South Africa's Health Product Regulatory Authority (SAHPRA) has approved lenacapavir, a twice-yearly HIV prevention drug.
The drug is recommended for adults and adolescents weighing at least 35 kg, who are HIV negative and 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.
SAHPRA's approval paves the way for the country to roll out the drug, expected to be available by April 2026, with South Africa being among the first countries to receive doses through a donation facilitated by the Global Fund and PEPFAR.
With approximately two million people on the daily HIV prevention pill since 2016, South Africa has the largest pre-exposure prophylaxis (PrEP) programme globally.
Author's summary: SAHPRA approves lenacapavir for HIV prevention in South Africa.