Thursday, Gilead Sciences Inc ( GILD )  shared topline results from an interim analysis of its Phase 3 PURPOSE 1 trial indicating its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, demonstrated 100% efficacy for the investigational use of HIV prevention in cisgender women.

PURPOSE 1 study met its key efficacy endpoints of the superiority of twice-yearly lenacapavir to once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) and background HIV incidence (bHIV).

Based on these results, the independent Data Monitoring Committee (DMC) recommended that Gilead stop the blinded phase of the trial and offer open-label lenacapavir to all participants.

“With zero infections and 100% efficacy, twice-yearly lenacapavir has demonstrated its potential as an important new tool to help prevent HIV infections,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences ( GILD ).

There were 0 incident cases of HIV infection among women in the lenacapavir group (incidence 0.00 per 100 person-years).

The results demonstrated the superiority of twice-yearly lenacapavir over bHIV (primary endpoint, incidence 2.41 per 100 person-years) and superiority of twice-yearly lenacapavir over once-daily Truvada (secondary endpoint), with p