After a lifetime on the frontiers of the fight against HIV, Linda-Gail Bekker could finally see the end of the epidemic in sight. For decades, HIV experts had dreamed of an elusive vaccine to block the ongoing chain of infections, which still sees more than 1 million people worldwide contract the virus annually. Bekker, a 62-year-old medical professor from the University of Cape Town, had helped identify a drug that could do just that.
But now, thanks to the Trump administration’s executive orders, it’s unclear when—or possibly even ever—this breakthrough medicine will see the light of day.
At the AIDS 2024 conference held in Munich last July, Bekker had triumphantly unveiled the results of a momentous clinical trial she had led, called PURPOSE 1. It showed that lenacapavir, an antiretroviral developed by the pharmaceutical company Gilead Sciences, could prevent sexual transmission of HIV with 100 percent efficacy by disrupting the function of the virus’s capsid protein, which allows it to replicate.
Even more remarkably, compared with existing daily pre-exposure prophylaxis (PrEP) pills, which do a similar job, injections are only required every six months. While not strictly a vaccine, lenacapavir promises to be the next best thing. It was named as 2024’s “Breakthrough of the Year” by the prestigious journal Science, and Gilead promptly committed to manufacturing 10 million doses by 2026, enough to treat 2.5 million people, ahead of anticipated regulatory approval later this year.
A collaborative effort between the medicines-financing initiative The Global Fund and PEPFAR, the US government’s global HIV/AIDS program, had pledged to procure 2 million of those doses over the course of three years, which would be directed toward countries with the highest incidence of HIV, most notably in sub-Saharan Africa. But with President Donald Trump’s decision to freeze all foreign aid funding, this plan has been left in tatters.
“There’s despondency and a sense of tragedy,” says Bekker. “Because just as we’ve had the breakthrough, we also see the taps turning off of resources. We had a laid-out map where the product would be supplied via PEPFAR and The Global Fund while we wait for generics [cheaper off-label versions of lenacapavir] to come online, which will take 18 months to two years. And at this moment, that plan is falling through in front of our eyes.”
While a temporary 90-day waiver has been issued for PEPFAR funding, this has only reinstated funding for life-saving antiretroviral treatments for HIV-positive individuals. Existing forms of PrEP are covered, but only for pregnant or breastfeeding women. There have been no indications that the planned purchase of lenacapavir will be fulfilled.
According to Kenneth Ngure, an HIV-prevention expert in Kenya and president-elect of the International AIDS Society, the loss of PEPFAR funding for prevention represents a major setback in the world’s ability to control HIV. “Even if The Global Fund partners with others, they will probably not be able to reach the number of doses they had promised,” he says. “We have this potential game-changer, which could accelerate the end of HIV as a public health threat, and yet it looks like access will be highly compromised.”