More than 300 government clinics are in line for the first roll-out of the widely-hailed twice-yearly anti-HIV jab lenacapavir within the next two years – with hopes that a cheaper generic will become available next year – marking a major turning point in the fight against HIV/Aids.
The Health Department plans to make lenacapavir available at the clinics between April 2026 and March 2028, and by April 2027, anticipates that it could start to use government money to buy cheaper generics, which are expected to become available early that year, writes Mia Malan for Bhekisisa.
Senior technical advisor for HIV prevention Hasina Subedar said the department would buy the original, branded version of lenacapavir – from Gilead Sciences – with R513m ($29.2m) of its larger three-year Global Fund for HIV, TB and Malaria grant of R7.1bn ($402 450 343), which kicks in on 1 October.
In July, the Global Fund said it would like to deliver a shipment for at least one of the countries before year-end, and Health Minister Aaron Motsoaledi, in his budget vote on the same day as that announcement, vowed to make South Africa that country.
According to a letter sent by the Fund to the Health Department, it would need to place its first order by 30 September. The funds are enough to put 456 396 people on the medicine over two years, said Subedar, “but we don’t yet know for how long people will be prepared to stay on the medicine”.
LEN, taken every six months, is a capsid inhibitor, meaning it interferes with HIV’s shell around its genes – called a capsid – in a way that makes it hard for the virus to get into the immune cells and replicate itself.
In April 2027, the department will start to use government money to also buy cheaper generics, expected to become available early that year, after Gilead issued six companies – Dr Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, 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 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 the daily HIV prevention pill will be the first to stock the shot, to ensure the constrained supplies are in facilities where they will not sit on shelves, but will be offered to people who will benefit most.
By the end of April, 1.9m people had taken the daily pill – available free at 97% of primary healthcare clinics – at least once since its introduction in 2016.
Clinics that have excelled at handing out the pill are in Johannesburg, Tshwane, Ekurhuleni, eThekwini and Gert Sibande (Mpumalanga), but facilities in Limpopo, the Western Cape and the Free State, have been particularly hard hit by America’s HIV funding cuts, Health Department data show.
Although South Africa buys the daily HIV pill with government funds, the United States funded non-profits, as well as some department staff like lay counsellors and data capturers, who helped with the administration of rolling out the pill.
“In some 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 non-profits, and, as a result, uptake declined,” said Subedar.
“Initiations” (new people starting on the pill) in the Western Cape, for instance, declined by between 32% and 50% in the first three months of 2025, compared with the same period in 2024.
SAHPRA could register LEN in October
The department’s plans depend, among other factors, on LEN being registered in time by the SA Health Products Regulatory Authority (SAHPRA).
EU-M4All, a European registration programme in which SAHPRA took part and which helps countries like South Africa to review data faster, approved the drug on 24 July.
SAHPRA’s CEO, Boitumelo Semete-Makokotlela, said the country has 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 said SAHPRA was doing an “expedited review”, so registration could happen before deadline.
How much will Gilead charge?
The Fund had asked the department to budget for countries for R1 054 ($60) per patient per year, but that isn’t the actual price at which Gilead Sciences sells the drug to the Fund: that price is being kept secret.
South Africa is one of 10 countries – with Zimbabwe, Zambia, Mozambique, eSwatini, Uganda, Lesotho, Nigeria and Kenya – selected by the Global Fund as “early adopters” of lenacapavir.
The transparency with the price of LEN is an aspect with which the department is “uncomfortable”, said head of procurement Khadija Jamaloodien. The fund will cover the difference between the actual sales 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 the Treasury requires us to follow with tenders, which includes revealing the price at which the medicine is bought,” Jamaloodien said.
But ultimately, some experts told Bhekisisa, the department may have to settle for the secret deal if it wants to place an order by 30 September, the deadline set by the Global Fund for the nine countries to order their first batch of shots.
LEN is sold in the US for $28 218 per person per year under the trade name Yeztugo.
Gilead hasn’t announced an introductory price for countries in Africa that would like to buy the medicine directly, but the “rumoured” price at launch was $100 per patient per year in the public sector, according to international health organisation Avac – about two-and-a-half times the public sector price of the daily HIV prevention pill.
Groups prioritised for LEN
Subedar said although anyone who asks for LEN at a government clinic should be given the product, those with a higher chance of contracting HIV will require special attention and be encouraged to consider taking LEN.
Teen girls and young women between 15 and 24 will be prioritised for LEN bought with Global Fund money.
Such young women in South Africa are contracting HIV much faster than anyone else – 122 of them get infected with the virus each day – according to stats from the Thembisa model, which the department uses to plan its programmes.
As a result, four out of every 10 new infections in SA are in this group, even though they comprise only about 8% of the total population.
LEN could change the future — if enough people take it
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 department had hoped for have been stopped by the pill, mainly because not enough people take it and users find it hard to stick to the daily medication – and then don’t use it correctly.
Lenacapavir, on the other hand, only has to be taken once every six months, and 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 annually.
A Wits University modelling study estimates that if between 2m and 4m South Africans take LEN each year for eight years, the jab could end Aids as a public health threat by 2032. By then the country would have reached a 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, SA had 178 000 new infections per year, with 105 000 HIV+ people 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 those numbers, and generics will only become available in 2027, the goal is unlikely to be reached.
The best we can do now, said Yogan Pillay, who heads up HIV and TB service delivery at the Gates Foundation, is to ensure 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 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 production costs if the amount of lenacapavir made by the company isn’t bought.
Unitaid, hosted by the WHO, will also work with some of the generic companies to make sure generics are made “in the shortest amount of time and the lowest possible price”, said spokesperson Kyle Wilkinson.
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, followed by Zambia, Uganda and Nigeria. “But it’s important to remember generic manufacturers aren’t charities, they have profit margins,” said executive director Mitchell Warren.
“We don’t know that all six who got licences will make it to the market, but because we hope 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.”
Importance of choice
Including lenacapavir in the country’s HIV prevention toolkit will offer people at risk of infection more choices for PrEP, showed findings from Project PrEP, an implementation study by the Wits RHI, which found there is a strong demand for long-acting injectable HIV prevention methods.
Health-e News reports that the study was conducted last year among participants aged 15 and older, who were offered the option of the daily oral PrEP. Access was later expanded to include the monthly dapivirine vaginal ring. In October, long-acting injectable cabotegravir (CAB-LA) was included in the study – the first two shots must be given a month apart, thereafter one injection is needed every eight weeks.
“There is a demand for long-acting injectable PrEP. Among more than 3 800 HIV negative individuals offered a choice of three prep options at enrolment, most (65%) chose cabotegravir, while 25% opted for oral PrEP; 2% chose the ring, and 8% declined a method,” said Catherine Martin, senior technical specialist at Wits RHI, who presented these findings at the IAS 2025.
“We’ve learned that one product doesn’t fit all of the people all the time. When CAB-LA was introduced, almost half of the oral PrEP users chose to stay with oral PrEP, while 46% switched to cab. Among ring users, 59% switched to cab, but 31% remained on the ring.”
See more from MedicalBrief archives:
‘Game-changing’ lenacapavir roll-out hangs in the balance
Lenacapavir demonstrates efficacy in people with highly resistant HIV
Gilead in talks with SAHPRA to register twice-yearly anti-HIV jab