Gilead reports results from pivotal Phase 3 PURPOSE 2 trial

Gilead (GILD) Sciences presented the first in-depth look at full results from its pivotal Phase 3 PURPOSE 2 trial, which is studying twice-yearly lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people. Newly presented results include data on adherence to and pharmacokinetics of lenacapavir among trial participants. The data were presented during an oral abstract session at the International Congress on Drug Therapy in HIV Infection and will be published in The New England Journal of Medicine. The release of the full PURPOSE 2 data follows the unblinding of the trial at interim analysis in September and a presentation of additional efficacy and safety data last month at the HIV Research for Prevention Conference in Lima, Peru. Those previously reported data showed that lenacapavir reduced HIV infections by 96% compared to background HIV incidence, or bHIV, with two incident cases among 2,179 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir also demonstrated superiority to once-daily Truvada for pre-exposure prophylaxis (PrEP) and was generally well-tolerated, with no significant or new safety concerns identified. Adherence to lenacapavir and to the placebo injections that were part of the oral PrEP study group was high: 91.0% of all trial participants received on-time injections at week 26, and 92.8% of participants received on-time injections at one year. Lenacapavir reduced HIV infections by 96% compared to background HIV incidence. Truvada adherence was initially high but declined over time. In the Truvada group, nine incident HIV infections occurred, all in participants with low or no adherence. PURPOSE 2 is a Phase 3, double-blind, multicenter, randomized study evaluating the safety and efficacy of twice-yearly subcutaneous lenacapavir for PrEP versus bHIV and once-daily oral Truvada in 3,271 cisgender gay, bisexual, and other men, transgender women, transgender men, and gender non-binary individuals aged 16 years or older who have sex with partners assigned male at birth. Gilead continues to focus on global access strategies, including for low-, middle- and high-income countries.