World Aids Day: Study on Lenacapavir use for HIV prevention begins in South Africa
On World Aids Day, it has been announced that the first South Africans have commenced use of lenacapavir for HIV prevention as part of a study led by Wits RHI and funded by Unitaid.
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As South Africa marks World Aids Day on Monday, December 1, it has been announced that the first individuals have begun using lenacapavir for HIV prevention in the country as part of a study funded by Unitaid and led by Wits Reproductive Health and HIV Institute (Wits RHI) at the Wits University.
Unitaid said in a statement on Monday that in Brazil, a similar study led by Fiocruz is also underway.
It said these achievements occur in record time – just 5 months after lenacapavir was first approved by the US FDA for HIV prevention – making it among the first real-world use of the 6-monthly injectable in low-and middle-income countries.
It has previously been reported that lenacapavir, administered as an injection, was shown in clinical trials to be safe and nearly 100% effective at preventing HIV.
Unitaid said this innovation comes at a crucial moment: despite major progress over the past decade, an estimated 1.3 million people were newly infected with HIV in 2024, with women and girls accounting for over 60% of new cases in sub-Saharan Africa.
“In South Africa, where lenacapavir rollout is planned to start in early 2026, the Wits RHI study will provide the Department of Health with the evidence they need to adapt quickly and in real time as they integrate lenacapavir into existing HIV prevention programs. These early learnings on real world use will also be applicable to other countries adopting lenacapavir.”
Health Minister Dr Aaron Motsoaledi said: “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 Pre-Exposure Prophylaxis (PrEP) option, especially adolescent girls, young women, and pregnant and breastfeeding women.”
Professor Saiqa Mullick, Director of Implementation Science at Wits RHI said: “This study is about more than a new product, it's about putting lenacapavir to the real-world test and learning what works, what doesn’t and what people want. It’s about building the pathways that make prevention work in the real world.
“Lenacapavir expands choice in HIV prevention, and choice matters. Protection only works when it fits people’s lives,” Mullick said.
“Access is not only about making a medicine available, it’s about ensuring it is acceptable and trusted by the people who will use it,” said Dr. Philippe Duneton, Executive Director of Unitaid.
“By learning on most effective delivery models for each of the populations at high risk of HIV, including young women, we are providing countries with the evidence required for most impactful lenacapavir roll out – and getting the most out of every dollar invested,” he said.
Unitaid said it along with Wits RHI and the Clinton Health Access Initiative (CHAI), announced in September a landmark pricing agreement with Dr. Reddy’s Laboratories to manufacture generic lenacapavir for US$40 per person per year by 2027, and are working with Ministries of Health and other partners to support lenacapavir introduction and demand generation in countries preparing for rollout.