South Africa has begun administering lenacapavir, a long-acting HIV prevention drug, to selected individuals as part of a new study led by Wits RHI at the University of the Witwatersrand and funded by Unitaid.
The move comes just five months after the US Food and Drug Administration granted its first approval for the drug’s use in HIV prevention.
Lenacapavir has shown remarkable results in clinical trials, offering near-complete protection against HIV and outperforming existing pre-exposure prophylaxis (PrEP) options.
The injectable drug is taken twice a year and was initially projected to cost about $28,000 per user annually.
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However, a pricing deal brokered by the Clinton Health Access Initiative (CHAI), working alongside Dr Reddy’s Laboratories, Unitaid, the Gates Foundation and Wits RHI, has slashed the cost to about $40 — a reduction aimed at making the drug affordable in low- and middle-income countries.
In a statement on Monday, Unitaid said the 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,” the statement reads.
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“Making new medicines widely available in low- and middle-income countries can take up to a decade or longer as regulatory approvals must be obtained, manufacturing must be secured, and prices must come down.
“Global momentum behind lenacapavir has set the drug on a rapid trajectory: South Africa registered the drug in record time in late October, followed by Zambia in November, and the first doses have already been delivered in Zambia and Eswatini through The Global Fund and PEPFAR. Broader rollout in early adopter countries is expected in early 2026.”
Aaron Motsoaledi, South Africa’s minister of health, said the country 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,” he said.
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In Brazil, a similar study led by Fiocruz is also underway.
Insights and tools from the Fiocruz study in Brazil will help guide rollout strategies within the country and across Latin America.
