The health department anticipates that it could start to use government money to buy cheaper generics of anti-HIV jab the lenacapvir by April 2027. (Unsplash)
The health department plans to make the twice-a-year anti-HIV jab, lenacapavir, available at more than 300 government clinics in health districts with high rates of new HIV infections between April 2026 and March 2028, says the department’s senior technical advisor for HIV prevention, Hasina Subedar.
The department will buy the original, branded version of lenacapavir, made by the pharmaceutical company Gilead Sciences, with R513 million of its larger three-year Global Fund for HIV, TB and Malaria grant of R7.1-billion, which kicks in on October 1.
In July, the Global Fund said in a press release that it would like to deliver a shipment for at least one of the countries before the end of the year — and Health Minister Aaron Motsoaledi, in his budget vote, delivered on the same day as the Global Fund announcement, vowed to make South Africa that country.
According to a letter the fund sent to the health department, it would need to place its first order through the fund by September 30. The department calculated that the funds are enough to put 456 396 people on the medicine over two years, says Subedar, but she adds: “We don’t yet know for how long people will be prepared to stay on the medicine.”
Lenacapavir, called LEN for short, is a type of PrEP (pre-exposure prophylaxis) for HIV infection, which is when medicine that is normally used to treat HIV-infected people is given to HIV-negative people to stop them from contracting the virus.
LEN, taken once every six months, is a capsid inhibitor, which means it messes with the shell around HIV’s genes, called a capsid, in a way that makes it hard for the virus to get into someone’s immune cells and make copies of itself.
Scientists reckon, if enough people take it, LEN could halt South Africa’s HIV epidemic, after studies released in 2024 showed near complete protection for HIV-negative people taking it.
In April 2027, the department will also start to use government money to buy cheaper generics, which are expected to become available early that year, after Gilead issued six companies — Dr Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited and Hetero and Mylan, a subsidiary of Viatris — with voluntary licences in October to make generics.
Subedar told Bhekisisa at the Southern African HIV Clinicians Society’s conference in Cape Town last week that, if tenders for generics are in place by 2027, the health department could expand the availability of LEN to more of the country’s 3 484 public primary healthcare facilities.
Which districts will get LEN first?
Subedar says “high-performing” clinics that have done well with handing out a daily HIV prevention pill, despite the Trump administration’s funding cuts this year, will be the first ones to stock the shot.
“We need to make sure that our constrained supplies are stocked in facilities where it’s not going to sit on the shelves but will, instead, be utilised and offered to people who will benefit most from it,” explains Subedar.
By the end of April 1.9 million people had taken the daily pill — it is available for free at 97% of primary healthcare clinics — at least once since it was introduced in 2016, according to health department data.
Clinics that have excelled at handing out the pill, also called oral PrEP, are in the City of Johannesburg, City of Tshwane, Ekurhuleni in Gauteng, eThekwini in KwaZulu-Natal and Gert Sibande in Mpumalanga.
Facilities in Limpopo, the Western Cape and the Free State have been particularly hard hit by the US’s HIV funding cuts, health department data shows. Although South Africa buys the daily HIV prevention pill with government funds, the US-funded nonprofits, and some of the health department’s staff, such as lay counsellors and data capturers, who helped with the administration of rolling out the pill, were affected.
“In some of the clinics that provided the pill, there seemed to have been an over-reliance on the US government’s support, such as for the services of nonprofits and, as a result, the uptake of the pill declined,” Subedar says.
“Initiations” (new people who are started on the pill) in the Western Cape, for instance, declined by between 32% and 50% in the first three months of 2025, when compared to the same period in 2024, health department figures show.
Says Subedar: “We first need to support such clinics to strengthen oral PrEP services before we can use them for LEN roll-out.”
Sahpra could register LEN in October
The department’s plans, however, depend, among other factors, on LEN being registered in time by the country’s medicines regulator, the South African Health Products Regulatory Authority, Sahpra. Without registration, the medicine can’t be used or sold in the country.
EU-M4All, a European registration programme in which Sahpra took part and that helps countries like South Africa to review data faster, approved the drug on 24 July.
Sahpra’s CEO, Boitumelo Semete-Makokotlela, told Bhekisisa the country now has 90 work days — up until 26 November — to use the review in combination with the information that Gilead submitted to Sahpra to register the drug locally.
Donors, policymakers and activists are, however, hoping for registration in October.
Semete-Makokotlela says Sahpra is doing an “expedited review”, so it’s possible that registration could happen before the mid-November deadline.
How much will Gilead charge SA for LEN?
In a letter, which Bhekisisa has seen and the health department confirmed the contents of in July, the fund asked the department to budget for countries for R1 054 ($60) per patient per year, but that isn’t the actual price at which lenacapavir’s maker, Gilead Sciences, sells the drug to the fund; that price is being kept secret.
