South Africa has taken the lead in HIV prevention by approving the lenacapavir HIV injection, a long-acting shot that protects against HIV for six months. This marks the first approval of the injection in Africa.
Health Minister Dr Aaron Motsoaledi confirmed that government aims to make lenacapavir available in public health facilities by March. He spoke at a national roundtable on access and sustainability of the drug. Importantly, the lenacapavir injection will soon be accessible to more people.
Government drives readiness
The South African National AIDS Council (SANAC) and the Department of Health hosted the session to plan distribution, funding and training, considering the upcoming rollout of lenacapavir HIV injection techniques.
Motsoaledi said: “We must close the gaps in HIV prevention. This injection offers people freedom, safety and choice.” With the approval of the lenacapavir HIV injection, South Africa takes a significant step forward.
How the injection works
Lenacapavir offers six months of HIV protection with only two injections per year. People start with a subcutaneous injection and tablets on day one and day two.
It works for HIV-negative adults and adolescents over 35 kg who are at high risk. However, the South African Health Products Regulatory Authority (SAHPRA) reminds users to still practise safe sex to avoid other sexually transmitted infections. The lenacapavir injection provides strong protection but isn’t a complete solution for all risks.
SAHPRA CEO Boitumelo Semete-Makokotlela said: “Lenacapavir is the strongest HIV prevention tool we have so far. With South Africa’s HIV rates, we cannot delay.” Thus, the widespread use of the lenacapavir HIV injection is a priority.
Partnerships and pricing
SAHPRA reviewed the drug with support from the European Medicines for All Procedure (EMA – EU-M4All). This process speeds up access to lifesaving medicines in low- and middle-income countries.
Meanwhile, Gilead Sciences and six pharmaceutical partners will supply the jab at US$40 per person per year, down from US$28 000. This price drop became possible through global funding deals and pressure from advocacy groups. Such partnerships are crucial to make the lenacapavir HIV injection more affordable.
In addition, Hetero and the Gates Foundation will support generic manufacturing. Government plans to fund the injection locally within two years and is exploring South African production.
SAHPRA’s oversight role
SAHPRA regulates and monitors all medicines in the country, including clinical trials, medical devices and in-vitro diagnostics. It now also oversees radiation control. Oversight extends to ensuring the safety of the new lenacapavir HIV injection as it becomes more widely used.




