A promising HIV-prevention drug, Lenacapavir, could be a game-changer in countries worst hit by Aids.
The Trump Administration said today that it would help provide a promising HIV-prevention drug, Lenacapavir, to countries worst impacted by the disease - confirming its support for a proposal first unveiled last year, during the Biden Administration.
The State Department said it would work with Gilead Sciences, a United States-based firm that developed the drug, and the Global Fund to Fight Aids, Tuberculosis and Malaria to ensure that up to two million people in up to a dozen countries could receive Lenacapavir by 2028. Hundreds of thousands of lives could be saved, officials said.
The programme would target pregnant and breastfeeding mothers to prevent mother-to-child transmission of HIV and be administered through the President’s Emergency Plan for Aids Relief, better known as Pepfar.
US President Donald Trump “has a goal of ending mother-child transmission of HIV by the end of the second term in office”, said Jeremy Lewin, a senior State Department official.
Some advocates said they were pleased that the plan appeared to show the Trump Administration remains committed to Pepfar and is working to expand availability of HIV pre-exposure prophylaxis, or PrEP, a type of drug which can prevent HIV transmission.
Lenacapavir, which is administered as a twice-a-year injection, has proved highly effective in randomised trials and was approved by the Food and Drug Administration in June.
“Lenacapavir is one of the most important innovations in the HIV response in years. Having the US Government back at the table can help save lives,” said Jennifer Kates, director of global health and HIV policy at KFF, a health policy organisation.
But others were dubious, noting that today’s announcement appeared to sidestep LGBTQ+ people, the most at-risk population for HIV, and made it clear that the Trump Administration would not work with nongovernmental organisations to administer the doses to populations with reason to fear their own government.
The plan to target up to two million people over several years also falls far below what advocacy groups had been pushing for.
Asia Russell, the executive director of Health GAP, a group that campaigns for access to HIV/Aids treatment, called the Trump Administration’s three-year plan “anaemic and performative”. Russell noted that key elements of the plan were first announced in December, under the Biden Administration.
Lewin, the State Department official, acknowledged that the Trump Administration would issue a “strong recommendation” that the drugs not be used for populations other than pregnant and breastfeeding mothers.
He said that the new programme is a shift in some ways, but a necessary one.
“For too long, the Pepfar budget has been drained by NGO implementing partners that are charging very high indirect cost rates,” he said, vowing that no “beltway bandits” would be involved with the initiatives.
There is major uncertainty, too, over what countries would receive Lenacapavir with US government support. The State Department declined to identify the 12 countries it said would be supported by the US.
The nation with the highest HIV-positive population is South Africa, but Trump issued an executive order in February that halted all US aid to the country, citing alleged mistreatment of White Afrikaners in the majority black country.
The Global Fund, an international financing and partnership organisation that seeks to end several epidemics, said last month that it would support efforts to bring Lenacapavir to South Africa, calling the country’s problem “particularly acute”.
Mitchell Warren, executive director of AVAC, a non-profit that focuses on HIV/Aids prevention efforts, said that any refusal to work with South Africa would be “shortsighted, epidemiologically and politically”, and that it would undermine the Trump Administration’s efforts to build a market for Lenacapavir.
“If you really want to build a market, of course South Africa is the largest market for PrEP. So we do need to see how South Africa is going to be involved in this,” Warren said.
Today’s announcement came after a period of deep uncertainty for Pepfar, a multiagency public health programme led by the State Department and established under President George W. Bush in 2003.
Pepfar disburses billions of dollars in aid to partners around the world to fight HIV every year, has generally enjoyed strong bipartisan support and is credited with saving 25 million lives.
The programme was thrown into turmoil in January, after the incoming Trump Administration issued a 90-day pause on foreign aid that halted all new and existing programmes.
Though Secretary of State Marco Rubio later issued a waiver for “lifesaving humanitarian assistance”, healthcare workers said that the disruption to Pepfar has left a heavy human toll.
The problem has been worsened, advocates argue, by the White House Office of Management and Budget, which has not obligated or disbursed much of the funding for Pepfar for the 2025 financial year under what it says is an ongoing funding review.
Speaking to reporters today, Lewin declined to say how much money would be put forward by the US but said that it was “significant” and praised Gilead for offering the doses at-cost and without profit.
With the US and the Global Fund pre-purchasing doses, Gilead and several generic manufacturing producers will be able to scale up production quickly, he said.
Peter Sands, a British banker who has led the Global Fund since 2018, said that by focusing on preventing the spread of HIV, recipient countries could ultimately wean themselves off outside support.
“It is much easier for countries to take on the funding responsibility of a disease with very few new infections with a long liability in terms of keeping people on antiretroviral treatment, but ultimately a declining one, then asking them to take on responsibility for a problem that is still growing within a capital. I think we have the opportunity to make that shift,” said Sands.
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