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 naive (≤ 10 days of prior therapy with any antiretroviral agent)

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

- Screening genotype report provided by Gilead Sciences must show sensitivity to
tenofovir (TFV) and FTC

- Adequate renal function as measured by estimated glomerular filtration rate ≥ 70
mL/min according to the Cockcroft-Gault formula

- CD4+ cell count > 200 cells/µL at screening

Key Exclusion Criteria:

- A new AIDS-defining condition diagnosed within the 30 days prior to screening as
defined in the study protocol

- Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post
exposure prophylaxis (PEP)

- Chronic hepatitis B virus (HBV) infection

- Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but
have a documented negative HCV RNA, are eligible)

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

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

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