The South African government is adamant that it could fill the potential gap in the number of doses it will need of the twice-yearly HIV prevention jab to end Aids by 2043 — enough for between 1-million and 2-million people per year — by getting a group of local pharmaceutical companies to make generic shots from 2027 onwards.
HIV-negative people can take the almost foolproof jab, lenacapavir (LEN), which was registered in South Africa in October, once every six months to stop themselves from getting HIV. South Africa had just over 170,000 new HIV infections in 2024, the highest number for a single country in the world.
In 2026 and 2027 South Africa will receive donated LEN doses paid for by the Global Fund to Fight Aids, Tuberculosis & Malaria to start and keep 456,360 people on LEN — a total of 974,450 doses — over a period of two years, according to health department data.
[ LEN rollout planOpens in new window ]
The first shipment of 115,000 doses for distribution at 360 government health clinics is scheduled to arrive in February, national health department deputy director-general for HIV Nonhlanhla Fikile Ndlovu tells Bhekisisa, though it’s possible that the arrival date could be moved forward.
Though South Africa is getting more than three-quarters of the LEN doses that the Global Fund is donating to nine countries, this still falls far short of the actual number that modelling scientists have calculated is needed to make a sufficient dent in new HIV infections to end the epidemic by 2043 —namely enough doses for between 1-million and 2-million people to each take it at least once a year.
Generics are expected to become available in 2027 that the health department will be able to buy for the same price as a daily HIV prevention pill from two Indian manufacturers, but South Africa may still need far more doses than the companies are able to provide.
The good news is that the government is prepared to buy generics, rather than just relying on donations — the country already buys all its supplies of the daily prevention pill.
Health minister Aaron Motsoaledi announced at a meeting of the South African National Aids Council (Sanac) in October that the health department will start to buy generic LEN in 2027 and that the department will be “earmarking resources in our medium-term expenditure framework to ensure that once generic versions become available or prices drop we can scale up access without interruption”.
The government’s local production plan’s goal is to make sure that South Africa has enough LEN — and an uninterrupted supply of it.
Glaudina Loots, director of health innovation at the science, technology & innovation department, tells Bhekisisa: “The goal is to be ready by 2027. It’s a collective that we’re putting together so that one pharmaceutical company doesn’t have to struggle through this alone.
“We were able to do it with the mRNA vaccine in South Africa because we pulled the process together. We can do exactly the same with LEN.”
Can we do it?
There is, however, a rather big complication.
None of the companies that will be involved — Aspen Pharmacare, Kiara Health, Adcock Ingram and Pharma-Q — has a licence from Gilead Sciences, the inventor of the lenacapavir (LEN) injection, to make generic shots.
Gilead gave six companies such licences, mostly in India, in October 2024. In South Africa’s case, three companies — Aspen Pharmacare, Pharmacare and Cipla Medpro — were evaluated, but they all failed the test.
And that’s where the hitch lies.
Gilead wants companies to manufacture LEN from start to finish, Sanac head Thembisile Xulu, who is leading the negotiations, tells Bhekisisa.
But South African companies aren’t able to do that, because they can’t make the active pharmaceutical ingredient (API) that makes the jab work. Instead, they would need to import it and then put the product together locally.
“It’s a complex 28-step process to make the API,” Loots says. “We need a different plan until 2029 so that we have time to get ready to make the API.”
The government departments working together with drug companies are health; trade, industry & competition; science, technology & innovation; and the National Treasury.
Expert advice will be provided by the South African Medical Research Council, Unitaid and the Medicines Patent Pool, a UN-backed organisation helping countries like South Africa to find ways to access lifesaving medicines.
Xulu says: “We are working towards a submission for a voluntary licence that allows South African manufacturers to import the API for Gilead to assess by July 2026.
“Whether we’d be able to make LEN by 2027 is dependent on Gilead.”
Wwe will position South Africa as a regional pharmaceutical hub with full sovereign manufacturing capability for LEN
— Glaudina Loots
How much LEN does South Africa need?
Research shows that a marked drop in HIV infections in a community is seen only if HIV prevention medication reaches a lot of people.
The higher the rate of new infections — known as the incidence rate — the fewer people need to get the medication to prevent one infection. When many people can infect each other, the chances are higher that those who take the medication would have contracted the virus had they not taken it.
For example, a study shows that in places where the incidence rate is 3% or more, 33 people need to take prevention medication to stop one HIV infection; in areas with much lower rates, up to 200 people may have to take HIV prevention drugs to stop one new infection.
Though South Africa’s overall HIV incidence rate is 0.32%, certain groups, such as sex workers, teen girls and young women, and gay and bisexual men, as well as certain health districts, have incidence rates as high as 4.5%.
For Aids to end being a public health threat, the incidence rate needs to be reduced to 0.1% or below. For 2024, during which there were 172,994 new HIV infections, that number should therefore be as low as 65,000 new infections if we want to end the epidemic.
Lise Jamieson, a modelling scientist at the Health Economics & Epidemiology Research Office (He2ro) at Wits University, has calculated — for a study that will be published within the next few weeks — that in South Africa 35-65 people need to use LEN to stop one HIV infection.
If most people use LEN for a year (so each person would take two consecutive doses, and turn up for their second dose in time), we will avert one HIV infection for every 35 people using LEN, and end Aids in 2039 (this comes to a total of 67-million doses we need between now and 2039).
But if most people on LEN use the medicine only once (so a single six-month dose), we would need 65 people to use it to stop one new infection, and will end Aids only in 2043 (this comes to a total of 31-million doses we need between now and 2043).
South Africa’s Global Fund LEN doses therefore only constitute about 3% (974,450/31-million = 3.14%) of the total number of doses that we would need to end Aids in 2043 (the more conservative scenario that Jamieson calculated).
Because LEN hasn’t yet been used widely in any country, we don’t know if people will stop using it after one dose or if they will use it for longer periods.
What do South Africa’s plans to make LEN entail?
Loots says South Africa could potentially be ready to make LEN’s API by 2029 by using the facilities of CPT Pharma, which is in the process of being upgraded. Wits University’s advanced drug delivery platform and the API cluster of the Council for Scientific & Industrial Research will provide expert advice.
“In essence,” Loots says, “we will position South Africa as a regional pharmaceutical hub with full sovereign manufacturing capability for LEN.”
Wendy Cupido, GM of Gilead Sciences in South Africa, said at the Sanac meeting that the company “would be pleased to consider an additional voluntary licence”, but Xulu says that even after “extensive engagements the bottom line is that Gilead has not committed to a licence”.
Caroline Almeida, Gilead’s senior director for global affairs, responded to Bhekisisa’s questions, saying: “While end-to-end manufacturing remains our preferred model, we continue to explore opportunities for local formulation in South Africa and have encouraged collaboration with our existing generic partners as a potential first step toward full-cycle production. We are open to partnering with a manufacturer outside South Africa to import the API and complete final formulation locally.” (Read Gilead’s full response).
Meanwhile, HIV activists from around the world have called on the South African government to begin taking steps to issue a compulsory licence — which is done when a government allows someone else to produce a patented product or process without the consent of the patent owner — against Gilead.
Ndlovu says the health department plans to start rolling out the first shots at the latest by April 1 at the 360 clinics that it has identified in six provinces — this covers about 10% of the country’s clinics.
In 2027, the year in which cheaper generics are expected to come to the market, the health department will increase the number of clinics stocking LEN to about 30%, and between 2028 and 2029 to 100%.
South Africa’s next LEN shipment has not yet been scheduled, but Ndlovu says shipments are expected once every six months.
This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.
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