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Biktarvy ® Demonstrates High Efficacy and Durable Viral Suppression at Five Years, in Treatment-Naïve Adults

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Biktarvy® Demonstrates High Efficacy and Durable Viral Suppression at Five Years, in Treatment-Naïve Adults | Pharmtech Focus

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of cumulative 5-year results from two Phase 3 studies (Study 1489 and Study 1490) of Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). The new, long-term data further demonstrate the sustained efficacy and safety profile and lack of treatment failure due to resistance in the final resistance analysis population associated with Biktarvy for the treatment of HIV-1 in treatment-naïve adults. The data were presented at the 29th Conference on Retroviruses and Opportunistic Infections (virtual CROI 2022).

In both studies, 98% of participants who initiated treatment with Biktarvy and remained in the study for all 240 weeks achieved and maintained an undetectable viral load (HIV-1 RNA <50 copies/mL) through five years of follow-up (Week 240, 1489 n=208/213, 1490: n=218/219, missing equals excluded analysis). Through five years of analysis, zero cases of treatment failure due to emergent resistance were detected among the final resistance analysis population of both studies, further demonstrating the efficacy and tolerability profile of Biktarvy for the treatment of HIV-1 in treatment-naïve adults.

“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. “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.”

Data support long-term use of Biktarvy, with no significant changes to metabolic, bone and renal markers. Among study participants, median change in weight from baseline through Week 240 was 6.1 kg, consistent with previously presented data. Study 1489 also demonstrated small impacts on bone mineral density (BMD) outcomes through five years. Mean percentage changes in hip and spine BMD through Week 240 in Biktarvy participants were -0.29% and -0.23%, respectively. In both studies, five participants (n=5/634) experienced a study-drug related adverse event (AE) that led to drug discontinuation. Furthermore, through 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. “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 five-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.”

Please see below for the U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy.

There is currently no cure for HIV or AIDS.

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