– PURPOSE 1 Data Showed Zero Infections and 100% Efficacy and Superiority of Lenacapavir to Background HIV Incidence and Daily Truvada® for PrEP –
– If Approved, Lenacapavir Would be the First and Only Twice-Yearly PrEP Choice and Could Address Critical Gaps in Uptake and Adherence for Individuals Who Need or Want PrEP –
– Gilead Commits to Prioritizing Swift Access and Enabling Efficient Paths for Regulatory Approval of Lenacapavir for PrEP in High-Incidence, Resource-Limited Countries –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced full efficacy and safety results from its pivotal, Phase 3 PURPOSE 1 trial. Detailed data from the trial’s interim analysis announced in June 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 (women assigned female at birth). Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF).
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 are being presented at a special late-breaking session at the 25th International AIDS Conference (AIDS 2024) in Munich, Germany and 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. “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.”
To ensure the groundbreaking data from PURPOSE 1 translates into decreased HIV incidence globally, Gilead is building an access strategy that prioritizes speed and enables the most efficient path for the regulatory approval of twice-yearly lenacapavir for PrEP in countries that account for most of the global disease burden. For more information, see Gilead’s statement on access planning in high-incidence, resource-limited countries for lenacapavir for PrEP.
Zero infections and 100% efficacy observed for lenacapavir at interim analysis
Overall, lenacapavir was highly effective among trial participants, with zero HIV infections observed in the lenacapavir group (0/100 person-years; 95% CI, 0.00 to 0.19) compared to background HIV incidence (bHIV) (2.41/100 person-years; 95% CI, 1.82 to 3.19), translating to a 100% reduction in HIV infections. Additionally, compared to once-daily Truvada, lenacapavir reduced HIV incidence by 100%, a result that was statistically superior (IRR 0; 95% CI, p