South Africa may be able to start rolling out the twice-yearly anti-HIV drug lenacapavir (LEN) in January 2026 – three months earlier than planned – but many people are still in the dark regarding costs, with details of the arrangements to bring the medication into the country being guarded by non-disclosure agreements (NDAs).
Even the SA National Aids Council (SANAC) says it doesn’t know what LEN will cost the country at the end of the Global Fund donation in two and a half years’ time, writes Ina Skosana for Health-e News.
National Department of Health Director-General Dr Sandile Buthelezi told delegates at last week’s 12th South African Aids Conference (SAAIDS 2025, under the Theme: Unite for Change), that Gilead Sciences had promised to deliver the first batch as soon as January. In fact, the government is pushing for an even earlier delivery, in time for the G20 leaders’ summit, to be held in Johannesburg in November.
“There is a commitment from the Global Fund of US$29m ring-fenced for lenacapavir over the next two and a half years,” Buthelezi said.
South Africa will be among the first countries set to receive doses of the drug through an access agreement secured by the Global Fund to Fight Aids, TB and Malaria, which negotiated a price with Gilead.
The agreement will make LEN available to 2m people in up to 12 low- and middle-income countries with a high HIV burden. Pepfar recently announced that it would support this initiative.
Lack of transparency
“We need LEN, but we also need transparency,” said Dr Thembisile Xulu. “As the CEO of SANAC, I don’t know the cost of LEN. So how can we make a case with National Treasury to fund the medication beyond the donation?”
Civil society organisations delivered a memorandum to Deputy Health Minister Dr Joe Phaahla at the conference’s closing ceremony, calling for the government to reject the NDAs.
The group argues that by signing the agreements, the government is allowing Gilead to price the drug out of reach of the masses who need protection.
While delivering the memorandum, Treatment Action Campaign’s Gcinumzi Sawuka said to Phaahla: “Gilead, just like Pepfar, is bullying South Africa. And instead of challenging them, you are accepting everything they say.”
Sawuka expressed disbelief to claims that the government was in the dark about the true cost of lenacapavir beyond the Global Fund commitment.
“Maybe you know the price or you’re teaming up with Gilead and the Global Fund at the people’s expense, just as it happened with Covid when we lost so many lives,” he said. “But we have not forgotten. We will never forget.”
In 2023, advocacy organisation Health Justice Initiative (HJI) won a court battle for the release of contracts showing that South Africa had been strong-armed and overcharged for Covid-19 vaccines. Until this judgment, the contracts had been protected by NDAs.
“When will you demand the price from Gilead and also insist it be made available to all low- and middle-income countries? At what price are you going to budget for more young people to get lenacapavir if you claim you don’t know how much it costs?”
But Buthelezi said the secrecy was key to ensuring South Africa’s supply.
“Some NDAs have been signed because they’ve (Gilead) cut the price so much to supply to us. We’re trying very hard to ensure the security of supply. As a private company, (Gilead) might be tempted to sell to the highest bidder,” he says.
“The Global Fund has negotiated a very good price of almost $60 per patient per year.”
Government commitment
According to the Joint United Nations Programme on HIV/Aids (UNAids), 1.3m people were newly infected with HIV in 2024; 170 000 of them in South Africa.
UNAids estimates that 20m people will need to be reached with antiretroviral-based prevention, like lenacapavir, to meet the global goal of ending Aids by 2030.
At the negotiated price, it was reported by Bhekisisa, only around 400 000 people in this country will get the jab. Activists say that this is an insult: the government should match the Global Fund’s contribution.
“This is a Global Fund and Pepfar commitment. Where’s the government? We need 2m people to be put on the drug, not just those covered by the commitment of international donors. We need domestic funds to be added,” said Dr Siyabonga Nzimande from the civil society forum.
Buthelezi is steadfast in the country’s readiness to roll out the drug.
“The issue of LEN is a matter of time,” he said. “The Gates Foundation and Wits RHI helped us with the plans for the roll-out, and the money is there. If Gilead says we will have the drugs by September, we are ready to hit the ground running.”
See more from MedicalBrief archives:
Lenacapavir to be rolled out via Pepfar to selected countries
‘Game-changing’ lenacapavir roll-out hangs in the balance
Gilead in talks with SAHPRA to register twice-yearly anti-HIV jab