The World Health Organization (WHO) has officially recommended the use of Ienacapavir, a long-acting injectable drug, for HIV prevention. This milestone announcement was made on July 14 during the 13th International AIDS Society Conference in Kigali. The recommendation aims to help countries adopt lenacapavir, especially in high-burden areas and among vulnerable populations. Lenacapavir, marketed as Sunlenca for treatment and Yeztugo for prevention, is a capsid inhibitor approved in 2022 for certain HIV treatments. Its unique mechanism blocks HIV replication by targeting the virus's protective protein shell. Unlike daily oral pills, lenacapavir is administered only twice a year via injection and has shown near-complete protection in clinical trials.
"These new recommendations are designed for real-world use," said Dr. Meg Doherty, director of WHO's Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes. "The first recommendation is that a long-acting injectable, lenacapavir, should be offered as an additional prevention choice for people at risk for HIV and as part of combination prevention. With that, we call it a strong recommendation with moderate to high certainty of the evidence."
The second guideline supports using rapid diagnostic tools, including at-home HIV tests, to screen individuals starting or continuing long-acting pre-exposure prophylaxis (PrEP) like lenacapavir.
WHO Director-General Dr. Tedros Adhanom Ghebreyesus praised the injectable as "the next best thing" to a vaccine. This endorsement builds on existing WHO-approved methods like daily PrEP pills, bi-monthly cabotegravir injections, and the dapivirine vaginal ring. WHO is also simplifying testing protocols to improve access through community clinics, pharmacies, and telehealth.
Lenacapavir's promise lies in its simplicity and effectiveness. Two annual injections reduce the burden of daily adherence, a challenge often faced by at-risk individuals. As trials showed, no infections occurred among lenacapavir users, compared to significant rates in oral PrEP groups. The approach is especially suited to high-risk groups, including sex workers, LGBTQ+ individuals, incarcerated people, adolescents, and drug users.
HIV is a virus that weakens the immune system and spreads primarily through unprotected sex and shared injection equipment. Left untreated, it progresses to AIDS, a life-threatening condition with no known cure. Although antiretroviral therapy (ARVs) can suppress the virus, no effective vaccine exists yet.
The WHO’s support for lenacapavir comes amid growing concern over global HIV funding. In early 2025, the U.S. paused foreign aid for HIV prevention and treatment, sparking fears of a resurgence in the epidemic. This context makes the WHO’s recommendation all the more critical.
Pharmaceutical company Gilead Sciences, the drug’s maker, announced a deal with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir at production cost, without profit. Gilead’s CEO Daniel O’Day stated, “We are providing the medicine at no profit to Gilead, and in enough supply to reach up to two million people in low- and lower-middle-income countries ahead of generic lenacapavir becoming available.”
Peter Sands, executive director of the Global Fund, emphasized the need for resources to ensure global access: "Our ambition is to reach 2 million people with long-acting PrEP. But we can only do that if the world steps up with the resources required. This is a pivotal moment, not just for the fight against HIV, but for the fundamental principle that lifesaving innovations must reach those who need them most, whoever they are, and wherever they live."
If distributed equitably, lenacapavir could redefine HIV prevention and bring the world closer to ending AIDS.
