The US Food and Drug Administration approved Gilead Sciences' Yeztugo, the first HIV-prevention injection designed to be administered twice a year. The drug, lenacapavir, is intended as pre-exposure prophylaxis, or PrEP, for people who test negative for HIV. It prevents infection but does not protect against other sexually transmitted diseases.
Two major studies produced the evidence behind the approval. In a trial involving more than 5,300 sexually active young women and adolescent girls in South Africa and Uganda, no participant receiving lenacapavir acquired HIV, while infections occurred in the comparison group taking daily pills. A separate study among gay and bisexual men and gender-nonconforming people found the injection highly effective. One analysis reported an HIV rate 89% below that in a group assigned daily Truvada and 96% below the estimated rate without PrEP.
Yeztugo is delivered by health workers as two injections under the skin of the abdomen, where the medicine is absorbed gradually. Its six-month duration could help people who struggle to take a pill every day or who find frequent clinic visits difficult. Existing options include daily oral drugs and Apretude, an injection given every two months.
Lenacapavir was already marketed as Sunlenca, in combination with other medicines, for highly drug-resistant HIV. The new brand and indication are for prevention. People must receive an HIV-negative test before each dose because Yeztugo is not a substitute for treatment in someone who already has the virus.
Access remained a major uncertainty. Gilead set a US list price of $28,218 a year before insurance, equivalent to $14,109 per injection. Insurance rules, possible copayments, changes to Medicaid and cuts affecting public-health outreach could all influence uptake. Internationally, Gilead arranged for generic manufacturing in 120 lower-income countries and planned interim no-profit supplies for two million people, but advocates warned that affordability and gaps affecting middle-income countries could restrict reach.
The approval therefore added a powerful, long-lasting prevention choice rather than ending the practical challenges around HIV. Its population-level effect would depend on testing, coverage, delivery through clinics and whether patients returned reliably for their next six-month dose.
