 
The medical monitor name and contact 
infonnation will be provided on the Key Study 
T earn Contact List. 
For fatal or life-threatening events, also e-mail or fax copies of hospital case repo1is, autopsy 
repo1is, and other documents when requested and applicable. Transmission of such documents 
should occur with Personal Subject Details de-identified, without losing the tI'aceability of a 
document to the Subject Identifiers. 
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Gilead Sciences may request additional information from the investigator to ensure the timely 
completion of accurate safety reports.
The investigator must take all therapeutic measures necessary for resolution of the SAE. Any 
medications necessary for treatment of the SAE must be recorded onto the concomitant 
medication section of the subject’s CRF and the event description section of the SAE form.
Follow-up of adverse events will continue through the last day on study (including the follow-up 
off-study medication period of the study) and/or until the investigator and/or Gilead Sciences 
determine that the subject’s condition is stable. Gilead Sciences may request that certain adverse 
events be followed until resolution.
Electronic Serious Adverse Event (eSAE) Reporting Process
Site personnel record all SAE data in the eCRF database and from there transmit the SAE 
information to Gilead GLPS within 24 hours of the investigator’s knowledge of the event. 
Detailed instructions can be found in the eCRF completion guidelines.
If for any reason it is not possible to record the SAE information electronically, ie, the eCRF 
database is not functioning, record the SAE on the paper serious adverse event reporting form 
and submit within 24 hours to Gilead GLPS 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.
7.5.2.
Investigator and Sponsor Reporting Requirements for SAEs
An SAE may qualify for reporting to regulatory authorities. Expectedness of SAEs will be 
determined by Gilead Sciences using reference safety information specified in the Investigator’s 
Brochure.
All investigators will receive a safety letter notifying them of relevant SUSAR reports. The 
investigator should notify the IRB or IEC as soon as is practical, of serious events in writing 
where this is required by local regulatory authorities, and in accordance with the local 
institutional policy.
In accordance with the EU Clinical Trials Directive (2001/20/EC), the Sponsor or specified 
designee will notify worldwide regulatory authorities and the relevant Ethics Committees in 
concerned Member States of applicable SUSARs.
7.5.3.
Post-Study Reporting Requirements
All AEs and SAEs including deaths, regardless of cause or relationship, must be reported for 
subjects on study (including any protocol-required post-treatment follow-up).
Any SAEs and deaths that occur after the post-treatment follow-up visit but within 30 days of the 
last dose of investigational medical product, regardless of causality, should also be reported.

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Investigators are not obligated to actively seek SAEs after the protocol-required post-treatment 
follow-up; however, if the investigator learns of any SAEs that occur after study participation 
and the event is deemed relevant to the use of investigational medicinal products, he/she should 
promptly document and report the event to Gilead GLPS.
7.6.
Clinical Laboratory Abnormalities and Other Abnormal Assessments as 
Adverse Events or Serious Adverse Events
Laboratory abnormalities are usually not recorded as AEs or SAEs. However, laboratory 
abnormalities (e.g., clinical chemistry, hematology, urinalysis) independent of the underlying 
medical condition that require medical or surgical intervention or lead to investigational 
medicinal product interruption 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 and 7.3. If the 
laboratory abnormality is part of a syndrome, record the syndrome or diagnosis (i.e., anemia) not 
the laboratory result (i.e., decreased hemoglobin).
Severity should be recorded and graded according to the GSI Grading Scale for Severity of 
Adverse Events and Laboratory Abnormalities (Appendix 4). For 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.
7.7.
Toxicity Management
All clinical and clinically significant laboratory toxicities will be managed according to uniform 
guidelines detailed in Appendix 3.
Grade 3 and 4 clinically significant laboratory abnormalities should be confirmed by repeat 
testing within 3 calendar days of receipt of results and before investigational medicinal product 
discontinuation, unless such a delay is not consistent with good medical practice.
Clinical events and clinically significant laboratory abnormalities will be graded according to the 
Table for GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities 
(Appendix 4).
When restarting investigational medicinal product following resolution of the adverse event, the 
investigational medicinal product should be restarted at full dose upon discussion with the 
Medical Monitor.
Any recurrence of the investigational medicinal product-related Grade 3 or 4 clinical or clinically 
significant laboratory adverse event following dose interruption mandates permanent 
discontinuation of investigational medicinal product.
Any questions regarding toxicity management should be directed to the Medical Monitor.

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7.7.1.
Management of Changes in Estimated Glomerular Filtration Rate
Estimated glomerular filtration rate (GFR), according to the Schwartz formula, will be followed 
post-baseline during the study. All subjects with estimated GFR < 50 mL/min must have serum 
creatinine and subject’s height and weight measured again within 3 calendar days of receipt of 
results. If a subject has confirmed estimated GFR < 50 mL/min, the Medical Monitor should be 
notified and investigational medicinal product discontinued.
7.7.2.
Management of Posterior Uveitis Cases
In a nine-month toxicology study conducted in dogs, some animals administered the highest dose 
of TAF (12-18 mg/kg) had minimal mononuclear cell infiltration in the posterior uvea, 
considered secondary to general debilitation; this finding did not occur in animals given lower 
doses and it has not occurred in other animal studies. This pre-clinical finding has also not been 
observed in humans where the dose is much lower, nor have there been reports of posterior 
uveitis in human clinical studies.
Across all ongoing Phase 2 and Phase 3 studies in which 2,394 subjects have received E/C/F/TAF 
STR for up to 96 weeks, eye disorders were uncommon, generally unrelated to treatment, and 
balanced between treatment arms. None were indicative of posterior uveitis, and none resulted in 
permanent discontinuation of study drugs. One subject in Study GS-US-292-0106 had an AE of 
intermediate uveitis that was considered related to study drug by the investigator but resolved 
while the subject continued on study drug without interruption.
Nonetheless, if any subjects develop signs or symptoms of posterior uveitis, investigators should 
contact the Gilead Medical Monitor to discuss the need for additional ophthalmologic evaluation 
including dilated fundoscopy and optical coherence tomography (OCT).
7.7.3.
Grades 1 and 2 Laboratory Abnormality or Clinical Event
Continue investigational medicinal product at the discretion of the investigator.
7.7.4.
Grade 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.
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.

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7.7.5.
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 4 laboratory abnormality (e.g., Grade 4 CK after strenuous exercise or 
triglyceride elevation that is nonfasting or that can be medically managed) or a clinical event 
considered unrelated to investigational medicinal product.

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8.
STATISTICAL CONSIDERATIONS
8.1.
Analysis Objectives and Endpoints
8.1.1.
Analysis Objectives
Cohort 1
The primary analysis objectives are:
Part A:

To evaluate the steady state PK for EVG and TAF and confirm the dose of the E/C/F/TAF 
STR in HIV-1 infected, ARV treatment-naive adolescents
Part B:

To evaluate the safety and tolerability of the E/C/F/TAF STR through Week 24 in HIV-1 
infected, ARV treatment-naive adolescents
The secondary analysis objectives are:

To evaluate the safety and tolerability of the E/C/F/TAF STR through Week 48 in HIV-1 
infected, ARV treatment-naive adolescents

To evaluate the antiviral activity of the E/C/F/TAF STR through Week 48 in HIV-1 infected, 
ARV treatment-naive adolescents
Cohort 2
The primary analysis objectives are:
Part A

To evaluate the PK of EVG and TAF in virologically suppressed HIV-1 infected children 
6 to < 12 years of age, weighing ≥ 25 kg, administered E/C/F/TAF STR
Part B

To evaluate the safety and tolerability of E/C/F/TAF STR through Week 24 in virologically 
suppressed HIV-1 infected children 6 to < 12 years of age
The secondary analysis objectives are:

To evaluate the antiviral activity of switching to E/C/F/TAF STR through Week 48 in 
virologically suppressed HIV-1 infected children 6 to < 12 years of age, weighing ≥ 25 kg.

To evaluate the safety and tolerability of E/C/F/TAF STR through Week 48 in virologically 
suppressed HIV-1 infected children 6 to < 12 years of age, weighing ≥ 25 kg

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Cohort 3 
The prirmuy analysis objectives are: 
Final 
Amendment 7 
• 
To evaluate the PK ofEVG and TAF and confnm the dose of the STR in virologically 
suppressed HIV-1 infected children ~ 2 years of age weighing ~ 14 to < 25 kg administered 
E/C/F/TAF LD STR 
• 
To evaluate the safety and tolerability of E/C/F/TAF LD STR through Week 24 in 
virologically suppressed HIV-1 infected children ~ 2 years of age and weighing ~ 14 to 
< 25 kg 
The secondaiy analysis objectives ai·e: 
• 
To evaluate the antiviral activity of switching to E/C/F/TAF LD STR through Week 48 in 
virologically suppressed HIV-1 infected children ~ 2 yeai·s of age and weighing ~ 14 to 
< 25 kg 
• 
To evaluate the safety and tolerability of E/C/F/TAF LD STR through Week 48 in 
virologically suppressed HIV-1 infected children ~ 2 yeai·s of age, weighing ~ 14 to < 25 kg 
• 
8.1.2. 
Primary Endpoints 
Cohort,1 
In Pait A the prima1y endpoints are PK parameter of AUC1au for EVG and AUC1ast for TAF and 
in Pait B the primaiy endpoints include incidence of treatment-emergent SAEs and all 
treatment-emergent adverse events. 
Cohort 2 
In Pait A the primaiy endpoints include PK pai·ameter of AUC1aufor EVG and AUC1asifor TAF, 
and in Pait B the primaiy endpoints include incidence of treatment-emergent SAEs and all 
treatment-emergent adverse events. 
Cohort 3 
The primaiy endpoints include PK pai·ameter of AUC1aufor EVG and TAF, incidence of 
treatment-emergent SAEs, and all treatment-emergent adverse events. 
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8.1.3.
Secondary Endpoints
Cohort 1
For Part A, the secondary endpoints include:

