Gilead’s Twice-Yearly Lenacapavir Shows 96% HIV Risk Reduction, Eyes 2025 Launch for HIV Prevention

Efficacy:
Gilead's twice-yearly lenacapavir has demonstrated a 96% reduction in HIV infections in the PURPOSE 2 trial, following a 100% efficacy rate in the PURPOSE 1 trial among cisgender women.

Trial Outcomes:
The PURPOSE 2 trial, which included cisgender men, transgender men, transgender women, and gender non-binary individuals, showed that only 2 out of 2,180 participants contracted HIV, indicating a 99.9% success rate.

Regulatory Filings:
Gilead plans to start global regulatory filings by the end of 2024, aiming for an initial launch in 2025.

Mechanism of Action:
Lenacapavir is a selective inhibitor of the HIV-1 capsid function, which disrupts several steps of the virus' life cycle, setting it apart from other antiviral HIV drugs.

Access Strategy:
Gilead is prioritizing high-incidence, low-resource countries for regulatory review and approval, and is working on voluntary licensing agreements to supply low-cost versions of lenacapavir.

Previous Approvals:
Lenacapavir was first approved in August 2022 by the European Commission for treating adults with multidrug-resistant HIV, marketed as Sunlenca.