Biktarvy Demonstrates High Efficacy, Durable Viral Suppression at Five Years in Treatment-Naive Adults with HIV

Cumulative 5-year results from a pair of phase 3 studies (Study 1489 and Study 1490) of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg [(B/F/TAF) Biktarvy, Gilead Sciences, Inc] showed a sustained efficacy and safety profile and lack of treatment failure from resistance associated with B/F/TAF for the treatment of HIV-1 in treatment-naïve adults, according to a Gilead press release.

Both studies found ≥98% of participants who were treated with B/F/TAF and who remained in the study for all 240 weeks achieved and maintained an undetectable viral load through 5 years of follow-up. No cases of treatment failure due to emergent resistance were detected among the final resistance analysis population of both studies, which shows the favorable efficacy and tolerability profile of B/F/TAF for HIV-1 in treatment-naïve adults, according to the researchers. The results of these studies were presented at the 29th Conference on Retroviruses and Opportunistic Infections (CROI).

“These latest data presented at CROI help us better understand the role of Biktarvy for long-term treatment and demonstrate its long-term viral suppression and durability,” said David Alain Wohl, MD, professor of Medicine, Division of Infectious Diseases, the University of North Carolina at Chapel Hill, in the press release. “Many people living with HIV are concerned about the ability of their therapy to achieve long-term viral suppression since they will likely be on treatment for the duration of their lives. Confidence in the efficacy and robustness of Biktarvy as a complete regimen helps me advance the conversation around what long-term treatment success may look like.”

The data support the long-term use of B/F/TAF with no significant changes to metabolic, bone, and renal markers, according to the study authors. The median change among study participants in weight from baseline through week 240 was 6.1 kg, which was consistent with previously presented data. Study 1489 also showed minimal impacts on bone mineral density (BMD) outcomes through 5 years. Further, mean percentage changes in hip and spine BMD through week 240 in B/F/TAF participants were -0.29% and -0.23%, respectively.

Five participants experienced a study drug-related adverse event that led to discontinuation across both studies. Through the 240 weeks, numerically small median changes in eGFR and stable TC:HDL ratios were observed in both studies.

“Effective treatment options, such as Biktarvy, are an important tool in addressing the specific needs of certain people living with HIV, including achieving and maintaining an undetectable viral load over the long-term,” said Jared Baeten, MD, PhD, vice president, HIV Clinical Development, Gilead Sciences, in the press release. “As we strive to improve HIV treatment and continue to advance scientific innovation, we’re committed to looking beyond viral load suppression to gain a better understanding of how to support the long-term and overall health of people living with HIV. The 5-year data presented at CROI are an important step in deepening our understanding of how to tailor our research program to address the individual needs of all people living with HIV, and to help end the global HIV epidemic.”

REFERENCE

Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression at Five Years, in Treatment-Naïve Adults. Gilead. February 11, 2022. Accessed February 14, 2022. https://www.gilead.com/news-and-press/press-room/press-releases/2022/2/biktarvy-demonstrates-high-efficacy-and-durable-viral-suppression-at-five-years-in-treatmentnave-adults