Open-label Safety Study of E/C/F/TAF (Genvoya®) in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

Key Inclusion Criteria:

Cohort 1 (treatment-experienced switch)

- Must not have a history of known resistance to elvitegravir (EVG), tenofovir
disoproxil fumarate (TDF), or emtricitabine (FTC)

- Plasma HIV-1 RNA concentrations (at least two measurements) at undetectable levels
(according to the local assay being used) in the 6 months preceding the screening
visit and have HIV-1 RNA < 50 copies/mL at screening

- Estimated glomerular filtration rate (GFR) 30-69 mL/min according to the
Cockcroft-Gault formula for creatinine clearance, using actual weight

- May be currently enrolled in Gilead studies GS-US-236-0102, GS-US-236-0103, and
GS-US-216-0114, but will be eligible to enroll only after the Week 144 visit for that
study is complete; or currently receiving Stribild® (STB) or atazanavir
(ATV)/cobicistat (COBI) + Truvada (TVD) in Gilead studies GS-US-236-0104 or
GS-US-216-0105, but will be eligible to enroll only after the Week 48 visit for that
study is complete.

Cohort 2 (treatment-naive)

- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

- Screening genotype report provided by Gilead Sciences must show sensitivity to EVG,
FTC, and TDF

- No prior use of any approved or investigational antiretroviral drug for any length of
time, except the use for pre-exposure prophylaxis (PrEP), or post-exposure prophylaxis
(PEP), up to 6 months prior to screening

- Estimated GFR 30-69 mL/min according to the Cockcroft Gault formula for creatinine
clearance, using actual weight

All Cohorts:

All subjects must meet all of the following inclusion criteria to be eligible for
participation in this study:

- The ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures

- CD4+ count of ≥ 50 cells/μL

- Stable renal function: serum creatinine measurements to be taken at least once (within
three months of screening)

- Cause of underlying chronic kidney disease (eg hypertension, diabetes) stable, without
change in medical management, for 3 months prior to baseline

- Normal electrocardiogram (ECG)

- Hepatic transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

- Adequate hematologic function

- Serum amylase ≤ 5 x ULN

- Females of childbearing potential must agree to utilize highly effective contraception
methods (two separate forms of contraception, one of which must be an effective
barrier method, or be non-heterosexually active, practice sexual abstinence) from
screening throughout the duration of study treatment and for 30 days following the
last dose of study drug

- Female subjects who utilize hormonal contraceptive as one of their birth control
methods must have used the same method for at least three months prior to study dosing

- Male subjects must agree to utilize a highly effective method of contraception during
heterosexual intercourse throughout the study period and for 30 days following
discontinuation of investigational medicinal product. A highly effective method of
contraception is defined as two separate forms of contraception, one of which must be
an effective barrier method, or male subjects must be non-heterosexually active, or
practice sexual abstinence

- Age ≥ 18 years

Key Exclusion Criteria:

- A new AIDS-defining condition (excluding CD4 cell count and percentage criteria)
diagnosed within the 30 days prior to screening,with the exception of the first two
bullet points

- Hepatitis C virus (HCV) antibody positive. Subjects who are HCV positive, but have a
documented negative HCV RNA, are eligible

- Hepatitis B surface antigen (HBVsAg) positive

- Subjects receiving drug treatment for Hepatitis C, or subjects who are anticipated to
receive treatment for Hepatitis C during the course of the study

- Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy, etc.)

- Females who are breastfeeding

- Positive serum pregnancy test

- Have an implanted defibrillator or pacemaker

- Current alcohol or substance use judged by the Investigator to potentially interfere
with subject study compliance

- A history of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous
squamous carcinoma

- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline

- Subjects on hemodialysis, other forms of renal replacement therapy, or on treatment
for underlying kidney diseases (including prednisolone and dexamethasone)

- Subjects receiving ongoing therapy with any medications not to be used with EVG, COBI,
FTC, or TAF or subjects with any known allergies to the excipients of E/C/F/TAF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.