PK parameters of Ctau, Cmax, apparent CL and apparent Vz for EVG, Cmax, apparent CL and 
apparent Vz for TAF, AUCtau, Cmax, and Ctau for FTC, TFV and COBI.
For Part B, the secondary endpoints include:

The percentage of subjects with plasma HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 as 
defined by the FDA snapshot analysis

The percentage of subjects with plasma HIV-1 RNA < 400 copies/mL at Weeks 24 and 48 as 
defined by the FDA snapshot analysis

The change from baseline in plasma log10 HIV-1 RNA (copies/mL) and in CD4+ cell count 
(cells/μL) and percentage at Weeks 24 and 48
Cohort 2
For Part A, the secondary endpoints include:

PK parameters of Ctau, Cmax, apparent CL and apparent Vz for EVG, Cmax, apparent CL and 
apparent Vz for TAF, AUCtau, Cmax, and Ctau for FTC, TFV and COBI.
For Part B, the secondary endpoints include:

The percentage of subjects with plasma HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 as 
defined by the FDA snapshot analysis

The change from baseline in CD4+ cell count (cells/μL) and percentage at Weeks 24 and 48
Cohort 3
The secondary endpoints include:

PK parameters of Ctau, Cmax, apparent CL and apparent Vz for EVG, Cmax, apparent CL and 
apparent Vz for TAF, AUCtau, Cmax, and Ctau, for FTC, TFV and COBI.

The percentage of subjects with plasma HIV-1 RNA < 50 copies/mL at Weeks 24 and 48 as 
defined by the FDA snapshot analysis.

The change from baseline in CD4+ cell count (cells/μL) and percentage at Weeks 24 and 48

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8.2.
Analysis Conventions
8.2.1.
Analysis Sets
8.2.1.1.
Full Analysis Set
The full analysis set will include all subjects who received at least one dose of study drug.
8.2.1.2.
Safety Analysis Set
The safety analysis set will include all subjects who received at least one dose of study drug.
All the data collected up to 30 days after subjects permanently discontinue their study regimen 
will be included in the safety summaries.
8.2.1.3.
BMD Analysis Sets
8.2.1.3.1.
Spine BMD Analysis Set
The spine BMD analysis set will include all subjects who received at least one dose of study 
drug, had nonmissing spine BMD value for the Baseline visit and at least one postbaseline visit.
8.2.1.3.2.
Total Body Analysis Set
The total body less head BMD analysis set will include all subjects who received at least one 
dose of study drug, had nonmissing total body less head BMD value for the Baseline visit and at 
least one postbaseline visit.
8.2.1.4.
Pharmacokinetics (PK) Analysis Sets
8.2.1.4.1.
Intensive PK Analysis Set
The Intensive PK analysis set will include all subjects who received at least one dose of study 
drug and for whom steady-state pharmacokinetic profiles at Intensive PK visit are evaluable. The 
Intensive PK analysis set will be used for detailed PK analysis of EVG, COBI, FTC, TAF, and 
TFV by cohort.
8.2.1.4.2.
PK Analysis Set
The PK analysis set will include all subjects who received at least one dose of study drug and for 
whom at least one observed concentration data of any analyte of interest is available. The PK 
analysis set will be used for analysis of general PK and trough blood concentrations by cohort.

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8.2.2. 
Data Handling Conventions 
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Natural logarithm trnnsfo1mation for key PK parameters, such as Cmax, Ctau and AUCtau, will be 
applied for phannacokinetic analysis. 
8.3. 
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, body mass index, HIV-I infection, and emollment 
distribution will be summarized. 
8.4. 
Efficacy Analysis 
The percentage of subjects with HIV-I RNA < 50 copies/mL at Week 24 (Windows: Study 
Days 140-195) as defined by the FDA-defined snapshot algorithms are described below. 
Virologic outcome at Week 24 for the Coho1t 1 (treatment-na'ive) subjects will be defined into 
the following 3 categories: 
• 
HIV-I RNA < 50 copies/mL: this includes subjects who have the last available on-treatment 
HIV-I RNA < 50 copies/mL in the Week 24 analysis window; 
• 
HIV-I RNA ~ 50 copies/mL: this includes subjects who have the last available on-treatment 
HIV-I RNA ~ 50 copies/mL in the Week 24 analysis window, or who do not have 
on-treatment HIV-I RNA data in the Week 24 analysis window and who discontinue study 
diug prior to or in the Week 24 analysis window due to lack of efficacy, or who discontinue 
study diug prior to or in the Week 24 analysis window due to reasons other than AE, death, 
or lack of efficacy and have the last available on-treatment HIV-I RNA ~ 50 copies/mL; 
• 
No Virologic Data in the Week 24 Analysis Window: this includes subjects who do not have 
on-treatment HIV-I RNA at Week 24 window because of the following: 
-
Discontinuation of study di11g prior to or in the Week 24 analysis window due to AE or 
death; or 
-
Discontinuation of study di11g prior to or in the Week 24 analysis window due to reasons 
other than AE, death, or lack of efficacy and the last available on-treatment HIV-I RNA 
< 50 copies/mL; or 
-
Missing data in the Week 24 window but on study diu g 
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Virologic outcome at Week 24 for the Cohort 2 and Cohort 3 (treatment suppressed) subjects 
will be defined similarly with the exception of classifying subjects who discontinue study drug 
due to AE or death and have the last available on-treatment HIV-1 RNA ≥ 50 copies/mL into the 
“HIV-1 RNA ≥ 50 copies/mL” category.
Virologic outcomes will be summarized using frequency counts and percentages based on the 
Full analysis set.
The percentage of subjects with HIV-1 RNA < 50 copies/mL at Week 48 (Windows: Study 
Days 308-377) and the percentage of subjects with HIV-1 RNA < 400 copies/mL at Weeks 24 
and 48 will be summarized in the same manner as described above.
The changes from baseline in plasma log10 HIV-1 RNA (Cohort 1 only) and in CD4+ cell count 
will be summarized using descriptive statistics.
8.5.
Safety Analysis
All safety analyses will be performed using the safety analysis set.
8.5.1.
Extent of Exposure
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.
Dosing information for individual subjects will be listed.
8.5.2.
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.
Adverse events meeting the following criteria are defined as treatment-emergent AEs.
1) Any AEs with onset date of on or after the study drug start date and no later than 30 days 
after permanent discontinuation of study drug
2) Any AEs leading to premature discontinuation of study drug.
Summaries (number and percentage of subjects) of treatment-emergent adverse events (by SOC 
and PT) will be provided. 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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8.5.3.
Laboratory Evaluations
Laboratory results will be expressed both in the original measurement and in terms of the 
toxicity grade according to toxicity grading table attached in Appendix 4. Changes from baseline 
in quantitative laboratory tests will be summarized by visit (including eGFR estimated by 
cystatin C clearance for Cohorts 1 and 2). Cystatin C will not be collected for Cohort 3. The 
maximum toxicity grade will be summarized by laboratory parameter. The post-baseline 
laboratory measurements obtained up to 30 days after the last dose date of the study drug will be 
included in the quantitative and qualitative summaries.
8.5.4.
Bone Safety
Selected bone safety, including:
Cohorts 1 and 2: serum bicarbonate, N-telopeptide, C-telopeptide, osteocalcin, procollagen type 
1 N-terminal propeptide (P1NP), and urine bicarbonate and N-telopeptide
For all cohorts: bone specific alkaline phosphatase, PTH, 25OH Vitamin D, and 1,25OH 
Vitamin D
All the above will be summarized by visit using descriptive statistics.
8.5.5.
Renal Safety
Selected renal safety, including urine chemistry, retinol binding protein, and 
beta-2-microglobulin, will be summarized by visit using descriptive statistics.
8.5.6.
Spine and Total Body Less Head Bone Mineral Density
For all cohorts, the percentage change from baseline in spine and total body less head BMD will 
be summarized by study visit. BMD z-score will be derived for each BMD measurement if the 
corresponding reference population is available. Z-scores for spine and total body less head 
BMD and change from baseline in z-scores will also be summarized by visit.
8.5.7.
Tanner Stage Assessment
The Tanner stage score will be summarized by study visit.
8.5.8.
Palatability
Palatability will be summarized using descriptive statistics by cohort.
8.5.9.
Acceptability
Acceptability will be summarized using descriptive statistics.

