By Dean Seal


Gilead Sciences said an interim analysis of its lenacapavir study showed 100% efficacy in HIV prevention in cisgender women, resulting in a recommendation that the treatment be opened to all trial participants.

The biopharmaceutical company said the phase 3 trial of its twice-yearly injectable HIV-1 capsid inhibitor met key efficacy endpoints of showing superiority to once-daily oral Truvada and background HIV incidence.

The independent data monitoring committee has recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

Gilead said this is the first phase 3 HIV prevention trial to show zero infections.

The company expects results from the lenacapavir program's other phase 3 trial in late 2024 or early 2025. That trial assesses the treatment for pre-exposure prophylaxis, or PrEP, in cisgender men who have sex with men, transgender men, transgender women and gender non-binary individuals who have sex with partners assigned male at birth.

Gilead said the regulatory filing for lenacapavir for PrEP will include the results of both Phase 3 trials.


Write to Dean Seal at dean.seal@wsj.com


(END) Dow Jones Newswires

06-20-24 0951ET