The World Health Organization is now recommending that countries include an HIV drug newly approved for prevention, lenacapavir, as a tool in their efforts to fight HIV infections – especially for groups most at risk and in areas where the burden of HIV remains high.
The global recommendation – issued Monday at the International AIDS Conference in Kigali, Rwanda – comes about a month after the US Food and Drug Administration approved lenacapavir as a twice-yearly injection for the prevention of the human immunodeficiency virus or HIV. Lenacapavir had been approved in 2022 to treat certain HIV infections and, in trials for prevention, it was found to dramatically reduce the risk of infection and provide almost total protection against HIV.
“These new recommendations are designed for real-world use. WHO is working closely with countries and partners to support the implementation,” Dr. Meg Doherty, director of WHO’s Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, said in a news briefing.
“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,” Doherty said. The second recommendation in the guidelines is that rapid diagnostic tests like at-home tests can be used to screen someone for HIV when they are starting, continuing or stopping long-acting medication to prevent infection – called pre-exposure prophylaxis, or PrEP.
HIV spreads primarily through unprotected sex or sharing needles. It attacks the body’s immune system, and without treatment, it can lead to acquired immunodeficiency syndrome, or AIDS. Globally, about 40 million people were living with HIV at the end of 2023, according to WHO.
PrEP has been used to prevent HIV infections for years. In the United States, this may involve taking pills, such as a daily medication called Truvada, or getting injections, such as every two months of the medication Apretude.
But twice-yearly injections of lenacapavir, or LEN, have become another option in the prevention toolbox – not just for the United States but for the world.
“LEN is a six-monthly injectable option, and it may be particularly attractive for people who prefer fewer clinic visits or have challenges with daily oral PrEP. … It could improve adherence and reach more people who need HIV prevention and can be used in pregnant and breastfeeding women,” Doherty said.
“WHO is providing technical assistance to countries interested in adopting LEN and simplified testing strategies, in coordination with global partners like the Global Fund, UNAIDS and several other partners and donors,” she said. “We call on governments, funders, implementers and civil society to work together for implementing and integrating LEN into the HIV programs. And we believe time to act is now.”
There has been growing concern around funding for global HIV prevention efforts.
International assistance accounts for 80% of prevention programs in low- and middle-income countries, according to the United Nations. But in the past six months, the United States has significantly withdrawn funding for much of its foreign assistance.
The Trump administration has dismantled the US Agency for International Development, or USAID, and reduced funding for the President’s Emergency Plan for AIDS Relief, or PEPFAR, which acts as the largest commitment by any nation to address a single disease in history.
Gilead Sciences, maker of lenacapavir, announced Wednesday that it has reached an agreement with the nonprofit Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir for HIV prevention at no profit to the company. Under this agreement, Gilead’s pricing reflects only the cost of producing and delivering lenacapavir.
“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,” Gilead Chairman and CEO Daniel O’Day said in a news release.
The company added that the cost of lenacapavir under this agreement remains confidential.
In the United States, the only place where lenacapavir has received approval for HIV prevention so far, the drug has an annual list price of $28,218 when used for HIV prevention. The cost is similar to the price of other prevention medicine options, according to Gilead.
Lenacapavir can “fundamentally change the trajectory of the HIV epidemic,” but only if it reaches the people who need it most, Peter Sands, executive director of the Global Fund, said in the news release.
“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,” he said. “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.”
The United Nations warned in a report released Thursday that millions more people could die from HIV-related causes by 2029 if funding for HIV programs permanently disappears.
Among the 60 low- and middle-income countries included in the report, 25 have indicated increasing their domestic budgets for HIV response efforts next year. But the report noted that may not be sufficient to replace the scale of international funding that these countries have been heavily reliant on.
“We know that PEPFAR had committed $4.3 billion to over 50 countries in 2025, and that support was suddenly ended in January of 2025,” Mary Mahy, director of UNAIDS’s Data for Impact department, said in a news briefing.
“If none of the PEPFAR funding is replaced, we’d expect something like 4 million additional deaths between 2025 and 2029, and another 6 million additional new infections,” she said. “We also know that drug resistance would likely occur with some of those people going off treatment.”
Some countries already have seen effects of the rollback of funding for HIV programs, according to Mahy. In Nigeria, facilities reported that there were about 40,000 people who received PrEP at least once during the later part of last year. That number dropped to fewer than 7,000 in April, according to UNAIDS data.
A similar trend emerged in Kenya, where there has been a decline in the number of women living with HIV who recently gave birth and received medications to reduce their risk of transmitting the virus to their newborns. About 3,000 women already received medications and nearly 900 initiated medications in October 2024, but those numbers fell to only about 300 already receiving and 100 starting medications in April.
“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,” UNAIDS Executive Director Winnie Byanyima said in a news release Thursday.
“There is still time to transform this crisis into an opportunity,” Byanyima said. “Countries are stepping up with domestic funding. Communities are showing what works. We now need global solidarity to match their courage and resilience.”
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