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8.6.
Pharmacokinetic Analysis
The concentration data of EVG, COBI, FTC, TAF, and TFV over sampling time will be listed 
and summarized. Pharmacokinetic parameters (e.g., AUCtau, AUClast, Cmax, Tmax, Clast, Tlast, Ctau, 
λz, apparent CL, apparent Vz and T½) will be listed and summarized for analytes EVG, COBI, 
FTC, TAF, and TFV using descriptive statistics (e.g., sample size, arithmetic mean, geometric 
mean, coefficient of variation %, standard deviation, median, Q1, Q3, minimum, and maximum).
To determine whether the adult dose of TAF in adolescents (Cohort 1) and children (Cohort 2 
and 3), respectively, achieves similar TAF systemic exposures to that in adults, an analysis of 
variance will be carried out for log-transformed AUC as a primary parameter while other 
pharmacokinetic parameters such as Cmax will be explored. TAF data from the current study will 
be compared to the integrated historical control data using pharmacokinetic equivalence testing 
with an equivalency boundary of 70% to 143% for the 90% confidence interval. In addition, the 
95% confidence interval of the geometric mean estimate of apparent CL and Vz of TAF will be 
provided.
Similar analysis will be done for log-transformed AUCtau as a primary parameter to determine 
whether the adult dose of EVG in adolescents and children, respectively, achieves similar EVG 
systemic exposures to that in adults. Other pharmacokinetic parameters such as Cmax and Ctau will 
be explored. EVG data from the current study will be compared to the integrated historical 
control data using pharmacokinetic equivalence testing with an equivalency boundary of 70% to 
143% for the 90% confidence interval. The 95% confidence interval of the geometric mean 
estimate of apparent CL and Vz of EVG will also be provided.
Pharmacokinetic parameters of COBI, FTC, and TFV will be summarized using descriptive 
statistics.
8.7.
Independent Data Monitoring Committee
An external Independent Data Monitoring Committee (IDMC) will review the progress, efficacy, 
and safety data of this study while the study is ongoing. No formal stopping rules will be used by 
the IDMC for safety outcomes. Rather, a clinical assessment will be made to determine if the 
nature, frequency, and severity of adverse events associated with a study regimen warrant the 
early termination of the study in the best interest of the participants. A separate IDMC charter 
will be finalized prior to initiation of dosing.
8.8.
Analysis Schedule
Cohort 1
A PK analysis will be performed after the first 18 subjects (regardless of age distribution) 
complete the Intensive PK portion of the study (Part A). With confirmation of TAF exposure 
from the first 18 subjects, screening in Part B will be initiated. If more than 18 subjects are 
enrolled in Part A, the final PK analysis will be performed after all subjects complete the 
Intensive PK portion of the study. The Week 24 analysis of efficacy and safety will be conducted 
after the last subject completes 24 weeks on study. The Week 48 analysis of efficacy and safety 
will be conducted after the last subject completes 48 weeks on study.

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Cohort 2
A PK analysis will be performed after all subjects complete the Intensive PK portion of the study 
(Part A). The Week 24 analysis of efficacy and safety will be conducted after the last Part A 
subject completes 24 weeks on study and also after all subjects complete 24 weeks on study. The 
Week 48 analysis of efficacy and safety will be conducted after the last subject completes 
48 weeks on study.
Cohort 3
A PK analysis will be performed after all subjects complete the Intensive PK portion of the 
study. The Week 24 analysis of efficacy and safety will be conducted after all subjects complete 
24 weeks on study. The Week 48 analysis of efficacy and safety may be conducted after the last 
subject completes 48 weeks on study.
8.9.
Sample Size and Power
Cohorts 1 and 2
A minimum of 18 Part A subjects from each cohort will receive E/C/F/TAF STR in this study. 
PK data from these subjects will have 92% power to conclude exposure equivalence of TAF 
AUClast in adolescents and children, respectively vs. 51 HIV-1 infected and HIV-negative adults 
(Studies GS-US-292-0102 and GS-US-292-0103 combined) using two one-sided tests with each 
performed at an alpha level of 0.05. In this power analysis, it is assumed that the expected 
geometric mean ratios of TAF AUClast between adolescent group and adult group are equal to 1, 
and the inter-subject standard deviation (natural log scale) of TAF AUClast is 0.37 ng•hr/mL, and 
the equivalency boundary is 70% to 143%.
A minimum of 18 Part A subjects from each cohort will also provide > 99% power to target a 
95% confidence interval within 60% and 140% of the geometric mean estimate of apparent CL 
and Vz of TAF respectively, assuming a coefficient of variation (CV) of 38% for CL and 42% for 
Vz (Studies GS-US-292-0102 and GS-US-292-0103 combined).
For each cohort, a total of 50 subjects (subjects from Part A and subjects from Part B combined) 
is planned to study the safety of the E/C/F/TAF STR. With this sample size, the present study 
will have 92% chance to observe at least 1 SAE, assuming the SAE incidence rate is 5% 
(observed in GS-US-292-0102).
After amendment 2 of the study protocol was finalized, the adult data included in Genvoya label 
have become available and will be used as historical control for comparison for Cohort 2 
(ie, intensive PK data from 19 HIV-1 infected adults in Study GS-US-292-0102 for EVG AUCtau 
and population PK data from 539 HIV-1 infected adults in Studies GS-US-292-0104 and 
GS-US-292-0111 combined for TAF AUClast). Given the actual number of enrollments in 
Cohort 2 Part A is 23, a total of 23 subjects will provide 90% power for EVG AUCtau and 88% 
power for TAF AUClast to conclude exposure equivalence between adults and children. In this 
power analysis, it is assumed that the expected geometric mean ratios are equal to 1, the 
intersubject standard deviation (natural log scale) of EVG AUCtau and TAF AUClast is 
0.34 ng•hr/mL and 0.52 ng•hr/mL, respectively, 2 one-sided statistical tests are done at an alpha 
level of 0.05, and the equivalency boundary is 70% to 143%.

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A total of 23 subjects will also provide > 86% power to target a 95% confidence interval within 
60% and 140% of the geometric mean estimate of CL and Vz of TAF respectively, assuming a 
CV of 53% for CL and 76% for Vz (based on population PK data from Studies GS-US-292-0104 
and GS-US-292-0111 combined).
Cohort 3
Twenty-five evaluable subjects compared to historical adult data will provide 90% power for 
each of EVG AUCtau and TAF AUCtau to conclude exposure equivalence between children and 
adults. In this power analysis, it is assumed that the expected geometric mean ratios is 1, 
equivalency boundary is 70% to 143%, two one-sided tests are each performed at an alpha level 
of 0.05, and the intersubject standard deviations (natural log scale) of EVG AUCtau and TAF 
AUCtau are 0.34 ng•hr/mL and 0.52 ng•hr/mL. For historical adult data, we used intensive PK data 
from 19 HIV-1 infected adults in Study GS-US-292-0102 for EVG AUCtau and population PK 
data from Studies GS-US-292-0104 and GS-US-292-0111 combined for TAF AUCtau.
Twenty-five evaluable subjects will also provide > 99% power to target a 95% confidence 
interval within 60% and 140% of the geometric mean estimate of apparent CL and Vz of TAF 
respectively, assuming the standard deviation in natural log scale is 0.51 for CL and 0.54 for Vz 
(based on population PK data from Studies GS-US-292-0104 and GS-US-292-0111 combined).
Sample size and power calculations were made using the software package nQuery Advisor 
(Version 6.0) and R.

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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, Washington, 
Seoul, 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. For studies conducted under a United States IND, the 
investigator will ensure that the basic principles of “Good Clinical Practice,” as outlined in 
21 CFR 312, subpart D, “Responsibilities of Sponsors and Investigators,” 21 CFR, part 50, 
”Protection of Human Subjects”, and 21 CFR, part 56, ”Institutional Review Boards”, are 
adhered to. These standards are consistent with the requirements of the European Community 
Directive 2001/20/EC.
Since this is a “covered” clinical trial, the investigator will ensure that 21 CFR, Part 54, 1998, is 
adhered to; a “covered” clinical trial is any “study of a drug or device in humans submitted in a 
marketing application or reclassification petition subject to this part that the applicant or FDA 
relies on to establish that the product is effective (including studies that show equivalence to an 
effective product) or that make a significant contribution to the demonstration of safety.” This 
requires that investigators and all subinvestigators must provide documentation of their financial 
interest or arrangements with Gilead Sciences, or proprietary interests in the drug being studied. 
This documentation must be provided before participation of the investigator and any 
subinvestigator. The investigator and subinvestigator agree to notify Gilead Sciences of any 
change reportable interests during the study and for one year following completion of the study. 
Study completion is defined as the date that the last subject has completed the protocol defined 
activities.
This study is also subject to and will be conducted in accordance with 21 CFR, part 320, 1993, 
“Retention of Bioavailability and Bioequivalence Testing Samples.”
9.1.2.
Institutional Review Board (IRB)/Independent Ethics Committee 
(IEC)/Research Ethics Board (REB) Approval
This protocol 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) will be submitted by the investigator to an IRB/EC/REB. Approval from the 
IRB/EC/REB must be obtained before starting the study and should be documented in a letter to 
the investigator specifying the protocol number, protocol version, protocol date, documents 
reviewed, and date on which the committee met and granted the approval.
Any modifications made to the protocol after receipt of IRB/EC/REB approval must also be 
submitted to the IRB/EC/REB for approval before implementation.

