Positive Findings for Biktarvy Presented at HIV Research Meeting in Glasgow

During the 30th International Congress on Drug Therapy in HIV Infection, which took place virtually from Glasgow, Scotland Oct. 23-26, Gilead Sciences, Inc., presented new data from its HIV research and development programs supporting its current and pipeline innovations in HIV treatment and the latest research from its ongoing cure development program.

Among its presentations, Gilead revealed new data on Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF), evaluating the safety, efficacy and resistance profile of the once-daily single-tablet regimen in a broad range of people with HIV.

Gilead cited the latest findings from the BICSTaR study, which evaluated the effectiveness, safety and tolerability of Biktarvy in treatment-naïve and treatment-experienced people with HIV with a high burden of co-morbidities.

“The latest findings from the BICSTaR study may help inform the future of coordinated, person-centered HIV care and the role of Biktarvy in long-term treatment,” said Jared Baeten,M.D., Ph.D., vice president, HIV clinical development for Gilead. “The burdens of HIV, aging and related health comorbidities necessitate a focus on improving long-term health and quality of life.”

He explained that as the average age of those living with HIV rises, the evaluation and management of comorbid conditions that may occur in an individual’s life takes on a larger role in HIV clinical care.

Gilead also offered its long-term safety and efficacy data from two Phase 3 studies (Study 1489 and Study 1490), which evaluated outcomes in adults with HIV who switched to treatment with Biktarvy following 144 weeks of initial treatment with a dolutegravir-based regimen.

The resulting data revealed additional long-term evidence of the safety and efficacy of Biktarvy in those who switch from a DTG-containing regimen.

“Our latest data further establish the robust and durable efficacy profile of Biktarvy and how treatment with Biktarvy can help a broad range of people with HIV, including those who may be experiencing common age-related conditions and comorbidities as they age with the virus,” he said.

Additionally, the five-year data from Studies 1489 and 1490 provide long-term evidence of the safety and efficacy of Biktarvy in those who switch from a dolutegravir-based regimen, with Baeten explaining that long-term clinical outcomes following a regimen switch are often lacking for modern antiretroviral therapy.

“These five-year data provide additional long-term evidence of the safety and efficacy of the single-tablet regimen in those who switched to treatment with Biktarvy following 144 weeks of initial treatment with a dolutegravir-based regimen,” Baeten said.

Gilead also shared new findings on long-acting HIV treatment strategies, presenting a subgroup analysis from the ongoing Phase 3 CAPELLA trial evaluating lenacapavir, recently approved in the EU and UK and marketed as Sunlenca.

The data presented at HIV Glasgow evaluates treatment effectiveness in a subgroup of CAPELLA participants with poor outcome measures at baseline, including high HIV-1 RNA, low CD4+ T cell counts and resistance to some or all the active agents in their optimized background regimen. The study found that despite poor outcome measures, lenacapavir with an optimized background regimen led to high rates of viral suppression in heavily-treatment experienced people with multi-drug resistant HIV.

“As we strive to advance scientific innovation with the goal of helping to end the HIV epidemic, we’re committed to a treatment research program that addresses the individual needs of all people with HIV, including people with multi-drug resistant HIV,” Baeten said. “These data may help us better understand the needs and responses of these individuals and could help us better understand the role lenacapavir may play in sustained viral suppression.”