November 27, 2024--FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced The New England Journal of Medicine ( NEJM ) published the full results from the company’s pivotal Phase 3 PURPOSE 2 trial evaluating twice-yearly lenacapavir for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people.
The study found that twice-yearly lenacapavir for pre-exposure prophylaxis (PrEP) was highly efficacious at reducing HIV infections, reducing them by 96% compared to background HIV incidence. There were two incident cases among 2,179 participants, corresponding to 99.9% of participants not acquiring HIV infection in the lenacapavir group. Twice-yearly lenacapavir for PrEP also demonstrated superiority to once-daily Truvada ® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) for PrEP and was generally well-tolerated, with no significant or new safety concerns identified. The strong efficacy and tolerability of lenacapavir are consistent with previous results from the PURPOSE 1 trial, which demonstrated zero infections and 100% efficacy for the investigational use of lenacapavir for PrEP in cisgender women in sub-Saharan Africa.
The NEJM publication of the full PURPOSE 2 results follows a data presentation during an oral abstract session at the International Congress on Drug Therapy in HIV Infection in Glasgow, Scotland (HIV Glasgow) earlier this month, the unblinding of the trial at interim analysis in September, and a presentation of additional efficacy and safety data in October at the HIV Research for Prevention Conference in Lima, Peru. PURPOSE 1 data were also published by NEJM in conjunction with the full data presentation at the 25th International AIDS Conference in Munich, Germany (AIDS 2024).
Gilead is executing an access strategy, informed by more than 100 global health advocates and organizations, that prioritizes speed and enables the most efficient paths for the regulatory review and approval of lenacapavir for PrEP in regions around the world. Data from both PURPOSE 1 and PURPOSE 2 will support a series of global regulatory filings for lenacapavir for PrEP that will begin by the end of 2024.
The use of lenacapavir for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally.
About Gilead HIV
For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people.
Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS.