HIV research company Gilead Sciences Inc (Nasdaq: GILD) on Wednesday presented full efficacy and safety results from its Phase 3 PURPOSE 1 trial at the 25th International AIDS Conference (AIDS 2024).

Lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, showed zero infections and 100% efficacy in preventing HIV among cisgender women. The trial also demonstrated lenacapavir's superiority over daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF).

Detailed data highlighted lenacapavir's high adherence rates and its effectiveness in reducing HIV infections compared to Truvada. These results were published in The New England Journal of Medicine and presented during a special late-breaking session at AIDS 2024 in Munich, Germany.

Gilead is prioritising swift access and regulatory approval for lenacapavir in high-incidence, resource-limited countries. This strategic move aims to address critical gaps in HIV prevention uptake and adherence.

PURPOSE 1 evaluated lenacapavir's safety and efficacy in a diverse cohort, including pregnant women and adolescents, across South Africa and Uganda. Participants received either twice-yearly lenacapavir injections or once-daily oral Descovy® (emtricitabine 200mg and tenofovir alafenamide 25mg; F/TAF), with Truvada as a secondary comparator. Lenacapavir showed high on-time injection rates and was generally well tolerated, with no serious injection site reactions reported.

The company expects additional results from the PURPOSE 2 trial by late 2024 or early 2025, assessing lenacapavir's efficacy in other populations. These combined results will support the regulatory filing for lenacapavir as a broad HIV prevention option.

Lenacapavir's unique multi-stage mechanism of action sets it apart from other antiviral agents. It is currently approved in several countries for treating multi-drug resistant HIV and is under investigation for HIV prevention.

A leader in HIV research for over 35 years, Gilead continues to drive innovations in treatment, prevention and cure research. The company remains committed to ending the HIV epidemic through scientific advancements, partnerships, and expanding access to care.