Gilead Sciences, Inc. 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.”
Biktarvy is indicated in the United States as a complete regimen for the treatment of HIV-1 infection in adults or pediatric patients weighing at least 25 kg who have no antiretroviral (ARV) treatment history. While it is also indicated for adults and pediatric patients weighing at least 25 kg who are virologically suppressed and on a stable ARV regimen, these people must have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Please see below for U.S. Important Safety Information for Biktarvy, including a Boxed Warning on the risk of post-treatment acute exacerbation of hepatitis B.
Gilead presented additional Biktarvy clinical development program data at IDWeek 2020, including 48-week findings from a Phase 3, open-label, 48-week extension study, which found that a once-daily regimen of Biktarvy maintained virologic suppression in people living with HIV on chronic hemodialysis. This shows the potential of Biktarvy as an effective treatment option with convenient single tablet regimen dosing that can lessen the burden of complex dose-adjusted regimens that many people living with HIV on hemodialysis require. In addition, Gilead will present findings from an in vitro simulation examining Biktarvy’s effect on drug resistance during short lapses in adherence.
“An HIV treatment clinical trial program that addresses the specific needs of people living with HIV such as disproportionately impacted and underrepresented populations, or those who have specific comorbidities, is central to Gilead’s mission of helping to end the HIV epidemic,” said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. “The data presented at IDWeek highlight Gilead’s commitment and Biktarvy’s potential to meet the specific treatment needs of diverse groups of people living with HIV today, from individuals facing drug resistance from prior treatment regimens to men and women aging with HIV who are managing other health conditions.”
Additional data from a late-breaking oral presentation provide important insight on tenofovir alafenamide’s (TAF) impact on weight, further supporting the hypothesis that a switch from tenofovir disoproxil fumarate (TDF) to TAF may result in weight gain because the TDF-induced weight suppression is no longer present. The study evaluated weight change in virologically suppressed people living with HIV on a standard regimen of two NRTIs plus an integrase strand transfer inhibitor (INSTI). After one year, those who switched from TDF to TAF (n=828) and those who switched from abacavir (ABC) to TAF (n=142) experienced a mean unadjusted weight gain of 1.4 kg and 0.2 kg, respectively (p=0.039). In the TDF to TAF switch group, 40% experienced weight gain ≥ 3% compared with 27% of those in the ABC to TAF switch group (p=0.003).
The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational; this use is not approved by the U.S. FDA, and the safety and efficacy of Biktarvy for this use has not been established. Please see below for the U.S. Indication for Biktarvy.
Biktarvy does not cure HIV or AIDS.