South Africa is among the first countries in line to receive doses of lenacapavir, the six-monthly injection for HIV prevention. According to national health department projections, the country could start rolling out lenacapavir in 2026.
“This is just the projected timeline. If we do have lenacapavir coming in and we have all the support, we hope that we could start by March to April 2026 – depending on regulatory approval and depending on availability of resources,” says Hasina Subedar, senior technical advisor for HIV Prevention in the National Department of Health.
Studies done in various countries, including South Africa, have shown that lenacapavir is highly effective in preventing HIV acquisition. It’s been hailed by researchers and activists as the drug that could end the HIV epidemic.
In June, the drug was approved by the U.S Food and Drug Administration. The European Medicines Agency is expected to make a final decision later this year. The nod from the World Health Organisation is still pending, although the global health body released guidelines on the use of lenacapavir at the International AIDS Conference (IAS 2025) in Rwanda last month.
But for the drug to be used in South Africa, it needs to be approved by the South African Health Products Regulatory Authority (SAHPRA).
“Following SAHPRA approval, we hope that it will be evaluated for inclusion in the essential medicines list. If a drug is not in the essential medicines list, we cannot procure it,” Subedar explained during a presentation at the Southern African HIV Clinicians Society conference in Cape Town this week.
The department also needs to finalise national policy and implementation guidelines, and get approval from the National Health Council.
Importance of choice
South Africa has around 7.6 million people living with HIV, with about 160,000 new HIV infections every year.
“These figures remind us that HIV prevention is not optional. It is urgent. Every infection we prevent today saves a lifetime of treatment and preserves a life. So it is really important that we pay very special attention to HIV prevention,” says Subedar.
The inclusion of lenacapavir into the country’s HIV prevention toolkit will offer people at risk of HIV more choices for PrEP (pre-exposure prophylaxis). Findings from Project PrEP, an implementation study by the Wits RHI show that there is a strong demand for long-acting injectable HIV prevention methods.
The study was conducted between April and November 2024 among participants aged 15 and older, in fixed and mobile clinics. Participants were offered the option of the daily oral PrEP. In April 2024, access was expanded to include the monthly dapivirine vaginal ring. In October, the long-acting injectable cabotegravir (CAB-LA) was included in the study – the first two shots must be given a month apart, thereafter one injection is needed every eight weeks.
“There is a demand for long-acting injectable PrEP. Among over 3,800 HIV negative individuals offered a choice of three prep options at enrolment, the majority (65%) chose injectable cabotegravir, while 25% opted for oral PrEP, 2% chose the ring, and 8% decline a method,” says Catherine Martin Senior Technical Specialist at Wits RHI, who presented these findings at the IAS 2025.
“We’ve learned that one product doesn’t fit all people all the time. It’s clear that no single PrEP method fits everyone’s needs all the time. When CAB-LA was introduced, almost half of the oral PrEP users chose to stay with oral PrEP, while 46% switched to cab. Among ring users, 59% switched to cab, but 31% remained on the ring,” she says.
Product availability
While there is a clear demand for more PrEP choices, only oral PrEP is currently included on South Africa’s essential medicines list. According to Subedar, this is mainly because of the cost.
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“Because we have oral prep that we’re currently purchasing at $40 per person per year, everything gets evaluated against that. As we move forward with new products, we must make sure that prices are competitive. Without competitive prices, it’s going to be really difficult,” she says.
There has been a lot of criticism over the cost of lenacapavir, which prices this drug out of reach for the countries where it’s most needed. Gilead Sciences, the manufacturer, reportedly priced the drug at over $28 000 per person per year. The Global Fund has negotiated an access agreement with Gilead to procure the drug for low- and middle-income countries. But the details of this agreement are not public.
“Hopefully, the support that we have been offered by the Global Fund will materialise so that we can actually implement it as soon as possible,” says Subedar. – Health-e News
