On June 18, 2025, the U.S. Food and Drug Administration approved Yeztugo (lenacapavir) for use as pre-exposure prophylaxis (PrEP) to prevent HIV infection among adults and adolescents weighing ≥35 kg. Lenacapavir is also approved in several countries as part of combination antiretroviral therapy for adults with multidrug-resistant HIV.
New Phase 3 data from the PURPOSE trials will be presented at IAS 2025, showing that twice-yearly injections of lenacapavir (Yeztugo) are effective, safe, and well tolerated among various populations interested in HIV prevention with PrEP, including adolescents, young people, and those who are pregnant or breastfeeding. The data will also support dosing recommendations for populations with specific medical conditions and needs, such as those being treated for tuberculosis or similar conditions. The data revealed a strong preference among participants for twice-yearly injections over daily oral PrEP.
These new findings from Gilead Phase 3 PURPOSE 1 and PURPOSE 2 trials on the safety and efficacy of Yeztugo, a twice-yearly dose to prevent HIV infection, will be presented at IAS 2025 in Kigali, Rwanda, on July 17 as poster and oral presentations. The presentations were held following the FDA’s approval of Yeztugo as the first biannual PrEP option. Gilead emphasized that the PURPOSE trials represent a model of inclusive research, shaped with input from community partners, and aim to reflect real-world diversity and needs in HIV prevention.
Dr. Moupali Das, VP Clinical Development, HIV Prevention and Pediatrics, at Gilead, stated, “It was exciting to return to Kigali with the community, advocacy, and research partners who provided input into making PURPOSE one of the most inclusive HIV prevention programs post-approvals. Being the only PrEP twice-yearly administration, Yeztugo has already shown outstanding efficacy and tolerability across diverse populations, and we are eager to announce further results at IAS 2025.”
Pregnant and lactating women who have a higher risk of HIV infection are usually excluded from the prevention trials. Based on community feedback, Gilead enclosed these groups in the Phase 3 PURPOSE 1 study of Yeztugo, in which cisgender women and adolescent girls in Sub-Saharan Africa gained a combination of two-yearly doses of Yeztugo. Evidence showed at IAS 2025 revealed that among the 184 pregnant or breastfeeding participants using Yeztugo, no new cases of HIV were reported. Across the cohort, 509 pregnancies occurred among the 487 participants. Yeztugo was well tolerated, and the safety results were similar between the groups of pregnant and non-pregnant women. Drug exposures were maintained at the same level during the gestational period and after the postpartum period, and the exposure of the infant via breastfeeding was minimal.
Yeztugo showed high efficacy and tolerance in studies involving pregnant and breastfeeding women, adolescents, and young individuals, and can be used safely combined with other therapy methods, including treatment of tuberculosis and other diseases.
According to the self-reported results of the PURPOSE 1 and 2 trials, more than 75% of participants preferred a biannual injection to daily oral PrEP, with more than 50% expressing a strong preference. The most common reasons were that they felt safer from HIV (69%) and more confident about adherence (77%).
“Groups like pregnant and lactating women, adolescents, and youth are at increased risk for HIV but have often been excluded from clinical trials,” said Dr. Linda-Gail Bekker, Director of the Desmond Tutu HIV Center, and former IAS President. The PURPOSE program raised the bar by including these populations from the start. The results of PURPOSE confirmed Yeztugo provides excellent protection against HIV and tolerability, while further emphasizing the importance of PrEP options designed around individual preferences that can reduce the access barriers and close prevention gaps.
References: Gilead. Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo®) for HIV Prevention at IAS 2025. Published Jul 14, 2025. Accessed Jul 16, 2025. Gilead Presents New Data on Twice-Yearly Lenacapavir (Yeztugo®) for HIV Prevention at IAS 2025
