Lenacapavir's 100% Efficacy: Gilead's Step Towards HIV Prevention

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Jared Baeten, MD, PhD emphasizes the importance of the innovative PURPOSE 1 study in the fight against HIV, coinciding with National HIV Testing Day, today serves as a reminder of the ongoing efforts to expand testing access and develop new tools to combat HIV globally.

On June 20, 2024, Gilead Sciences unveiled groundbreaking results from its Phase 3 PURPOSE 1 trial of lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor. The trial demonstrated 100% effectiveness in preventing HIV transmission among cisgender women, prompting the recommendation to halt the blinded phase early due to lenacapavir's superiority over current oral treatments like Truvada and Descovy in both efficacy and safety.

The independent Data Monitoring Committee recommended halting the blinded phase of the trial after an interim analysis, prompted by lenacapavir's superiority over current oral HIV prevention treatments—specifically Truvada and Descovy—in both efficacy and safety.

Jared Baeten, MD, PhD, vice president of Clinical Development at Gilead Sciences, commented on the trial's success:

“This is a three-arm randomized trial of Lenacapavir, Descovy - a twice-a-year injection, Descovy once a day pill, and Truvada a once a day pill as well, that's that's been established for for over a decade for HIV prevention. The results of the trial released early after an interim analysis by an independent data safety and monitoring committee revealed that Lenacapavir was superior to both to daily, early Truvada and to the background HIV incidents, a measure of what HIV incidence would have been if nobody had been using PrEP.”

PURPOSE 1, conducted across 25 sites in South Africa and three in Uganda with over 5,300 participants aged 16-25, confirmed lenacapavir's superiority over Truvada in preventing HIV transmission, showing a statistically significant difference (p<0.0001). Importantly, lenacapavir was well-tolerated with no new safety concerns identified.

“Lenacapavir was well tolerated. It's a medication that's already approved for the treatment of HIV, with no new safety considerations in our perusal of the data compared to what's already what's already in the label for Lenacapavir for HIV treatment. All together, this really sets up for a medication that could be given just twice a year, privately discreetly, for someone to be able to really substantially reduce their HIV chances.”

These findings are part of Gilead's broader PURPOSE program, which includes extensive and diverse HIV prevention trials. The program aims to innovate in scientific approaches, trial design, and community engagement, particularly in underserved populations.

“There has been community engagement throughout the trials, with standing community accountability groups established for both to reflect the diverse populations involved in terms of geography, gender, and race/ethnicity. They've walked hand-in-hand with us and held us accountable on how to conduct these trials better—how to formulate the right questions, communicate results effectively, and ensure inclusivity from the outset.”

Looking ahead, Gilead plans to submit regulatory filings based on combined results from PURPOSE 1 and ongoing trials like PURPOSE 2.

“For the PURPOSE program, in particular, engagement with the community on how to design and implement the trials began before words even went onto paper to write up the protocol. I've been extraordinarily lucky to see this in full action. For both of the primary PURPOSE trials—there are two Phase 3 trials, one being PURPOSE 1, and a second one among cisgender men, transgender women, transgender men, and gender non-binary individuals called PURPOSE 2—that trial is still ongoing.”

Reference
Gilead Sciences Inc. GILEAD'S TWICE-YEARLY LENACAPAVIR DEMONSTRATED 100% EFFICACY AND SUPERIORITY TO DAILY TRUVADA® FOR HIV PREVENTION. PRNewswire. Published June 26, 2024. Accessed June 27, 2024. https://prnmedia.prnewswire.com/news-releases/gilead-s-twice-yearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-r-for-hiv-prevention-839879807.html
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