The U.S. Food and Drug Administration (FDA) has approved Gilead Sciences’ Yeztugo (lenacapavir), a groundbreaking HIV prevention injection administered just twice a year. This new long-acting pre-exposure prophylaxis (PrEP) offers a more convenient alternative to daily pills or more frequent injections, potentially transforming HIV prevention efforts worldwide.
Clinical trials in 2024 demonstrated exceptional results, with infection rates nearly eliminated among recipients. In a key study involving over 2,000 women in sub-Saharan Africa, none contracted HIV, showing Yeztugo’s powerful protective effect.
“It’s difficult to overstate the importance of this for global public health. Yeztugo really will bend the arc of the epidemic as we roll this out across the globe,” Gilead CEO Daniel O’Day said.
Traditional PrEP options face challenges such as adherence difficulties and stigma, especially among disproportionately affected groups like Black and Hispanic communities, gay and bisexual men, and transgender individuals.
“Getting a twice-a-year injection really gives you that privacy that people have been looking for,” Johanna Mercier, Gilead’s chief commercial officer, noted.
Yeztugo’s annual list price is about $28,218 in the U.S., similar to other branded PrEP drugs. Gilead offers copayment assistance and free doses for eligible uninsured patients. The company has also licensed generic manufacturers to produce affordable versions for 120 low- and middle-income countries and pledged to supply two million doses at no profit before generics become widely available.
However, the rollout faces potential hurdles from proposed federal funding cuts to HIV prevention programmes and Medicaid, which covers many people living with HIV.
With approximately 1.3 million new HIV infections globally in 2023 and 700 new U.S. diagnoses weekly, Yeztugo’s approval is timely. Ensuring wide access and addressing systemic barriers will be crucial to realising Yeztugo’s promise in reducing HIV transmission worldwide.