By Lehlohonolo Lehana.
South Africa has become the first African country to register the revolutionary twice a year anti-HIV jab — Lenacapavir (LEN).
The South African Health Products Regulatory Authority (Sahpra) approved LEN on October 21.
SAHPRA is tasked with monitoring, evaluating, investigating, inspecting and registering all health products.
In South Africa the LEN injection has been registered under the name Lenacapavir 464mg solution injection Gilead.
In March 2025, Gilead, a biopharmaceutical company based in the United States, applied to SAHPRA, the local drug regulatory authority.
Two weeks ago, Health Minister, Dr Aaron Motsoaledi, announced that South Africa plans to launch lenacapavir, a groundbreaking long-acting HIV prevention method, as early as March 2026.
Lenacapavir is a revolutionary long-acting injectable drug that offers six months of protection with just two annual doses.
At a national roundtable meeting, Motsoaledi highlighted the drug’s potential to address critical gaps in current HIV prevention methods.
“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.
According to the SAHPRA, lenacapavir for pre-exposure prophylaxis (PrEP) should always be used in combination with safer sex practices, such as using condoms, to reduce the risk of getting other sexually transmitted infections.
“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, Boitumelo Semete-Makokotlela.
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.