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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 utilize an IRB/EC/REB-approved consent form for documenting written 
informed consent. Each informed consent will be appropriately signed and dated by the subject 
or the subject’s legally authorized representative and the person obtaining consent.
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, and an 
identification code (i.e., not names) should be recorded on any form or biological sample 
submitted to the Sponsor, IRB/EC/REB, or laboratory. The investigator must keep a Screening 
log showing codes, names, and addresses for all subjects screened and for all subjects enrolled in 
the trial.
The investigator agrees that all information received from Gilead Sciences, including but not 
limited to the Investigator’s Brochure, this protocol, CRFs, the investigational new drug, and any 
other study information, remain the sole and exclusive property of Gilead Sciences 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 Sciences. The investigator further agrees to take all 
reasonable precautions to prevent the disclosure by any employee or agent of the study site to 
any third party or otherwise into the public domain.
9.1.5.
Study Files and Retention of Records
The investigator must maintain adequate and accurate records to enable the conduct of the study 
to be fully documented and the study data to be subsequently verified. These documents should 
be classified into at least the following two categories: (1) investigator’s study file, and 
(2) subject clinical source documents.
The investigator’s study file will contain the protocol/amendments, CRF and query forms, 
IRB/EC/REB 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, but is not limited to 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);

Participation in trial (including trial number);

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Trial discussed and date of info1med consent; 
• 
Dates of all visits; 
• 
Documentation that protocol specific procedures were perfo1med; 
• 
Results of efficacy parameters, as required by the protocol; 
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• 
Staii and end date (including dose regimen) of trial medication (preferably diug dispensing 
and return should be documented as well); 
• 
Record of all adverse events and other safety parameters (staii and end date, and preferably 
including causality and intensity); 
• 
Concomitant medication (including staii and end date, dose if relevant; dose changes should 
be motivated); 
• 
Date of trial completion and reason for eai·ly discontinuation, if applicable. 
All clinical study documents must be retained by the investigator until at least 2 yeai·s after the 
last approval of a mai·keting application in an ICH region (i.e., United States, Europe, or Japan) 
and until there are no pending or contemplated mai·keting 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 regulato1y authorities have been notified. Investigators may be 
required to retain documents longer if required by applicable regulato1y requirements, by local 
regulations, or by an agreement with Gilead Sciences. The investigator must notify 
Gilead Sciences before destroying any clinical study records. 
Should the investigator wish to assign the study records to another paiiy or move them to another 
location, Gilead Sciences must be notified in advance. 
If the investigator cannot guai·antee this ai·chiving requirement at the study site for any or all of 
the documents, special aiTangements must be made between the investigator and Gilead Sciences 
to store these in sealed containers outside of the site so that they can be returned sealed to the 
investigator in case of a regulato1y audit. When source documents ai·e required for the continued 
cai·e of the subject, appropriate copies should be made for storage outside of the site. 
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9.1.6.
Electronic Case Report Forms (eCRFs)
An eCRF casebook will be completed by an authorized study personnel member whose training 
for this function is completed in the electronic data capture system unless otherwise directed. 
This also applies to records for those subjects who fail to complete the study (even during a 
prerandomization screening period if an eCRF was initiated). If a subject withdraws from the 
study, the reason must be noted on the eCRF. If a subject is withdrawn from the study because of 
a treatment-limiting adverse event, thorough efforts should be made to clearly document the 
outcome. The eCRF casebook will only capture the data required per the protocol schedule of 
events and procedures, unless collected by a nonelectronic data capture vendor system 
(eg, central laboratory). The Inclusion/Exclusion Criteria and Enrollment eCRFs should be 
completed only after all data related to eligibility are available. Data entry should be performed 
in accordance with the case report form Completion Guidelines provided by the sponsor. 
Subsequent to data entry, a study monitor may perform source data verification. 
System-generated or manual queries will be issued in the electronic data capture system as data 
discrepancies are identified by the study monitor or Gilead personnel who routinely review the 
data for completeness, correctness, and consistency. The site investigator, site coordinator, or 
other designee is responsible for responding to the queries in a timely manner, within the system, 
either by confirming the data as correct or updating the original entry, and providing the reason 
for the update (eg, data entry error). Original entries as well as any changes to data fields will be 
stored in the audit trail of the system. Regular oversight by the principal investigator of the data 
entered into the electronic data capture system is expected to occur on an ongoing basis 
throughout the study to ensure quality and completeness. At a minimum, before any interim, 
final, or other timepoints (as instructed by Gilead), the investigator should apply his/her 
electronic signature to confirm that the forms have been reviewed and that the entries accurately 
reflect the information in the source documents. At the conclusion of the study, Gilead will 
provide the site investigator with a read-only archive copy of the data entered. This archive must 
be stored in accordance with the records retention requirements outlined in Section 9.1.5.
9.1.7.
Drug Accountability
The investigator is responsible for ensuring adequate accountability of all used and unused study 
drug kits. This includes acknowledgment of receipt of each shipment of study drug (quantity and 
condition). All used and unused study drug kits dispensed to subjects must be returned to the site.
Each study site must keep accountability records that capture:

The date received and quantity of study drug kits 

The date, subject number, and the study drug kit number dispensed.

The date, quantity of used and unused study drug kits returned, along with the initials of the 
person recording the information.
All drug supplies and associated documentation will be periodically reviewed and verified by the 
study monitor over the course of the study. While performing drug accountability at an on-site 
monitoring visit is preferred, remote drug accountability can be performed with prior Gilead 
approval.

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9.1.8.
Inspections
The investigator should understand that source documents for this trial should be made available 
to appropriately qualified personnel from Gilead Sciences or its representatives, to 
IRB/EC/REBs, 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.
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 Sciences. All protocol modifications must be submitted to the IRB/EC/REB 
in accordance with local requirements. Approval must be obtained before changes can be 
implemented.
9.2.2.
Study Report and Publications
A clinical study report will be prepared and provided to the regulatory agency(ies).
Gilead Sciences 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.
After conclusion of the study and without prior written approval from Gilead Sciences, 
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 Sciences in an abstract, manuscript, or presentation form; or

The study has been completed at all study sites for at least 2 years.
No such communication, presentation, or publication will include Gilead Sciences’ confidential 
information (see Section 9.1.4).
The investigator will submit 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. The investigator will comply with Gilead Sciences’ 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.

EVG/COBI/FTC/TAF
Protocol GS-US-292-0106
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 96
01 June 2021
9.3.
Joint Investigator/Sponsor Responsibilities
9.3.1.
Payment Reporting
Investigators and their study staff may be asked to provide services performed under this 
protocol (eg, attendance at Investigator 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 study payments, meal, 
travel expenses or reimbursements, consulting fees, and any other transfer of value.
9.3.2.
Access to Information for Monitoring
In accordance with ICH Good Clinical Practice (ICH GCP) guidelines, the study monitor must 
have direct access to the investigator’s source documentation in order to verify the data recorded 
in the eCRFs for consistency.
The monitor is responsible for routine review of the eCRFs 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 eCRFs. The investigator agrees to cooperate with the monitor to ensure 
that any problems detected in the course of these monitoring visits are resolved.
9.3.3.
Access to Information for Auditing or Inspections
Representatives of regulatory authorities or of Gilead Sciences 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 Sciences medical monitor immediately. The investigator 
agrees to provide to representatives of a regulatory agency or Gilead Sciences 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 Sciences and the 
investigator will assure that adequate consideration is given to the protection of the subjects’ 
interests.

EVG/COBI/FTC/TAF
Protocol GS-US-292-0106
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 97
01 June 2021
10.
REFERENCES
Airoldi M, Zaccarelli M, Bisi L, Bini T, Antinori A, Mussini C, et al. One-pill once-a-day 
HAART: a simplification strategy that improves adherence and quality of life of 
HIV-infected subjects. Patient preference and adherence 2010;4:115-25.
Bangsberg DR, Ragland K, Monk A, Deeks SG. A one-pill, once-daily, fixed-dose combination 
(FDC) of efavirenz, emtricitabine, and tenofovir disoproxil fumarate 
(EFV/FTC/TDF) regimen is associated with higher unannounced pill count 
adherence than non-one pill, once-daily [Poster]. 17th Conference on Retroviruses 
and Opportunistic Infections (CROI); 2010 February 16-19; San Francisco, CA. 
Capeau J. Premature Aging and Premature Age-Related Comorbidities in HIV-Infected Patients: 
Facts and Hypotheses. Clin Infect Dis 2011;53 (11):1127-9.
Dejesus E, Young B, Morales-Ramirez JO, Sloan L, Ward DJ, Flaherty JF, et al. Simplification 
of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, 
emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral 
therapy in virologically suppressed HIV-1-infected patients. J Acquir Immune 
Defic Syndr 2009;51 (2):163-74.
Department of Health and Human Services (DHHS), Panel on Antiretroviral Therapy and 
Medical Management of HIV-Infected Children. Guidelines for the Use of 
Antiretroviral Agents in Pediatric HIV Infection. Available at 
https://aidsinfo.nih.gov/guidelines. [Report] Last Updated: May 22.  2018.
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. VIREAD® (tenofovir disoproxil fumarate) Tablets and Powder for oral use. 
US Prescribing Information. Foster City, CA. Revised August 2012:
Hodder SL, Mounzer K, Dejesus E, Ebrahimi R, Grimm K, Esker S, et al. Patient-Reported 
Outcomes in Virologically Suppressed, HIV-1-Infected Subjects After Switching 
to a Simplified, Single-Tablet Regimen of Efavirenz, Emtricitabine, and 
Tenofovir DF. AIDS Patient Care STDS 2010;24 (2):87-96.
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.
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.

EVG/COBI/FTC/TAF
Protocol GS-US-292-0106
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 98
01 June 2021
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.
Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of 
antiretroviral agents in HIV-1-infected adults and adolescents. Department of 
Health and Human Services. 1–239. Available at  
http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 
August 22.  2012.
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.
Sax PE, Meyers J, Mugavero M, Davis KL. Adherence to Antiretroviral Treatment Regimens 
and Correlation with Risk of Hospitalization Among Commercially Insured HIV 
Patients in the United States [Poster O113]. 10th International Congress on Drug 
Therapy in HIV Infection; 2010 November 7-11; Glasgow, UK. 
Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, et al. Tenofovir alafenamide versus 
tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and 
emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-
blind, phase 3, non-inferiority trials. Lancet 2015;385:2606-15.
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.
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. 

