Gilead announces PURPOSE 2 trial data published in NEJM

Gilead (GILD) announced The New England Journal of Medicine, or NEJM, published the full results from the company’s pivotal Phase 3 PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people. The study found that twice-yearly lenacapavir for pre-exposure prophylaxis, or PrEP, was highly efficacious at reducing HIV infections, reducing them by 96% compared to background HIV incidence. There were two incident cases among 2,179 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir for PrEP also demonstrated superiority to once-daily Truvada for PrEP and was generally well-tolerated, with no significant or new safety concerns identified. The efficacy and tolerability of lenacapavir are consistent with previous results from the PURPOSE 1 trial, which demonstrated zero infections and 100% efficacy for the investigational use of lenacapavir for PrEP in cisgender women in sub-Saharan Africa. The NEJM publication of the full PURPOSE 2 results follows a data presentation during an oral abstract session at the International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland earlier this month, the unblinding of the trial at interim analysis in September, and a presentation of additional efficacy and safety data in October at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 1 data were also published by NEJM in conjunction with the full data presentation at the 25th International AIDS Conference in Munich, Germany.