Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Yeztugo® (lenacapavir), an injectable HIV-1 capsid inhibitor, for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg. This landmark approval makes Yeztugo the first and only FDA-approved HIV prevention option offering six months of protection with twice-yearly injections.

The approval is based on impressive data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials, which demonstrated that ≥99.9% of participants who received Yeztugo remained HIV negative. In PURPOSE 1, there were zero HIV infections among 2,134 participants in the Yeztugo group, showing a 100% reduction in HIV infections and superiority over once-daily oral Truvada in cisgender women in sub-Saharan Africa. In PURPOSE 2, two HIV infections occurred among 2,179 participants in the Yeztugo group, demonstrating 99.9% effectiveness and superiority over Truvada in a diverse group of cisgender men and gender-diverse people. Both trials found Yeztugo to be generally well-tolerated with no new safety concerns. These pivotal results led to Science naming lenacapavir its 2024 "Breakthrough of the Year."

This approval represents a significant advancement in the fight against HIV, especially given that only about 1 in 3 eligible individuals in the U.S. were prescribed PrEP in 2022, with notable disparities among women, Black/African American, and Hispanic/Latino populations. Barriers such as adherence challenges, stigma, and low awareness of existing PrEP options have contributed to this low uptake. Yeztugo's twice-yearly dosing aims to address these barriers, potentially boosting PrEP uptake and adherence.