SA gets R520 million to buy the twice-a-year anti-HIV jab – but there’s a snag

South Africa has accepted an offer of just over $29 million (about R520 million) from the Global Fund to Fight Aids, TB and Malaria to buy the twice-a-year anti-HIV jab, lenacapavir, that research shows could help to end Aids in the country, says health department spokesperson, Foster Mohale. 

But there’s a snag. 

The country isn’t getting extra money from the fund to buy the medicine; it has to use cash from a grant that it has already been awarded and that was cut by 16% in June. Moreover, the fund, at this stage, won’t tell the health department — or any of the other eight countries it has selected for early roll-out — how much they’re paying lenacapavir’s maker, Gilead Sciences, for the product.  

Boitumelo Semete-Makokotlela, the chief executive of the country’s medicine regulator, the South African Health Products Regulatory Authority, Sahpra, told Bhekisisa it is aiming to have lenacapavir registered in South Africa before the end of the year.

According to the health department’s head of procurement, Khadija Jamaloodien, the lenacapavir funds from the Global Fund will become available in October, when the roll-out period of South Africa’s next grant, known as Grant Cycle 7, kicks in. 

But roll-out — probably in early 2026 — can only start once Sahpra has registered the medicine, the country’s essential medicines list committee has reviewed and recommended lenacapavir, procurement processes are in place and health workers and clinics have all they need to hand the drug safely to patients. 

Two studies released last year showed the medicine completely protects young women from contracting the virus and works almost as well for men, transgender and gender-nonbinary people.

In fact, a modelling study shows that if between two and four million HIV-negative people in South Africa use the jab every year over the next eight years, the medication could end Aids as a public health threat by 2032.

Ending Aids as a public health threat means reaching a stage where fewer people are getting newly infected with HIV than the number of people with HIV who are dying (increasingly for other reasons than HIV, for example old age). 

According to the latest Joint United Nations Programme on HIV and Aids (UNAids) report, which was released last week, 170 000 people got newly infected with HIV in 2024, while there were 53 000 Aids-related deaths. 

The Global Fund money for South Africa is, however, not nearly enough to put two to four million people a year in South Africa on the lenacapavir jab (see price explanation below) — and even if it was, the country’s health system won’t be able to roll the medicine out that fast, scientists and policymakers say. 

Will the US help to pay for the jab? 

The fund’s offer follows the body’s announcement on July 9, that it has the “ambition” to finance enough lenacapavir for two million HIV-negative people — in the low- and middle-income countries it supports — over the next three years. But fulfilling this ambition will depend on whether the governments of wealthy countries give enough money to the fund in its next replenishment round. 

The US government’s Aids fund, Pepfar, was originally going to help to pay to roll out lenacapavir in poorer countries. 

And, although some activists say it’s still possible for the US administration to come on board (lenacapavir is mentioned in President Donald Trump’s budget proposal for the next financial year, but is understood to be only for pregnant and breastfeeding women), it’s not clear at all how this might happen after the Trump administration’s drastic cuts to funding for HIV projects in countries like South Africa this year. 

The Global Fund’s offer, however, is a way to get branded, “bridging” doses from Gilead to South Africa while the world waits for cheaper generics to become available around 2027. 

“We now stand at a moment of reckoning and a moment of choice,” Mitchell Warren, the executive director of the international advocacy organisation, Avac, told Bhekisisa at the 13th conference on HIV science in Kigali this week. 

“While a lot of the choices over the last six months have been made by an American politician [Donald Trump] who doesn’t care about the pandemic or science generally, our choice is to make decisions based on the science that we all now know. Which is that lenacapavir is our most potent opportunity.” 

Countries have to budget just under R600 per dose

Jamaloodien, however, cautions further discussions with the Global Fund and Gilead will be needed about the governance around the pricing of the product.  

