Health GAP issued the following statement in response to an announcement by the U.S. State Department regarding Long Acting Lenacapavir (LEN-LA) for HIV pre exposure prophylaxis (PrEP):
Right now this administration’s illegal actions are the biggest obstacle to getting LEN-LA into the hands of tens of millions of people who urgently need effective HIV prevention. Russell Vought, OMB Director, is withholding billions of dollars in already appropriated FY25 PEPFAR funding which is essential for countries to introduce LEN-LA at scale. Instead of releasing this chokehold that includes funding for PrEP, Jeremy Lewin has announced an anemic, weak rationing of LEN-LA for only 667,000 people per year—a target which has already been funded by the Global Fund. This renders the plan hollow, and virtually meaningless. 2 million over 3 years is less than a drop in the ocean. This coverage target marks a painfully slow pace of roll out given the urgent need among people at risk of HIV infection. Severe rationing of LEN-LA doses will result in virtually no impact on global HIV epidemiology—doses will be spread so thin, over so many countries, this plan will fail to bend the curve of new infections despite the virtual 100% protection LEN-LA confers.
said Asia Russell, Health GAP Executive Director.
Jeremy Lewin, State Department Under Secretary for Foreign Assistance, Humanitarian Affairs and Religious Freedom, who made today’s announcement, himself helped oversee the unlawful and abrupt termination of PEPFAR awards for programs that delivered PrEP and other HIV prevention services for people at far greater risk of HIV acquisition, including young women and men, gay men, transgender people, sex workers, people who use drugs and their sex partners, undermining effective HIV programs and contradicting scientific evidence.
Access for 2 million people over three years in 9 countries (for Kenya, Lesotho, Uganda, Eswaini, Mozambique, Nigeria, Zambia, Zimbabwe, and South Africa) was already announced by the Global Fund and Gilead on July 9, following a December 17, 2024 announcement by PEPFAR and the Global Fund of the same initiative. We demand an about face by his administration—restoring PEPFAR to normal so countries can finish the job of defeating HIV as a public health threat, and restoring programs focused on the health needs of key populations, abiding by science.
said Bellinda Thibela, Health GAP International Policy and Advocacy Coordinator.
Further background:
- AIDS activists protested Vought’s obstruction of PEPFAR funding apportionment for PrEP and other lifesaving programs on September 2 at his office. (Protest images available here and here.)
- By rationing this product to only 2 million people, countries will be unable to ensure everyone who wants LEN-LA can get it; criminalization and scapegoating of vulnerable populations, which has been intensified by this Administration’s homophobia, transphobia and attacks on efforts to flatten health disparities, undermines science, human rights, and access to PrEP—and will sabotage this effort.
- Gilead has refused to reveal its ‘access price,’ although it is widely believed to be $100/year (an amount reduced for 9 Global Fund countries to $60/year because of a one-time subsidy by the Children’s Investment Fund Foundation (CIFF) of $50 million. The State Department should require price transparency from Gilead, and also insist that this price be made available to all low- and middle income countries, not only the subset being discussed.
- A recent academic study estimates LEN-LA could be produced generically for $25–$40 per person per year at scale, a price comparable with oral PrEP.
- In May 2025, global estimates of new HIV infections rose sharply from 3500 to 5800 HIV infections daily, due to the Trump administration’s abandonment of many HIV prevention programs globally, including PEPFAR-funded PrEP programs reaching 3.5 million people. Global estimates indicate between 10-20 million people need PrEP to prevent HIV acquisition now.
- Gilead has issued voluntary licenses to only six generic manufacturers and restricted countries eligible for that supply to 120 low- and middle-income countries (LMICs).
- More than one in four new HIV acquisitions occur in the 26 countries excluded by Gilead in its license, including Argentina, Brazil, Mexico, and Peru, countries where Gilead carried out pivotal lenacapavir clinical trials. Gilead intends to maximize profit in excluded countries through opaque, unaffordable “tiered pricing” deals as well as a partnership agreement in Brazil, also announced today.
For more information, read the original press release.
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