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This section summarizes the trials evaluating the efficacy and safety of Biktarvy.
The efficacy and safety of Biktarvy versus comparator regimens were evaluated in two randomized, double-blind, active-controlled trials involving treatment-naive adults with HIV-1. Treatment outcomes showed that at Week 144, the proportion of participants with HIV-1 RNA < 50 copies/mL was similar between the Biktarvy group and the comparator group. The treatment difference was not statistically significant. Treatment outcomes were consistent across subgroups defined by age, sex, race, baseline viral load, and baseline CD4+ cell count. The mean increase in CD4+ cell count from baseline to Week 144 was similar between the Biktarvy group and the comparator group.
The use of Biktarvy in treatment-experienced, virologically unsuppressed individuals is based on the scientific rationale that this population is expected to achieve virologic response rates similar to those of treatment-naive individuals, provided the virus is susceptible to each component of the regimen.
The efficacy and safety of switching from various stable antiretroviral regimens to Biktarvy were evaluated in multiple trials involving virologically suppressed adults with HIV-1. Treatment outcomes showed that at Week 48, the Biktarvy switch group and the group maintaining the original regimen had similar virologic suppression, with a low rate of virologic failure. In trials including participants with pre-existing M184V/I substitutions, most participants maintained virologic suppression. Sustained virologic suppression was also observed in elderly patients and patients with end-stage renal disease receiving hemodialysis after switching to Biktarvy.
The efficacy, safety, and pharmacokinetics of Biktarvy were evaluated in an open-label, single-arm trial involving virologically suppressed pediatric participants with HIV-1. Across three age/weight cohorts, the vast majority of participants maintained virologic suppression at Week 48 or Week 24 after switching to Biktarvy. The mean change in CD4+ cell count was minimal. The safety profile was consistent with that observed in adults.
FDA，2025.07
