20 November 2025, 09h00 SAST
U.S. Government’s Donation of 500 Doses versus More Than One Billion Lives: Africa Demands More Than Tokenism US Government Announces Arrival of Paltry 500 Lenacapavir Doses for Eswatini and 500 Lenacapavir
Doses for Zambia While Excluding South Africa
(CAPE TOWN, SOUTH AFRICA) Ahead of World AIDS Day, the United States government, Gilead and the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) announced the arrival of a donation of just 500 doses of lenacapavir (LEN-LA) each for Zambia and Eswatini. Activists sharply criticised this move as a public relations stunt, despite platitudes to the contrary. LEN-LA is a potentially revolutionary new twice yearly HIV pre-exposure prophylaxis (PrEP) prevention injection, which confers virtually 100% protection against HIV infection.
“Africa and the Global South are being offered merely symbolic handouts, while Gilead and donors shape markets to serve corporate and geopolitical interests, not urgent public health needs. By procuring a minuscule number of doses, Gilead can claim LEN-LA is ‘introduced’ in Africa, creating demand and laying the path for commercial bullying instead of introducing the product at actual cost, and at scale. This is a profit seeking, corporate strategy dressed up as solidarity,” said Fatima Hassan, Director of the Health Justice Initiative (HJI).
At least 10 million people need LEN-LA in Africa alone, in order to help achieve the global goal of a 90% reduction in new HIV infections by 2030. US State Department Under Secretary Jeremy Lewin said the US would provide LEN-LA doses for only 300,000 people in 2026 in total, globally.
”Protection for only 300,000 people is insulting, compared with the unmet need for HIV prevention, and the superiority of LEN-LA when compared with oral PrEP. Instead of crumbs, the US should be providing millions of LEN-LA doses, to alter the course of the HIV pandemic and to repair the harms caused by their illegal and deadly cuts to HIV programmes since January,” said Bellinda Thibela, Health GAP’s International Policy and Advocacy Coordinator.
Africa is the epicenter of the global HIV pandemic, with 60% of all new HIV infections occurring in sub-Saharan Africa. Beginning in January, the US decimated HIV testing, treatment and prevention programmes when it issued stop work and funding freeze orders and then abruptly terminated the vast majority of USAID-funded PEPFAR awards and unilaterally slashed PEPFAR funding by almost 40%, refusing to spend money already budgeted for HIV, defying the will of US Congressional lawmakers.
While announcing a trickle of LEN-LA doses, Trump has also, in effect, been going behind the back of the US Congress and negotiating bilateral Memoranda of Understanding (MoUs) in 18 Africa countries. These MoUs are being used to continue illegal PEPFAR funding cuts, restrict prevention (especially for key populations), and attempt to end programmes in as few as 2-5 years.
As a result, ”HIV testing has fallen, infections have increased, and treatment has stalled, all causing deaths and illness far more than any impact the US’s small and stunt driven, LEN-LA donations will have,” said Sibongile Tshabalala, Chairperson of the Treatment Action Campaign (TAC). Shockingly, the US government also announced it would exclude South Africa from its LEN-LA rollout plan, because in effect, the Trump Administration has made South Africa the target of harsh foreign policy decisions based on the Trump administrations racism, lies and conspiracy theory.
Nigeria is also being pushed out from LEN-LA support, coincidentally after being criticised by US government officials, including for refusing to imprison US detainees extracted during US immigration raids. By contrast Eswatini has accepted the offer of not just the 500 LEN-LA doses ahead of World AIDS Day, but also $5.1 million in funding from the US government in exchange for imprisoning US detainees.
