Tuesday, June 9, 2026
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Health
South Africa: Activists Call for Greater Access to Newly-Launched HIV Prevention Drug
South African President Cyril Ramaphosa and Health Minister Aaron Motsoaledi at the official launch of the new injectable drug for HIV prevention, Lenacapavir. Credit: GCIS
- As South Africa officially launches the rollout of a groundbreaking HIV prevention drug, civic groups in the country have slammed the plan, saying it will not reach anywhere near enough people.
President Cyril Ramaphosa on June 5 launched the roll-out in South Africa of lenacapavir, a twice-yearly injectable HIV pre-exposure prophylaxis (PrEP) drug that has been shown to offer almost complete protection against the disease, billing it as a ‘historic event’.
But activists say there is nothing to celebrate, warning the targets set in the rollout are too low, and the volumes of the drug provided by the pharma firm behind its development, Gilead, are tiny.
“In an ideal world, South Africa would not be rolling out lenacapavir as a small pilot. We would be treating it as an epidemic-ending intervention. The objective should be to get millions of people onto lenacapavir as quickly as possible, not a few hundred thousand over several years,” Tian Johnson, founder and strategist of the Pan-African health justice advocacy group, African Alliance, told IPS.
“South Africa has the world’s largest HIV epidemic. We also helped generate the scientific evidence that made lenacapavir possible. An appropriate response would therefore be a national scale-up plan linked to epidemiological need, not constrained by artificial scarcity created by patent monopolies, donor allocations, and supply decisions made outside the country,” he added.
South Africa has the world’s highest burden of HIV, with around 8 million people living with HIV. In 2024 it recorded 170,000 new infections, accounting for roughly 13% of the 1.3 million new cases globally that year.
Lenacapavir has been shown in trials to provide almost complete protection against HIV acquisition. It has been praised not just for its effectiveness but also for its potential for very high adherence, as it is an injection given only every six months.
Civic groups say that if rolled out in a timely manner and with greater volumes, it could avert up to 52,200 new infections per year in South Africa alone.
They also point to modelling which has shown that around 2 million people in South Africa need to be taking lenacapavir annually for it to have a real impact on the number of new HIV infections.
But the government’s rollout is expected to reach only around 450,000 people over the next two years. Moreover, only just under 38,000 doses have so far arrived in the country.
Activists blame adversarial US policy and effective monopolies on the drug’s supply for this and say it has highlighted concerns over who has real control over efforts to end the epidemic in the country.
The Global Fund to Fight Aids, TB and Malaria (GF) and the United States President’s Emergency Plan for Aids Relief (PEPFAR) have historically been central to funding South Africa’s HIV response.
But days after Donald Trump entered the White House early last year, PEPFAR slashed around half of its funding for HIV in South Africa – what is left of it is due to run out this month.
So far, the Trump administration is refusing to fund lenacapavir for South Africa as the two countries lock horns politically and ideologically.
This means that the doses to be used in South Africa over the next 18 months to two years will be funded by the Global Fund and are expected to be only sufficient for 456,000 people.
Meanwhile, since Gilead is currently the only manufacturer of lenacapavir and generics are not available on the market yet, there is no alternative path available to secure more doses for the rollout.
Currently the cost of Lenacapavir is about USD 28,000 per person a year in the U.S., but Gilead has issued six licences to companies to manufacture generics, which will be available to 120 low- and middle-income countries. These are expected to become available in 2027, potentially for as little as USD 40 per person per year.
Earlier this year, it was announced the South African government was working to identify a local company to manufacture lenacapavir. Once identified, that company would then be recommended to Gilead for a voluntary licence to produce the drug.
In 2024, Gilead granted such licences to six generic manufacturers across India, Egypt and Pakistan to produce and supply the drug to 120 low- and middle-income countries. At the time, critics pointed out that no South African drugmakers were included.
Gilead has said it is open to adding another licence for local manufacturing in Sub-Saharan Africa. But activists warn that any final decision on a licence will rest with the company.
The groups also highlighted previous delays in the rollout of the programme, which had initially been scheduled to begin in April. When the first doses arrived in South Africa in March and April, they were subject to obligatory regulatory tests. Gilead could have asked for an exemption to the tests but did not, activists claim.
They say all this means properly protecting people against HIV in South Africa is effectively dependent on a pharmaceutical firm and US political policy.
“Gilead currently exercises extraordinary influence over who receives lenacapavir, in what quantities, and on what timeline. When a country with the world’s largest HIV epidemic cannot independently determine access to a medicine that was partly researched within its own borders, something is fundamentally wrong with the balance of power. The uncomfortable reality is that key decisions affecting South Africa’s HIV response are still being made in corporate boardrooms and donor negotiations rather than in South Africa. That should concern everyone, regardless of where they stand on this rollout,” said Johnson.
