The South African Health Products Regulatory Authority (SAHPRA) announced the registration this week, calling it a “game-changer” for HIV prevention in a country that remains one of the most affected worldwide.
The approval follows an application submitted by US biopharmaceutical company Gilead Sciences in March 2025.
The HIV vaccine is a major milestone in the global fight against the HIV/ AIDS virus.
Health Minister Dr Aaron Motsoaledi said government plans to introduce Lenacapavir as early as March 2026. He described the drug as a crucial breakthrough in closing the gaps in existing HIV prevention methods.
The Minister was speaking at the national roundtable on Lenacapavir access and sustainability in South Africa.
The South African National AIDS Council (SANAC) and the Department of Health held a multi-stakeholder roundtable session to discuss the country’s readiness to implement the wonder drug.
How Lenacapavir works
Lenacapavir offers protection against HIV infection for up to six months with just one injection.
This means people only need two doses a year. The regimen begins with an initial injection, supported by tablets taken on days one and two.
The drug is intended for HIV-negative adults and adolescents weighing at least 35kg who are at risk of infection.
SAHPRA stressed that 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,” said SAHPRA CEO, Boitumelo Semete-Makokotlela.
“This product is the most effective HIV prevention measure thus far.”
Affordable access and production
To ensure widespread access, Gilead has partnered with six pharmaceutical manufacturers, including one in Egypt, to produce the injection at around US$40 (R690) per person per year – a dramatic reduction from its original cost of US$28 000.
Motsoaledi added that South Africa plans to integrate Lenacapavir into domestic funding mechanisms within two years.
The initiative will be backed by the Gates Foundation and generic producers such as Hetero to enable local manufacturing.
South Africa’s neighbour Eswatini is said to be the next African country in line to receive Lenacapavir.