South Africa is one of nine countries — the others are Zimbabwe, Zambia, Mozambique, Eswatini, Uganda, Lesotho, Nigeria and Kenya — that the Global Fund selected as “early adopters” of lenacapavir.
The department is uncomfortable with transparency on the price of LEN, its head of procurement, Khadija Jamaloodien, told Bhekisisa. The fund will cover the difference between the actual sale price and the $60 with money from the Children’s Investment Fund.
“We have a transparent pricing system, guided by the Public Finance Management Act. Even if we procure medicine with Global Fund money, we have to follow the same rules that the treasury requires us to follow with tenders, which includes revealing the price at which the medicine is bought,” Jamaloodien explained.
But, in the end, some experts told Bhekisisa, the health department might have to settle for the secret deal if it wants to place an order by September 30, the deadline that the Global Fund set for the nine countries to order their first batch of shots.
LEN for HIV prevention is sold in the US for $28 218 (around R505 300) per person per year under the trade name Yeztugo.
Gilead hasn’t announced an introductory price for countries in Africa that want to buy the medicine directly from them, but the price at launch is widely rumoured to be $100 per patient per year in the public sector, according to the international health organisation, Avac, which is about 2.5 times the public sector price of the daily HIV prevention pill.
Groups that will be prioritised for LEN
Subedar says although anyone who asks for LEN at a government clinic should be given the product, groups that have a higher chance of getting HIV than the general population will require special attention and be encouraged to consider taking LEN.
Teen girls and young women between the ages of 15 and 24 will be prioritised for LEN bought with Global Fund money.
In South Africa, young women are contracting HIV much faster than anyone else — 122 of them get infected with the virus each day — figures from the country’s Thembisa model, which the health department uses to plan its programmes, shows.
As a result, 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.
When lenacapavir was tested on teen girls and young women between the ages of 16 and 25 in South Africa and Uganda results showed not a single one of the 2 134 study participants who received the six-monthly injection contracted HIV.
Other groups that will be prioritised are gay and bisexual men, transgender people, sex workers and pregnant and breastfeeding women.
The health department will work with community organisations, co-design campaigns with high-risk groups and use social media and radio stations to inform people about LEN and help them become aware of their risk of contracting HIV.
Why LEN could be a gamechanger
Although close to 40% of the world’s oral PrEP users live in South Africa, and the country has done considerably better than many others with roll-out, not nearly as many infections as the health department had hoped for have been stopped by the pill. This is mainly because not enough people take it and users find it hard to stick to the daily medication and don’t use it correctly.
“We’ve struggled to keep people on oral PrEP for as long as they need it. We’re not even sure if they stop taking it because their level of risk decreased or because they simply became disinterested,” says Subedar.
Lenacapavir, on the other hand, only has to be taken once every six months, and although we don’t yet know how things will play out in real life, scientists are hopeful that far more people will be prepared to use the jab — and stay on it for as long as they need it, as they would only need to visit a health facility twice a year.
A Wits University modelling study released in March estimates that, if between two and four million people in South Africa take LEN each year for the next eight years, the jab could end Aids as a public health threat by 2032. By then the country would have reached the stage where fewer people are getting newly infected with HIV than the number of HIV-positive people dying (increasingly for other reasons than HIV, for example, old age).
In 2024 South Africa had 178 000 new infections per year, with 105 000 people with HIV dying of any cause during that period. So in that year, there were 73 000 new HIV infections, more than HIV-positive people dying.
But because Global Fund money for LEN isn’t nearly enough to cover two to four million people a year — it will cover only between 9% and 19% of such a group — and generics will only become available in 2027, that goal is highly unlikely to be reached.
The best we can do now, says Yogan Pillay, who heads up HIV and TB service delivery at the Gates Foundation is to make sure there aren’t delays with generic production.
Pillay is also the former deputy director general who was in charge of HIV at the health department.
The foundation is working with one of the six companies that received voluntary licences to help the company develop the facilities and skills required to produce generic LEN fast enough to go to market with its product by early 2027. The foundation will also undertake to recover the cost of production in case the amount of lenacapavir that the company made isn’t bought.
Unitaid, an organisation hosted by the World Health Organisation, will also be working with some of the companies to make sure generics are made “in the shortest amount of time and the lowest possible price”, Unitaid spokesperson Kyle Wilkinson told Bhekisisa.
Both the Gates Foundation and Unitaid will announce the names of the companies they’re working with within the next couple of weeks.
Avac says South Africa will be the world’s top LEN market, with Zambia, Uganda and Nigeria to follow. “But it’s important to remember generic manufacturers aren’t charities, they have profit margins,” says executive director, Mitchell Warren.
“We don’t know that all six who got licences will make it to the market, but because we hope that there will be a few at least, they will be competing for the market, which will drive down prices and eventually get us to the goal of making LEN available at the same price as the daily HIV prevention pill.”
The Gates Foundation is quoted in this story. Bhekisisa gets funding from the Gates Foundation, but the foundation doesn’t exercise editorial control over what we publish.
This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.