A groundbreaking injectable designed to curb the global spread of HIV is now at risk of being delayed due to President Donald Trump’s recent executive orders.
Lenacapavir, an innovative twice-yearly injection that prevents HIV transmission, was recognized as the breakthrough medicine of 2024. However, Trump’s decision to freeze all foreign aid funding now jeopardizes its global distribution to millions in need, Wired reports.
Linda-Gail Bekker, 62, is a medical professor from the University of Cape Town who helped identify Lenacapavir. She attended the AIDS 2024 Conference held in Munich, Germany, last July and proudly presented the groundbreaking results of the PURPOSE 1 clinical trial she led. The study revealed that the Gilead Sciences-developed Lenacapavir could prevent sexual transmission of HIV with 100% efficacy by targeting the virus’s capsid protein, a crucial component for its replication.
Unlike existing daily pre-exposure prophylaxis (PrEP) pills, which serve a similar purpose, Lenacapavir requires just two injections per year. While not a vaccine, it represents the next best option for HIV prevention. After the prestigious journal Science recognized Lenacapavir as 2024’s “Breakthrough of the Year,” Gilead committed to producing 10 million doses by 2026—enough to treat 2.5 million people—in preparation for anticipated regulatory approval later this year.
With over one million people contracting HIV each year, a partnership between The Global Fund and PEPFAR, the U.S. government’s global HIV/AIDS program, had pledged to acquire 2 million doses of Lenacapavir over
three years. These doses were intended for countries with the highest HIV rates, particularly in sub-Saharan Africa. However, President Donald Trump’s decision to freeze all foreign aid funding has thrown this plan into disarray.“There’s despondency and a sense of tragedy. Because just as we’ve had the breakthrough, we also see the taps turning off of resources,” Bekker said.
“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.”Many studies and research expected to be funded by U.S. resources are on hold, Bekker explains.
“It’s not just PEPFAR; we’re also worried about restrictions being placed on other sorts of research funding, such as the National Institutes of Health,” she says. “It’s just going to get harder to innovate and move progress forward.”
There is still hope that alternative donors could step up to support The Global Fund in securing Lenacapavir. Bekker is actively exploring new funding avenues for HIV prevention and research through European agencies and potential donor contributions from Scandinavia, Japan, and Australia. However, she fears that without the same level of support from the U.S., the unique opportunity Lenacapavir presents could be at risk of slipping away.
“It’s incredible that this has happened just as we’ve had the breakthrough,” Bekker said.
“I think this is going to set us back many years and ultimately cost a lot more in public health spending. Because ultimately, if we can bring this epidemic under control more quickly, it’s going to save the planet more money in the long run and save lives, too.”
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