SAHPRA approves groundbreaking six-month HIV prevention injection

The South African Health Products Regulatory Authority (SAHPRA) has approved Lenacapavir, a long-acting HIV prevention medicine that can be administered just twice a year.

The antiviral drug, developed by Gilead Sciences, is recommended for use as pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent HIV-1 infection in adults and adolescents weighing at least 35 kilograms.

An application for Lenacapavir was submitted to SAHPRA in March 2025, and the review process was conducted in collaboration with the European Medicines for All Procedure (EUM4all). The initiative allows the European Medicines Agency (EMA) and participating regulatory authorities to jointly assess priority medicines intended for use outside the European Union, accelerating access to essential treatments.

“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.

Lenacapavir is administered as a six-monthly subcutaneous injection — given just under the skin — following an initial dose accompanied by tablets taken on days one and two. It is designed for HIV-negative individuals at substantial risk of infection.

SAHPRA said the approval marks a major step in strengthening HIV prevention efforts in South Africa, where millions remain vulnerable to new infections despite existing prevention tools such as oral PrEP and condoms.

The regulator emphasised that Lenacapavir should always be used alongside safer sex practices, including condom use, to reduce the risk of contracting other sexually transmitted infections.

Health experts have welcomed the move, noting that long-acting PrEP options like Lenacapavir could significantly improve adherence and expand access, particularly among young women and other high-risk groups.