Positive Findings on Biktarvy at the HIV Research Meeting, Glasgow

Gilead Sciences, Inc. presented data from its HIV research, development and treatment programs at the 30th International Congress on Drug Therapy in HIV Infection, held virtually from Glasgow, Scotland, Oct. 23-26.

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 presented its long-term safety-and-effectiveness data from two Phase 3 Studies (Study1489 and Study1490), which evaluated outcomes among adults with HIV who had received 144 weeks’ of initial treatment with a regimen containing dolutegravir.

The data showed that Biktarvy was safe and effective in long-term use for people who had previously been on a DTG-containing treatment.

“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.

Studies 1489 and 1490 also provide evidence over five years of the safety and efficacy Biktarvy for those who have switched from a dolutegravir-based treatment. Baeten explained that the long-term clinical results following a regimen change are often poor 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 recent findings on long-acting HIV treatment methods. She presented a subgroup analysis of the Phase 3 CAPELLA trial, which evaluated lenacapavir. This drug was recently approved in the EU, UK, and marketed under the name Sunlenca.

HIV Glasgow presented data that evaluates treatment effectiveness in a subgroup CAPELLA participants who had poor outcomes at baseline. This includes high HIV-1 RNA levels, low CD4+ T cells counts, and resistance to any or all active agents in their optimized background regimen. The study revealed that lenacapavir, when combined with an optimized background regimen, led to high rates for viral suppression in highly-treated HIV-resistant HIV-positive people.

“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.”