Twice-Yearly HIV Shot Approved, But Price and Licenses Limit Access

Twice-yearly injectable lenacapavir has regulatory approval in the United States and Europe and a World Health Organization recommendation as an additional pre-exposure prophylaxis (PrEP), medicine taken before exposure to lower HIV risk. Price, licensing geography and shrinking HIV funding are constraining delivery.

Lenacapavir is a capsid inhibitor developed by United States pharmaceutical company Gilead Sciences. In plain terms, it blocks the protein shell HIV needs to copy itself. It is given as a subcutaneous injection, a shot under the skin, twice a year. In the United States it is marketed as Yeztugo. Gilead describes Yeztugo as the first and only FDA-approved HIV prevention option offering six months of protection.

Efficacy data come from the PURPOSE trials. In a 2024 trial with more than 2,000 young women in South Africa and Uganda, none of the participants who received lenacapavir contracted HIV, according to Al Jazeera. The published PURPOSE 1 evaluation tested twice-yearly subcutaneous lenacapavir or daily F/TAF for HIV prevention. In Bekker et al., HIV incidence with lenacapavir was significantly lower than background incidence, with an incidence rate ratio of 0.00 (95% CI, 0.00 to 0.04; P<0.001). That ratio compares infection rates in the trial with expected rates without PrEP. In Kelley et al., incidence in the lenacapavir group was significantly lower than background incidence, with an incidence rate ratio of 0.04.

Regulatory and normative action followed quickly. The U.S. Food and Drug Administration approved lenacapavir for HIV prevention in June 2025. The European Commission authorized twice-yearly Yeytuo (lenacapavir) for HIV prevention. WHO announced its recommendation of injectable lenacapavir for HIV prevention on 14 July 2025, recommending twice-yearly use as an additional PrEP option, and subsequently published guidelines on lenacapavir for HIV prevention and testing strategies for long-acting PrEP, according to WHO. New CDC guidelines strongly recommend twice-yearly lenacapavir for PrEP.

Pricing remains split in two. In the United States, lenacapavir costs about $28,000 per person per year. Generic versions are expected to cost about $40 per person per year. Gilead has licensed six manufacturers to produce generic versions, with large-scale generic rollout expected in 2027.

In the interim, Gilead is supplying its own version at no profit for Global Fund- and PEPFAR-supported programmes, with rollouts under way in South Africa, Kenya, Zambia, Nigeria and Eswatini. In September 2025, Gilead announced a partnership with the U.S. State Department and PEPFAR to deliver twice-yearly lenacapavir for up to two million people in primarily low- and lower-middle-income countries. Zimbabwe rolled out lenacapavir in February 2026. The product was available in 10 countries as of August 2026 and was expected to reach 24 low- and middle-income countries by the end of 2026.

That rollout is occurring as prevention coverage contracts. International funding for HIV fell 18 percent in 2025 to $7.3 billion, its lowest level in nearly two decades, according to UNAIDS. The number of people receiving medicine to reduce HIV risk fell from 1.4 million in 2024 to 1.1 million in 2025.

Licensing scope is the other constraint. MSF says at least 26 middle-income countries are excluded from Gilead's generics agreement, including Brazil, Mexico, Argentina and Peru. Countries excluded from the licence accounted for close to 23 percent of new HIV infections globally in 2023, according to MSF. Gilead announced a separate agreement with the Pan American Health Organization creating an access pathway for 14 Latin American and Caribbean countries outside its generic licensing territory, including Brazil, Mexico, Argentina and Peru.

The broader context here is the gap between global endorsement and the ability to pay for and deliver a new tool. Voluntary licensing has lowered the forward price to $40, but the 2027 timeline leaves a two-year interval dependent on no-profit supply through multilateral channels. Those channels now operate with reduced fiscal space. At the same time, the exclusion of upper-middle-income epidemics from generic territory, even with a PAHO pathway, places procurement negotiations back onto bilateral and regional mechanisms. For practitioners, the near-term variables to watch are generic manufacturing readiness, PAHO pricing terms, and whether PEPFAR-supported delivery for up to two million people can offset the documented decline in PrEP uptake.