Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naive, HIV-1 and Hepatitis B Co-Infected Adults

Key Inclusion Criteria:

- HIV-1 co-infection:

- Must be HIV antiretroviral treatment naive with plasma HIV-1 RNA ≥ 500 copies/mL
at screening

- ≤ 10 days of prior therapy with any antiretroviral agent, including lamivudine
and entecavir, following a diagnosis of HIV-1 infection (except the use for
pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one
month prior to screening)

- Screening genotype report must show sensitivity to emtricitabine (FTC) and
tenofovir (TFV). This report will be provided by Gilead Sciences. Alternatively,
if genotype results from a local laboratory obtained ≤ 90 days prior to screening
visit date show sensitivity to these drugs, this genotype will be acceptable to
fulfill this inclusion criterion in the event that the genotype obtained at
screening is not yet available and all other inclusion/exclusion criteria have
been confirmed

- HBV co-infection:

- Must be HBV treatment naive (defined as < 12 weeks of oral antiviral treatment)

- Screening HBV DNA ≥ 2000 IU/mL

- Hepatic transaminases (aspartate aminotransferase (AST) and ALT) ≤ 10 x upper limit of
normal (ULN)

- Total bilirubin ≤ 2.5 x ULN

Key Exclusion Criteria:

- Hepatitis C virus (HCV) antibody positive and HCV RNA detectable

- Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or
variceal bleeding) or with Child-Pugh-Turcotte (CPT) C impairment

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

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

- Participation in any other clinical trial, including observational studies, without
prior approval from the sponsor is prohibited while participating in this trial

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