EVG/COBI/FTC/TAF
Protocol GS-US-292-0106
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 99
01 June 2021
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.
Stage-3-Defining Opportunistic Illnesses in HIV Infection
Appendix 7.
Tanner Stages

DocuSign Envelope ID: 48BA9425-445E-46FD-800O-4O5E56317043 
EVG/COBI/FTC/TAF 
Protocol GS-US-292-0106 
Final 
Gilead Sciences, Inc. 
Amendment 7 
Appendix 1. 
Investigator Signature Page 
GILEAD SCIENCES, INC. 
333 LAKESIDE DRIVE 
FOSTER CITY, CA 94404 
STUDY ACKNOWLEDGEMENT 
A Phase 2/3, Open-Label Study of the Pha1macokinetics, Safety, and Antiviral Activity of 
the Elvitegra:vir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet 
Regimen (STR) in HIV-I Infected Antiretroviral Treatment-Naive Adolescents and 
Virologically Suppressed Children 
GS-US-292-0106, Amendment 7, 01 June 2021 
This protocol has been approved by Gilead Sciences, Inc. The following signature 
documents this approval. 
PD 
Name Printed 
PD 
Date 
INVESTIGATOR STATEMENT 
I have read the protocol, including all appendices, and I agree that it contains all necessaiy 
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 effo1i 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 
info1mation provided by Gilead Sciences, Inc. I will discuss this material with them to ensme 
that they ai·e fully info1med about the diugs and the study. 
Principal Investigator Name (Printed) 
Signature 
Date 
Site Number 
CONFIDENTIAL 
Page 100 
01 June 2021 

EVG/COBI/FTC/TAF
Protocol GS-US-292-0106
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 101
01 June 2021
Appendix 2.
Study Procedures Table
End of Weekb
Post-Week 48b
Cohorts 1 and 2 
Post-Week 240; 
Cohort 3 
Post-Week 96
Study Procedures
Screeninga Baseline 
(Day 1)
Week 1 
(Day 7) Week 2b
Intensive 
PKc
4
8
12
16
24
32
40
48
Every 
12 weeksgg
Every 24 weeks
30-Day 
Follow-upd ESDDe
Assent/Informed 
Consent
X
Medical History
X
Adverse Events
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Concomitant 
Medications
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Vital Signsf
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Complete Physical 
Exam
X
X
X
X
X
Symptom-Directed 
Physical Examg
X
X
X
X
X
X
X
X
X
X
X
X
Height
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Weight
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Tanner Stage 
Evaluationsh
X
X
X
X
X
12-lead ECG - 
performed supine
X
HIV-1 Genotypei
X
Hematology Profilej
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Chemistry Profilek
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Full flow cytometry 
panel testing
X
X
X
X
X
X
X
X
X
X
X
X
Xii
X
X
Metabolic 
Assessmentsl
Xff
Xee
X
X
X
Plasma HIV-1 RNAm
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Plasma Storage 
Samplen
Xee
Xz
X
X
X
X
Xee
X
X
X
X
X

EVG/COBI/FTC/TAF
Protocol GS-US-292-0106
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 102
01 June 2021
End of Weekb
Post-Week 48b
Cohorts 1 and 2 
Post-Week 240; 
Cohort 3 
Post-Week 96
Study Procedures
Screeninga Baseline 
(Day 1)
Week 1 
(Day 7) Week 2b
Intensive 
PKc
4
8
12
16
24
32
40
48
Every 
12 weeksgg
Every 24 weeks
30-Day 
Follow-upd ESDDe
Whole Blood Sample 
(Cohort 3)
X
HBV and HCV 
Serologies
X
Urinalysis
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Estimated Glomerular 
Filtration Rateo
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Serum Pregnancy 
Testq
X
Urine Pregnancy Testq
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Dispense Dosing Diary 
(for Part A subjects, 
inclusive of Cohort 3)
Xff
X
Review Dosing Diary 
(For Part A subjects, 
inclusive of Cohort 3)
X
Single PK Samplingr
Xz
X
X
X
Xdd
Xdd
X
Trough PK Samples
Xcc
Xee
Xff
X
X
Intensive PK 
Samplingt
X
DXA Scan (Lumbar 
spine & Total Body)v
X
X
X
X
Xjj
Bone Safetyw
Xff
Xee
Xdd 
X
X
X
X
Xkk
Urine Renal Safetyx
Xff
Xee
X
X
X
X
CCI
CCI
CCI

EVG/COBI/FfC/TAF 
Protocol GS-US-292-0106 
Gilead Sciences, Inc. 
Study Procedul'es 
Sc.l'eeninga 
Study Drug 
Dispensation 
In-clinic DosingY 
Drug Accountabili~ 
Palatability and 
Acceptability 
Assessment 
Baseline 
(Day 1) 
X 
X 
xbb 
Week l 
Intensive 
(Day7) Week 2b 
PKC 
4 
8 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
xbb 
End of Weekb 
Post-Week 4gb 
Evel'y 
12 
16 
24 
32 
40 
48 
12 weeksgg 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
xaa, bb xaa 
xaa xaa, bb 
xaa 
a 
Evaluations to be completed within 35 days prior to Baseline (or 42 days for subjects who require repeat testing of the HIV-I genotype). 
Cohol'ts 1 and 2 
Post-Week 240; 
Cohort 3 
Post-Week 96 
Evel'y 24 weeks 
X 
X 
Final 
Amendment 7 
30-Day 
Follow-upd ESDDe 
X 
xcc 
xcc 
b 
All study visits are to be scheduled relative to the Baseline/Day I visit date. Visit windows are± 2 days of the protocol-specified visit date from Week 2 through Week 8, 
± 4 days of the protocol-specified visit date from Week 12 through Week 48, and ± 6 days of the protocol-specified visit date post-Week 48, unless otherwise specified. 
c 
Patt A subjects only, inclusive of Cohort 3. TI1e Intensive PK evaluation will occur at the Week 4 (Cohotts I and 2) or Week 2 (Cohort 3) visit. For the purpose of scheduling 
the Intensive PK visit, a+ 7 days window may be used. If the subject has already dosed prior to the Intensive PK evaluation visit or is not in a fasted state, the Intensive PK 
assessments must not be completed. TI1e subject should be instructed to rettun in a fasted state within 7 days of their Week 4 (Cohotts I and 2) or Week 2 (Cohort 3) visit for 
the Intensive PK visit. 
d 
Only required for those subjects not enrolling in the extension phase of the study or those subjects who petmanently discontinue study dmg and do not continue in the study 
through at least one subsequent visit after the Early Study Dmg Discontinuation Visit. For the ptupose of scheduling a 30-Day Follow-Up Visit, a± 6 days window may be used. 
e 
ESDD visit should occm· within 72 hom·s of last dose of study dmg. 
f 
Vital signs include blood pressm·e, pulse, respiration rate, and temperature. 
g 
Symptom-directed physical examinations performed as needed. 
h 
Tanner assessments will be etfotmed on sub' ects c:: 6 ears of aoe and no Ion 
erse transcriptase, protease and integrase resistance will be done at Screening. The investigator must have received the results from the Screening genotype 
before proceeding with the Baseline visit. (Cohort I only) 
J 
CBC with differential and platelet count. 
k 
• 
·ofile: alkaline phosphatase, AST, AL 
I bilimbin, direct and indir . . • • 
• 
• 
• 
• e, Weeks 2 [C 
m 
es will not be collected at Weeks I, 2, and 4 visits for Cohott I and at Weeks I through 16 for Cohotts 2 and 3. For 
Patt B subjects, back-up samples will be collected at all visits. 
CONFIDENTIAL 
Page 103 
01 June 2021 

EVG/COBI/FfC/TAF 
Protocol GS-US-292-0106 
Gilead Sciences, Inc. 
r 
0 r 
q 
ema es o c 11 
eanng potentia on y. os1ttve unne pregnancy tests w1 
e con ume w1 a senun test at any v1S1t. 
Final 
Amendment 7 
r 
Coho1t 1: a timed random PK sample collected at Week 4 (Part B subjects only) and Week 12 between 0.25-4 hours post-dose. A random PK sample collected at Week 8, 
Week 16, and Week 32. Cohort 2: a timed PK at Week 12 between 0.25-4 hotu·s post-dose. A random PK samples at Week 8 and Week 16. Coho1t 3: a timed PK sample 
collected between 0.25 and 4 hom·s post-dose at Week 8, 12, and 16. 
s 
Subjects must come into the clinic without taking theit·dose of E/C/F/TAF STR and subjects should fast ovemight (a minimtun of 8 hours). A trough (20 to 24 hotu-s post-dose) 
plasma PK sample will be collected at Weeks 1, 2, and 24 for subjects in Coho1ts 1 and 2 and Week 48 for Coho1t 1 only. For subjects in Coho1t 3, a trough sample will be 
collected at Weeks 4 and 24. 
Pait A subjects only, inclusive of Cohort 3. Intensive PK sampling will be performed on Week 4 (Cohorts 1 and 2) or Week 2 (Coho1t 3). For the purpose of scheduling the 
Intensive PK visit a + 7 days window may be used. If the subject has already dosed prior to the Intensive PK visit or is not in a fasted state, the Intensive PK assessments must 
not be completed. The subject should be instructed to rettun within fotu· days for the Intensive PK visit. If dosing non-compliance is identified on or prior to the Intensive PK 
visit, the Intensive PK assessments must not be completed. The subject should be counseled regarding 
er dosing and asked to rettun for the Intensive PK visit no sooner 
than three da s followino com liant dosino and no later than Week 4 + 7 da s. Please refer to the PK 
manual for sam le collection and rocessingdetails. 
I' 
V 
w 
or o orts an 
, one sa ety mc u mg: 
Senun: bicarbonate, N-telopeptide, C-telopeptide (CTIC), osteocalcin, procollagen type 1 N-terminal propeptide (Pl NP) 
Urine: bicarbonate, N-telopeptide 
For all coho1ts, bone safety including: 
Senun: bone specific alkaline phosphatase, parathyroid hormone (PTH), 25OH Vitaniin D and 1, 25OH Vitaniin D 
x 
Urine Renal Safety including: urine chem.istiy, retinol binding protein, and beta-2-microglobulin. 
4and48 (± lOdays).-
y 
All subjects will be given their dose of E/C/F/TAF STR with food. For those subjects that take theit· medication in the evening, the in-clinic dosing will not be pe1fon11ed. 
z 
Coho1t 1 Pait B subjects only 
aa 
To be pe1fo1med for all Cohort 1 subjects ctm·ently on stt1dy at theit· next scheduled visit. 
bb To be pe1fo1med at Baseline and Week 4 for all Coho1t 2 subjects and at Baseline, Weeks 4, 24, and 48 for all Coho1t 3 subjects enrolled. 
cc To be pe1fo1med at ESDD or 30-Day Follow-Up Visit for either Cohort 1 or 2, as applicable. 
dd Coho1t 1 subjects only 
Coho1ts 1 and 2 subjects only 
Coho1t 3 sub'ects 
• g dmg accotmtability at an on-site monitoring visit is preferred. Gilead prior app 
• 
or Cohorts 1 and 2 
CONFIDENTIAL 
Page 104 
01 June 2021 