Amidst these developments, China is announcing today, a new HIV prevention project in South Africa, focusing on young people and people who inject drugs in partnership with UNAIDS. 14% of all new HIV infections occur in South Africa. More than 2 million people need LEN-LA annually in South Africa alone, particularly young women, adolescent girls and key population groups including sex workers; lesbian, gay and bisexual people; transgender people, and people who use drugs. South Africa has been promised LEN-LA doses but they will only be paid for from a reallocation of its Global Fund budget and will only be enough for 480,000 people from April 2026 – 2028. South
African modelers have shown this rationing of doses will have no demonstrable impact on reducing South Africa’s pandemic, likely averting only 5,000 of the country’s 180,000 new HIV infections per year.
“Gilead and the US government are thwarting efforts to increase LEN-LA volumes and use cheaper generic versions sooner. Their profit seeking and at times deeply exclusionary and racist ‘market shaping’ efforts will unnecessarily prolong the pandemic,” added Fatima Hassan of the HJI.
LEN-LA costs only $25 per year to make generically, once sufficient volumes are achieved. Gilead’s
global strategy to roll out LEN-LA is deeply flawed: of 6 voluntary licensees, no South African or Sub-Saharan African generic manufacturer received a license from Gilead yet – despite the capacity for manufacturing injectables on the continent.
Worse, Gilead is frustrating the speed at which generic entries are possible: Gilead has not yet filed with India’s drug regulatory authority to enable faster generic entry, and it has prioritised registration in only 22 LMICs, effectively delaying supply for millions.
Gilead has also demanded LEN-LA price secrecy in a move to increase its corporate power.
”Gilead’s price secrecy demands are unacceptable, especially when health ministries in low – and middle – income countries are already squeezed by the debt crisis, high or punitive US tariffs and massive US government funding cuts,” said Tian Johnson, Strategist at the African Alliance.
As a result, countries excluded from the Global Fund’s supply agreement and Gilead’s voluntary licenses (Gilead excluded several high HIV burden countries and only 6 generic companies were licensed) will be left to negotiate directly with Gilead, facing the prospect of unaffordable “tiered” prices designed to maximise profit. And despite registration of LEN-LA with SAHPRA recently, Gilead is excluding the South African private sector – which will create a limitation on access and undermine South Africa’s ambition for HIV prevention. This must be urgently remedied.
South Africa’s Government should act decisively for equitable access
”Considering the US government’s pettiness directed at the people of South Africa for its stance against a genocide, and their non-factual depiction of South Africa with respect to land expropriation, coupled with Gilead’s corporate minded market strategy for access that threatens equity, we would urge the South African government to no longer sit back and wait,” added Tian Johnson, Strategist at the African Alliance.
Almost one year has passed since Gilead’s so-called access strategy was released. Today, ahead of World AIDS Day, we call on the Department of Health, Department of Trade, Industry and Competition, and the Office of the Presidency to take the necessary steps to issue a compulsory license to guarantee supplies and protect the lives of millions of people, in South Africa and beyond – especially in the countries and territories excluded from Gilead’s voluntary licenses.
”It is a public health emergency. Global North countries have previously taken similar measures, and South Africa should take these life-saving steps now,” continued Thibela of Health GAP.
”Cheap politics and zero foresight will thwart global efforts for a proper rollout. No smart access effort can exclude South Africa in HIV prevention programming. South Africa was also one of the countries that contributed to the success of LEN-LA – and we should remember that HIV knows no borders, and that our fight for human rights is not for sale,” said Yvette Raphael, Co-founder of Advocacy for Prevention of HIV and AIDS (APHA).
Global generic entry for local use is critical if Africa is to secure equitable access to lenacapavir
”South Africa has domestic companies that can manufacture quality assured LEN-LA for domestic and regional use and to supply excluded countries. Gilead should either license such companies without territorial and other restrictions for LMICs and include full technology transfer, or the South African government should use its lawful powers to issue compulsory licenses,” said Sibongile Tshabalala, Chairperson of the Treatment Action Campaign (TAC).
