Conducted across 88 sites in seven countries, the trial included subjects from a diverse demographic. Credit: New Africa/Shutterstock.

Gilead Sciences has announced the outcomes from the randomised Phase III PURPOSE 2 trial evaluating lenacapavir for human immunodeficiency virus (HIV) prevention.

The trial demonstrated a 96% reduction in HIV infections compared to background incidence, with lenacapavir showing strong efficacy and tolerability.

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The double-blind, multicentre PURPOSE 2 trial compared the safety and efficacy of twice-yearly subcutaneous lenacapavir for pre-exposure prophylaxis (PrEP) against once-daily oral Truvada.

This trial was conducted across 88 sites in seven countries, involving subjects of diverse demographics.

In the trial, only two incident cases of HIV were reported among 2,179 participants in the lenacapavir group, demonstrating a 99.9% success rate in preventing HIV acquisition.

The trial’s findings are consistent with the earlier PURPOSE 1 trial, which reported zero infections among cisgender women in sub-Saharan Africa.

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The company’s access strategy for lenacapavir, shaped by input from more than 100 global health advocates and organisations, aims for swift regulatory review and approval worldwide.

The PURPOSE programme, encompassing five HIV prevention trials, is focused on health equity, scientific innovation, trial design, and community engagement.

Findings from PURPOSE 1 and 2 are set to support global regulatory filings for lenacapavir for PrEP, expected to commence by the end of the year.

Currently, the use of lenacapavir for HIV prevention remains investigational and is not approved globally.

The trial data was published in the New England Journal of Medicine (NEJM).

Earlier this month, the company reported outcomes from a Phase III study of its other candidate, Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC).