South Africans will receive the groundbreaking lenacapavir drug, seen as the best option to help end Aids in the country, thanks to a R520m offer to buy the twice-a-year anti-HIV jab from the Global Fund to Fight Aids, TB and Malaria.
But, writes Mia Malan for Bhekisisa, 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 which 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, CEO of the South African Health Products Regulatory Authority (SAHPRA), told Bhekisisa it was aiming to have lenacapavir registered here before the end of the year.
National Health Department head of procurement Khadija Jamaloodien said the lenacapavir funds from the Global Fund would 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.
According to the latest Joint United Nations Programme on HIV and Aids (UNAids) report 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 2m to 4m people per year in South Africa on the lenacapavir jab, and even if it were, 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 9 July that it has the “ambition” to finance enough lenacapavir for 2m 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.
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 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 recent 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 many of the choices over the past 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 must budget just under R600 per dose
Jamaloodien, however, warns that further discussions with the Global Fund and Gilead will be needed regarding 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 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 per 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 department had received such a letter.
The letter also states that the gap between the price that the Fund pays Gilead per patient per 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 $150m 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 won’t Gilead talk about price?
Lenacapavir, also referred to as LEN for short, was registered for HIV prevention (PrEP) by the US Food and Drug Administration on 18 June, and is sold in that country for $28 218 per person per year under the trade name Yeztugo.
The US is the only country in which Lencapavir has been registered so far as PrEP.
For low- and middle-income countries like South Africa, Gilead, however, said it will have a “not-for-profit” price like the one negotiated with the Global Fund – but isn’t allowing the Fund to make it public.
Several scientists and activists at the HIV science conference told Bhekisisa that the rumoured not-for-profit price Gilead negotiated with the Global Fund is $100 per person per year, and Avac confirms it in its analysis of events.
But neither Gilead or the Global Fund has confirmed this amount.
If South Africa budgets for $60 per person per year, the $29.2m that Global Fund says we can use to buy lenacapavir translates to putting and keeping around 400 000 people on the medicine over three years (Global Fund grants run for three years at a time).
Gilead argues that 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 (like 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 our high number of new HIV infections.
The country’s 170 000 new infections in 2024 is 13% of the 1.3m new HIV infections around the world in 2024.
And research released by Wits RHI in Kigali shows South Africans are open to using the jab: 56% of just more than 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 last week.
Warren added: “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.”
Dire statistics
The UNAIDS Global Update report said that in South Africa, an adolescent girl or young woman is infected with HIV every 10 minutes, those aged between 15 and 24 remaining disproportionately at risk, with 1 000 new cases in this group every week.
Professor Linda-Gail Bekker of the Desmond Tutu HIV Centre at the University of Cape Town told News24 this was a key vulnerable population, “who are not only experiencing their sexual debut, but also facing challenges in accessing healthcare – and stigma.”
She said a way had to be found to protect this group, and “try to stem the circulation of the virus”.
“We also have to give these young women the tools to be able to protect themselves, which is where pre-exposure prophylaxis comes in.”
She added that oral PrEP had not been well taken up, that people “don’t want a bunch of rattling pills in their pocket, and they forget to take them every day”.
“This is where there is hope for a long-acting injectable agent like lenacapavir. In the same way that long-acting reversible contraception has made such a huge difference to reproductive health, we hope the same will happen …for pre-exposure prophylaxis for HIV prevention.”
Health Minister Aaron Motsoaledi said the rollout of lenacapavir represented one of the most significant advances in HIV prevention in decades.
See more from MedicalBrief archives:
‘Game-changing’ lenacapavir roll-out hangs in the balance
Lenacapavir demonstrates efficacy in people with highly resistant HIV
Gilead in talks with SAHPRA to register twice-yearly anti-HIV jab