Full efficacy and safety results for the phase 3 PURPOSE 1 trial were announced by Gilead at AIDS 2024.
Full data from a phase 3 trial that’s evaluating the safety and efficacy of twice-yearly lenacapavir injections for PrEP to prevent HIV infection in women were presented recently at the AIDS 2024 conference, Gilead Sciences announced in a release.1
Results from the study showed that the therapy met its key efficacy endpoints of superiority of twice-yearly lenacapavir to background HIV incidence and once-daily oral emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg (Truvada). Data from the study were published in the New England Journal of Medicine.2
Trial Name: Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
Clinicaltrials.gov Identifier: NCT04994509
Sponsor: Gilead Sciences
Summary: The goal of this study is to evaluate the efficacy in preventing HIV infection of the study drugs, lenacapavir (LEN) and emtricitabine/tenofovir alafenamide (F/TAF), in adolescent girls and young women.
“These stellar results show that twice-yearly lenacapavir for PrEP, if approved, could offer a highly effective, tolerable and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally,” Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, said in a release.1 “PURPOSE 1 also sets a new standard for person-centered HIV prevention trials, demonstrating what can happen when a thoughtful scientific and community-focused trial design, a promising drug candidate and an inclusive trial implementation plan come together.”
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PURPOSE 1 (
The study cohort included 5338 HIV-negative adolescent girls and young women between the ages of 16 and 25 who were sexually active with male individuals. Key exclusion criteria included prior receipt of an HIV vaccine, prior use of long-acting systemic PrEP therapy, or prior use of HIV postexposure prophylaxis therapy. Of the patients, 2134 received lenacapavir, 2136 received Descovy, and 1068 received Truvada.
Investigators found that there were 0 incident HIV infections in the lenacapavir group, 39 in the Descovy group, and 16 in the Truvada group. Compared to a background HIV incidence of 2.41 per 100 person-years in the screened population of 8094, the incidence with lenacapavir was found to be significantly lower. Lenacapavir also had a high adherence rate: 91.5% of all trial participants received on-time injections at week 26, and 92.8% received on-time injections at one year.
Additionally, lenacapavir was seen to be generally well tolerated with no new safety concerns being identified during the trial. Aside from injection site reactions, the most common adverse events were headache, urinary tract infection, genitourinary chlamydia infection, and nausea. Serious adverse events were reported in 2.8% of the lenacapavir group, compared to 4% in the Descovy group and 3.3% in the Truvada group.
Gilead said in the release that it expects results from the PURPOSE 2 study, which is assessing lenacapavir among cisgender men, transgender men, transgender women and gender non-binary individuals, in late 2024 or early 2025.
“As the most comprehensive and diverse HIV prevention trial program ever conducted, the PURPOSE program embodies both the scientific and person-centered innovations that Gilead believes are critical to help end the HIV epidemic for everyone, everywhere,” Jared Baeten, MD, PhD, senior vice president of Clinical Development and HIV Franchise Head at Gilead, said in a release.1 “As the only twice-yearly choice for HIV prevention, lenacapavir for PrEP could provide a critical new option for people who need or want PrEP around the world.”
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