New Delhi: On June 18, 2025, Gilead Sciences’ lenacapavir, marketed as Yeztugo, received FDA approval as the first HIV pre-exposure prophylaxis (PrEP) agent that was shown to almost perfectly prevent HIV infections when injected twice yearly, with groundbreaking implications for the global battle to end HIV.
Gilead’s Phase 3 PURPOSE trials demonstrated remarkable outcomes with Yeztugo, administered every six months. In PURPOSE 1, more than 5000 cisgender women in South Africa and Uganda received lenacapavir, none of whom^11 contracted HIV, meaning 100% efficacy. METHODS HIV Infection Outcomes in Purpose 2 (CisGendered men and gender-diverse persons) – multi-national (n=7) – ∼ 2000 participants – 2 Infections = 99.9% efficacy and 96% HIV incidence risk reduction (vs. background incidence). Yeztugo proved superior to daily oral Truvada in both trials with few significant safety concerns. — injection-site reactions occurred in 12% of participants, but only 1.2% developed serious adverse events.
Gilead CEO Daniel O’Day said in a statement, “We’re on the verge of a landmark moment in the decades-long battle against HIV. “ Yeztugo dosed twice yearly could change HIV prevention, eliminating the need for a daily pill. Yeztugo affects HIV in a different way—specifically, it is a long-acting capsid inhibitor that interrupts the replication cycle of the virus. It could be easier for especially at-risk groups for HIV to remain adherent to the new solution than it has been with available solutions like Truvada or the bimonthly Apretude use of antiretrovirals.
However, the drug’s $28,218 annual U.S. list price raises concerns about accessibility. Gilead provides copay assistance for up to $7,200 for the charges that insured patients have to pay out of pocket, along with doses free of cost for low-income uninsured patients, too. It then also entered into royalty-free licensing agreements with six generic manufacturers with an aim to supply 120 low-income countries, promising, until generics can scale up, to provide 2 million doses at cost. But critics – including Andrew Hill of Liverpool University – say it could be produced for $25 a year and that high prices and cuts to U.S. funding under the Trump administration are likely to reduce its global impact.
AVAC Executive Director Mitchell Warren remarked that “If lenacapavir were available, it could stop HIV transmission.” However, the absence of low pricing and funding support could potentially limit its promise. Excited posts on X included pledges to remove cost barriers, with one person specifically calling for global subsidies.
There are even efforts to revolutionise PrEP further with a once-a-year formulation of lenacapavir, which Gilead is taking through Phase 3 trials. In the meantime, the approval of Yeztago provides a glimmer of hope in combating the 1.3 million new HIV infections occurring worldwide every year, but it will only be effective if access is equitable and there is a continued focus on investment in public health.