Lenacapavir could end Aids in South Africa by 2032. How much should we pay for it? (Canva)
“If HIV could talk, it would say ‘thank God for the US president, because I can now spread more easily. I love the Trump administration’,” says HIV activist Mitchell Warren, who is the executive director of the New York-based advocacy organisation, Avac.
“In fact, the new administration has created an incubator for disease outbreaks.”
It was against this backdrop, which advocates like Warren call the Trump administration’s “wilful destruction of systems” that the American government’s Aids fund, Pepfar, which, until two months ago was providing 20-million people with lifesaving HIV treatment and many more with prevention services, was not reauthorised by Congress on March 25.
The scenario unfolded with “a striking contradiction”, writes Jirair Ratevosian, a former Pepfar head of staff — two weeks after the release of groundbreaking HIV studies at the Conference on Retroviruses and Opportunistic Infections, Croi, that was held in San Francisco; one which showed if South Africa is able to roll out a twice-yearly anti-HIV jab to enough HIV-negative people, new infections could slow down fast enough to end Aids by 2032.
But now, says Ratevosian, who is an associate research scientist at Yale University, the “political and financial commitment to scaling up these innovations is faltering”.
What does no reauthorisation mean?
Although the falling to reauthorise Pepfar doesn’t mean the fund ceases to exist — there’s an approved budget through September 30 — it does mean the rules for how that money gets spent have fallen away.
The executive branch (read: Trump and his advisers) are now able to spend the budget in whichever way they like, where previously, there were earmarks; 50% of the funds had to, for instance, go towards HIV treatment, care and making sure people with HIV had healthy food to eat.
The Trump administration stopped transferring funds to organisations who received their money through USAid, after President Donald Trump signed an executive order on 20 January after his inauguration to put a 90-day pause on foreign aid.
On 26 February he cut the funding of 5 800 such organisations around the world for good.
“Pepfar,” explains Ratevosian, “now sits in purgatory.”
And, “the real crisis is that the state department [the home of the United States Agency for International Aid, USAid] isn’t releasing those funds to implementing partners [nonprofits and government projects funded by Pepfar]”, Ratevosian told Bhekisisa.
“We still don’t know how the Trump Administration will land its foreign aid review by April 20. But if the freeze on Pepfar prevention funding holds, it will slam the brakes on global HIV prevention — shattering momentum, stalling the scale-up of anti-HIV medication that can stop people from getting infected and putting millions at risk.”
A drug that could stop HIV infections in teen girls and young women
In July, one of South Africa’s top HIV researchers, Linda-Gail Bekker, who heads the Desmond Tutu Health Foundation, released the groundbreaking results of a study that showed not a single teen girl or young woman who used the anti-HIV shot, lenacapavir, taken every six months, contracted HIV.
Lenacapavir works by stopping HIV from making more copies of itself and so getting into someone’s immune cells.
What made scientists especially excited about the findings was that they showed that new HIV infections among the group of people in East and Southern Africa who have the highest chance of getting the virus — teen girls and young women aged 15 to 24 years old — could potentially be slowed down dramatically.
About 122 such girls and women got infected with HIV in South Africa each day in 2023, figures from the country’s Thembisa model, which the health department uses to plan its programmes, show. So about four out of every 10 new infections in the country are in this group, even though they make up only about 8% of the total population.
At the Croi conference, Katherine Gill, who works with Bekker, revealed the results of a study that showed lenacapavir works as well in 16 and 17-year-olds as in women between 18 and 25 years, and, because Bekker’s research included teens, it means there’s enough data for medicines regulators to look to also register lenacapavir for this group.
A second lenacapavir study revealed that the jab, medicine known as pre-exposure prophylaxis, (because it’s taken before someone gets exposed to the virus), worked almost as well for gay and bisexual men, as well as for transgender people, as it did for young women.
The findings of the two studies were so promising that Pepfar and the Global Fund for Aids, TB and Malaria announced in December they had signed a product supply deal with lenacapavir’s manufacturer, Gilead Sciences, to buy enough of the drug for two million people over the next three years to hand out in countries supported by these donors, including South Africa, until cheaper generics become available in 2027.
Will Pepfar funds be used for PrEP?
Up until the end of 2024, Pepfar funded 91% of preventive HIV medication — mainly a daily pill — in poorer countries where it works, the epidemiologist and director of the Duke Global Health Institute, Chris Beyrer told the Croi conference during a plenary session.
Although Pepfar didn’t pay for the actual medicine in South Africa — provincial health departments buy it — it did support demand creation campaigns to get the preventive daily pill to people.
The national health department’s goal is to get about 700 000 new HIV-negative people to use the anti-HIV pill at least once in 2025, a department spokesperson says. Pepfar offered to support about 520 000 of these “initiations”, health department data shows.
The Pepfar-Global Fund-Gilead lenacapavir deal would essentially build on the payoffs of Pepfar’s and the Global Fund’s previous investments.
But now that agreement hangs in the balance.
Not just because the Trump administration has ended USAid projects, but because, over the past 11 weeks, the US government has made it clear: it no longer considers HIV prevention projects to be lifesaving, and that pre-exposure prophylaxis — in short known as PrEP — can only be paid for with US funds if it’s given to pregnant and breastfeeding women to stop them from infecting their babies.
Experts warn that’s a dangerously unscientific way to deal with new infections, as it cuts out groups of people, such as transgender women, gay and bisexual men, injecting drug users, sex workers and non-pregnant young, African women, who have a much higher risk of contracting HIV than the general population.
