Gilead Announces New Data on Biktarvy for the Treatment of HIV in Black Americans
Gilead Sciences, Inc. (Nasdaq: GILD) today announced 48-week data from the BRAAVE 2020 study, a Phase 3 clinical trial evaluating the safety and efficacy of switching to Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically suppressed adults living with HIV who self-identified as Black or African American. These data presented at IDWeek 2020 show that switching from a standard regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent to Biktarvy is an effective treatment regimen in Black Americans with HIV who are virologically suppressed, including individuals with a history of treatment failure or pre-existing resistance.
BRAAVE 2020 is a Phase 3 clinical trial evaluating the specific treatment responses of virologically suppressed adults living with HIV who self-identified as Black or African American following a switch to Biktarvy from a variety of regimens. A total of 495 study participants were randomized 2:1 to switch to open-label Biktarvy or to stay on a standard regimen of two NRTIs plus a third agent for 24 weeks with a delayed switch to Biktarvy until week 48. The study demonstrated that at 48 weeks, treatment with Biktarvy maintained high rates of virologic suppression in study participants and did not result in treatment-emergent resistance to any component of Biktarvy. In the analysis of preexisting resistance and virologic outcomes, similar virologic suppression rates were achieved irrespective of the presence of preexisting drug resistance substitutions. Through 48 weeks, 99% of study participants in the Biktarvy group (324/327) and 100% of study participants in the delayed switch group (162/162) maintained HIV-1 RNA <50 copies/mL. The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational.
“Black and African Americans in this country have the highest rates of new HIV infections every year compared to other races. Adding to that burden are other inequalities such as lack of health insurance, difficulties navigating the healthcare system, and poverty; all of which contribute to higher rates of drug resistance,” explained Debbie P. Hagins, MD, FAPCR, Medical Director, CARE Centers of Southeast Georgia, Coastal Health District, Savannah, GA and Principal Investigator for the BRAAVE 2020 study. “As drug resistance builds, treatment options become more limited, sometimes leading to less desirable, but often necessary, complicated treatment regimens. Again, lending itself to further adherence challenges. These data from BRAAVE 2020, a landmark study, designed with community input to understand specific treatment responses of Black and African Americans, show Biktarvy is an effective regimen for Black Americans, including those with a history of some drug resistance.”
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