The South African Health Products Regulatory Authority (SAHPRA) announced the registration of Lenacapavir, a groundbreaking antiviral medicine for HIV-1 prevention, on 27 October. Lenacapavir presents a significant innovation in combating HIV by offering a reliable pre-exposure prophylaxis (PrEP) option.
Key purpose of Lenacapavir
Lenacapavir is recommended for HIV-negative adults and adolescents weighing at least 35kg. Therefore, it should be paired with safer sex practices, such as condom use, to maximise effectiveness in preventing HIV-1 infection.
How Lenacapavir works
The medication requires an initial dose consisting of a subcutaneous injection and oral tablets taken on days 1 and 2. After the initial dose, patients receive injections every six months, offering a long-term, convenient preventative solution.
Collaborative approval process
Gilead submitted Lenacapavir’s registration to SAHPRA in March 2025. It was evaluated via the European Medicines for All Procedure (EU-M4all), an initiative supporting quicker registration of medicines for high-need cases in markets outside the EU.
Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, described Lenacapavir as a “game-changer” in the fight against HIV, addressing South Africa’s alarming HIV prevalence rates. It now stands as one of the most effective measures for HIV prevention available to date.
About SAHPRA’s commitment
SAHPRA is responsible for regulating all health products in South Africa. By prioritising safety, quality, and efficacy, the authority ensures that medicines approved for public use meet international standards. Lenacapavir is a testament to their commitment to enhancing local health outcomes through global collaboration.
