Bictegravir/Emtricitabine/Tenofovir Alafenamide Maintained Virologic Suppression in Patients With HIV

Virologic suppression was maintained in Black patients with HIV who switched to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) after they had achieved virologic suppression for 48 weeks, according to the results of a phase 3b study published in the Journal of Medical Virology.¹ Virologic suppression was shown to last through 72 weeks.

Black individuals living in the United States have a higher incidence of HIV, accounting for 40% of new HIV diagnoses in 2021, despite being only 12% of the population.² B/F/TAF is a treatment for HIV-1 that can be taken orally once per day and has been effective in people with HIV who are treatment naive or virologically suppressed. However, past studies had small numbers of Black individuals. The present phase 3b study, BRAAVE, was conducted as a means to evaluate the efficacy of B/F/TAF in Black individuals who were virologically suppressed.

B/F/TAF was found effective in maintaining virologic suppression in Black patients living with HIV through 72 weeks | Image credit: Jelena Stanojkovic - stock.adobe.com

Participants were eligible for the BRAAVE trial, which was a phase 3b randomized, open-label study conducted in the United States, if they were 18 years or older, self-described themselves as Black or African American, and had suppressed HIV on an antiretroviral regimen other than B/F/TAF. Participants who had prior virologic failure on a non-integrase strand transfer inhibitor (INSTI)–containing regimen and participants who had resistance to nonnucleoside reverse transcriptase inhibitors were all eligible for the study. All participants were separated in a 2:1 ratio to switch to B/F/TAF or stay on their baseline regimen.

Preexisting resistance was assessed using genotype reports and proviral DNA sequencing. Plasma HIV-1 RNA concentration was measured every 12 weeks after a measure was taken on the first day. Participants taking B/F/TAF had a measurement taken after 4 weeks on the treatment. Returned pill counts were used as a means of measuring adherence.

There were 495 participants included in the study, of which 330 were in the B/F/TAF group and 165 were in the control group to start; 493 of the participants ended the study using B/F/TAF after being offered to switch at week 24. The median (range) age of the participants was 49 (18-79) years, median time on baseline antiretroviral therapy was 2 years, and 32% of the participants were female.

The median duration of B/F/TAF was 72 (71.4-72.3) weeks in the B/F/TAF group and 48 (47.3-48.3) weeks for the delayed switch group. The total of participants who had HIV-1 RNA with 50 or less copies/mL ranged from 98% to 100% in participants who had been on B/F/TAF for up to 72 or 48 weeks, depending on group.

A total of 99% of the participants were virologically suppressed at their last study visit either 72 weeks or 48 weeks after starting the treatment. There were 3 participants who had 50 or more copies/mL at their last visit, 1 participant who discontinued the study with 55 copies/mL, 1 participant in the delayed switch group who had 489 copies/mL who had to switch to commercial B/F/TAF for results, and 1 participant lost to follow-up after week 24 with 248 copies/mL. Viral blips, wherein a participant had a measured HIV-1 RNA of 50 copies or more preceded and followed by less than 50 copies/mL, occurred with a mean frequency of 0.9%. There were 22 participants who had viral blips, of whom 19 had adherence of 95% or greater.

There were some limitations to this study. The only participants included in the study were virologically suppressed, which does not give information on the efficacy of B/F/TAF in patients who are not virologically suppressed. A total of 25% of the participants did not have final laboratory assessments due to the COVID-19 pandemic. Data from after the 72-week period will be helpful to assess long-term outcomes.

The researchers concluded that B/F/TAF is effective in Black individuals who were virologically suppressed in a period of 72 weeks, with suppression being maintained throughout the treatment period. Future studies should focus on long-term results and how B/F/TAF works in Black individuals who are not virally suppressed.

References

1. Andreatta K, D’Antoni ML, Chang S, et al. 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. J Med Virol. 2024;96:e29899. doi:10.1002/jmv.29899
2. The impact of HIV on black people in the United States. KFF. September 9, 2024. Accessed October 7, 2024. https://www.kff.org/hivaids/fact-sheet/the-impact-of-hiv-on-black-people-in-the-united-states/