The World Health Organization has issued a global recommendation for the use of lenacapavir, a twice-yearly injection for HIV prevention, as part of combination prevention efforts for individuals at high risk of contracting the virus. This recommendation comes after the US Food and Drug Administration approved lenacapavir for HIV prevention last month.
Dr. Meg Doherty, director of WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, emphasized that these new recommendations are designed for real-world use, stating, “These new recommendations are designed for real-world use. WHO is working closely with countries and partners to support the implementation.” The guidelines recommend lenacapavir as an additional prevention choice for people at risk for HIV, particularly for groups most at risk and in areas where the burden of HIV remains high.
Lenacapavir has shown significant promise in preventing HIV infections, with trials demonstrating dramatic reductions in the risk of infection and providing almost total protection against HIV. According to Greg Millett, public policy director at amfAR, The Foundation for AIDS Research, “This really has the possibility of ending HIV transmission.” The twice-yearly injection could improve adherence and reach more people who need HIV prevention, especially those who prefer fewer clinic visits or have challenges with daily oral PrEP.
Despite the promising developments, concerns loom over funding for global HIV prevention efforts. International assistance accounts for 80% of prevention programs in low- and middle-income countries, but the United States has significantly withdrawn funding for much of its foreign assistance. The dismantling of the US Agency for International Development and reduced funding for the President’s Emergency Plan for AIDS Relief have raised concerns about the future of HIV prevention and treatment programs.
UNAIDS Executive Director Winnie Byanyima warned, “This is not just a funding gap — it’s a ticking time bomb. … We have seen services vanish overnight. Health workers have been sent home. And people — especially children and key populations — are being pushed out of care.” The United Nations projects that millions more people could die from HIV-related causes by 2029 if funding for HIV programs permanently disappears.
Gilead Sciences, the maker of lenacapavir, has announced an agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir for HIV prevention at no profit to the company. The company’s chairman and 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 global solidarity, saying, “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”.