SA first in Africa to approve ‘most effective’ HIV jab

The South African Health Products Regulatory Authority (SAHPRA) has finally delivered a breakthrough in Lenacapavir HIV prevention, registering the revolutionary six-monthly injectable drug on Monday, 27 October 2025, making South Africa the first country on the continent to approve the “game-changing” tool.

The approval, coming roughly eight months after Gilead Sciences filed its application in March 2025, was unusually fast, due in part to SAHPRA’s collaboration with the European Medicines for All Procedure (EU-M4all).

This long-acting antiretroviral medicine offers protection for six months at a time, providing a transformative alternative for millions who struggle with the adherence required by daily oral pre-exposure prophylaxis (PrEP) pills.

SAHPRA CEO Dr Boitumelo Semete-Makoktlela hailed the registration, calling lenacapavir the “most effective HIV prevention measure thus far,” a crucial development given South Africa’s high HIV prevalence rate. The respected journal Science previously recognised it as its “breakthrough of the year” for 2024.

Health Minister Dr Aaron Motsaoledi plans to launch a limited public sector rollout starting as early as March 2026 or April 2026. The initial phase targets 360 high-performing clinics across 23 high-incidence districts in six provinces. The rollout aims to prioritise populations at the highest risk of HIV infection, including men who have sex with men (MSM), female sex workers (FSW), and adolescent girls and young key populations (AGYW).

Global partnerships have secured a monumental price reduction, ensuring this cutting-edge medicine is affordable for low- and middle-income countries. While the drug is sold for approximately $28 000 per person per year in the United States, agreements are in place with generic manufacturers, including Dr. Reddy’s, to supply the jab starting in 2027 at a drastic cost of just $40 (roughly R700) per person per year.

This price is lower than the R1 000 per person per year the government currently spends on daily oral prevention pills. Until the generics become available, South Africa is procuring limited amounts from Gilead at $60 per person per year, with private donors covering the remaining cost.

Lenacapavir: Key Details

Benefits and uses, according to World Health Organization:

• Highly Effective Prevention: Lenacapavir has shown exceptional effectiveness in preventing HIV infection. It is considered the most effective HIV prevention measure thus far.
• Dosing Schedule: It is a long-acting injectable providing protection for six months at a time, requiring only a twice-yearly dose.
• Target Population: It is used for PrEP in adults and adolescents weighing at least 35kg, who are HIV negative and at risk of acquiring HIV.
• Convenience: The twice-yearly schedule is expected to be transformational for millions of people who struggle with adherence to daily oral PrEP pills.
• Required Combination: The jab must always be used in combination with safer sex practices, such as using condoms, to reduce the risk of acquiring other sexually transmitted infections (STIs).
• Initial Regimen: Starting the regimen requires an initiation oral dose of two tablets taken on the day of the first injection and two tablets taken on the following day, ensuring protective levels are quickly achieved.