Lenacapavir Shows 100% Efficacy and Zero Infections in HIV Prevention

Gilead Sciences, Inc. today announced full efficacy and safety results from its pivotal HIV-1 Phase 3 clinical trial.

Detailed data from the trial’s interim analysis announced in June 2024 showed that lenacapavir, the company’s twice-yearly injectable HIV-1 capsid inhibitor, demonstrated zero infections, 100% efficacy, and superiority to background HIV incidence for the investigational use of HIV prevention in cisgender women.

Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada.

The new data provide details on the efficacy, safety, and tolerability of twice-yearly lenacapavir injections; drug adherence among trial participants, including poor levels of adherence to daily oral pre-exposure prophylaxis (PrEP) and high levels of adherence to lenacapavir; and demographic and behavioral characteristics of trial participants, including pregnant women and adolescents.

The data were published today in The New England Journal of Medicine.

“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,” said 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, and former President of the International AIDS Society, in a press release on July 24, 2024.

“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.”

Gilead expects results in late 2024/early 2025 from the program’s other pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP among men.

Currently, there are no cures for HIV or AIDS or preventive vaccines available.