The government says it could fill the potential gap in the number of doses of the HIV prevention jab Lenacapavir (LEN) needed to end Aids by 2043 by getting a group of local pharmaceutical companies to produce generic shots from 2027 onwards, but there’s one hitch – and that involves making the API, writes Mia Malan for Bhekisisa.
In 2026 and 2027, South Africa will receive donated LEN doses paid for by the Global Fund to Fight Aids, TBs and Malaria, to start and keep 456 360 people on LEN – a total of 974 450 doses – over two years, according to Health Department data.
The first shipment of 115 000 doses for distribution at 360 government health clinics is due to arrive in February, the National Department of Health’s Deputy DG for HIV, Nonhlanhla Fikile Ndlovu, told Bhekisisa, though it’s possible that the arrival date could be moved forward.
Although South Africa is getting more than three quarters of the LEN doses that the Global Fund is donating to nine countries, this is still far short of the actual number (enough doses for between 1m and 2m people to each take it at least once a year) modelling scientists have calculated is needed to make a sufficient dent in new HIV infections to end the epidemic by 2043.
Generics are expected to become available in 2027 – which the NDoH will be able to buy for the same price as a daily HIV prevention pill – from two Indian manufacturers, but far more doses are needed than what the companies can provide.
The good news is the government is prepared to buy generics, rather than only relying on donations – the country already buys all of its supplies of the daily prevention pill.
Health Minister Aaron Motsoaledi announced at a National Aids Council (SANAC) meeting in October that the department will start buying generic LEN in 2027 and that it 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 local production plan’s goal is to make sure South Africa has enough LEN, as well as an uninterrupted supply of it, he said.
Glaudina Loots, Director for Health Innovation at the Department of Science, Technology & Innovation, said: “The goal is to be ready by 2027. It’s a collective 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 the injection’s creator, Gilead Sciences, to do so.
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 therein lies the hitch.
Gilead wants companies to manufacture LEN from start to finish, said head of SANAC Thembisile Xulu, who is leading the negotiations.
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, and would, instead, need to import it and then put the product together locally.
“It’s a complex 28-step process to make the API,” Loots said. “We need a different plan until 2029, so that we have time to get ready to make the API.”
Working with the drug companies are the Health Department, the Department of Trade Industry & Competition, the Department of 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.
“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 (quarter two of 2026),” added Xulu.
“Whether we’d be able to make LEN by 2027 is dependent on Gilead.”
How much LEN does SA 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 (incidence rate), the fewer people need to get the medication to prevent one infection, because when there are lots of people who can infect each other, the chances are higher than the people taking the medication could potentially be one of those who would have contracted the virus, had they not taken it.
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.
Although South Africa’s overall HIV incidence rate is 0.32%, certain groups and health districts have incidence rates as high as 4.5%.
For Aids to end as a public health threat, the incidence rate needs to be reduced to 0.1% or below. For 2024, when 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 and 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, between 35 and 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 67m 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 end Aids only in 2043 (a total of 31m doses needed between now and 2043).
South Africa’s Global Fund LEN doses therefore only constitute about 3% (974 450/31m = 3.14%) of the total number of doses 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 SA’s plans entail?
Loots said South Africa could potentially be ready to make LEN’s API by 2029 by using the facilities of CPT Pharma, which are in the process of being upgraded. Wits University’s advanced drug delivery platform and the API cluster of the Council for Scientific and Industrial Research will provide expert advice.
“In essence,” Loots said, “we will position South Africa as a regional pharmaceutical hub with full sovereign manufacturing capability for LEN.”
Wendy Cupido, GM for Gilead Sciences in South Africa, said at the SANAC meeting that the company “would be pleased to consider an additional voluntary licence”, but Xulu said that even after “extensive engagements, the bottom line is Gilead has not committed to a licence”.
Gilead’s senior director for Global Affairs, Caroline Almeida, said: “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.”
Meanwhile, HIV activists worldwide have called on the South African Government to begin taking steps to issue a compulsory licence – when a government allows someone else to produce a patented product or process without the consent of the patent owner – against Gilead.
Ndlovu said the NDoH plans to start rolling out the first shots at the latest by 1 April at the 360 clinics identified in six provinces: this covers about 10% of the country’s clinics.
In 2027, when cheaper generics are expected to come to the market, the 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 been yet scheduled, but Ndlovu said these are expected every six months.
See more from MedicalBrief archives:
Twice-yearly anti-HIV jab added to SA’s Essentials Medicines List
SA firms lose out on lenacapavir production
Lenacapavir to be rolled out via Pepfar to selected countries
‘Game-changing’ lenacapavir roll-out hangs in the balance