By Bunmi Yekini
The U.S. Food and Drug Administration (FDA) has approved lenacapavir, a long-acting injectable that can prevent HIV infections for up to six months, marking what experts say is one of the most significant breakthroughs in HIV prevention in decades.
Developed by Gilead Sciences and marketed as Yeztugo, lenacapavir arrives as a “vaccine-like shield,” offering a new option in the fight against HIV, which still infects an estimated 1.3 million people globally every year.
“This is a historic day in the decades-long fight against HIV,” said Gilead CEO in a statement. “Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.”
Public health experts, too, hailed the news. “This is the most transformative prevention product we’ve had in 44 years of this epidemic,” said Mitchell Warren, executive director of AVAC, a nonprofit focused on HIV prevention advocacy.
Lenacapavir belongs to a new class of HIV drugs that target the viral capsid, making resistance unlikely and simplifying prevention for people who struggle with daily pre-exposure prophylaxis (PrEP) pills. Researchers note that uptake of daily PrEP has grown, but most of the world’s most vulnerable people still lack access.
“Overall, an estimated 3 million people worldwide take a daily PrEP pill — far short of a goal of 21 million,” Warren added.
Yet lenacapavir’s rollout faces hurdles. U.S. funding for PEPFAR — the President’s Emergency Plan for AIDS Relief — is under threat. Donald Trump’s proposed budget would slash PEPFAR by one-third, which could undermine plans to put 2 million people in low- and lower-middle-income countries on lenacapavir within three years.
“We all had this expectation that PEPFAR would be the major driver for the global rollout of lenacapavir,” said Beatriz Grinsztejn, an HIV researcher at Brazil’s Oswaldo Cruz Foundation. “Now other actors need to take the lead.”
Gilead has granted royalty-free licenses to six generic manufacturers to sell the drug across 120 lower-income countries, and will provide lenacapavir at no profit until generics arrive. However, middle-income countries like Brazil and Peru may not see generic versions.
“Hopefully there will be a way for us to have access to this drug at an affordable price,” Grinsztejn said.
Jirair Ratevosian, a former chief of staff at PEPFAR, noted a glimmer of hope in White House language. “That is a really strong signal that they are interested,” he said. “I think that is a huge window of opportunity that we need to drive a truck through.”
And the Global Fund — despite facing uncertain U.S. contributions — remains committed to putting 2 million people on lenacapavir. “Expanding access early is important to show generic manufacturers there is demand,” said Hui Yang, head of supply operations.
For Salim Abdool Karim, who heads the Centre for the AIDS Programme of Research in South Africa, ensuring lenacapavir reaches those who need it most will require “innovative thinking and a lot of studies.”
“This is a completely new approach,” he said. “If we simply take lenacapavir and put it into clinics and pharmacies, it will sit on the shelves.”
The World Health Organization will issue guidelines next month at the International AIDS Conference in Kigali, Rwanda, and is also pursuing “prequalification” to clear the way for rapid global access.
And while lenacapavir is already revolutionary, it might just be the start. Gilead is pursuing a once-yearly version and other companies are working on monthly oral options, holding out the promise that by 2028 “we begin to see a decline in incidence,” Warren said.
“There’s also a possibility that we get this half right with lenacapavir,” Warren added. “And we build the platform to move to once-a-year lenacapavir and a monthly oral tablet by 2028.”