The news that the US Government has made a pre-market commitment to purchase the twice-yearly highly effective injectible drug lenacapavir from Gilead Sciences for the President’s Emergency Plan for Aids Relief (Pepfar) to distribute in eight to 12 high-burden HIV countries in 2026 has been welcomed by experts, including South Africans.
Authorities say Pepfar “is seeking to meaningfully reduce the number of new HIV infections, especially in pregnant and breastfeeding mothers”, but have emphasised that no NGOs will be involved in the rollout within the chosen countries, and that all dealings will be with governments.
The United States and the Global Fund are co-funding the advanced market commitment to purchase lenacapavir for up to 2m individuals by 2028, which Gilead has agreed to provide at cost.
In addition, the company has also agreed to provide its intellectual property to generic manufacturers who can produce the drug at scale and help bring down the price so that future purchases can be sustained by local governments.
Pepfar is prioritising the recipient countries based on countries’ HIV burden and the strength of that country’s existing infrastructure to distribute and deliver the drug. The agency will be working with countries over the next several months to develop a roll-out plan for lenacapavir, with a focus on prioritising distribution to pregnant and breastfeeding mothers.
Scientists believe that the drug could help end the HIV epidemic, and have welcomed the announcement.
“It’s really the only way to bring this epidemic under control,” Professor Linda-Gail Bekker, director of the Desmond Tutu HIV Centre in the Institute of Infectious Disease and Molecular Medicine at the University of Cape Town, told WGNH News.
“We have 31m people on treatment around the world, but if we don’t address protecting people who are susceptible to acquire HIV, we aren’t going to bring the epidemic under control.”
Jeremy Lewin, a senior official for Foreign Assistance, Humanitarian Affairs, and Religious Freedom at the US State Department, declined to put a dollar figure on how much America is spending on this effort, or to specify which countries would be receiving the doses, but said more information would be available in the coming weeks.
“Many of us were in a great deal of dismay and despair,” said Bekker, reflecting on the massive aid cuts that hobbled many HIV programmes. “This announcement brings hope. It’s huge.”
“Prevention programmws were absolutely gutted by the aid cuts,” said Mitchell Warren, Executive Director of Aids Vaccine Advocacy Coalition (AVAC), an HIV prevention organisation that works globally.
“This announcement about lenacapavir is a really important statement that Pepfar and the US Government are back in the PrEP business. It’s a step forward from where we’ve been in a fairly paralytic state for the past seven months, and I hope that this breaks the logjam and at least can get prevention back on the agenda.”
Peter Sands, executive director of the Global Fund, echoed that sentiment, pointing out that lenacapavir could help reduce the 1.3m new HIV infections that happen each year.
“We can change the nature of the HIV/Aids pandemic quite dramatically,” he said. “That will obviously save lives, but it will also reduce significantly future health system costs because if an 18-year-old gets infected with HIV, you’re talking about 50 to 60 years of treatment that someone in the system is going to have to bear.”
Lewin said the announcement was an indication of what type of work Pepfar would be doing in the future and, more broadly, what global health work will look like under the Trump administration.
“This is the type of thing we’re going to do more of,” he said at a press briefing.
“There’s been a lot of media attention on some of the programmes that we have cut because they’re no longer aligned with our priorities. This is where our focus is going to be: on the purchasing, at scale, of commodities that can really help have an outsized impact in fighting HIV and across our various global health disease areas.”
Lewin also emphasised that this work was in co-ordination with countries and national health systems rather than NGOs and international health organisations, as was the case in the past.
“There are no NGOs involved in this. There are none of those sorts of beltway bandits here,” he said. “It is not the United States job to be paying shadow healthcare workers … for Americans to be in these countries telling local healthcare systems that they’re doing things wrong and offering a competitor to the healthcare system.
“That creates a bad incentive for the country not to develop its own national healthcare infrastructure.”
Warren of AVAC said he was worried this exclusion of NGOs “would diminish the reach and impact” of the drug, making it harder to get it to the people who need it, since the NGO groups run a lot of the programmes and clinics that will be involved in the rollout.
But he agreed that countries need to own and operate their own Aids responses.
When will the drug be available?
Experts are thinking through the logistics and timeline of the rollout with the hope that the drugs could make it to hot spots in Africa by the end of this year or early next year.
But first African countries have to green light the drug – as the US Food and Drug Administration, World Health Organisation and European Medicines Agency have already done. Warren said he expects those approvals to begin in the next few months.
Bekker said clinics are able to mobilise quickly to support the rollout.
“We are ready. We have sites and facilities that are willing and able. It’s very doable and very urgent,” she added.
The US support will help defray the cost – although the exact price tag Gilead is charging is not public, Warren estimates it is around $100 per person per year. That’s more than double the cost of oral PrEP.
Gilead’s CEO, Daniel O’Day, said the company is offering this drug to Pepfar and the Global Fund at cost and without a profit – the result of 17 years of research and development work.
“The support of the US Government through Pepfar means that we can get to places with the greatest need faster,” he said.
A cheaper generic version is coming. Gilead Sciences has shared the licence for lenacapavir as well as information on how to make it with six generic manufacturers. However, Bekker said, generics probably won’t be available until 2027 because of the time needed to start production and do the required testing.
Until then, she said, lenacapavir “is probably outside most governments’ budgets in low and middle income countries”.
She noted that the announcement has her reflecting on the power of Pepfar – in the past and today.
“I’m eternally grateful to the American taxpayers for just what they have done for us (in Africa). It’s changed lives, communities. It’s completely transformed what could have been an everlasting tragedy, and now we have hope.”
GBH News – Why the medical community is thrilled by U.S. support for a 'breakthrough' HIV drug
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