The World Health Organization (WHO) has officially recommended the use of lenacapavir, a groundbreaking injectable HIV prevention drug, particularly for high-risk groups. This endorsement comes at a critical time, as funding concerns loom large over global health initiatives. Gilead Sciences, the manufacturer of lenacapavir, has committed to providing the drug at no profit through the Global Fund, aiming to significantly impact HIV prevention efforts and move closer to a world without AIDS.
Lenacapavir, marketed under the brand names Sunlenca for treatment and Yeztugo for prevention, is a long-acting capsid inhibitor that has revolutionized HIV prevention strategies. Administered via injection just twice a year, lenacapavir targets the structural protein (capsid) of the HIV virus, effectively blocking its ability to replicate within the body. Approved in 2022 for certain HIV infections, clinical trials have shown that lenacapavir can dramatically lower the risk of HIV infection, offering nearly complete protection.
Dr. Meg Doherty, director of WHO’s Department of Global HIV, Hepatitis, and Sexually Transmitted Infections Programmes, emphasized the practicality of these new recommendations during a news briefing. “These new recommendations are designed for real-world use,” she stated. WHO is collaborating closely with countries and partners to facilitate implementation. The primary recommendation encourages the use of lenacapavir as an additional prevention method for individuals at risk of HIV, enhancing existing combination prevention strategies.
Furthermore, WHO has suggested that rapid diagnostic tests, including at-home tests, be utilized to screen individuals for HIV when they are beginning, continuing, or discontinuing long-acting medication for prevention, commonly referred to as pre-exposure prophylaxis (PrEP). WHO’s Director-General, Dr. Tedros Adhanom Ghebreyesus, praised lenacapavir as “the next best thing” to an HIV vaccine, highlighting its importance in the current landscape of HIV prevention.
The shift to a twice-yearly injection presents several advantages that could enhance adherence and convenience for those at risk of HIV. Daily pills require consistent intake, which can be challenging for many individuals. Lenacapavir simplifies this process by reducing the need for frequent clinic visits, thus helping to overcome barriers such as stigma, pill fatigue, and limited access to healthcare.
Effectiveness is another critical factor. Clinical trial data has shown that no infections occurred among participants receiving lenacapavir, in stark contrast to higher infection rates among those using traditional pill-based PrEP methods. Additionally, lenacapavir is poised to benefit high-risk populations—including sex workers, LGBTQ+ individuals, people who inject drugs, incarcerated individuals, and adolescents—by providing a long-lasting, easy-to-administer prevention tool.
HIV, or human immunodeficiency virus, attacks the cells that help the body fight infections, making individuals more susceptible to various diseases. The virus spreads through contact with certain bodily fluids, predominantly during unprotected sex or sharing injection drug equipment. Without treatment, HIV can progress to AIDS (acquired immunodeficiency syndrome), which is characterized by severe immune system damage and a range of symptoms, including weight loss, recurrent infections, and fatigue.
While there is currently no cure for AIDS, strict adherence to antiretroviral regimens (ARVs) can significantly slow disease progression and prevent secondary infections. Although several vaccines for HIV are under trial, an effective vaccine has yet to be developed.
In early 2025, the global fight against HIV/AIDS encountered a significant setback due to the United States' decision to halt foreign aid funding for HIV prevention and treatment programs. This decision triggered widespread concern in the international health community, raising fears of a potential resurgence of the epidemic. However, WHO’s endorsement of lenacapavir as a preventive measure offers hope in these challenging times.
Gilead Sciences has announced an agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir for HIV prevention at no profit. This arrangement ensures that Gilead's pricing reflects only the production and delivery costs, allowing the drug to reach up to two million people in low- and lower-middle-income countries. Gilead's Chairman and CEO, Daniel O’Day, expressed the company's commitment to making lenacapavir accessible to those in need.
Peter Sands, executive director of the Global Fund, emphasized that lenacapavir could “fundamentally change the trajectory of the HIV epidemic,” provided it reaches the populations that need it most. He urged for global support to facilitate the required resources for this pivotal moment in the fight against HIV/AIDS.
If implemented equitably and thoughtfully, lenacapavir could reshape the landscape of HIV prevention, bringing us closer to a world free from AIDS.
