Pretoria – The South African Health Products Regulatory Authority (SAHPRA) has announced the registration of Lenacapavir, an antiviral medicine to prevent HIV-1 infection.
In a statement announcing the registration on Monday, 27 October 2025, SAHPRA explained that 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.
An application by Gilead was submitted to SAHPRA in March 2025.
The SAHPRA review process was done in collaboration with the European Medicines for All Procedure (EU-M4all).
This procedure enables the European Medicines Agency (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.
Dosage
This product, developed to prevent new HIV infections, is a six-monthly injection.
There is an initiation dose of a subcutaneous injection (administered just under the skin) with tablets (taken on days 1 and 2).
It 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.
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,” indicated Dr. Boitumelo Semete-Makokotlela, CEO: SAHPRA.
“This product is the most effective HIV prevention measure thus far.”
