Biktarvy Demonstrates Efficacy, Viral Suppression in Treatment-Naïve Adults With HIV

A pooled analysis of a 48-week open-label extension of a pair of phase 3 studies (Study 1489 and Study 1490) found that 99% of patients with HIV who initiated treatment using bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets (Biktarvy, Gilead; B/F/TAF) maintained an undetectable viral load through 4 years of follow-up. Throughout this 48-week extension, zero cases of treatment-emergent resistance to any components of B/F/TAF were encountered for the arm using the treatment.

The findings were presented at the 11th International AIDS Society Conference on HIV Science.

“Four decades after the virus was first reported, it is imperative to commit to driving scientific innovation to meet the needs of people living in today’s world. Globally, the number of older adults with HIV is increasing and communities of color, especially Black adults, continue to be disproportionately affected by HIV while underrepresented in HIV clinical trials,” said Chloe Orkin, MBBCH, FRCP, lead for HIV research at Queen Mary University, in a press release. “To help end the global HIV epidemic, effective treatment needs to be acceptable and accessible to everyone. The long-term data reinforce the durability of Biktarvy and highlight its potential role in helping to meet the treatment needs of a diverse group of people living with HIV.”

The presenters also reviewed the findings from the BRAAVE 2020 Study, a phase 3 clinical trial designed with community input to evaluate the specific treatment responses of virologically suppressed adults living with HIV who self-identified as Black or African American following a switch to B/F/TAF from a variety of regimens. The study divided its 495 participants in a 2 to 1 ratio either to switch to open-label Biktarvy for up to 72 weeks (n=330) or to stay on a standard regimen of 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent for 24 weeks with a delayed switch to Biktarvy for up to 48 weeks (n=165).

After 72 weeks, 99% of participants who had switched to B/F/TAF at the beginning of the study had maintained an undetectable viral load, regardless of age or sex at birth.

“A clinical research program that aims to address the differentiated unmet needs of people living with HIV can help inform long-term treatment strategies and is central to Gilead’s mission to help end the HIV epidemic,” said Frank Duff, senior vice president and virology therapeutic area head at Gilead Sciences, in the release. “The 4-year data presented at IAS demonstrate the robust and durable efficacy and safety profile of Biktarvy as a treatment option for a diverse range of people living with HIV.”

Further study results presented by Gilead demonstrated both the safety and non-inferior efficacy of switching to B/F/TAF in those replacing their existing treatment regimen, according to the investigators. The use of B/F/TAF in patients known to be resistant to the components of B/F/TAF is still investigational, with no approval from the FDA and unknown safety and efficacy.

REFERENCE

Four-year Biktarvy® data presented at IAS 2021 demonstrate high efficacy and durable viral suppression in treatment-naïve adults [news release]. Gilead; July 17, 2021. Accessed July 22, 2021. https://www.gilead.com/news-and-press/press-room/press-releases/2021/7/four-year-biktarvy-data-presented-at-ias-2021-demonstrate-high-efficacy-and-durable-viral-suppression-in-treatment-nave-adults