Gilead Presents Additional Efficacy, Safety and Demographic Data From PURPOSE 2 Trial at 5th HIV Research for Prevention Conference

– Efficacy and Safety Data Demonstrated 96% Reduction in HIV Infections with Lenacapavir Compared to Background HIV Incidence Among a Geographically Diverse Population of Cisgender Men and Gender-Diverse People –

– Gilead to Begin Regulatory Filings for Lenacapavir for PrEP by End of 2024 –

– Gilead Recently Announced Voluntary Licensing Partners to Expand Future Access in High-Incidence, Resource-Limited Countries –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced additional data from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752) providing an overview of the efficacy and safety of twice-yearly lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people.

The new data are being presented during an oral abstract session on October 8 at the 5th HIV Research for Prevention Conference (HIVR4P) in Lima, Peru and follow the unblinding of the trial at interim analysis in September, which showed that twice-yearly lenacapavir reduced HIV infections by 96% compared to background HIV incidence (bHIV) and demonstrated superiority to once-daily Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) for HIV prevention as pre-exposure prophylaxis (PrEP).

“These data reinforce that twice-yearly lenacapavir could be a highly effective and potentially game-changing HIV prevention choice that we have long hoped for in our efforts to end the HIV epidemic,” said Colleen Kelley, MD, MPH, Professor of Medicine at Emory University and a PURPOSE 2 Principal Investigator. “PURPOSE 2 was intentionally designed to reflect the lives and locations of many people who are disproportionately affected by HIV around the world by focusing on gender, racial, ethnic and geographic diversity.”

Lenacapavir was highly effective in PURPOSE 2, reducing HIV infections by 96% with two incident cases among 2,179 participants receiving lenacapavir

Lenacapavir was highly effective at reducing infections among trial participants: 99.9% of participants did not acquire HIV in the lenacapavir group, with 2 incident cases among 2,179 participants (0.10/100 person-years, 95% CI, 0.012 to 0.373). The results demonstrated superiority of twice-yearly lenacapavir over bHIV (2.37/100 person-years, 95% CI, 1.649 to 3.417; primary endpoint), with 96% relative risk reduction (IRR 0.04, 95% CI, p