“Many countries are receiving doses funded by the US, and then also being funded as a result of re-allocation of already committed Global Fund funding repurposed for lenacapavir. The US is refusing to fund South Africa ‘s lenacapavir program, even though there is no better example of a country that needs lenacapavir, and [the programme] would immediately show impact,” Asia Russell, Executive Director of HIV advocacy group Health Gap, told IPS.
“The US government has stated its goal is to bend the curve of new HIV infections, but it is blocking access to the doses urgently needed in South Africa, which means it will fail to reach its goal. It should immediately reverse this decision, stop bullying South Africa, and provide doses – South Africa’s minuscule allocation of lenacapavir only from the Global Fund means the pandemic will continue raging in South Africa,” she added.
It will also have a detrimental effect on wider efforts to tackle HIV outside South Africa, others say.
“South Africa accounts for more than 13 percent of new HIV infections globally each year, and is a home for millions of other public health care recipients from other countries who benefit from the South African health care system. The US government’s refusal to support South Africa with lenacapavir and cut off other funding is not only cruel but also contributes to delays in ending the HIV pandemic,” Bellinda Thibela, Coordinator for Health Justice and Human Rights at Health GAP, told IPS
Meanwhile, activists point out what they see as another huge injustice in the situation.
South Africa was key to the development of the drug – it hosted testing sites, its clinics were used in research, and subjects came from its communities – yet it is now struggling to secure sufficient supplies of that same drug.
“South Africa played a pivotal role in the clinical development of lenacapavir, hosting 25 of the 28 trial sites that participated in the PURPOSE 1 Phase III study of this groundbreaking long-acting HIV prevention tool. Yet, despite this substantial contribution, my country has found itself in the difficult position that, following approval by the US FDA and rollout in several high-income countries, access to lenacapavir at scale for PrEP remains abysmally low and challenging. And not just for South Africa,” Fatima Hassan of the Health Justice Initiative (HJI), told IPS.
“This underscores persistent inequities within the global innovation ecosystem, where countries that bear a disproportionate burden of disease and contribute significantly to research and development often face delays in accessing the very health technologies they helped bring to fruition. It also raises important questions about local manufacturing, technology transfer, regulatory capacity, affordability, and equitable access in markets that are frequently perceived as less commercially attractive, despite their central role in generating the evidence that drives global health innovation and the development of new health technologies,” she added.
In a statement, Gilead said the launch of the rollout was an important step toward expanding access to lenacapavir for communities most affected by HIV.
“South Africa is at the heart of global efforts to end HIV. With the country’s launch of lenacapavir, there is now an opportunity to rapidly accelerate progress,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “Through partnerships with country leadership, the Global Fund, and the U.S. State Department via PEPFAR, Gilead is working to bring lenacapavir to the communities most in need, ahead of the broad rollout of generic versions of the medicine.”
The company also highlighted what it said was its commitment to supporting broad, equitable and sustainable access to lenacapavir for HIV prevention globally, pointing to its royalty-free voluntary licence agreements with six manufacturers enabling generic supply across 120 low- and lower-middle-income countries to support long-term, lower-cost medication supply.
“As highlighted by today’s announcement and the strong, coordinated leadership demonstrated in South Africa, the continued collaboration between countries, global health partners and industry will be critical to reaching people with new innovations at scale, reducing new HIV infections and advancing our shared goal of ending HIV as a public health threat,” the company said in the statement.
Civic groups have called on South Africa’s government to scale up the volumes for the rollout and expand it to make sure it can be accessed by more people – they have criticised the fact that out of more than 3,000 public clinics, just 300 in 23 districts have been chosen for the rollout, and mobile clinics, which would be more likely accessed by some communities, are not being used.
They also want to see more pressure put on Gilead to drastically expand its current licence territories to help manufacture lenacapavir.
“At the moment, we have a Gilead-driven launch event, but we do not have a credible epidemic-ending plan. The bigger issue is that South Africa appears to have accepted the limits imposed by Gilead rather than challenging them,” said Johnson.
He added that under the current roll-out plan a crucial opportunity to end the HIV epidemic sooner in South Africa was being missed.
“The tragedy is that South Africa is not dealing with a scientific failure – the science worked. Lenacapavir is one of the most promising HIV prevention tools ever developed. What we are facing is a political and access failure. If we know that roughly two million people need access annually to achieve maximum public health impact, then a faux roll out reaching a fraction of that number inevitably means preventable infections will continue occurring.
“Every year we delay large-scale access is another year in which tens of thousands of South Africans will acquire HIV despite the existence of a prevention tool capable of dramatically reducing transmission. This is why the debate is not really about a rollout. It is about whether South Africa intends to end the epidemic or manage it. The current approach manages the epidemic dismally. An epidemic-ending strategy would look very different,” Johnson said.
IPS UN Bureau Report
Inter Press Service (IPS), IPS News,
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