In a demonstration of government’s commitment to advancing public healthcare, South Africa is taking a bold step toward the future with plans to manufacture the groundbreaking HIV drug, Lenacapavir, locally.
During the launch of the drug in Secunda last week, Health Minister, Dr Aaron Motsoaledi, assured that in the future, South Africa will have the capability to manufacture a generic of Lenacapavir.
“It has been said that unless we put two million people on Lenacapavir, we won’t be able to end HIV and AIDS. There’s anxiety within civil society that we might not reach that number because… the doses that have been donated by Global Fund are 900 000 doses. Because you need two doses per annum, it means only [it's now] 400 000 people...
“I’m standing to allay their fears. While Gilead is the originator of Lenacapavir, in terms of international rules, they have a 20-year intellectual property right. But I’m standing here to thank Gilead because they were told by civil society and experts that the world does not have 20 years to wait and they agreed,” the Minister said.
He noted that Gilead has given six voluntary licences to countries to start manufacturing the generics. However, South Africa is not one of those.
Motsoaledi was firm that this would change.
“But we told Gilead that South Africa is going to be the world’s biggest consumer of Lenacapavir because in ARVS [antiretrovirals], we are already [a top consumer]. Twenty-five percent of all ARVs consumed in the world are consumed in South Africa. So, with Lenacapavir, it’s going to be the same... We told Gilead that we also deserve a license.
“I can tell you without any equivocation or fear of contradiction, Gilead has just informed us [that] if there is a South African company that can stand up and say, 'Here we are', they will be given that voluntary licence.
“Lenacapavir is going to be manufactured in South Africa. I don’t know by which company [as] it’s not my job to choose. There’s a selection committee in which SANAC and many organisations are involved… and they will be choosing which company in South Africa is going to produce Lenacapavir. So very soon, it will be introduced here at home,” he said.
Motsoaledi emphasised that beyond that, there are other plans in place to ensure that generics reach South African soil.
“There are many [organisations] that support us to bring an end to AIDS. When we were at the United Nations General Assembly [UNGA] last year, two things happened.
“One, there was a meeting convened by the Clinton Health Access Initiative… where they called a company called Dr Reddy’s, together with Wits RHI and with UNITAID. They agreed with Dr Reddy’s that [the company] must produce a generic. They will help them financially such that the price of that generic will be 700 times less than the price of Lenacapavir.
“The second thing that happened at UNGA is that the Gates Foundation also called a company called Hetero, which is based in India and told them that they will do the same that Bill Clinton has done for Dr Reddy’s… so that Hetero can start manufacturing a generic,” he said.
Furthermore, the Minister revealed that he visited the company in Hyderabad, India, and held discussions on how quickly the drug could be manufactured.
“I went there and they said: If SAHPRA [South African Health Products Regulatory Authority] gives us a licence; if SAHPRA approves our plans, we can start manufacturing the generic this year. So… I phoned SAHPRA and they said they’ve received all the documents. It will take them about six months to go through them.
“All this means one thing: we want human beings to be safe. Very early next year, there must be a generic here in South Africa, which is 700 times cheaper than the present originator drugs,” Motsoaledi said.
The game changer
Lenacapavir represents one of government’s most groundbreaking efforts to provide healthcare to South Africans.
According to 2025 Statistics, an estimated 8.15 million people in South Africa are HIV positive, with millions on treatment.
This drug represents a change in how they consume ARVS, moving from everyday or bi-monthly ingestion to a twice-yearly injection.
Late last year, Motsoaledi described the drug as a “true breakthrough in prevention science and service delivery”.
“What makes Lenacapavir groundbreaking is its dosing schedule and efficacy. Lenacapavir is delivered via injection only twice a year, offering six months of continuous protection per dose. just two injections a year could protect an individual from HIV.
“This six-monthly dosing schedule has the potential to overcome many of the barriers we’ve seen with daily oral PrEP: it offers greater discretion, convenience, and likely much better adherence for users, especially for people who struggle with taking a pill every day or making frequent clinic visits,” he said.
The Minister added that the drug has also demonstrated “outstanding efficacy… in preventing HIV” during clinical trials.
“In one trial among women, it showed 100% efficacy within the study period – and in another trial amongst men who have sex with men and transgender women, efficacy was around 96%.
“On the strength of this evidence, the World Health Organization (WHO) this year issued new guidelines recommending Lenacapavir as an additional HIV prevention choice. WHO now strongly recommends offering long-acting injectable Lenacapavir to people at risk of HIV, as part of combination prevention approaches.
“This global guidance gives us confidence that we are on the right track by introducing Lenacapavir in South Africa,” the Minister said.
The rollout
On Monday, the Gauteng Department of Health (GDoH) announced that the rollout of Lenacapavir has begun in earnest.
The provincial rollout forms part of nationwide efforts as 360 public health facilities across six provinces and 24 high-burden districts are poised to deliver this transformative intervention, with an ambitious target of reaching some 1 million people by the end of 2027.
“As the country’s most populous province and one of the regions carrying a significant HIV burden, Gauteng has been identified as a key implementation site for the first phase of the programme.
“The province will introduce Lenacapavir at 133 facilities across Johannesburg, Tshwane, Ekurhuleni, Sedibeng and the West Rand, targeting populations at high risk of HIV infection.
“Phase one of the rollout will prioritise adolescent girls and young women, adolescent boys and young men, key populations including sex workers, men who have sex with men, transgender persons and people who inject drugs, as well as pregnant and breastfeeding women who remain vulnerable to HIV infection,” the GDoH said in a statement.
The province has received sufficient stock to “initiate 56 079 eligible clients between 8 June 2026 and 31 March 2027 across the province”.
“The department has already received its initial allocation to initiate 18 809 individuals. Distribution to districts commenced on 24 May 2026 and has enabled facilities to prepare for implementation ahead of the official rollout. Additional stock will be supplied quarterly to ensure continuity of the programme and access to services.
“To prepare for implementation, the department has trained healthcare workers, pharmacists, programme managers and data personnel, established monitoring and reporting systems, and distributed clinical guidelines to support safe and effective implementation of the programme,” the statement continued.
The public are encouraged to seek accurate information on Lenacapavir from healthcare workers and trusted sources.
“In an effort to increase public understanding of Lenacapavir and eligible individuals to access HIV prevention services, the Department will support the rollout through facility activations, community dialogues, media engagements, radio campaigns, peer educator programmes and social media awareness initiatives.
“Members of the public who believe they may benefit from HIV prevention services are encouraged to visit participating healthcare facilities for information, HIV testing and screening for eligibility,” the statement read.
The GDoH emphassied that the drug is not a replacement of the full range of HIV prevention methods available but forms part of interventions.
“The department reminds the public that Lenacapavir forms part of a comprehensive package of HIV prevention interventions and does not replace HIV testing, condom use, STI prevention and treatment, voluntary medical male circumcision, or treatment services for people living with HIV,” the statement said. – SAnews.gov.za
