Switching to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Black Americans With HIV-1: A Randomized Phase 3b,...

Area of Science:

• Infectious Diseases
• Virology
• Clinical Research

Background:

• Black Americans experience disproportionately high rates of HIV/AIDS in the U.S.
• Underrepresentation of Black Americans in HIV medical research remains a significant issue.
• This study addresses the need for effective HIV treatment options within this demographic.

Purpose of the Study:

• To evaluate the efficacy and safety of switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in virologically suppressed Black Americans with HIV.
• To compare B/F/TAF against staying on a baseline regimen (SBR) in a randomized trial.
• To assess the noninferiority of B/F/TAF in maintaining viral suppression.

Main Methods:

• A phase 3b, randomized, multicenter, open-label study (BRAAVE) involving virologically suppressed Black adults with HIV.
• Participants were randomized (2:1) to switch to B/F/TAF or stay on their SBR.
• The primary endpoint was the proportion of participants with HIV-1 RNA ≥50 copies/mL at week 24, assessing noninferiority.

Main Results:

• Switching to B/F/TAF demonstrated noninferiority to SBR, with 0.6% vs 1.8% having HIV-1 RNA ≥50 copies/mL at week 24.
• High rates of viral suppression (<50 copies/mL) were maintained through week 48 in both groups (96% B/F/TAF, 95% SBR).
• No treatment-emergent resistance was observed, and both regimens were well-tolerated with minimal adverse events.

Conclusions:

• Switching to B/F/TAF is a noninferior treatment option for Black Americans with HIV compared to continuing various baseline regimens.
• This includes individuals with pre-existing nucleoside reverse transcriptase inhibitor (NRTI) mutations, excluding integrase strand transfer inhibitor resistance.
• B/F/TAF offers a safe and effective alternative for maintaining HIV viral suppression in this population.