Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants

Key Inclusion Criteria:

- Self-describes as Black, African American, or mixed race, including Black

- Currently receiving an ARV regimen other than FDC of B/F/TAF that consists of any two
NRTIs + allowed 3rd agent for ≥ 6 months

- Allowed 3rd agents include any FDA-approved INSTI, with the exception of bictegravir,
any FDA-approved NNRTI with the exception of etravirine, PI or the CCR5 antagonist,
maraviroc.

- If the baseline 3rd agent is dolutegravir, dosing other than 50 mg once daily is
excluded.

- Baseline regimens containing investigational drugs or > 2 classes of ARVs are not
permitted, with the exception of the pharmacologic enhancers cobicistat (taken with
elvitegravir or a PI), or ritonavir (taken with a PI).

- Have no documented or suspected resistance to INSTIs and no history of virologic
failure on an INSTI containing regimen (2 consecutive HIV-1 RNA ≥ 50 copies/mL after
achieving <50 copies/mL while on an INSTI-containing regimen).

- History of 1-2 thymidine analogue mutations (TAMs), M184V/I, and any other RT
substitutions are allowed, with the following exceptions: History of 3 or more TAMs
(M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R), T69-insertions, or K65R/E/N in RT
will be excluded.

- Documented plasma HIV-1 RNA < 50 copies/mL during treatment with the baseline regimen
for a minimum period of 6 months and at least the last two HIV-1 RNA measurements
prior to the Screening visit

- HIV-1 RNA levels < 50 copies/mL at Screening

- Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the
Cockcroft-Gault formula for creatinine clearance

Key Exclusion Criteria:

- History of 3 or more TAMs (M41L, D67N, K70R, L210W, T215F/Y, and K219Q/E/N/R),
T69-insertions, or K65R/E/N in RT

- No desire to switch from current antiretrovirals (ARVs)

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

- Participants experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, or
variceal bleeding)

- Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3
months of study screening, or expected to receive these agents or systemic steroids
during the study (eg, corticosteroids, immunoglobulins, and other immune- or
cytokine-based therapies)

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

- Active, serious infections (other than HIV-1 infection) requiring 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

- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the participant unsuitable for the study or unable to comply
with the dosing requirements

- Known hypersensitivity to FDC of B/F/TAF tablets, their metabolites, or formulation
excipient

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

- Females who are breastfeeding

- Acute hepatitis in the 30 days prior to randomization

- Active tuberculosis infection

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