Beyrer explains: “The reality is that you can’t pick and choose which kinds of populations you care about and which you don’t in a pandemic. You have to deal with everybody who’s affected.
You don’t have a choice because that’s where the virus is.”
What now — will poorer countries still get the six-monthly jab?
The Global Fund confirmed to Bhekisisa in March that it plans to go ahead with the lenacapavir deal, with or without Pepfar, even if it has to buy fewer doses than originally planned. “We cannot afford to miss such a game-changing opportunity,” executive director Peter Sands said.
The drug is likely to get approved for HIV prevention use in the United States by June 19, with a recommendation of the World Health Organisation (WHO) shortly thereafter, that will help countries develop national introduction guidelines.
South Africa’s application forms part of a joint review by the European Medicines Agency, WHO and our medicines regulator, the South African Health Products Regulatory Authority (Sahpra) as part of a system called EU Medicines for All. The EU Medicines For All application was made in February, and takes between seven and nine months. Once that process is done, says Sahpra’s CEO, Boitumelo Semete-Makokotlela, South Africa needs to also do a local assessment, which takes about three months.
But, even though the Global Fund plans to stick to its commitment, the Trump administration’s funding cuts means the South African government, other countries and philanthropic foundations may also have to step in to buy lenacapavir, says Warren. “In 44 years of this epidemic we’ve never had an opportunity like lenacapavir, we need to get as much of the medicine as possible to people who need it.”
How much the medicine will cost is, however, unclear.
The price at which Gilead would sell the medication to Pepfar and the Global Fund has been kept secret, and, although Gilead had already announced in October that it will sell its branded lenacapavir at a special price to 18 “high incidence, resource-limited countries” (of which South Africa is one) until generics come onto the market, that price, too, hasn’t been revealed.
Study: up to R2 152 per LEN dose will be cost effective in SA
But a modelling study released at Croi does give an indication at which price the medicine would be worth the South African health department’s while to buy.
The research shows if lenacapavir is sold to South Africa at between $117 and $225 (about R2 238–R4 304) per person a year — about 3.5 to 6.8 times what the health department pays for a daily anti-HIV pill (R629.40 per person per year) — it would be as cost-effective as scaling up the pill to one to three million new people using it a year.
But the national health department’s head of medicine procurement, Khadija Jamaloodien, says the National Essential Medicines List Committee, NEMLC, first needs to do a technical review and its own costing analysis. However, since the committee members’ terms expired in March this year, a new committee will only be appointed later this month or in early May to continue with the work.
“Currently, no cost estimate for lenacapavir — the actual price at which Gilead would sell it — is available in South Africa,” Jamaloodien says. “Until we have that, we can’t start negotiating; we can also only start to negotiate once the product is registered.”
Would lenacapavir work better than the daily pill?
By the end of 2024, 1.78-million HIV-negative people in South Africa had used the daily pill, also called oral PrEP, at least once, making the country’s programme the world’s largest; about 70% of users are women between the ages of 15 and 34.
The pill works well to stop people from getting infected with HIV — if it’s taken correctly, it can lower someone’s chances of getting HIV through sex, to close to zero.
But studies show many people find it hard to stick to a daily dose, especially young women. And even if they do take it consistently, they often don’t stay on oral PrEP for longer than a month.
That’s where lenacapavir comes in.
It’s long-acting, so the periods in between doses are much longer — six months compared to each day. The results of a study released at Croi, that compared young women’s preferences between two types of daily preventive pills and lenacapavir, show many prefer the jab, particularly girls between the ages of 16 and 17 years, who said they liked the “worry-free” and “discreet nature” of the six-monthly jab (pills they had to take home and hide, while lenacapavir they could have injected at a clinic).
One participant said: “I will be injected [with lenacapavir]. Taking pills every day … sometimes there is that one day you will forget. So, the six-month [intervals] are not a problem … I will only go twice in a year [for the PrEP injection] and after that I will be free.”
LEN could end Aids in SA by 2032
The authors of the Croi cost-effectiveness analysis showed that if each person who needs lenacapavir gets between one and four six-monthly injections, over six months to two years, the medication could slash new infections by between 27–41% over 20 years, bringing down the rate at which people get infected in South Africa to such low levels that Aids would be ended as a public health threat ten years earlier than without the shot — by 2032 instead of 2042.
Ending Aids as a public health threat means reaching a stage where fewer people are getting newly infected with HIV than the number of people with HIV who are dying, increasingly for other reasons than HIV, for example old age, explains Gesine Meyer-Rath, one of the authors of the study. In the model it is represented by HIV incidence falling to below 0.1%.
In 2024 South Africa had about 178 000 new infections a year, with 105 000 people with HIV dying of any cause during that period.
But for lenacapavir to turn this around and end Aids by 2032, Meyer-Rath says, between two and four million HIV-negative people in the country would need to use the jab every year over the next eight years.
Where are we headed?
Stopping Pepfar-funded PrEP programmes in East and Southern Africa, Beyrer says, will be disastrous. “I think it’s fair to say that what we’re looking at is really a collapse of biomedical prevention,” he told Bhekisisa.
The only people who are going to be continued on PrEP with Pepfar dollars are pregnant and lactating women. For so many other people at risk, they’re abruptly going to go off unless the in-country governments are going to pick it up.
Some governments will, many will not. I hope the South African government would — including in the case of lenacapavir.”
This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.