An HIV drug that jams the virus's shell needs only two shots a year
Lenacapavir attacks HIV at a target no earlier drug had touched: the protein shell, or capsid, that carries the virus's genetic material. It is so potent and lingers so long in tissue that twice-yearly injections keep levels high enough. It was hailed as the 2024 Breakthrough of the Year.
Developed by Gilead Sciences, lenacapavir binds where the p24 protein subunits of the HIV-1 capsid meet. That over-stabilises the shell so it cannot release its contents properly, and it also disrupts assembly and release of new virus particles. Because nothing before it targeted the capsid, mutations that let HIV dodge other antiretrovirals leave it unaffected, although changes in the capsid itself can still produce resistance. The US Food and Drug Administration classes it as first-in-class.
It first reached patients as a treatment for people whose HIV resisted multiple drug classes. A trial of 72 such participants, all with high viral levels despite therapy, supported approval in the European Union in August 2022, Canada in November and the United States in December, where it had received priority review, fast track and breakthrough designations. Sold as Sunlenca, it is used alongside other antiretrovirals.
Prevention made headlines. One large trial in women recorded no infections at all in the lenacapavir group, and another, among men and gender-diverse people who have sex with men, reported 99.9 percent efficacy; it has also proved effective for heterosexual women in Africa. Few people stopped because of injection-site reactions, 0.2 percent in one trial and 1.2 percent in the other. The FDA approved it for prevention as Yeztugo in June 2025, the EU followed in September 2025, it was introduced in China the same year, and it reached Australia as Yeytuo in 2026.
Price is the sticking point. It cost US$42,250 for the first year as of 2024, and Gilead listed Yeztugo at $28,218 in 2025. A July 2024 study calculated that generic mass production could turn a 30 percent profit at $40 a year if 10 million people used it. In September 2025 partnerships involving Unitaid, the Gates Foundation and the Clinton Health Access Initiative secured Indian-made supplies at that $40 price for 120 low- and middle-income countries, with first doses reaching Zambia and Eswatini.
Source: Lenacapavir
