The South African Health Products Regulatory Authority (SAHPRA) says a multinational company, Gilead Sciences, is in discussion with the South African government to manufacture the next doses of the newly approved twice-a-year anti-HIV injection, Lenacapavir.
Lenacapavir is an antiviral medicine that is recommended, in combination with safer sex practices, for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection in adults and adolescents weighing at least 35 kg.
SAHPRA Chief Executive officer, CEO Dr. Boitumelo Semete-Makokotlela told YOUFM Newshour that Gilead focused on developing and commercializing innovative medicines to treat life-threatening diseases has submitted their application in March 2025 and to the European Medicines agency a month before in February.
“What enabled us to be able to make this decision so swiftly is that we were part of a collaborative review with the European medicine agency and the world health organisation (WHO) so we worked through this with our experts and some global experts and that’s how we arrived at this decision.
“The first set of doses that will be made available in the country are those that were made outside of South Africa, however they have entered into licenses with some of the companies to make generics and I know that they’re also talking to the government to identify a South African company to make the drug in the country, but those are still in discussions,” said Semete-Makokotlela.
She adds that the benefits of this pathway will strengthen regulatory systems and accelerate access to essential medicines.
SAHPRA emphasised that Lenacapavir, developed to prevent new HIV infections, is a six-monthly injection.
“It is not your immune system fighting the virus, which is the case with the vaccine, it’s more the drug itself then hence it needs to be long acting. So, this is an injection that you get every six months because it needs to be in your system for a long time,” emphasised the CEO.
Furthermore, Semete-Makokotlela said that unlike the vaccine, Lenacapavir will ensure that the virus is unable to survive in the body.
“It blocks the replication of HIV, so you will be exposed but a virus can only survive in your body, if it integrates into your cell and uses your cell machinery to make more of itself.
What Lenacapavir does is that it blocks the virus from entering the cell and multiplying itself and the virus will eventually die on its own,” explained the CEO.
It has also been maintained that Lenacapavir for 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,” insisted Dr. Semete-Makokotlela.
