Lenacapavir for PrEP Demonstrates Strong Efficacy, Adherence in Phase 3 Trial
The data from PURPOSE 2 will be published in The New England Journal of Medicine.
Full 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 The data were presented at the International Congress on Drug Therapy in HIV Infection and will be published in The New England Journal of Medicine.
Lenacapavir for PrEP Demonstrates Strong Efficacy, Adherence in Phase 3 Trial / nito - stock.adobe.com
Data from an interim analysis of the phase 3 PURPOSE 2 (NCT04925752) study were previously announced in September 2024. The analysis 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. Due to the data, the independent Data Monitoring Committee recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
READ MORE: Q&A: Insights on HIV Care, Pharmacists’ Expanding Role
“We’re at a crossroads in the HIV epidemic, and a twice-yearly choice for HIV prevention, if approved, could be transformative as we work toward achieving the UNAIDS 2030 targets around the world,” Onyema Ogbuagu, MBBCh, FACP, FIDSA, principal Investigator on the PURPOSE 2 trial, said in a release.1 “Lenacapavir for PrEP could provide an important alternative to existing preventative medications that require more frequent dosing, and could help transform the HIV prevention landscape by addressing a range of unmet needs for individuals who need or want PrEP globally.”
PURPOSE 2 is a double-blind, multicenter, randomized phase 3 study evaluating the safety and efficacy of twice-yearly subcutaneous lenacapavir for PrEP compared to background HIV incidence and once-daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada) 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.
Despite high levels of reported sexual behavior, chemsex and sexually transmitted infections among participants, the study showed that 99.9% in the lenacapavir group did not acquire HIV, with 2 incident cases among the 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.
Of the trial participants, 91% received on-time injections at week 26 and 92.8% received on-time injections at 1 year, indicating a high adherence rate to lenacapavir. While adherence to Truvada was initially high, it declined over time. Diphosphate levels consistent with high adherence were seen in 82% of participants at week 8, 67% at week 26 and 62% at 1 year.
Last month, the FDA granted PrEP Breakthrough Therapy Designation and rolling review to lenacapavir. Gilead said in the release that the data from PURPOSE 1 (NCT04994509) and PURPOSE 2 will support a series of global regulatory filings for lenacapavir that will begin by the end of 2024.
“Gilead recognizes the importance of prevention in ending the HIV epidemic and is deeply committed to ensuring broad, sustainable global access to lenacapavir for PrEP, if approved,” Jared Baeten, MD, PhD, senior vice president of Clinical Development and Virology Therapeutic Area Head at Gilead Sciences, said in a release.1
READ MORE: Infectious Disease Resource Center
Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.
