Clinical Trials Arena

Gilead’s twice-yearly shot prevents 100% of HIV cases in trial with women

Gilead’s share price jumped by 5.7% following the announcement that its Phase III trial of lenacapavir met its primary endpoint.

Gilead has announced topline results from an interim analysis of its Phase III PURPOSE 1 trial showing that its HIV drug Sunlenca (lenacapavir), prevented 100% of HIV cases in cisgender women.

The trial (NCT04994509) involved women and female adolescents aged between 16 and 25 years in South Africa and Uganda, some of whom received Gilead’s Sunlenca, and others who received Gilead’s other once-daily drugs like Truvada (emtricitabine/tenofovir disoproxil fumarate) or Descovy (emtricitabine/tenofovir alafenamide). The trial met its primary endpoint, showing clear superiority of Sunlenca to once-daily oral Truvada and background HIV (bHIV) for HIV prevention in cisgender women.

In the study, none of the women who received Sunlenca contracted HIV, demonstrating superiority over Truvada, bHIV, and Descovy. The long-acting shot was well-tolerated with no significant safety concerns, according to Gilead. Based on these results, the independent Data Monitoring Committee (DMC) recommended that Gilead stop the blinded phase of the trial and offer open label Sunlenca to all participants.

Gilead’s share price has jumped by 5.7% following the announcement.

Sunlenca – a HIV-1 capsid inhibitor – was being trialled as a type of pre-exposure prophylaxis (PrEP) medication, a group of drugs that HIV-negative people can take to minimise the risk of contracting HIV.

While traditional HIV prevention options are highly effective when taken as prescribed, Sunlenca as PrEP could help address the stigma and discrimination some people may face when taking or storing oral PrEP pills, as well as potentially help increase PrEP adherence and persistence given its twice-yearly dosing schedule, said Linda-Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa.

Sunlenca is already approved as an HIV treatment for individuals resistant to other medications. It gained US Food and Drug Aministration (FDA) approval in December 2022, backed by findings from the Phase II/III CAPELLA clinical trial of the drug plus an optimised background regimen.

“Twice-yearly lenacapavir for PrEP, if approved, could provide a critical new choice for HIV prevention that fits into the lives of many people who could benefit from PrEP around the world—especially cisgender women,” added Bekker.