Aids activists say that if South Africa was able to roll out the twice-yearly anti-HIV jab to enough HIV-negative people, new infections could slow down fast enough to end Aids by 2032.
But, said Mitchell Warren, executive director of the New York based advocacy organisation Avac, the Trump administration “has now created an incubator for disease outbreaks”.
In fact, writes Mia Malan for Bhekisisa, he added that “If HIV could talk, it would say ‘thank God for the US President, because I can now spread more easily’”.
The scenario and circumstances of the non-reathorisation of Pepfar by Congress on 24 March had unfolded with “a striking contradiction”, said Jirair Ratevosian, a former Pepfar head of staff – two weeks after the release of ground-breaking HIV studies at the Conference on Retroviruses and Opportunistic Infections, in San Francisco.
Unfortunately, said Ratevosian, currently an associate research scientist at Yale University, the “political and financial commitment to scaling up these innovations is now faltering”.
What does no reauthorisation mean?
Although the failure to reauthorise Pepfar doesn’t mean the fund ceases to exist – there’s an approved budget until 30 September – it does mean the rules for how that money gets spent have fallen away.
Trump and Co are now able to spend the budget however 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.
“Pepfar,” said Ratevosian, “now sits in purgatory.”
“The real crisis is that the state department isn’t releasing those funds to implementing partners (non-profits and government projects) funded by Pepfar”, he told Bhekisisa.
“We still don’t know how the government will land its foreign aid review by 20 April. 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.”
In July, Linda-Gail Bekker, who heads the Desmond Tutu Health Foundation, released the results of a study showing that not one single teen or young woman who used the anti-HIV six-monthly shot – lenacapavir – had contracted HIV.
Lenacapavir works by stopping HIV from making more copies of itself and so getting into someone’s immune cells.
What especially excited scientists was that the findings showed new infections among the group of people in East and Southern Africa with the highest chance of getting the virus – young women between 15 and 24 – could potentially be slowed down dramatically.
Around 122 such girls and women got infected with HIV in South Africa daily in 2023, show figures from the country’s Thembisa model, which the Health Department uses to plan its programmes. So about four out of every 10 new infections are in this group, even though they comprise only about 8% of the total population.
At the US conference, Katherine Gill, who works with Bekker, revealed the results of a study that showed lenacapavir works as well in 16- to 17-year-olds as in women between 18 and 25, and, because Bekker’s research included teens, it means there are enough data for medicines regulators to also register lenacapavir for this group.
A second lenacapavir study revealed that the pre-exposure prophylactic jab worked almost as well for gay and bisexual men, and 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 that they had signed a product supply deal with lenacapavir’s manufacturer, Gilead Sciences, to buy enough of the drug for 2m people over the next three years to supply to 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, epidemiologist and director of the Duke Global Health Institute, Chris Beyrer, told the US conference.
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 goal of the National Department of Health (NDoH) is to get around 700 000 new HIV-negative people to use the anti-HIV pill at least once in 2025. Pepfar offered to support about 520 000 of these “initiations”.
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 has made it clear: it no longer considers HIV-prevention projects to be lifesaving, and pre-exposure prophylaxis (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 it’s a dangerously unscientific way to deal with new infections, cutting out groups of people, like 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 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.”
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,” said executive director Peter Sands.
The drug is likely to get approved for HIV prevention use in the US by 19 June, 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 the South African Health Products Regulatory Authority (SAHPRA) as part of a system called EU Medicines for All. This application was made in February, and takes between seven and nine months.
Once that process is done, said 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 mean the South African Government, other countries and philanthropic foundations. may also have to step in to buy lenacapavir, said 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 would sell its branded lenacapavir at a special price to 18 “high incidence, resource-limited countries” (of which South Africa is one) until generics come on to the market, that price, too, hasn’t been revealed.
Up to R2 152 per dose – cost-effective in SA
A modelling study gives an indication of at what price the medicine would be worth the NDoH’s while to buy.
The research shows if lenacapavir is sold to SA at between $117 and $225 per person per year – about 3.5 to 6.8 times what the department pays for a daily anti-HIV pill – it would be as cost-effective as scaling up the pill to 1m to 3m new people per year.
But the NDoH’s head of medicine procurement, Khadija Jamaloodien, said 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,” she said. “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 pill?
By the end of 2024, 1.78m HIV-negative people in South Africa had used the daily pill (oral PrEP) at least once, making the country’s programme the world’s largest; about 70% of users are women between 15 and 34.
The pill works well to stop people from getting infected with HIV if it’s taken correctly, 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.
Being long-acting, the periods between doses are much longer, and the results of a study released at the US conference, comparing young women’s preferences between two types of daily preventive pills and lenacapavir, showed many preferred the jab, particularly those aged 16 and 17.
They liked the “discreet nature” of the six-monthly jab (pills they had to take home and hide, while lenacapavir they could have injected at a clinic).
The authors of the 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% and 41% over 20 years, reducing infections to such low levels that Aids would be ended as a public health threat 10 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, said 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 per 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 said, between 2m and 4m HIV-negative people would need to use the jab annually over the next eight years.
Stopping Pepfar-funded PrEP programmes in East and Southern Africa, Beyrer said, would be disastrous. “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. But for so many other people at risk, they’re abruptly going to go off the drug unless the in-country governments pick it up.
Some governments will, many will not.”
HIV modelling study
See more from MedicalBrief archives:
Lenacapavir demonstrates efficacy in people with highly resistant HIV
Gilead in talks with SAHPRA to register twice-yearly anti-HIV jab
Efficacy of six-monthly anti-HIV jab confirmed in second study