“We have a transparent pricing system, guided by the Public Finance Management Act. Even if we procure medicine with Global Fund money, we have to follow the same rules that the treasury requires us to follow with tenders, which includes revealing the price at which the medicine is bought,” Jamaloodien says. 

In a Global Fund letter sent in early July to the nine early roll-out countries — South Africa, Zimbabwe, Eswatini, Lesotho, Zambia, Mozambique, Kenya, Uganda and Nigeria — the fund asked the governments to budget for $60 (about R1 076) per patient a year ($30, or R576, per six-monthly dose), to buy lenacapavir. But in the document, which Bhekisisa has seen, the fund makes it clear that the amount “reflects the country contribution only, to be used for budgeting purposes, and should not be considered the product price”. 

Jamaloodien has confirmed that the health department did receive such a letter. 

The letter also states that the gap between the price that the fund pays Gilead per patient a year and the $60 that countries will pay for with their Global Fund grants, will be covered by private sector funding, which Hui Yang, the fund’s head of supply operations, confirmed to Bhekisisa will be paid for by a $150 million (about R2.68 billion) donation of the UK-based Children’s Investment Fund Foundation to the Global Fund. 

Furthermore, says Jamaloodien, South Africa’s letter instructs the country to submit its first order, for planning purposes, by 30 September under an “agreed procurement mechanism”.

Why does Gilead not want to talk about LEN’s price? 

Lenacapavir, also referred to as LEN for short, was registered for HIV prevention — also called PrEP — by the US medicines regulator, the Food and Drug Administration on 18 June, and is sold in that country for $28 218 (about R505 269) per person a year under the trade name Yeztugo.  

The US is the only country in which LEN has been registered so far as PrEP. 

For low- and middle-income countries such as South Africa, Gilead said it will have a “not-for-profit” price such as the one they negotiated with the Global Fund, but isn’t allowing the fund to make it public.

Several scientists and activists at the HIV science conference, have, however, told Bhekisisa the rumoured not-for-profit price that Gilead has negotiated with the Global Fund is $100 per person a year, and Avac, confirms it in its analysis of events. 

But neither Gilead or the Global Fund have confirmed this amount. 

If South Africa budgets for $60 per person a year, the $29.2-million that Global Fund says we can use to buy lenacapavir, translates to putting and keeping about 400 000 people on the medicine over three years (Global Fund grants run for three years at a time).

Gilead argues because the not-for-profit price is based on the actual cost of making lenacapavir, and shipping it to countries, it can’t declare that cost. “Gilead doesn’t publicly disclose manufacturing costs for any of our medications,” Caroline Almeida, Gilead’s head of public affairs, told Bhekisisa in Kigali. 

But activists don’t buy this argument.

“Gilead’s secrecy will obstruct civil society activism for lower drug prices and keep prices high in middle-income countries [such as South Africa] where Gilead negotiates prices directly,” the Health Justice Initiative and other activist groups said in a press release last week. 

Avac has identified 16 top lenacapavir markets, of which South Africa is — by far — the largest because of the country’s high number of new HIV infections. 

The country’s 170 000 new infections in 2024 is 13% of the 1.3 million new HIV infections around the world in 2024.

And research released by Wits RHI on Tuesday in Kigali shows South Africans are open to using the jab: 56% of just over 1 700 participants in a survey in Tshwane, Mthatha and Gqeberha, who were already using public sector HIV prevention services, said they would take a lenacapavir shot. 

But for LEN to be affordable, activists argue, Gilead needs to be open about its price.  

“Such secrecy undermines the power of buyers to negotiate affordable prices and violates the human rights of all people to access information and lifesaving tools,” activists said in last week’s press release. 

Warren concludes: “Pricing transparency has been a long-standing challenge, as companies try to balance their commercial pricing and marketing strategies with their global public health strategies. We clearly need a new model or compact for pricing that helps break the cycle of small thinking and limited impact.”

This story was produced by the Bhekisisa Centre for Health Journalism. Sign up for the newsletter.