Phase 3 PURPOSE 1 trial indicated that the twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women.
Foster City, Calif. – June 20, 2024 – Gilead Sciences, Inc. today announced topline results from an interim analysis of its pivotal, Phase 3 PURPOSE 1 trial indicating that the company’s twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women.
PURPOSE 1 met its key efficacy endpoints of superiority of twice-yearly lenacapavir to once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence. Based on these results, the independent Data Monitoring Committee recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
“With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We look forward to additional results from the ongoing PURPOSE clinical program and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere.”
These are the first data generated from Gilead’s landmark PURPOSE program, which is the most comprehensive and diverse HIV prevention trial program ever conducted. The PURPOSE program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity.
Read the full press release here.
Gilead statement: Access planning in high-incidence, resource-limited countries for lenacapavir for HIV prevention
SEE ALSO:
- Unitaid calls for accelerated global access to long-acting HIV prevention drug lenacapavir after positive trial results
- Treatment Action Group statement on lenacapavir PrEP: Getting from efficacy to access requires generic licensing and cost reductions
- AfroCAB: “Long overdue long-acting products” A call to action to accelerate access to lenacapavir!
- ICWEA statement on Gilead’s announcement of twice-yearly lenacapavir for HIV prevention
- AVAC: Landmark trial in South Africa and Uganda finds twice yearly HIV prevention injection safe and highly effective
- Aidsmap: No HIV infections seen in groundbreaking trial of twice-yearly injectable PrEP
- POZ: Twice-yearly lenacapavir PrEP prevents HIV in women
Source : Gilead Sciences, Inc.
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