Gilead’s Twice-Yearly Lenacapavir Shows 96% HIV Risk Reduction, Paving Way for Regulatory Filings

Efficacy:
Gilead's twice-yearly lenacapavir demonstrated a 96% reduction in HIV infections compared to background HIV incidence in the PURPOSE 2 trial.

Study Population:
The trial included cisgender men, transgender men, transgender women, and gender non-binary individuals who have sex with partners assigned male at birth.

Comparison to Truvada:
Twice-yearly lenacapavir showed superiority to daily Truvada (emtricitabine/tenofovir) for HIV pre-exposure prophylaxis (PrEP).

Regulatory Plans:
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, disrupting several steps of the virus' life cycle.

Previous Approval:
Lenacapavir was first approved in August 2022 for treating adults with multidrug-resistant HIV under the brand name Sunlenca.

Access Strategy:
Gilead is prioritizing high-incidence, low-resource countries and is finalizing voluntary licensing agreements to ensure affordable access to lenacapavir.