The Global Fund for HIV, TB and Malaria says it will fund the roll-out of the twice-yearly anti-HIV jab, lenacapavir, for poorer countries, including South Africa, with or without the help of the US government’s Aids fund, Pepfar.
Pepfar is short for the US President’s Emergency Plan for Aids Relief, the fund that US President Donald Trump has halted almost all support for over the past few weeks.
“We are still maintaining our ambition on lenacapavir for PrEP,” Global Fund executive director, Peter Sands, told Bhekisisa. “We see lenacapavir as a potential game changer in the fight against HIV as an injectable, long-acting PrEP solution that is pretty well 100% effective. It’s not going to be right for everybody, but we need to find out more from having people use it.”
PrEP, which is short for pre-exposure prophylaxis, is medicine that HIV-negative people can take to prevent themselves from contracting HIV through sex.
In December, Pepfar and the Global Fund announced a commitment to fund the roll-out of lenacapavir in countries they support, once regulators registered the medicine as PrEP.
At the time, Pepfar funded projects in 28 developing countries with high HIV infection rates, including South Africa. The Global Fund continues to support South Africa and more than 100 other countries.
Pepfar and the Global Fund said, alongside the Children’s Investment Fund Foundation and the Gates Foundation, they would pay for 2 million people to get the jab at least once over three years. The shot is taken every six months.
Lenacapavir, which is made by the drug company Gilead Sciences, made world headlines in June when trial results found that not one of the 2 134 young women who received the medicine contracted HIV. A second study showed that lenacapavir also dramatically reduced the chances of HIV infection for other groups of people — gay men, trans and non-binary people of 16 years and older, who have sex with partners classified as male at birth — by 96%.
Gilead applied for the registration of lenacapavir as PrEP with the US’s medicine regulator, the Food and Drug Administration in December, and the European Medicines Agency and EU Medicines for All project in February. South Africa’s registration forms part of the latter.
The US government has not yet made clear whether it will honour the December announcement but many key players fear that the Trump administration’s recent termination of USAid-funded Pepfar projects — and their particular aversion to HIV prevention projects — are telling signs that Pepfar is likely to pull out of the lenacapavir deal.
Sands, however, says he’s going to make sure that the Global Fund’s share of the funding happens, even if the roll-out is on a smaller scale.
“We cannot afford to miss such a game-changing opportunity,” he says.
And, he argues, the US would be unwise to quit now, if the Global Fund’s new “investment case” is anything to go by.
Dealing with the dealmaker-in-chief
Sands is a former investment banker who speaks in a language that the dealmaker-in-chief understands. With the moral argument out of the equation, what’s in it for the US?
The Global Fund has drafted an investment case for funding health products and programmes proved to work, saying it is a smart business decision.
It comes down to this — an economically prosperous and stable world is in the interests of everybody, wherever they live. When societies are so afflicted by disease that their people can’t be economically productive, they are prone to conflicts over resources. This creates more incentives for migration, says Sands.
“If you can address insecurity due to ill-health, that would be a sort of self-interested logic for [countries] in other parts of the world to do this investment.”
Since the Global Fund was founded 23 years ago, $26.6 billion has been invested in HIV programmes alone. Every three years, the fund asks donors, including the US, France, UK, Germany, Japan, Canada and others, to replenish the coffers. The US usually puts in the lion’s share — just under a third; to date it has contributed $26.31 billion to the fund.
This year, the fund’s appeal is for $18 billion, which they estimate will prevent 400 million new infections and cases across the three diseases, saving 23 million lives by 2029.
This time, the US’s contribution to the fund could decrease — or disappear.
To make the case for this round’s request, the Global Fund ran the numbers with the help of Imperial College, London. Researchers found that for every dollar invested in successful health interventions, a return of $19 is expected.
Show me the money
Alan Whiteside, a global health policy professor at the Balsillie School of International Affairs in Canada, has spent decades researching the economic impact of HIV in South Africa.
“Walking away from past investments just to cut losses would be pure waste,” he says. “It directly hurts your return on investment, which is a way to measure whether spending money on something leads to benefits. Investments in health lead to much greater benefits than the initial cost.”
But even if the pledges aren’t as high as hoped, or if a donor withdraws, “investing something is still better than investing nothing”, Whiteside says, “especially if there is so much at stake with that investment”.
Some investment in the branded form of lenacapavir is crucial while countries wait for cheaper generic versions to become available.
Gilead issued licences for generic versions of lenacapavir to six companies last year. But the companies are still putting the technology in place to make the drug. Once they’ve made it, it needs to be registered with regulators in each country. That time lag means generics will only be available in 2027.
Gilead offered to sell its branded version of lenacapavir at no profit to countries like South Africa, but it hasn’t said how much that will be. Experts say it’s likely to be considerably higher than what South Africa, or any other African country, could afford.
A cost model, which looked at the affordability of another PrEP injection, CAB-LA, which is taken every other month, shows if that jab is to become widely available at state clinics, the shots need to cost the same as — or at most double — the amount the government pays to give someone two months of prevention pills. Using that logic, the lenacapavir jab should not cost more than R629.40 a shot, or R1 258.80 for a year. (The health department pays R629.40 for a year’s supply of HIV prevention pills for one patient.)
But a policy document from the New York-based advocacy organisation Avac, which sets targets and timelines for prices, says the medicine’s initial price for a year’s stock should be about $100 (R1 870) — that’s R611.20 more than what SA would be able to pay if it wants to make lenacapavir cost effective.
As Bhekisisa reported in July, to slow down new HIV infections enough to get South Africa close to the UN goal of ending Aids as a public health threat by 2030, we would need millions of lenacapavir doses — and soon. The more of the drug made, the cheaper the meds will get. But only if there are buyers. Only a targeted investment in the anti-HIV jab will get us there.
Diseases without borders
Linda-Gail Bekker, who heads up the Desmond Tutu Health Foundation and was also the chief researcher for the lenacapavir study conducted among young women, says even with some Global Fund investment, we’ll need a way to ensure researchers and governments learn as much as possible about how keen people are to take the jab and what kind of staff training is needed to make it work.
“So the tricky thing is maybe we would have to quickly convene a group of experts to say, ‘If we had a limited supply, what is the best way? What is the most equitable but also the most return on investment, bang-for-the-buck way to deploy a limited supply?’”
The investment case logic is not new for South Africa, explains Gemma Oberth, research associate at the Centre for Social Science Research at the University of Cape Town. A 2023 South African HIV investment case by the Wits Health Consortium’s health economic and epidemiology research office, (HE²RO), shows how spending on HIV prevention makes people live significantly longer, and more productively, which has an economic benefit for the investor.
But that means governments have to believe in the science — and use it — Whiteside says, pointing to the concerning rise in TB cases in Kansas, and the measles outbreak in Texas, in the US, the result of a lack of investment in TB prevention and childhood vaccinations.
Sands says that while three diseases — HIV, TB and malaria are part of the Global Fund’s name — it’s actually about all diseases. The fund’s investments in infrastructure and expertise make it possible to, for instance, detect new germs and bring any other existing health threats under control.
“We know all too well from Covid-19 that diseases don’t stick within borders,” he says, “and while we have been successful in beating HIV, TB and malaria down from where they were, the fight [hasn’t been] won. We know that if you let up on any of these diseases, they will come back.”
Additional reporting by Mia Malan
This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.