Switching to bictegravir/emtricitabine/tenofovir alafenamide in Black Americans with HIV-1: A randomized phase 3b, multicenter, open-label study
Journal of Acquired Immune Deficiency Syndromes Aug 24, 2021
Hagins D, Kumar P, Saag M, et al. - Non inferiority of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) vs continuing a variety of regimens was demonstrated for Black Americans with HIV, including those with preexisting nucleoside reverse transcriptase inhibitors (NRTIs) mutations.
In BRAAVE, a randomized, phase 3b, multicenter, open-label US study, 495 patients were randomized (2:1) to switch to open-label bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) once daily or stay on baseline regimen (SBR) for 24 weeks.
At week 24, HIV-1 RNA ≥ 50 copies/mL were detected in 0.6% on B/F/TAF vs 1.8% on SBR, establishing noninferiority of B/F/TAF vs SBR.
Ninety-six percent of those on B/F/TAF vs 95% on SBR had HIV-1 RNA < 50 copies/mL at week 24.
Treatment-emergent resistance to study drug was not identified in any of the participants.
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