28 October 2025 | 12:46 CAT
4-minute read

Image: IOL/Sigciniwe

South Africa has made medical history as the first African nation to approve Lenacapavir, a revolutionary twice-yearly injectable drug for HIV prevention. The announcement by the South African Health Products Regulatory Authority (SAHPRA) marks a turning point in the country’s decades-long fight against one of the world’s highest HIV infection rates.

For millions living with or at risk of HIV, the approval offers renewed hope. Instead of taking daily pre-exposure prophylaxis (PrEP) pills, individuals can now receive a simple injection every six months—dramatically improving adherence and accessibility. Speaking to Radio Islam International, Minister of Health Dr Aaron Motsoaledi hailed the development as a historic breakthrough.

“We have got an injectable that is a prevention for HIV/AIDS. You are aware that all the pre-exposure prophylaxis we have got are oral tablets that must be taken daily. Now, this one is an injection which will just take once every six months,” Dr Motsoaleid said.

Developed by Gilead Sciences, Lenacapavir was first approved for treatment use in the United States and Europe, where trials demonstrated exceptional efficacy in preventing HIV transmission. According to UNAIDS, South Africa has the world’s largest HIV epidemic, with around 7,8 million people living with the virus and an estimated 150 000 new infections recorded annually.

The World Health Organization (WHO) has praised long-acting PrEP innovations like Lenacapavir as critical to achieving the 2030 goal of ending the AIDS epidemic.

What makes this approval even more notable is the speed of South Africa’s regulatory review. The biopharmaceutical company submitted its application in March 2024, and SAHPRA granted approval just eight months later—an unusually fast turnaround for a new drug.

“The European Medical Regulatory Authority started before us and SAHPRA joined them,” explained Dr Motsoaledi. “SAHPRA scientists were there helping Europe to register Lenacapavir, so it was quite easier to review it faster in South Africa because you don’t start from scratch.”

While Lenacapavir’s clinical promise is undeniable, its affordability has been a major barrier. In the United States, a single dose costs around US$28 000—nearly R500 000, an unthinkable price for public health systems in the Global South. However, South Africa’s approval comes with an international funding commitment to make the drug accessible.

Dr Motsoaledi confirmed that the Global Fund has negotiated a deal with Gilead to supply two million doses worldwide, with South Africa set to receive 488 000 doses in the first year. This, he said, will ensure equitable access across urban and rural regions.

“Everybody who needs to have it will have access, whether rural or urban. Out of the two million doses, South Africa is going to get 488 000 people in the first year,” Dr Motsoaledi stated.

To ensure long-term affordability, international health partners—including the Clinton Health Access Initiative (CHAI), UNITAID, and the Reproductive Health Institute (RHI)—have partnered with Dr Reddy’s Laboratories in India to produce a generic version of Lenacapavir. The generic, expected by 2027 or early 2028, will cost approximately US$40 per dose, reducing the price by over 700 times.

This partnership was made possible through a voluntary licensing agreement between Gilead and 20 manufacturers, a rare move that accelerates generic access to life-saving medication.

Public health experts have lauded South Africa’s leadership in HIV innovation, describing the approval as a model for other African regulators. According to UNAIDS, sub-Saharan Africa accounts for 65% of global HIV infections, and access to long-acting prevention could drastically reduce new cases—especially among young women, who remain disproportionately affected.

Dr Motsoaledi expressed optimism that the rollout will help reduce new infections and relieve pressure on the healthcare system.

“We are still having about 150 000 new infections annually. Now you want to cut that pathway of new infections… and we are hoping to cut it down to such levels as to regard them as insignificant,” he said.

South Africa prepares for a potential rollout in March 2026. The current reliance on external funding and voluntary licensing from Gilead underscores Africa’s continued vulnerability to Western-controlled drug patents and market pricing. Without a clear, long-term local manufacturing strategy, South Africa risks celebrating a short-term victory that remains dependent on global charity rather than self-sufficiency.

Critics and skeptics have raised concerns that the approval of Lenacapavir may have broader geopolitical and economic implications for South Africa. Some argue that the country’s reliance on Western pharmaceutical giants and global funding bodies like the Global Fund and UNITAID gives these actors disproportionate influence over South Africa’s health agenda and, by extension, elements of its policy direction. Such perceptions reflect a deeper public mistrust rooted in historical patterns—where international aid and patents have shaped local economies and health priorities to align with external interests.

Listen to the full interview with Health Minister Dr Aaron Motsoaledi on Sabaahul Muslim hosted by Moulana Ahmed Waja.