For decades, preventing HIV has depended on condoms, behavior change and, more recently, daily pills that people must remember to take. In 2026, a new tool is reaching the countries hit hardest by the epidemic: lenacapavir, an injection given just twice a year. In clinical trials, it showed near-100% effectiveness in preventing new infections [1]. Public health experts have called it one of the most promising developments in the fight against HIV since antiretroviral treatment.
What lenacapavir is
Lenacapavir, developed by Gilead Sciences, is used as pre-exposure prophylaxis, or PrEP: medicine taken by people who do not have HIV to prevent them from getting it. Existing PrEP pills work very well when taken consistently, but many people struggle to take a pill every day, face stigma when others see their medication or have difficulty reaching clinics for frequent refills. A shot every six months could remove many of those barriers [1][2].
The drug received U.S. Food and Drug Administration approval for HIV prevention in
2025, after large clinical trials in Africa and elsewhere, including studies among young women and among men who have sex with men. The World Health Organization subsequently recommended it as an additional prevention option.
The rollout
The rollout is being led largely by the Global Fund to Fight AIDS, Tuberculosis and Malaria, a Geneva-based financing partnership, and the U.S. President's Emergency Plan for AIDS Relief (PEPFAR). On April 14, 2026, the United States and the Global Fund announced an expanded commitment to reach 1 million more people with lenacapavir over three years, bringing the combined target to 3 million people through 2028 [1][3]. The Children's Investment Fund Foundation is also a funding partner [1]. First deliveries have been completed in nine countries: Eswatini, Kenya, Lesotho, Mozambique, Nigeria, South Africa, Uganda, Zambia and Zimbabwe. As of the April announcement, six of those countries had started offering the shot, with the rest expected to begin soon [1]. The Global Fund is also supporting introduction in 12 more countries: Benin, Botswana, the Dominican Republic, Fiji, Georgia, Haiti, Honduras, Indonesia, Morocco, Papua New Guinea, Rwanda and Thailand [1]. "We are delighted that first deliveries have already been completed within our planned timelines across nine countries," said Hui Yang, the Global Fund's head of supply operations [1]. Early uptake has been strongest among pregnant and breastfeeding women, adolescent girls and young women, and people starting PrEP for the first time [1]. Those groups matter: in eastern and southern Africa, young women account for a disproportionate share of new HIV infections. "Long-acting lenacapavir could reshape HIV prevention by overcoming some of the structural challenges" that have limited PrEP use, said Peter Sands, the Global Fund's executive director [1].
The price question
Cost is a major factor in how far lenacapavir can reach. The brand-name drug has a high list price in the United States. To expand global access, Gilead has granted voluntary licenses allowing several manufacturers to produce lower-cost generic versions for low- and middle-income countries [1]. In April 2026, the Global Fund invited manufacturers to submit generic products for review, and wider generic availability is expected as early as 2027 [1]. Public health advocates have argued that generic competition will be essential for the drug to reach millions rather than hundreds of thousands of people.
Rollout amid funding cuts
The lenacapavir rollout is unfolding in a difficult funding environment. In 2025, the United States sharply reduced foreign aid, dismantled the U.S. Agency for International Development and disrupted many HIV programs, including some PEPFAR-funded services. The administration's new America First Global Health Strategy now channels U.S. health aid through bilateral agreements that require partner countries to pay a growing share of costs. Against that backdrop, the U.S. commitment to lenacapavir stands out as an area of continued investment, which the administration has highlighted as part of its global health priorities [2][4]. UNAIDS welcomed the expanded rollout in a statement the day after the announcement [5]. Advocates note, however, that the success of a prevention tool depends on the health systems that deliver it: testing, clinics, trained health workers and outreach to people at risk. Cuts to those systems could limit how many people the new drug reaches, even if supplies are available.
The potential impact
About 1.3 million people were newly infected with HIV worldwide in 2024, according to UNAIDS estimates, far above the global target set for 2025. Modeling studies have suggested that widespread use of long-acting prevention among people at highest risk could significantly reduce new infections. Because lenacapavir is given only twice a year, it may also be easier to provide through existing health visits, such as prenatal care. There are also limits. The shot does not protect against other sexually transmitted infections, and people still need regular HIV testing. Reaching 3 million people by 2028 would be a major achievement, but it is a fraction of the tens of millions who could benefit from PrEP worldwide.
How the shot is delivered
Lenacapavir is injected under the skin every six months by a health worker. Before starting, a person must test negative for HIV, and testing continues at each visit, because using a prevention drug while already infected can lead to drug resistance [1]. Health ministries are integrating the injection into existing services, such as family planning clinics, prenatal care and youth-friendly health centers, which is one reason early uptake has been strong among pregnant and breastfeeding women and young women [1]. Mark Edington, the Global Fund's head of grant management, said that "countries recognize the transformative potential" of the drug to reach these populations [1].
Why it matters
HIV remains one of the world's leading infectious killers, especially in sub-Saharan Africa. For the first time, there is a prevention tool that does not require daily action and that was nearly perfectly effective in trials. Whether it changes the course of the epidemic will depend on price, generic production, funding and the ability of health systems to reach the people who need it most. The next two years of rollout will offer the first real-world answers.
Sources
- 1. "US and Global Fund expand commitment to long-acting HIV prevention as country rollout of lenacapavir accelerates," The Global Fund, April 14, 2026. https://www.theglobalfund.org/en/updates/2026/2026-04-14 -us-global-fund-expand-commitment-long-acting-hiv-prevention-country-rollout-lenacapavir-accelerates/
- 2. "PEPFAR and the Global Fund Make Additional Investment in Gilead's Lenacapavir for HIV Prevention to Further Expand Access," Gilead Sciences, April 14, 2026. https://www.gilead.com/news/news-details/2026/ pepfar-and-the-global-fund-make-additional-investment-in-gileads-lenacapavir-for-hiv-prevention-to-further -expand-access
- 3. "Global Fund expands commitment to improve access to HIV drug," ARY News, April 2026. https://arynews.tv/global-fund-expands-commitment-to-improve-access-to-hiv-drug
- 4. "US unveils landmark HIV prevention rollout," Voice of Nigeria, 2026. https://von.gov.ng/us-unveils-landmark-hiv-prevention-rollout/
- 5. UNAIDS, press statement on expanded lenacapavir rollout, April 15, 2026. https://unaids.org/en/resources/ presscentre/pressreleaseandstatementarchive/2026/april/20260415_lenacapavir_expanded_rollout Information in this article is current as of October 10, 2026. Bracketed numbers refer to the sources listed above.