HIV medication company Gilead Sciences Inc (Nasdaq: GILD) reported on Monday that it has presented new data at IAS 2025 from its Phase 3 PURPOSE trials, confirming the efficacy and tolerability of twice-yearly injectable lenacapavir (Yeztugo) for HIV pre-exposure prophylaxis (PrEP) across diverse populations, including pregnant and lactating women, adolescents and young adults.

Data from PURPOSE 1 and PURPOSE 2 showed zero HIV infections among pregnant and breastfeeding participants on Yeztugo, with no safety concerns and minimal drug exposure in infants. Efficacy and pharmacokinetic profiles were consistent in adolescents aged 16–25, and modeling supported co-administration with tuberculosis treatments through adjusted dosing. No new safety issues were reported.

Over 75% of surveyed trial participants preferred twice-yearly injections to daily oral PrEP, citing increased confidence in adherence and protection against HIV. These findings support Yeztugo as a compelling alternative to daily regimens.

Gilead secured US Food and Drug Administration approval for Yeztugo on 18 June 2025 and has filed for regulatory authorisations in Europe, Australia, Brazil, Canada, South Africa and Switzerland. Further filings are planned in Argentina, Mexico and Peru. A recent partnership with the Global Fund will provide lenacapavir at no profit to up to two million individuals over three years in eligible countries.

The PURPOSE program, comprising five global trials, is the most comprehensive HIV prevention trial initiative to date. Lenacapavir, a first-in-class capsid inhibitor with a multi-stage mechanism of action, is being developed as a foundation for long-acting treatment and prevention strategies.

Gilead continues to drive innovation in HIV prevention and treatment, with a commitment to health equity, global access and reducing new infections worldwide.