The World Health Organization currently recommends the inclusion of newly approved HIV drugs from Renacapavir for prevention as a tool in efforts to combat HIV infection.
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 two annual injections for the prevention of human immunodeficiency virus or HIV. Renacapavir was approved in 2022 to treat certain HIV infections. It has been found to dramatically reduce the risk of infection and provide almost complete protection against HIV.
“These new recommendations are designed for real-world use. Who works closely with countries and partners to support implementation,” Dr. Meg Doherty, director of WHO Global HIV, Hepatitis and Sexually Transmitted Diseases Program, said in a news briefing.
“The initial recommendation is that long-acting, injectable lenacapavir should be offered as an additional preventative option for those at risk of HIV as part of concurrent use prevention, which is why we call it a strong recommendation with moderate to high certainty of evidence,” Doherty said. The second recommendation in the guidelines is to use rapid diagnostic tests such as home testing to use screening for HIV to start, continue or stop infection, pre-exposure prevention, or PREP.
HIV is spread primarily through sharing unprotected genders and needles. It attacks the body’s immune system and, without treatment, can lead to acquired immune deficiency syndrome or AIDS. Globally, around 40 million people lived with HIV at the end of 2023, according to the WHO.
PREP has been used to prevent HIV infection for years. In the United States, this can involve taking pills such as daily drug therapy called trovada, or receiving injections every two months of medication.
However, Lenacapavil, or twice the injection of Len annually has become another option in the prevention toolbox, not just for the US but also for the world.
“Wren is a six-month injectable option that may be particularly appealing to people who prefer clinic visits in daily oral preparations or are challenged. It can improve compliance, reach people who need HIV prevention and can use it for pregnant and breastfeeding women,” Doherty said.
“Who is working with global partners such as Global Funds, UNAIDS and several other partners and donors to provide technical assistance to countries interested in adopting LEN and simplified testing strategies?” she said. “We call on governments, funders, implementers and civil society to work together to implement and integrate LEN into HIV programs.
There is growing concern about funding global HIV prevention efforts.
According to the United Nations, international aid accounts for 80% of prevention programs in low- and middle-income countries. However, over the past six months, the US has largely withdrawn funds due to much of its foreign aid.
The Trump administration has dismantled the US International Development Agency, or the USAID agency, reducing funding for Pepfah, which serves as the president’s emergency plan for AIDS relief, or the biggest commitment of any country to deal with a single illness in history.
Gilead Science, the maker of Lenacapaville, announced Wednesday that it had reached an agreement with the nonprofit Global Fund to supply the company with no profits to combat AIDS, tuberculosis and malaria. Under this agreement, Gilead’s pricing only reflects the cost of production and delivery of Renacapaville.
“We provide futile medicines to Gilead and provide ample supply to reach up to 2 million people in low- and middle-income countries before the general renacapavir becomes available,” Gilead’s chairman and CEO Daniel O’Day said in a news release.
The company added that the costs of Renacapaville under this agreement remain secret.
In the US, Renacapavil is the only place where HIV prevention has been approved So far, the annual list price is $28,218 when used to prevent HIV. According to Gilead, the cost is similar to the prices of other preventive medicine options.
While Lenacapaville can “radically change the HIV epidemic trajectory,” only if it reaches the people who need it most, Peter Sons, executive director of Global Funds, said in a news release.
“Our ambition is to reach two million people with long-acting preparations, but we can only do that if the world stomps the resources it needs,” he said. “This is a pivotal moment. They are, wherever they are, not just because of the fight against HIV, but also because of the fundamental principle that life-saving innovation must reach those that need most.”
The United Nations warned in a report released Thursday that if funds for the HIV program disappear forever, millions of people could die from HIV-related causes by 2029.
Of the 60 low- and middle-income countries included in the report, 25 indicate that they are increasing their domestic budgets next year for HIV response efforts. However, the report said it may not be sufficient to replace the scale of international funding that these countries rely heavily on.
“We know that in 2025, Pepfar committed $4.3 billion to over 50 countries and that support suddenly ended in January 2025,” Mary Mahy, director of UNAIDS’ Impact Department Department, said in a news briefing.
“If PEPFAR funds are not replaced, we can expect 4 million additional deaths and 6 million additional new infections between 2025 and 2029,” she said. “We also know that drug resistance is likely to occur in some people who are not treating.”
Mahy said some countries have already seen the impact of HIV program funding rollbacks. In Nigeria, the facility reported that around 40,000 people received their PREP at least once in the second half of last year. That number fell below 7,000 in April, according to UNAIDS data.
A similar trend has emerged in Kenya. There, the number of women living with HIV, who recently gave birth, is decreasing. He was given medication to reduce the risk of spreading the virus to newborns. In October 2024, around 3,000 women were already administered the drug, and around 900 women started the drug, but these numbers fell to about 300 and 100 starting drugs already administered in April.
“This isn’t just a fundraising gap, it’s a time bomb. …We’ve seen services disappear overnight, and health workers have been sent home.
“There is still time to turn this crisis into an opportunity,” says byanyima. “The country is stepping into domestic funding. The community is showing what works. Now we need global solidarity to match courage and resilience.”
