Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

Key Inclusion Criteria:

- Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral
agent 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

- Plasma HIV-1 RNA levels ≥ 500 copies/mL at screening

- Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL/min (≥ 0.50
mL/sec) according to the Cockcroft-Gault formula

Key Exclusion Criteria:

- An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
to screening

- Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)

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

- Females who are pregnant (as confirmed by positive serum pregnancy test)

- Females who are breastfeeding

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