HIV activists slam South Africa’s lenacapavir rollout as too slow and too small

A coalition of civil society organisations has criticised South Africa’s planned rollout of lenacapavir (LEN), warning that the programme is too limited in scope and risks becoming “more about the pomp than the public health impact” despite the drug’s potential to reduce new HIV infections dramatically.

In a joint statement released ahead of Friday’s official launch by President Cyril Ramaphosa and health minister Dr Aaron Motsoaledi, the organisations said the rollout targets are too low and fail to adequately prioritise the populations most at risk of HIV infection.

The statement was issued by the African Budget and Information Advocacy (ABIA), Health Justice Initiative (HJI), SANKALP, Health GAP, Just Treatment, Sisonke, African Alliance and the Treatment Action Campaign (TAC).

Lenacapavir, a twice-yearly injectable pre-exposure prophylaxis (PrEP) drug, has been hailed as a game-changing HIV prevention tool. Research conducted in several countries, including in the Global South, found the medicine to be highly effective in preventing HIV infection.

However, activists argue that South Africa’s initial allocation falls far short of what is required to make a meaningful impact on the country’s HIV epidemic.

While South Africa has secured funding through the Global Fund to Fight Aids, Tuberculosis and Malaria (GFATM) to purchase lenacapavir, only 37,920 doses arrived in the country in late March and early April. The shipment was subsequently subjected to mandatory post-importation testing, delaying the rollout from its original target date of April 2026.

The official launch is now scheduled for Friday, nearly two years after the first major efficacy results were announced.

The organisations argue that global supply shortages and Gilead Sciences’ patent monopoly have severely restricted access to the drug.

Last year, the coalition called for South Africa’s allocation of lenacapavir to be expanded to reach at least two-million people annually, arguing that the planned allocation of 480,000 doses would not significantly reduce new HIV infections.

South Africa already runs one of the world’s largest PrEP programmes, with more than two-million people using oral PrEP. Despite these efforts, the country recorded an estimated 149,000 new HIV infections in 2023.

With about eight-million people living with HIV, South Africa is home to the world’s largest HIV epidemic.

“South Africa did not come to this point as a bystander,” the organisations said.

“Researchers, clinicians, trial sites, communities and participants helped generate the evidence that established lenacapavir as one of the most promising HIV prevention tools ever developed.

“So, just like during Covid-19, despite helping produce the science, South Africa continues to be dependent on decisions made elsewhere about how much we can receive, when it will arrive, how quickly production can be scaled up and who will ultimately gain access.

“That is the contradiction of our reality: a country carrying the world’s largest HIV burden is dependent on a pharmaceutical company to determine how and when we can properly protect our people.”

A programme that does not adequately prioritise key and vulnerable populations such as sex workers, particularly outside of clinic settings, will leave those most in need of HIV prevention services even more vulnerable.

—  Katlego Rasebitse of the Sisonke Movement

The groups cited modelling by health economics and epidemiology research organisation HE²RO, which suggests that about two-million people in South Africa would need to receive lenacapavir each year for the intervention to substantially reduce new HIV infections.

According to the modelling, a large-scale rollout could prevent up to 52,200 new HIV infections annually and potentially place South Africa on a path to ending the epidemic within the next eight years.

Bellinda Thibela of Health GAP said government leaders needed to take stronger action to secure greater access to the drug.

“We need millions more doses, but we cannot access them when we need them most. The president and the minister have the power to act against Gilead, and once again, in our Aids crisis, they are not,” she said.

“Their leadership can take the form of state action against Gilead. They can insist on millions more doses, support regulatory exemptions to speed up the programme and expand the priority groups eligible to receive the drug.”

Katlego Rasebitse of the Sisonke Movement warned that the success of the programme would depend on whether key populations, particularly sex workers, were adequately included.

“A programme that does not adequately prioritise key and vulnerable populations such as sex workers, particularly outside of clinic settings, will leave those most in need of HIV prevention services even more vulnerable,” said Rasebitse.

“Sisonke acknowledges the arrival of a few thousand doses of lenacapavir in some clinic settings, but before any premature celebration, the government must address the hostility that sex workers continue to face in the health system.

“A prevention programme that could be game-changing will only be effective if public health evidence is used to ensure those most at risk are properly included.”

The coalition also called on Gilead to expand its licensing agreements to allow more manufacturers to produce lenacapavir, increase supplies for countries in the Global South and invest in laboratory capacity in South Africa to speed up product testing.

The organisations further urged the company to support regulatory exemptions where appropriate to prevent future delays in the rollout of the highly anticipated HIV prevention medicine.