The South African Health Products Regulatory Authority (SAHPRA) has officially registered Lenacapavir, an antiviral drug that only needs to be taken twice a year to prevent HIV infection.
Lenacapavir is the world’s first injectable pre-exposure prophylaxis (PrEP) specifically designed to reduce the risk of contracting HIV. The long-acting drug represents a major breakthrough in HIV prevention, offering a far more convenient alternative to daily PrEP pills.
SAHPRA emphasized that Lenacapavir should be used in combination with safer sex practices, such as consistent condom use, to minimize the risk of 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,” said SAHPRA CEO Dr. Boitumelo Semete-Makokotlela.
South Africa continues to face one of the highest HIV burdens in the world, with an estimated 7.7 million people living with HIV, approximately 12% of the population. Despite steady progress in treatment and prevention, around 170 000 new infections were reported in 2024, according to UNAIDS.
Health experts say the approval of Lenacapavir could significantly improve prevention outcomes by addressing one of the biggest barriers to PrEP use: daily adherence. A twice-yearly injection could simplify prevention for those at high risk, particularly among young women, men who have sex with men, and other vulnerable groups.
While SAHPRA’s approval marks a critical milestone, challenges remain in ensuring equitable access, affordability, and rollout. Public health officials note that effective implementation will require partnerships between government, donors, and community organisations to reach those most in need.
