Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV

The goal of this clinical trial is to assess the effectiveness and safety of switching to bictegravir/lenacapavir (BIC/LEN) fixed-dose combination (FDC) compared with continuing stable baseline regimens (SBR) in virologically suppressed people with HIV. The primary objective of this study is to evaluate the efficacy of switching to BIC/LEN (75/50 mg) fixed-dose combination (FDC) tablets versus continuing their stable baseline regimen (SBR) in virologically suppressed people with HIV.

Key Inclusion Criteria: * Currently receiving a SBR defined as (1) integrase strand-transfer inhibitor (INSTI) + 1 or 2 nucleoside reverse transcriptase inhibitors (NRTIs) (excluding bictegravir/emtricitabine/tenofovir alafenamide (BIC/emtricitabine (FTC)/tenofovir alafenamide (TAF)), (2) boosted-protease inhibitor (PI) + 2 NRTIs, (3) nonnucleoside reverse transcriptase inhibitor (NNRTI) + 2 NRTIs, (4) dolutegravir (DTG)/RPV or (5) cabotegravir (CAB)/rilpivirine (RPV) for at least 3 months without switch prior to screening, and willing to continue their SBR through at least Week 24. * HIV-1 RNA \< 50 copies/mL for ≥ 3 months before screening * Estimated creatinine clearance (eCLcr) rate ≥ 15 mL/min according to the Cockcroft-Gault formula for creatinine clearance (CLcr) at screening * Plasma HIV-1 RNA levels \< 50 copies/mL at screening Key Exclusion Criteria: * Actively pregnant or breastfeeding (nursing) * Chronic hepatitis B virus (HBV) * Known hypersensitivity to the study drug, its metabolites, or formulation excipient. * Currently receiving renal replacement therapy (eg, hemodialysis) * Documented or suspected resistance to BIC * History of, or current severe decompensated cirrhosis * Requirement for ongoing therapy with any prohibited medications listed for BIC/LEN FDC * Prior use of, or exposure to, LEN * Ongoing treatment with BIC/FTC/TAF Note: Other protocol defined Inclusion/Exclusion criteria may apply.