FDA Clears Gilead’s Twice-Yearly Shot Yeztugo for HIV Prevention

The U.S. Food and Drug Administration on 18 June cleared Gilead Sciences’ lenacapavir, to be marketed as Yeztugo, marking the first HIV pre-exposure prophylaxis that requires only two injections a year. The decision gives Gilead a long-acting option in a market currently dominated by daily oral pills and ViiV Healthcare’s bimonthly shot Apretude.

Lenacapavir is a capsid inhibitor that releases drug slowly from a subcutaneous ‘depot’. In Phase 3 trials it delivered near-complete protection: no infections were recorded among more than 5,000 young women in South Africa and Uganda, while infections in a separate study of gay men, bisexual men and transgender people fell by roughly 90% compared with daily Truvada. Overall efficacy approached 99.9%, according to study investigators.

Under the FDA label, Yeztugo can be given to adults and adolescents as young as 12 who weigh at least 35 kg. Patients receive two loading tablets followed by a 463.5 mg injection and return six months later for the second shot, cutting annual clinic visits to two.

Gilead set a U.S. list price of about $28,218 a year—comparable with existing branded PrEP options but far above the roughly $30 monthly cost of generic Truvada. The company will offer copay assistance and a patient-aid programme, yet insurers’ willingness to cover the drug remains uncertain ahead of a key Supreme Court ruling on preventive-care benefits.

Advocacy groups welcomed the ‘milestone’ approval but warned that budget cuts to domestic HIV programmes and pressure on PEPFAR funding could slow uptake. Gilead has struck voluntary licences intended to supply up to 120 low- and lower-middle-income countries, and the World Health Organization plans to publish use guidelines next month.