High efficacy of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in Black adults in the United States, including those with pre‐existing HIV resistance and suboptimal adherence

Abstract BRAAVE (NCT03631732), a Phase 3b, multicenter, open‐label US study, demonstrated the efficacy of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) among Black individuals with suppressed HIV through 48 weeks. Here, 72‐week resistance, adherence, and virologic outcomes are presented. Enrollment criteria permitted nonnucleoside reverse transcriptase inhibitor (NNRTI)–resistance (R), protease inhibitor (PI)–R, and certain nucleos(t)ide reverse transcriptase inhibitor (NRTI)–R (M184V/I allowed; ≥3 thymidine analog mutations [TAMs] excluded); but excluded primary integrase strand transfer inhibitor (INSTI)‐R. Pre‐existing resistance was determined using historical genotypes and retrospective baseline proviral DNA genotyping. Adherence, virologic outcomes, and viral blips were assessed. Of 489 participants receiving B/F/TAF with ≥1 post‐switch HIV‐1 RNA measurement: pre‐existing NRTI‐R (15% of participants), M184V/I (11%), ≥1 TAMs (8%), NNRTI‐R (22%), and PI‐R (13%) were observed; pre‐existing INSTI‐R substitutions (2%) were detected post‐randomization; mean viral blip frequency was 0.9% across all timepoints (unassociated with virologic failure); 24% of participants had <95% adherence (98% of whom had HIV‐1 RNA <50 copies/mL at last visit); none had treatment‐emergent study‐drug resistance. Overall, 99% of participants, including all with baseline NRTI‐R/INSTI‐R, had HIV‐1 RNA <50 copies/mL at the last visit, demonstrating that B/F/TAF maintained virologic suppression through 72 weeks regardless of pre‐existing resistance, viral blips, and suboptimal adherence.