SA Officially Registers “Game-Changer” Twice-a-Year HIV Prevention Jab

A major advance in the fight against HIV is a step closer to reality after the South African Health Products Regulatory Authority (SAHPRA) officially registered lenacapavir.

Lenacapavir is an injectable form of PrEP (pre-exposure prophylaxis) that is administered just twice a year to prevent HIV infection in people who are HIV negative. Studies have shown that it has a near 100% efficacy rate in preventing the virus.

How Lenacapavir Works

The regimen begins with an initiation dose — an injection given just under the skin, along with tablets taken on days one and two — followed by a single injection every six months.

Manufactured by Gilead Sciences, lenacapavir is approved for use in adults and adolescents weighing at least 35 kg who are HIV negative and at risk of contracting HIV. The SAHPRA review process was conducted in collaboration with the European Medicines for All Procedure.

A Breakthrough for HIV Prevention

A pill form of PrEP is currently available in South Africa but must be taken daily to ensure continued protection against HIV. For many users, the need for daily adherence can lead to “pill fatigue,” reducing its effectiveness in real-world use.

Injectable PrEP options like lenacapavir could transform HIV prevention by offering a discreet, long-acting alternative that encourages consistency. Experts say the breakthrough could significantly strengthen efforts to curb South Africa’s HIV epidemic.

“The registration of lenacapavir is a game-changer, given the high prevalence rate of HIV in South Africa,” said Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA, in a press statement. “This product is the most effective HIV prevention measure thus far,” she added.

Government Rollout Plans

According to reports, the Department of Health will purchase lenacapavir from Gilead and roll it out at around 300 clinics in the first half of 2026.

The initial rollout is expected to prioritise girls and young women aged 15 to 24, men who have sex with men (MSM), transgender individuals, sex workers, and pregnant and breastfeeding women — populations at higher risk of HIV infection.

From April 2027, the Department plans to procure cheaper generic versions of lenacapavir as they become available, expanding access to more clinics nationwide.