Now that the Trump administration has openly tied the global rollout of LEN-LA to a political standoff rewarding ”compliance” but punishing African political autonomy and sovereignty, South Africa must step forward with principled global leadership and show solidarity with countries excluded by the US government in its rollout announcement, and also by Gilead in its licensing arrangements, by supporting and including countries in Latin America and elsewhere, that like South Africa, participated in the very clinical trials that enabled Gilead to hold monopoly power.
Today, we call on the South African government to demand that Gilead includes additional African licensees with manufacturing capacity in its voluntary licensing arrangements in the interests of fostering self-reliance; and to begin to take steps to issue a compulsory license against Gilead. This will open pathways to generic supply and ensure lifesaving innovations are not held hostage to corporate greed and political interests. South Africa must also insist on and ensure that the Global Fund disclose the prices it will pay Gilead, for the initial allocation, since public resources are implicated. Transparency is not negotiable, nor our lives.
Contact for interviews: Angie Richardson: angie@thepressoffice.net (Media Officer)
Notes:
- South Africa is at the epicenter of the global HIV pandemic with a record number of HIV infections.
- Modelling by the Health Economics and Epidemiology Research Office (HE2RO) at WITS University indicates that a more ambitious rollout of lenacapavir, going beyond the initial proposed NDoH allocation of about 456 00 doses in year 1, to instead, 2 million doses in year 1 could drastically drop new HIV infections to below 0.1% by 2038, effectively ending the epidemic via a targeted rollout amongst key populations.
- The NDoH LEN-LA roll out ”targets” per NDoH public representations are: For April 2026 onwards, 492 560 – made up of the following allocations: a. ”272 800 general population 15+ (incl adolescent girls and young women)” b. “98 960 pregnant and lactating women” c. ‘’50,660 sex workers’’ d. ‘’20,685 transgender people’’ e. ‘’43 505 gay, bisexual, and other men who have sex with men’’. Note: Researchers and civil society groups have also repeatedly warned that the target for year 1 should be more ambitious and not conditional on what Gilead and the GFATM are ”willing” to offer the SA market.
- According to media interviews given by officials from the NDoH: a. About 300 SA government clinics (or 10% of all clinics in the country) will rollout twice-yearly lenacapavir between April 2026 and March 2028; far greater volumes are needed to bring down new infections. Note: It is estimated that LEN-LA for 2 million people is needed, prioritising especially: Young women, gay men, trans women, sex workers, and people who use drugs. b. By April 2027 the NDoH ‘could start to use government money to buy cheaper generics’; c. The ”department would buy the original, branded version of lenacapavir – from Gilead Sciences – with R513m ($29.2m) of its larger three-year Global Fund for HIV, TB and Malaria grant of R7.1bn ($402 450 343), which kicks in on 1 October” 2025.
- Presentation to the SA National Roundtable on Lenacapavir Access and Sustainability in South Africa held on 14 October 2025 in Gauteng.
- SAHPRA registration in SA: 27 October 2025 (For now private sector use is not available because of Gilead’s decision to register LEN-LA, but not market it, for the private sector).
Resources:
1. CSO FAQ on Gilead’s License and Implications: FAQ 2
2. PEPFAR Watch: https://healthgap.org/resources/pepfar-watch/
3. LEN-LA CSO Registration tracker: Tracking Gilead’s Registration of Lenacapavir for PrEP (25/09/2025)
Articles indicating USG position on: ”Excluding” South Africa; ”500 doses” scandal ahead of WAD countries:
1. https://www.washingtonpost.com/national-security/2025/11/18/trump-hiv-drug-south-africa/
18 November 2025, Trump HIV prevention plan shuts out South Africa – the nation most affected, Adam Taylor
2. Al Jazeera, Opinion: https://aje.io/qkiyu6
18 November 2025, Trump’s war on South Africa betrays a sinister threat, Tafi Mhaka
3. Stat. U.S. begins to provide HIV prevention drug, but skips South Africa.2025
18 November 2025, Trump administration touts moves to provide HIV prevention drug, but refuses to include South Africa, Ed Silverman