Lenacapavir for PrEP Demonstrates Strong Efficacy in Second Phase 3 Trial

Positive results have been announced from a phase 3 trial evaluating the safety and efficacy of twice-yearly lenacapavir for PrEP to prevent HIV infection in individuals aged 16 years or older who have sex with male partners, Gilead announced in a release.¹ Gilead said that it intends to present more detailed data from the study at a future conference.

Data from an interim analysis of the PURPOSE 2 (NCT04925752) study showed that lenacapavir met its primary efficacy endpoint of superiority to background HIV incidence. The therapy also met its key secondary endpoint of superiority to once-daily oral Truvada for PrEP. Because of the positive data, the independent Data Monitoring Committee recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

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“In the United States, the stubbornly high rate of HIV diagnoses—especially in the US South, and particularly among gay and bisexual men of color and transgender people—demands novel approaches to help people prevent HIV acquisition,” said Colleen Kelley, MD, MPH, a principal investigator on the PURPOSE 2 trial, in a release.¹ “Because adherence to oral products can be challenging for some people, twice-yearly injectable lenacapavir for PrEP has the potential to be one of the most impactful interventions we could have to drive down new infections and bring us closer to ending the HIV epidemic in the United States.”

PURPOSE 2 is a double-blind, multicenter, randomized phase 3 study evaluating the safety and efficacy of twice-yearly subcutaneous lenacapavir for PrEP in cisgender men, transgender men, transgender women and gender non-binary individuals aged 16 years or older. The study cohort included 3295 participants from 88 sites across the world, including the US, Argentina, Thailand, Brazil, Mexico, Peru, and South Africa.

The study showed that 99.9% of participants in the lenacapavir group did not acquire HIV, with 2 incident cases among 2180 patients. There was a 96% risk reduction from lenacapavir when compared to background HIV incidence. In the Truvada group, there were 9 incident cases among 1087 individuals, demonstrating that lenacapavir was 89% more effective. Lenacapavir was generally well tolerated, with no significant or new safety concerns being observed during the study.

Gilead also recently released data from the PURPOSE 1 trial, a double-blind, active-controlled, multicenter, randomized phase 3 trial evaluating the safety and efficacy of lenacapavir for the investigational use of HIV prevention in women. Data from that study showed there were 0 incident HIV infections in the lenacapavir group, compared to 39 in patients taking Descovy and 16 in patients taking Truvada.

Gilead said in the release that data from the 2 studies will support global regulatory filings for lenacapavir, which the company plans to begin by the end of the year. The company also said it is executing an access strategy that will prioritize high-incidence, low-resource countries, which are primarily low- and lower-middle income countries.

“The difficulty some people can experience with taking an oral pill every day, including challenges with adherence and stigma, have hindered uptake and persistence of the standard of care for too long, thus blunting PrEP’s impact on HIV prevention,” said Onyema Ogbuagu, MBBCh, FACP, FIDSA, a principal investigator on the PURPOSE 2 trial, in a release.¹ “The incredible efficacy demonstrated in the PURPOSE 2 trial, the potential benefits of a twice-yearly injection, and the diversity of trial sites and participants show the impact that lenacapavir for PrEP could have for people around the world who need new choices to reduce their chances of acquiring HIV.”

READ MORE: HIV Resource Center

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References

1. Gilead’s Twice-Yearly Lenacapavir for HIV Prevention Reduced HIV Infections by 96% and Demonstrated Superiority to Daily Truvada® in Second Pivotal Phase 3 Trial. News Release. Gilead. September 12, 2024. Accessed September 13, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/9/gileads-twiceyearly-lenacapavir-for-hiv-prevention-reduced-hiv-infections-by-96-and-demonstrated-superiority-to-daily-truvada-in-second-pivotal-ph