– New Data from PURPOSE Trials Further Demonstrate that Lenacapavir (Yeztugo®) was Effective and Well Tolerated Across a Broad Range of Populations, Including Pregnant and Lactating Women, Adolescents and Young People –

– Data Also Showed Twice-Yearly Injectable PrEP was Preferred vs. Daily Oral Medication Among PURPOSE Trial Participants –

– Gilead's Research Presentations and Community Events at IAS Reflect Commitment to Partnerships in Developing Person-Centered Options for a Diverse Range of Populations –

Gilead Sciences, Inc. (NASDAQ:GILD) today announced that Gilead researchers and collaborators will present new Phase 3 PURPOSE trial data at IAS 2025 showing that twice-yearly lenacapavir (Yeztugo®) was effective and well tolerated among a broad range of populations who need or want pre-exposure prophylaxis (PrEP) for HIV prevention, including pregnant and lactating women, adolescents and young people, and supports lenacapavir dosing recommendations for people in special situations, such as those taking medication to treat tuberculosis (TB) and other conditions. Researchers will also present new quantitative and qualitative data showing that participants in both Phase 3 PURPOSE trials indicated a preference for twice-yearly PrEP injections over daily oral medication.

The new data, from the company's pivotal Phase 3 PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) trials that assessed the efficacy and safety of twice-yearly Yeztugo for PrEP, will be presented via poster sessions and during a Yeztugo-dedicated oral session at the International AIDS Society (IAS) 2025, the 13th IAS Conference on HIV Science in Kigali, Rwanda on Thursday, July 17. The data presentations come less than a month after the U.S. Food and Drug Administration (FDA) approved Yeztugo as the first and only twice-yearly HIV prevention option. The data underscore Gilead's focus on intentional inclusion in the PURPOSE program to ensure broad and robust population data at the trials' primary analyses, as well as spotlight the community and organizational collaborations that guided the trial design and implementation process.