EVG/COBI/FTC/TAF
Protocol GS-US-292-0106
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 105
01 June 2021
Appendix 3.
Management of Clinical and Laboratory Adverse Events
Gl'ade l 
~,J!i..,y rnnrlioue 
dosing at the 
fil"Jcrecli.on o,f&e 
im-e~tigafor 
Grade . 
ff 1i!lonrfi1uoo. and possiM)· an 01 p1l'(lbably nL,ted to 
inrr,es,tigatioo."ll mooidnal p11oduciis: 
Repe. tlal to 
couii:1.'.m tonri.ty 
grade 
1. \\iithhoM imrestiga.li.onru m.edicinaJ p11oduds until 5: 1GFade . 
2. Restal't aU im"'e&li.ganon.,t medfr:iu.,t pl'oducts at flull dose 
ff Grade J, OF .:I 11ecm'.1·enl1'f that 1.~ coumrned and posstb~; Oil' 
pl'Ob, bly 1-d:lted to innr,e:Stig.uiomlil mfdi.cmru products,. dioo:intinue 
all in/\if:S~tiorml mooicin, l pmd!ucis dosing pet manenfi)· 
Geade3 
Repe, t lab to 
cou.fi:rm toncih; 
~t. dti: 
• 
e 
ll ,ironfurmed and um.1eL: ted to 
innsli.gamnaJ mediciJml pm ducts, 
dmi.ng may ,i!\ontinue at the 
dfair:r.·etion of the im-estigat,or 
If con.fumed and 
possibh· OF pmbab~y 
I-ii> refated to 
im-e tigatfon::d 
med!ici.na] pt"Oduds 
diseontinue 
ini-e: tigationa) 
medicmaJ pt"Oduct~ 
dosing pet mane,nrth· 
and follow at pe1rio die 
intf:n-als at [1east 
wee,k!J~; until a, 1remrn 
fo has~line 01· is 
otihet"\TI~e ex:pj ained 
H G1rade J, 0 1 -l 1·,ecurr,ence tiha.t iB ,eon~idered uni·eL'lted ro 
in,-estigartional medicina] pt"Odud continue aU innsli.ganon.,~ 
mesdkmru products at the sa:me dooe , t fhe disn1eoon of the 
innstigar~oF 

EVG/COBI/FTC/TAF
Protocol GS-US-292-0106
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 106
01 June 2021
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
1.00 to 1.30 GI/L
750 to  1000/mm3
0.75 to  1.00 GI/L
500 to  750/mm3
0.50 to  0.75 GI/L
 500/mm3
 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

EVG/COBI/FTC/TAF
Protocol GS-US-292-0106
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
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HEMATOLOGY
Grade 1
Grade 2
Grade 3
Grade 4
Absolute CD4+ Count
HIV NEGATIVE ONLY
Adult and Pediatric
300 to 400/mm3
200 to  300/mm3
100 to  200/mm3
 100/mm3
13 Years
300 to 400/μL
200 to  300/μL
100 to  200/μL
 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
2.00 GI/L to 2.50 GI/L
1,500 to  2,000/mm3
1.50 to  2.00 GI/L
1000 to  1,500/mm3
1.00 to  1.50 GI/L
 1000/mm3
 1.00 GI/L
Hypofibrinogenemia
100 to 200 mg/dL
1.00 to 2.00 g/L
75 to  100 mg/dL
0.75 to  1.00 g/L
50 to  75 mg/dL
0.50 to  0.75 g/L
 50 mg/dL
 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
20 to 40 mg/L
40 to 50 μg/mL
40 to 50 mg/L
50 to 60 μg/mL
50 to 60 mg/L
60 μg/mL
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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CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hyponatremia
130 to <LLN mEq/L
130 to <LLN mmol/L
125 to  130 mEq/L
125 to  130 mmol/L
121 to  125 mEq/L
121 to  125 mmol/L
 121 mEq/L
 121 mmol/L
Hypernatremia
146 to 150 mEq/L
146 to 150 mmol/L
 150 to 154 mEq/L
 150 to 154 mmol/L
 154 to 159 mEq/L
 154 to 159 mmol/L
159 mEq/L
159 mmol/L
Hypokalemia
3.0 to 3.4 mEq/L
3.0 to 3.4 mmol/L
2.5 to  3.0 mEq/L
2.5 to  3.0 mmol/L
2.0 to  2.5 mEq/L
2.0 to  2.5 mmol/L
 2.0 mEq/L
 2.0 mmol/L
Hyperkalemia
5.6 to 6.0 mEq/L
5.6 to 6.0 mmol/L
 6.0 to 6.5 mEq/L
 6.0 to 6.5 mmol/L
 6.5 to 7.0 mEq/L
 6.5 to 7.0 mmol/L
7.0 mEq/L
7.0 mmol/L
Hypoglycemia
Adult and Pediatric
 1 Month
55 to 64 mg/dL
3.03 to 3.58 mmol/L
40 to  55 mg/dL
2.20 to  3.03 mmol/L
30 to  40 mg/dL
1.64 to  2.20 mmol/L
 30 mg/dL
 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
6.42 to 8.91 mmol/L
 160 to 250 mg/dL
 8.91 to 13.90 mmol/L
 250 to 500 mg/dL
 13.90 to 27.79 mmol/L
 500 mg/dL
 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 Infant,  7 Days
7.8 to 8.4 mg/dL
1.94 to 2.10 mmol/L
6.5 to 7.5 mg/dL
1.61 to 1.88 mmol/L
7.0 to  7.8 mg/dL
1.74 to  1.94 mmol/L
6.0 to  6.5 mg/dL
1.49 to < 1.61 mmol/L
6.1 to  7.0 mg/dL
1.51 to  1.74 mmol/L
5.5 to  6.0 mg/dL
1.36 to < 1.49 mmol/L
 6.1 mg/dL
 1.51 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
>ULN to 2.88 mmol/L
 11.5 to 12.5 mg/dL
 2.88 to 3.13 mmol/L
 12.5 to 13.5 mg/dL
 3.13 to 3.38 mmol/L
 13.5 mg/dL
 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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CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hypocalcemia (ionized)
3.0 mg/dL to  LLN
0.74 mmol/L to  LLN
2.5 to < 3.0 mg/dL
0.62 to  0.74 mmol/L
2.0 to  2.5 mg/dL
0.49 to  0.62 mmol/L
 2.0 mg/dL
 0.49 mmol/L
Hypercalcemia (ionized)
ULN to 6.0 mg/dL
ULN to 1.50 mmol/L
 6.0 to 6.5 mg/dL
 1.50 to 1.63 mmol/L
 6.5 to 7.0 mg/dL
 1.63 to 1.75 mmol/L
7.0 mg/dL
1.75 mmol/L
Hypomagnesemia
1.40 to <LLN mg/dL
1.2 to <LLN mEq/L
0.58 to <LLN mmol/L
1.04 to  1.40 mg/dL
0.9 to  1.2 mEq/L
0.43 to  0.58 mmol/L
0.67 to  1.04 mg/dL
0.6 to  0.9 mEq/L
0.28 to  0.43 mmol/L
 0.67 mg/dL
 0.6 mEq/L
 0.28 mmol/L
Hypophosphatemia
Adult and Pediatric
 14 Years
Pediatric 1 Year–14 Years
Pediatric  1 Year
2.0 to < LLN mg/dL
0.63 to  LLN mmol/L
3.0 to 3.5 mg/dL
0.96 to 1.12 mmol/L
3.5 to 4.5 mg/dL
1.12 to 1.46 mmol/L
1.5 to  2.0 mg/dL
0.47 to  0.63 mmol/L
2.5 to  3.0 mg/dL
0.80 to < 0.96 mmol/L
2.5 to  3.5 mg/dL
0.80 to < 1.12 mmol/L
1.0 to  1.5 mg/dL
0.31 to  0.47 mmol/L
1.5 to  2.5 mg/dL
0.47 to < 0.80 mmol/L
1.5 to  2.5 mg/dL
0.47 to < 0.80 mmol/L
 1.0 mg/dL
 0.31 mmol/L
 1.5 mg/dL
< 0.47 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
>ULN to 597 μmol/L
 10.0 to 12.0 mg/dL
 597 to 716 μmol/L
 12.0 to 15.0 mg/dL
 716 to 895 μmol/L
 15.0 mg/dL
 895 μmol/L

EVG/COBI/FTC/TAF
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Amendment 7
CONFIDENTIAL
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CHEMISTRY
Grade 1
Grade 2
Grade 3
Grade 4
Hypouricemia
1.5 mg/dL to  LLN
87 μmol/L to  LLN
1.0 to  1.5 mg/dL
57 to  87 μmol/L
0.5 to  1.0 mg/dL
27 to  57 μmol/L
 0.5 mg/dL
 27 μmol/L
Creatinine
 1.50 to 2.00 mg/dL
 133 to 177 μmol/L
 2.00 to 3.00 mg/dL
 177 to 265 μmol/L
 3.00 to 6.00 mg/dL
 265 to 530 μmol/L
 6.00 mg/dL
 530 μmol/L
Bicarbonate
16.0 mEq/L to  LLN
16.0 mmol/L to  LLN
11.0 to  16.0 mEq/L
11.0 to  16.0 mmol/L
8.0 to  11.0 mEq/L
8.0 to  11.0 mmol/L
 8.0 mEq/L
 8.0 mmol/L
Triglycerides (Fasting)
NA
500 to 750 mg/dL
5.64–8.47 mmol/L
 750 to 1200 mg/dL
 8.47–13.55 mmol/L
 1200 mg/dL
 13.55 mmol/L
LDL
(Fasting)
130 to 160 mg/dL
3.35 to 4.15 mmol/L
>160 to 190 mg/dL
>4.15 to 4.92 mmol/L
190 mg/dL
>4.92 mmol/L
NA
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
5.16 to 6.19 mmol/L
 239 to 300 mg/dL
 6.19 to 7.77 mmol/L
300 mg/dL
7.77 mmol/L
NA
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

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ENZYMES
Grade 1
Grade 2
Grade 3
Grade 4
AST (SGOT)
1.25 to 2.50  ULN
 2.50 to 5.00  ULN
 5.00 to 10.00  ULN
 10.00  ULN
ALT (SGPT)
1.25 to 2.50  ULN
 2.50 to 5.00  ULN
 5.00 to 10.00  ULN
 10.00  ULN
GGT
1.25 to 2.50  ULN
 2.50 to 5.00  ULN
 5.00 to 10.00  ULN
 10.00  ULN
Alkaline Phosphatase
1.25 to 2.50  ULN
 2.50 to 5.00  ULN
 5.00 to 10.00  ULN
 10.00  ULN
Total Amylase
 1.0 to 1.5  ULN
 1.5 to 2.0  ULN
 2.0 to 5.0  ULN
 5.0  ULN
Pancreatic Amylase
 1.0 to 1.5  ULN
 1.5 to 2.0  ULN
 2.0 to 5.0  ULN
 5.0  ULN
Lipase
 1.0 to 1.5  ULN
 1.5 to 3.0  ULN
 3.0 to 5.0  ULN
 5.0  ULN
Albumin
3.0 g/dL to  LLN 30 g/L to 
 LLN
2.0 to  3.0 g/dL 20 to 
 30 g/L
 2.0 g/dL
 20 g/L
NA

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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.

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

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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
Pediatric  16 Years
Asymptomatic, QTc interval
0.45 to 0.47 sec OR Increase 
interval  0.03 sec above 
baseline
Asymptomatic, QTc interval
0.450 to 0.464 sec
Asymptomatic, QTc interval
0.48 to 0.49 sec OR Increase 
in interval 0.03 to 0.05 sec 
above baseline
Asymptomatic, QTc interval
0.465 to 0.479 sec
Asymptomatic, QTc interval
 0.50 sec OR Increase in 
interval  0.06 sec above 
baseline
Asymptomatic, QTc interval
 0.480 sec
Life-threatening 
consequences, eg, Torsade de 
pointes or other associated 
serious ventricular 
dysrhythmia
Life-threatening 
consequences, eg, Torsade de 
pointes or other associated 
serious ventricular 
dysrhythmia
Thrombosis/Embolism
NA
Deep vein thrombosis AND 
No intervention indicated (eg, 
anticoagulation, lysis filter, 
invasive procedure)
Deep vein thrombosis AND 
Intervention indicated (eg, 
anticoagulation, lysis filter, 
invasive procedure)
Embolic event (eg, pulmonary 
embolism, life- threatening 
thrombus)
Vasovagal Episode 
(associated with a procedure 
of any kind)
Present without loss of 
consciousness
Present with transient loss of 
consciousness
NA
NA
Ventricular Dysfunction 
(congestive heart failure, 
CHF)
NA
Asymptomatic diagnostic 
finding AND intervention 
indicated
New onset with symptoms OR 
Worsening symptomatic CHF
Life-threatening CHF

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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,
Diffuse macular,
Extensive or generalized
maculopapular, or
maculopapular, or
bullous lesions OR Stevens-
morbilliform rash OR Target
morbilliform rash with
Johnson syndrome OR
lesions
vesicles or limited number of
Ulceration of mucous
bullae OR Superficial
membrane involving two or
ulcerations of mucous
more distinct mucosal sites
membrane limited to one site
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 [eg, 
tube feeding or total 
parenteral nutrition]
Ascites
Asymptomatic
Symptomatic AND 
Intervention indicated (eg, 
diuretics or therapeutic 
paracentesis)
Symptomatic despite 
intervention
Life-threatening consequences
Cholecystitis
NA
Symptomatic AND Medical 
intervention indicated
Radiologic, endoscopic, or 
operative intervention 
indicated
Life-threatening 
consequences (eg, sepsis or 
perforation)
Constipation
NA
Persistent constipation 
requiring regular use of 
dietary modifications, 
laxatives, or enemas
Obstipation with manual 
evacuation indicated
Life-threatening 
consequences (eg, 
obstruction)
Diarrhea
Adult and Pediatric
 1 Year
Transient or intermittent 
episodes of unformed stools 
OR Increase of  3 stools over 
baseline/24 hr
Persistent episodes of 
unformed to watery stools OR 
Increase of 4–6 stools over 
baseline per 24 hrs.
Bloody diarrhea OR Increase 
of  7 stools per 24-hour 
period OR IV fluid 
replacement indicated
Life-threatening consequences
(eg, hypotensive shock)
Pediatric  1 Year
Liquid stools (more unformed 
than usual) but usual number 
of stools
Liquid stools with increased 
number of stools OR Mild 
dehydration
Liquid stools with moderate 
dehydration
Liquid stools resulting in 
severe dehydration with 
aggressive rehydration 
indicated OR Hypotensive 
shock

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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 (eg, aspiration, 
choking)
Nausea
Transient ( 24 hours) or 
intermittent nausea with no or 
minimal interference with oral 
intake
Persistent nausea resulting in 
decreased oral intake for 24– 
48 hours
Persistent nausea resulting in 
minimal oral intake for
 48 hours OR Aggressive 
rehydration indicated
(eg, IV fluids)
Life-threatening consequences
(eg, hypotensive shock)
Pancreatitis
NA
Symptomatic AND 
Hospitalization not indicated 
(other than ER visit)
Symptomatic AND 
Hospitalization indicated 
(other than ER visit)
Life-threatening 
consequences (eg, sepsis, 
circulatory failure, 
hemorrhage)
Proctitis
(functional- symptomatic) 
Also see Mucositis/Stomatitis 
for Clinical Exam
Rectal discomfort AND No 
intervention indicated
Symptoms causing greater 
than minimal interference 
with usual social & functional 
activities OR Medical 
intervention indicated
Symptoms causing inability to 
perform usual social/ 
functional activities OR 
Operative intervention 
indicated
Life-threatening 
consequences (eg, 
perforation)
Vomiting
Transient or intermittent 
vomiting with no or minimal 
interference with oral intake
Frequent episodes of vomiting 
with no or mild dehydration
Persistent vomiting resulting 
in orthostatic hypotension OR 
Aggressive rehydration 
indicated
Life-threatening consequences
(eg, hypotensive shock)

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NEUROLOGICAL
Grade 1
Grade 2
Grade 3
Grade 4
Alteration in Personality- 
Behavior or in Mood (eg, 
agitation, anxiety, depression, 
mania, psychosis)
Alteration causing no or 
minimal interference with 
usual social & functional 
activities
Alteration causing greater 
than minimal interference 
with usual social & functional 
activities
Alteration causing inability to 
perform usual social & 
functional activities
Behavior potentially harmful 
to self or others (eg, 
suicidal/homicidal ideation or 
attempt, acute psychosis) OR 
Causing inability to perform 
basic self-care functions
Altered Mental Status
For Dementia, see Cognitive 
and Behavioral/Attentional 
Disturbance (including
dementia and ADD)
Changes causing no or 
minimal interference with 
usual social & functional 
activities
Mild lethargy or somnolence 
causing greater than minimal 
interference with usual social 
& functional activities
Confusion, memory 
impairment, lethargy, or 
somnolence causing inability 
to perform usual social & 
functional activities
Delirium OR obtundation, OR 
coma
Ataxia
Asymptomatic ataxia 
detectable on exam OR 
Minimal ataxia causing no or 
minimal interference with 
usual social & functional 
activities
Symptomatic ataxia causing 
greater than minimal 
interference with usual social 
& functional activities
Symptomatic ataxia causing 
inability to perform usual 
social & functional activities
Disabling ataxia causing 
inability to perform basic self-
care functions
Cognitive and 
Behavioral/Attentional 
Disturbance (including 
dementia and Attention 
Deficit Disorder)
Disability causing no or 
minimal interference with 
usual social & functional 
activities OR Specialized 
resources not indicated
Disability causing greater than 
minimal interference with 
usual social & functional 
activities OR Specialized 
resources on part-time basis 
indicated
Disability causing inability to 
perform usual social & 
functional activities OR 
Specialized resources on a 
full-time basis indicated
Disability causing inability to 
perform basic self-care 
functions OR 
Institutionalization indicated
CNS Ischemia (acute)
NA
NA
Transient ischemic attack
Cerebral vascular accident 
(CVA, stroke) with 
neurological deficit
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 (eg, 
status epilepticus), or difficult 
to control (eg, 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 (eg, 
severity or focality)
Seizures of any kind that are 
prolonged, repetitive (eg, 
status epilepticus), or difficult 
to control (eg, refractory 
epilepsy)
Seizure
– Pediatric  18 Years
Seizure, generalized onset 
with or without secondary 
generalization, lasting
< 5 minutes with < 24 hours 
post ictal state
Seizure, generalized onset 
with or without secondary 
generalization, lasting 5–20 
minutes with
< 24 hours post ictal state
Seizure, generalized onset 
with or without secondary 
generalization, lasting
20 minutes
Seizure, generalized onset 
with or without secondary 
generalization, requiring 
intubation and sedation
Syncope (not associated with 
a procedure)
NA
Present
NA
NA
Vertigo
Vertigo causing no or minimal 
interference with usual social 
& functional activities
Vertigo causing greater than 
minimal interference with 
usual social & functional 
activities
Vertigo causing inability to 
perform usual social & 
functional activities
Disabling vertigo causing 
inability to perform basic self-
care functions

