The South African Well being Merchandise Regulatory Authority (SAHPRA) introduced the registration this week, calling it a “game-changer” for HIV prevention in a rustic that is still probably the most affected worldwide.
The approval follows an utility submitted by US biopharmaceutical firm Gilead Sciences in March 2025.
The vaccine is a significant milestone within the international struggle in opposition to the HIV/ AIDS virus.
Well being Minister Dr Aaron Motsoaledi stated authorities plans to introduce Lenacapavir as early as March 2026. He described the drug as an important breakthrough in closing the gaps in present HIV prevention strategies.
The Minister was talking on the nationwide roundtable on Lenacapavir entry and sustainability in South Africa.
The South African Nationwide AIDS Council (SANAC) and the Division of Well being held a multi-stakeholder roundtable session to debate the nation’s readiness to implement the surprise drug.
How Lenacapavir works
Lenacapavir presents safety in opposition to HIV an infection for as much as six months with only one injection.
This implies individuals solely want two doses a yr. The routine begins with an preliminary injection, supported by tablets taken on days one and two.
The drug is meant for HIV-negative adults and adolescents weighing a minimum of 35kg who’re liable to an infection.
SAHPRA pressured that Lenacapavir for pre-exposure prophylaxis (PrEP) ought to at all times be utilized in mixture with safer intercourse practices, resembling utilizing condoms, to scale back the chance of getting different sexually transmitted infections.
“The registration of Lenacapavir is a game-changer, given the excessive prevalence price of HIV in South Africa,” stated SAHPRA CEO, Boitumelo Semete-Makokotlela.
“This product is the simplest HIV prevention measure to this point.”
Inexpensive entry and manufacturing
To make sure widespread entry, Gilead has partnered with six pharmaceutical producers, together with one in Egypt, to provide the injection at round US$40 (R690) per individual per yr – a dramatic discount from its unique value of US$28 000.
Motsoaledi added that South Africa plans to combine Lenacapavir into home funding mechanisms inside two years.
The initiative might be backed by the Gates Basis and generic producers resembling Hetero to allow native manufacturing.
South Africa’s neighbour Eswatini is alleged to be the following African nation in line to obtain Lenacapavir.
