South Africa has reached a major milestone in HIV prevention as the first individuals in the country begin using Lenacapavir, a six-monthly injectable proven in clinical trials to be safe and nearly 100% effective at preventing HIV. The breakthrough comes on World AIDS Day, marking one of the earliest real-world uses of the drug anywhere in the world and placing South Africa at the forefront of global HIV-prevention innovation.
The work is being led by Wits RHI at the University of the Witwatersrand as part of a Unitaid-funded study designed to generate critical evidence before the national rollout planned for early 2026.
South Africa approved Lenacapavir for HIV prevention at record speed in late October, accelerating access to a tool that could significantly reduce new HIV infections, particularly among adolescent girls, young women, and other populations at high risk.
Speaking at a World AIDS Day event on Monday, 1 December, Minister of Health Dr Aaron Motsoaledi said the government is working closely with partners to ensure Lenacapavir reaches those who need it most.
“South Africa is working with relevant stakeholders to make lenacapavir available to the most vulnerable populations who are at higher risk of HIV infections. These early efforts from Unitaid and Wits RHI will help us fine-tune how lenacapavir is delivered through our health system so we can reach as many people as possible with this new PrEP option,” he said.
The Wits RHI study will help the Department of Health refine how the drug is introduced into existing HIV-prevention programmes, providing early insights on real-world use, uptake, and delivery models. These findings will allow the national programme to adapt in real time once rollout begins in 2026.
South Africa has one of the world’s largest HIV burdens with an estimated 8.45 million people living with HIV, which is 12% of the population, and despite major progress, new infections remain high. Globally, an estimated 1.3 million people were newly infected in 2024, with women and girls accounting for over 60% of new cases in sub-Saharan Africa. Lenacapavir’s six-month dosing could be a game-changer for individuals who struggle with daily or monthly prevention methods.
International partners are also working to accelerate access. A landmark pricing agreement announced in September between Unitaid, Wits RHI, the Clinton Health Access Initiative (CHAI), and Dr Reddy’s Laboratories will see generic lenacapavir manufactured for US$40 per person per year by 2027, helping ensure long-term affordability across low- and middle-income countries.
On World AIDS Day, the start of Lenacapavir use in South Africa represents not only scientific progress but a renewed commitment to ending the HIV epidemic. Unitaid and Wits RHI say they remain committed to working with the government to overcome remaining access barriers and ensure that the promise of this groundbreaking prevention tool becomes a reality for millions.
