Clinical Trials

Gilead Sciences has announced results from an interim analysis of its pivotal, phase 3 PURPOSE 1 trial, which assessed the twice-yearly treatment with injectable HIV-1 capsid inhibitor, lencapavir, for the investigational use of HIV prevention in cisgender women.

The trial met its key efficacy endpoints of superiority to once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg) and background HIV incidence (bHIV).

Following these results, an Independent Data Monitoring Committee (DMC) has recommended that the company stop the blinded phase of the trial and offer open-label lenacapavir to all of the participants.

Merdad Parsey MD PhD, chief medical officer at Gilead Sciences, commented: “With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections. We look forward to additional results from the ongoing PURPOSE clinical programme and continuing toward our goal of helping to end the HIV epidemic for everyone, everywhere.”

This is the first data to be announced from Gilead’s PURPOSE programme, which is currently the most comprehensive and diverse HIV prevention programme to have been conducted. The programme includes five HIV prevention trials globally, with a focus on innovation in science, trial design, engagement and health equity.