SA’s medicines regulator has registered Gilead’s HIV prevention jab, lenacapavir, opening the way for the government to begin providing the twice-yearly shot.
Hopes are high that the jab, which almost completely prevented new infections in clinical trials, could transform prevention efforts and end HIV as a public health threat. It offers people an alternative to taking a daily HIV prevention pill or other shorter-action options such as ViiV Healthcare’s two-monthly jab, cabotegravir.
Experts hope the convenience of lenacapavir will help them overcome some of the challenges that have hampered the effects of current prevention tools, such as limited access to health services or difficulty sticking to a daily pill regimen.
“The registration of lenacapavir is a game-changer, given the high prevalence rate of HIV in SA. This product is the most effective HIV prevention measure thus far,” said SA Health Products Regulatory Authority (Sahpra) CEO Boitumelo Semete-Makokotlela.
SA has the world’s worst HIV/Aids epidemic, with an estimated 8-million people living with the disease. There were about 173,000 new infections in 2024, according to the Thembisa model.
The health department is expected to begin providing lenacapavir in April 2026, starting with 360 government clinics in health districts with high rates of new HIV infections. It will purchase more than 450,000 doses of Gilead’s lenacapavir at $60 a dose, using a R513m grant from the Global Fund to Fight HIV/Aids, Tuberculosis, and Malaria to fund the first two years of its rollout.
Gilead applied to register lenacapavir with SA’s medicines regulator in March, and the review process was expedited by collaborating with the European Medicines for All procedure, said Sahpra. This initiative enables the European Medicines Agency and other participating regulatory authorities to accelerate access to essential medicines by providing scientific input on high-priority drugs intended for markets outside the EU.
The US Food and Drug Administration registered lenacapavir in June, and it was recommended as an HIV prevention tool by the World Health Organisation a month later.
Lenacapavir has been registered for use in the public and private sectors, said Semete-Makokotlela. It is unclear at this stage how medical scheme members who usually rely on private healthcare facilities will access the jab, as Gilead has yet to announce plans for the private sector.
A Gilead spokesperson said the company was in ongoing discussions with the health department to understand its needs.
“We are evaluating private market strategies to expand product availability in SA as soon as possible. At this time, we do not have a registered price for lenacapavir for the prevention of HIV,” said the spokesperson.
The price of all medicines sold in the private sector must be published, in line with SA’s medicine pricing regulations.
In the US, lenacapavir will cost $28,218 for a year’s treatment, according to the New York Times. However, treatment with a generic version could cost $35-$46, and fall to $25 per person per year if there were guaranteed uptake of between 5-million and 10-million people within the first year, according to a research paper published in The Lancet.
A partnership between Dr Reddy’s Laboratories and Unitaid, the Clinton Health Access Initiative, and Wits RHI announced in September that generic lenacapavir will be available in 120 low- and middle-income countries at $40, starting in 2027.
SA researchers released a modelling study earlier this year that found widespread use of lenacapavir would speed up SA’s efforts to eliminate HIV as a public health threat and lead to epidemic control by 2032, instead of 2042.
Even at $100 a shot, it would be much more cost-effective than increasing the use of oral pre-exposure prophylaxis or cabotegravir, they said in a paper presented at the Conference on Retroviruses and Opportunistic Infections.
Update: October 27 2025
This story has new information.
