Phase 3 Double-Blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/ Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People with HIV-1

HIV-1 infection

Proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 48 as determined by the United States (US) Food and Drug Administration (FDA)–defined snapshot algorithm.

Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm, Change from baseline in CD4 cell count at Week 48, Proportion of participants from Treatment Group 1 with HIV-1 RNA ≥ 50 copies/mL at Week 96 (96 weeks on BIC/LEN including blinded and open-label [OL] phases) as determined by US FDA–defined snapshot algorithm, Proportion of participants from Treatment Group 1 with HIV-1 RNA < 50 copies/mL at Week 96 (96 weeks on BIC/LEN including blinded and OL phases) as determined by US FDA–defined snapshot algorithm, Change from baseline in CD4 cell count at Week 96 for participants from Treatment Group 1 (96 weeks on BIC/LEN including blinded and OL phases), Proportion of participants experiencing treatment-emergent adverse events (AEs) through Week 48, Proportion of participants from Treatment Group 1 experiencing treatment-emergent AEs through Week 96 (96 weeks on BIC/LEN including blinded and OL phases)

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