News & Features
27th October 2025 | Marcus Low
An HIV prevention jab that provides six months of protection at a time was given the green light by South Africa’s medicines regulator. The approval helps to clear the way for a limited public sector rollout of the “game-changing” shot set to start in April 2026.
An HIV prevention injection containing the antiretroviral drug lenacapavir has been registered by the South African Health Products Regulatory Authority (SAHPRA), the medicines regulator announced on Monday. The jab, which provides six months of protection at a time, has been hailed by experts as a game-changer in the fight against HIV. The respected journal Science named it its “breakthrough of the year” for 2024.
HIV prevention pills that have to be taken daily are already widely available in South Africa’s public sector, but there is evidence that many people prefer the twice-yearly jabs to the daily pills. This is partly because of the convenience of not having to take a pill every day, but also because some people may not want others to know that they are taking HIV prevention medicines.
“The registration of Lenacapavir is a game-changer, given the high prevalence rate of HIV in South Africa. This product is the most effective HIV prevention measure thus far,” said SAHPRA CEO Dr Boitumelo Semete-Makokotlela in a media statement.
Lenacapavir was registered by SAHPRA around eight months after the drug-maker filed their application in March 2025. This is an unusually fast turn-around – it typically takes well over a year from application to registration. One reason for the rapid approval was that SAHPRA was not working alone. (See this recent Spotlight piece for more on how such “reliance” on other medicines regulators works.)
“The SAHPRA review process was done in collaboration with the European Medicines for All Procedure (EU-M4all),” SAHPRA explained in a statement. “This procedure enables the EMA, together with the participating regulatory authorities, to provide scientific opinions on high-priority medicines, such as Lenacapavir, intended for markets outside the European Union. The benefits of this pathway are to strengthen regulatory systems and accelerate access to essential medicines.”
The SAHPRA statement also specified that the jab “is used to reduce the risk of HIV in adults and adolescents who weigh at least 35 kg, are HIV negative, and are at risk of getting HIV”. SAHPRA also said that lenacapavir should always be used in combination with safer sex practices, such as using condoms, to reduce the risk of getting other sexually transmitted infections.
SA rollout planned
With SAHPRA registration secured, the next step now is for South Africa’s National Essential Medicines List Committee to give the go-ahead to procure the jab. Should the committee give the green light, the focus will shift to the actual procurement and rolling out of the jab.
The Department of Health has indicated that it intends to launch a limited rollout of the new jab at around 10% of public sector clinics in April 2026.
Earlier in October, at a multi-stakeholder roundtable to discuss the country’s readiness to roll out lenacapavir, a health department presentation stated that phase one of the rollout will start in 23 high-incidence districts across six provinces. It will target 360 high-performing public clinics that are already being prepared for implementation.
“Government will provide ongoing support to those using Lenacapavir through reminder systems, community follow-ups and retention programmes to help them stay on treatment,” the presentation reads.
Health Minister Dr Aaron Motsaoledi said in a prepared speech at the round table that the initial rollout will focus on those populations at highest risk of HIV.
“In particular, prioritising pregnant and breastfeeding women (PBFW), adolescent girls and young key populations (AGYW), female sex workers (FSW), and men who have sex with men (MSM), would yield the highest impact,” he said.
The plan is to expand the programme to more clinics in the years that follow.
The prospects for that scale-up to more clinics was recently given a major boost when it was announced that from 2027, two generic drug manufacturers from India would start offering the jab at a price of $40 (roughly R700) per person per year. This is lower than the R1 000 per person per year that government currently pays for prevention pills. The $40 price is also well within the range that experts reckon would be affordable and cost-effective for the South African government. By spending on a prevention jab, government can save money by preventing HIV infections and thus reducing later spending on HIV treatment.
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Until the $40 generics from India become available, the plan is to procure limited amounts of lenacapavir from the pharmaceutical company Gilead, who hold the relevant patents and for now have the only lenacapavir product available on the market. As explained in previous reporting, South Africa will pay $60 per person per year for the jab, although that is not the full price – private donors are picking up the rest of the tab, but how big that “rest” is has not been disclosed. Activists have raised questions about this lack of price transparency.
Gilead is selling lenacapavir for around $28 000 per person per year in the United States (700 times the price South Africa is likely to pay for generics from 2027). A private sector price for South Africa has not yet been announced.
“The registration of lenacapavir by SAHPRA is a welcome step forward in getting this groundbreaking tool to those who need it in South Africa and Eswatini. But it is a step forward that leaves behind many other countries and people at risk, with no catch-up plan in place,” said Carlota Baptista, HIV/HCV Access Advocacy Manager at Doctors without borders (MSF). Much of the concern around international availability stems from the fact that licensing restrictions will prevent the low-cost generics from being sold in several countries with large HIV epidemics.
Baptista also pointed out that despite regulatory approval in South Africa, many people here will still not have access to lenacapavir. “Within South Africa, the number of people estimated to receive this HIV prevention option in the first year is around 450 000 people, far less than the 1-2 million people a year in South Africa required to make an impact on the country’s epidemic. While insufficient, this 450 000 nonetheless represents more than half of the lenacapavir that will be made available to low- and middle-income countries by global funders in the first year,” she said.
Choice of products
Lenacapavir has now largely overtaken another HIV prevention injection containing the antiretroviral drug cabotegravir. That product, called long-acting cabotegravir (CAB-LA for short), was registered by SAHPRA in 2022, but it hasn’t yet been made available in either the public or private sector in South Africa. CAB-LA provides two months of protection per shot, compared to six months with lenacapavir.
Meanwhile, research is under way testing formulations that will provide even longer protection at a time. Maybe most notably, early signs are promising for a lenacapavir formulation that can provide a year of protection at a time and a new pill that looks like it will offer a month of protection per tablet.