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MUSCULOSKELETAL
Grade 1
Grade 2
Grade 3
Grade 4
Arthralgia
Joint pain causing no or
Joint pain causing greater
Joint pain causing inability to
Disabling joint pain causing
See also Arthritis
minimal interference with
than minimal interference
perform usual social &
inability to perform basic
usual social & functional
with usual social & functional
functional activities
self-care functions
activities
activities
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 [eg, 
tube feeding or total 
parenteral nutrition]

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

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

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GENITOURINARY
Grade 1
Grade 2
Grade 3
Grade 4
Intermenstrual Bleeding
Spotting observed by
Intermenstrual bleeding not
Intermenstrual bleeding
Hemorrhage with
(IMB)
participant OR Minimal
greater in duration or amount
greater in duration or amount
life-threatening hypotension
blood observed during
than usual menstrual cycle
than usual menstrual cycle
OR Operative intervention
clinical or colposcopic exam
indicated
Urinary Tract obstruction (eg, 
stone)
NA
Signs or symptoms of urinary 
tract obstruction without 
hydronephrosis or renal 
dysfunction
Signs or symptoms of urinary 
tract obstruction with 
hydronephrosis or renal 
dysfunction
Obstruction causing
life-threatening consequences
INFECTION
Grade 1
Grade 2
Grade 3
Grade 4
Infection (any other than
Localized, no systemic
Systemic antimicrobial 
treatment
Systemic antimicrobial 
treatment
Life-threatening
HIV infection)
antimicrobial treatment 
indicated
indicated OR Symptoms
indicated AND Symptoms
consequences
AND Symptoms causing no
causing greater than minimal
causing inability to perform
(eg, septic shock)
or minimal interference with
interference with usual social
usual social & functional
usual social & functional
& functional activities
activities OR Operative
activities
intervention (other than
simple incision and drainage)
indicated
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) Definitions
a. Definition of Childbearing Potential
For the purposes of this study, a female born subject is considered of childbearing potential 
following the initiation of puberty (Tanner stage 2) until becoming post-menopausal, unless 
permanently sterile or with medically documented ovarian failure.
Women are considered to be in a postmenopausal state when they are > 54 years of age with 
cessation of previously occurring menses for > 12 months without an alternative cause. In 
addition, women of any age with amenorrhea of > 12 months may also be considered 
postmenopausal if their follicle stimulating hormone (FSH) level is in the postmenopausal range 
and they are not using hormonal contraception or hormonal replacement therapy.
Permanent sterilization includes hysterectomy, bilateral oophorectomy, or bilateral 
salpingectomy in a female subject of any age.
b. Definition of Male Fertility
For the purposes of this study, a male born subject is considered fertile after the initiation of 
puberty unless permanently sterile by bilateral orchidectomy or medical documentation.
2) Contraception Requirements for Female Subjects
a. Study Drug Effects on Pregnancy and Hormonal Contraception
Data from clinical pharmacokinetic interaction studies of E/C/F/TAF STR have demonstrated 
that a clinically relevant interaction with contraceptive steroids was observed or suspected. If 
used, a hormonal contraceptive should contain at least 30 mcg of ethinyl estradiol. In addition, 
non-clinical toxicity studies of E/C/F/TAF STR have demonstrated no adverse effect on fertility 
or embryo-fetal development. However, there is no clinical data of E/C/F/TAF STR in pregnant 
women. Please refer to the latest version of the Investigator’s Brochure for additional 
information.
b. Contraception Requirements for Female Subjects of Childbearing Potential
The inclusion of female subjects of childbearing potential requires using at least an acceptable 
effective contraceptive measure. They must have a negative serum pregnancy test at Screening 
and a negative pregnancy test on the Baseline/Day 1 visit prior to randomization. In the event of 
a delayed menstrual period (over one month between menstruations), a pregnancy test must be 
performed to rule out pregnancy. This is applicable also for women of childbearing potential 
with infrequent or irregular periods. They must also agree to one of the following Screening until 
the last dose of study drug.

Complete abstinence from intercourse of reproductive potential. Abstinence is an acceptable 
method of contraception only when it is in line with the subject’s preferred and usual 
lifestyle.
Or

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
Consistent and correct use of 1 of the following methods of birth control listed below. 
Intrauterine device (IUD) with a failure rate of < 1% per year
Tubal sterilization
Essure® micro-insert system (provided confirmation of success 3 months after procedure)
Vasectomy in the male partner (provided that the partner is the sole sexual partner and 
had confirmation of surgical success 3 months after procedure)
Barrier methods (one female barrier and one male barrier must be used in combination)
■
Female barriers: Diaphragm with spermicide or Cervical cap with spermicide
■
Male barriers: Male condom (with or without spermicide)
Hormonal methods (including Intrauterine hormone-releasing system (IUS)) must be 
used with barrier methods described above. The hormonal contraceptive should contain at 
least 30 mcg of ethinyl estradiol.
Female subjects must also refrain from egg donation and in vitro fertilization during treatment 
and until the last study drug dose. 
3) Contraception Requirements for Male Subjects
During the study, male subjects with female partners of childbearing potential should use 
condoms when engaging in intercourse of reproductive potential. Male subjects must also refrain 
from sperm donation during treatment and until at least the end of the protocol-defined 
posttreatment period.
4) Unacceptable Birth Control Methods
Birth control methods that are unacceptable include periodic abstinence (eg, calendar, ovulation, 
symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and 
lactational amenorrhea method (LAM). A female condom and a male condom should not be used 
together.
5) Procedures to be Followed in the Event of Pregnancy
Subjects will be instructed to notify the investigator if they become pregnant at any time during 
the study, or if they become pregnant within 30 days of last study drug dose. Subjects who 
become pregnant or who suspect that they are pregnant during the study must report the 
information to the investigator and discontinue study drug immediately. Subjects whose partner 
has become pregnant or suspects she is pregnant during the study must report the information to 
the investigator. Instructions for reporting pregnancy, partner pregnancy, and pregnancy outcome 
are outlined in Section 7.4.2.1.

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Appendix 6.
Stage-3-Defining Opportunistic Illnesses in HIV Infection
Bacterial infections, multiple or recurrent* Candidiasis of bronchi, trachea, or lungs Candidiasis 
of esophagus
Cervical cancer, invasive†
Coccidioidomycosis, disseminated or extrapulmonary Cryptococcosis, extrapulmonary
Cryptosporidiosis, chronic intestinal (>1 month’s duration)
Cytomegalovirus disease (other than liver, spleen, or nodes), onset at age >1 month 
Cytomegalovirus retinitis (with loss of vision)
Encephalopathy attributed to HIV§
Herpes simplex: chronic ulcers (>1 month’s duration) or bronchitis, pneumonitis, or esophagitis 
(onset at age >1 month)
Histoplasmosis, disseminated or extrapulmonary Isosporiasis, chronic intestinal (>1 month’s 
duration) Kaposi sarcoma
Lymphoma, Burkitt (or equivalent term) Lymphoma, immunoblastic (or equivalent term) 
Lymphoma, primary, of brain
Mycobacterium avium complex or Mycobacterium kansasii, disseminated or extrapulmonary 
Mycobacterium tuberculosis of any site, pulmonary†, disseminated, or extrapulmonary 
Mycobacterium, other species or unidentified species, disseminated or extrapulmonary 
Pneumocystis jirovecii (previously known as “Pneumocystis carinii”) pneumonia 
Pneumonia, recurrent†
Progressive multifocal leukoencephalopathy
Salmonella septicemia, recurrent Toxoplasmosis of brain, onset at age >1 month 
Wasting syndrome attributed to HIV§
*
Only among children aged <6 years.
†
Only among adults, adolescents, and children aged ≥6 years.
§
Suggested diagnostic criteria for these illnesses, which might be particularly important for HIV encephalopathy and HIV 
wasting syndrome, are described in the following references: CDC. 1994 Revised classification system for human 
immunodeficiency virus infection in children less than 13 years of age.
MMWR 1994;43(No. RR-12). CDC. 1993 Revised classification system for HIV infection and expanded surveillance case 
definition for AIDS among adolescents and adults. MMWR 1992;41(No. RR-17).

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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.