Black Americans have the highest rates of HIV/AIDS in the US but are under-represented in HIV medical research. The single-tablet regimen bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) is a guidelines-recommended treatment for HIV. We evaluated the safety and efficacy of switching to B/F/TAF among Black adults.
In the Phase 3 BRAAVE 2020 study, adults with HIV who self-identified as Black or African American and were virologically suppressed on 2 NRTIs plus a 3rd agent were randomized (2:1) to switch to open-label B/F/TAF once daily or stay on their baseline regimen (SBR). Prior virologic failure was permitted with the exception of failure on an INSTI-based regimen. Prior resistance to NNRTIs, PIs and/or NRTIs was permitted except for K65R/E/N, ≥3 thymidine analogue mutations or T69-insertions; primary INSTI-resistance was excluded. Primary efficacy endpoint was the proportion with HIV-1 RNA ≥50 c/mL at Week (W) 24 (FDA snapshot); noninferiority was assessed through 95% confidence intervals (CI). Change from baseline in CD4 was a secondary endpoint. The HIV-Treatment Satisfaction Questionnaire (HIV-TSQ) was assessed at baseline, W4 and W24.
558 were screened, 495 randomized and treated (B/F/TAF n=330, SBR n=165): 32% cis women, 2% trans women, median age 49 yrs (range 18-79), median HIV treatment duration 10 yrs (IQR 6,17), 11% had M184V/I mutation, 62% lived in the US South. Baseline 3rd agents: INSTIs 61%, NNRTIs 31% and PIs 9%. At W24, 0.6% on B/F/TAF and 1.8% on SBR had HIV-1 RNA ≥50 c/mL (difference -1.2%; 95% CI -4.8% to 0.9%) demonstrating noninferiority of B/F/TAF. The proportion with HIV-1 RNA <50 c/mL was 96% B/F/TAF and 95% SBR. No participant had treatment emergent resistance to study drugs. The mean (SD) changes in CD4 were +13 (209) and +1 (171) (p=0.56), median changes in weight 0.9 and 0.2 kg for B/F/TAF and SBR respectively. Study drug related AEs occurred in 10% on B/F/TAF, most were grade 1. Drug related AEs led to discontinuation in 5 participants on B/F/TAF vs 0 on SBR. Participants on B/F/TAF had higher HIV-TSQ scores at W4 and W24 compared to SBR (p<0.001).
For Black Americans, switching to B/F/TAF was noninferior to continuing their regimen with high efficacy in both arms. The single-tablet regimen B/F/TAF was safe and effective for people switching from a variety of regimens, including those with pre-existing NRTI resistance, and was associated with greater treatment satisfaction.