South Africa’s Plan to Combat HIV with Lenacapavir
South Africa is aiming to end the AIDS epidemic by 2043 through the use of a twice-yearly HIV prevention jab called lenacapavir (LEN). The government has proposed that local pharmaceutical companies begin producing generic versions of the jab from 2027 onwards, which would help fill the gap in the number of doses needed. However, this plan faces a significant challenge: none of the companies involved have a license from Gilead Sciences, the inventor of LEN, to manufacture the drug.
The South African government estimates that it will need between one and two million doses of LEN per year to achieve its goal. Currently, the country receives about 500,000 shots annually from the Global Fund for 2026 and 2027. This number is far below what is required to make a meaningful impact on new HIV infections.
HIV-negative individuals can take LEN, a highly effective jab registered in South Africa in October, once every six months to prevent infection. In 2024, South Africa reported over 170,000 new HIV infections, the highest number for any single country in the world.
In 2026 and 2027, South Africa will receive donated LEN doses paid for by the Global Fund to start and maintain treatment for 456,360 people, totaling 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 scheduled to arrive in February, though the date could be moved forward.
Although South Africa is receiving 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 needed to make a sufficient dent in new HIV infections to end the epidemic by 2043. Generics are expected to become available in 2027, and the health department plans to buy them for the same price as a daily HIV prevention pill from two Indian manufacturers. However, South Africa may still need far more doses than what the companies can provide.
The government is prepared to buy generics rather than relying solely on donations, as it already purchases all its supplies of the daily prevention pill. Health Minister Aaron Motsoaledi announced at a Sanac meeting in October that the health department will start buying generic LEN in 2027 and will “earmark 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.”
Challenges in Local Production
The government’s local production plan aims to ensure South Africa has enough LEN and an uninterrupted supply of it. Glaudina Loots, director for health innovation at the department of science, technology, and Innovation, told Bhekisisa that 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,” she said.
However, there is a major complication: none of the companies involved—Aspen Pharmacare, Kiara Health, Adcock Ingram, and Pharma Q—have a license from Gilead Sciences to manufacture LEN. Gilead gave six companies such licenses, mostly in India, in October 2024. In South Africa’s case, three companies were evaluated but failed the test.
Gilead wants companies to manufacture LEN from start to finish, according to Thembisile Xulu, head of South Africa’s National Aids Council (Sanac) and leading negotiations. But South African companies aren’t able to do that because they can’t make the active pharmaceutical ingredient (API), which makes the jab work. Instead, they would need to import it and then assemble the product 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.”
Expert Collaboration and Future Plans
The state departments working together with drug companies include the health department, department of trade, industry and competition, department of science, technology, and Innovation, and the national treasury. Expert advice will be provided by the South African Medical Research Council, Unitaid, and the Medicines Patent Pool, a United Nations-backed organization helping countries like South Africa access lifesaving medicines.
Xulu concludes: “We are working towards a submission for a voluntary license that allows South African manufacturers to import the API for Gilead to assess by July (quarter two of 2026). Whether we’d be able to make LEN by 2027, is dependent on Gilead.”
Calculating the Need for LEN
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. For example, 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, 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 as a public health threat, the incidence rate needs to be reduced to 0.1% or below. For 2024, with 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.
South Africa’s Plans for LEN Production
Loots says 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 says, “we will position South Africa as a regional pharmaceutical hub with full sovereign manufacturing capability for LEN.”
Wendy Cupido, general manager for Gilead Sciences in South Africa, said at the Sanac meeting that the company “would be pleased to consider an additional voluntary license,” but Xulu says, even after “extensive engagements the bottom line is Gilead has not committed to a license.”
Gilead’s senior director for global affairs, Caroline Almeida, responded to Bhekisisa’s questions on Monday morning: “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 from around the world have called on the South African government to begin taking steps to issue a compulsory license—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 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 around 30% and between 2028 and 2029 to 100%.
South Africa’s next LEN shipment has not been yet scheduled, but Ndlovu says shipments are expected once every six months.
