Gilead Presents Full PURPOSE 2 Data Results for Twice-Yearly Lenacapavir for HIV Prevention at HIV Glasgow

– Newly Presented Results, to be Published in The New England Journal of Medicine, Include Adherence and Pharmacokinetics Data; Data Underscore High Efficacy and Safety Profile of Lenacapavir Among Broad and Geographically Diverse Range of Individuals –

– FDA Recently Granted Breakthrough Therapy Designation for Lenacapavir for PrEP; Gilead to Begin Regulatory Filings by End of 2024 –

– Gilead Spearheading Lenacapavir Access Strategies to Ensure Scientific Innovation Translates to Global Access and Real-World Impact –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first in-depth look at full results from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752), which is studying 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. Newly presented results include data on adherence to and pharmacokinetics of lenacapavir among trial participants.

The data were presented during an oral abstract session at the International Congress on Drug Therapy in HIV Infection (HIV Glasgow) and will be published in The New England Journal of Medicine. The release of the full PURPOSE 2 data follows the unblinding of the trial at interim analysis in September and a presentation of additional efficacy and safety data last month at the HIV Research for Prevention Conference in Lima, Peru. Those previously reported data showed that lenacapavir reduced HIV infections by 96% compared to background HIV incidence (bHIV), with two incident cases among 2,179 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir also demonstrated superiority to once-daily Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) for pre-exposure prophylaxis (PrEP) and was generally well-tolerated, with no significant or new safety concerns identified.

“We’re at a crossroads in the HIV epidemic, and a twice-yearly choice for HIV prevention, if approved, could be transformative as we work toward achieving the UNAIDS 2030 targets around the world,” said PURPOSE 2 Principal Investigator Onyema Ogbuagu, MBBCh, FACP, FIDSA, Associate Professor of Medicine and Pharmacology at Yale School of Medicine and Director of the Yale Antivirals and Vaccines Research Program. “Lenacapavir for PrEP could provide an important alternative to existing preventative medications that require more frequent dosing, and could help transform the HIV prevention landscape by addressing a range of unmet needs for individuals who need or want PrEP globally.”

Participants demonstrated high adherence to lenacapavir and injections

Adherence to lenacapavir and to the placebo injections that were part of the oral PrEP study group was high: 91.0% of all trial participants received on-time injections at week 26, and 92.8% of participants received on-time injections at one year. On-time injection rates (within 28 weeks of prior injection) were similar across both study groups, whether receiving lenacapavir or placebo injections.

Lenacapavir reduced HIV infections by 96% compared to background HIV incidence (bHIV)

Lenacapavir was highly effective at reducing HIV infections among trial participants: 99.9% of participants did not acquire HIV in the lenacapavir group, with two incident cases among 2,179 participants (0.10/100 person-years, 95% CI, 0.01 to 0.37), despite reported high levels of sexual behavior, chemsex and sexually transmitted infections observed among PURPOSE 2 participants. The results demonstrated superiority of twice-yearly lenacapavir over bHIV (2.37/100 person-years, 95% CI, 1.65 to 3.42; primary endpoint), with 96% relative risk reduction (IRR 0.04; 95% CI, 0.01 to 0.18; p