After 44 years of battling the HIV epidemic, a major breakthrough may finally turn the tide. The first HIV drug to offer 100% protection through just two injections a year has been approved a milestone that could save millions of lives worldwide.
To ensure broad access, the drug’s developers have signed royalty-free agreements with six generic manufacturers, enabling affordable global distribution.
In the U.S., the FDA has approved this groundbreaking treatment: lenacapavir, marketed as Yeztugo. It’s part of a new class of medications called capsid inhibitors and delivers near-total protection against HIV, which still infects around 1.3 million people annually.
Lenacapavir Named 2024 Breakthrough of the Year for Offering 99% HIV Protection Through PrEP
In 2024, Science magazine named lenacapavir the Breakthrough Invention of the Year, recognizing its significant impact on HIV prevention. We’ve closely followed its journey to approval. As a pre-exposure prophylaxis (PrEP), lenacapavir offers HIV-negative individuals approximately 99% protection against sexual transmission of the virus.
As explained last year, lenacapavir works as a capsid inhibitor. In HIV-1, the capsid is a protein shell that encloses the virus’s genetic material and plays a key role in delivering it into host cells. Once inside, the capsid disassembles, allowing the virus to replicate. Lenacapavir disrupts this process, preventing the virus from multiplying.
“This is a historic moment in the decades-long battle against HIV,” said Daniel O’Day, Chairman and CEO of Gilead Sciences, following the FDA’s approval. “Yeztugo represents one of the greatest scientific advances of our time and offers a real chance to bring the HIV epidemic to an end.
“This medicine only requires two doses per year and has delivered outstanding results in clinical trials. It has the potential to revolutionize HIV prevention. For our scientists, ending HIV has been a lifelong mission, and with Yeztugo’s approval and support from our partners, we’re closer than ever to achieving that.”
While lenacapavir was first approved in 2022—under the brand name Sunlenca—for treating individuals already living with HIV, creating a long-acting prevention method has proven far more challenging until now.
Twice-Yearly Yeztugo Injections Could Overcome Adherence and Stigma Barriers in HIV Prevention
“Yeztugo could be the game-changing PrEP solution we’ve long awaited,” said Dr. Carlos del Rio, Distinguished Professor of Medicine at Emory University School of Medicine and Co-Director of the Emory Center for AIDS Research. “Its twice-yearly injection schedule has the potential to boost both PrEP uptake and long-term use by overcoming common obstacles like daily adherence and stigma—issues that often affect those on more frequent regimens, such as daily oral PrEP. Research also shows that many individuals prefer less frequent dosing, making Yeztugo an appealing option.”
Gilead has submitted regulatory approval requests in countries including Australia, Brazil, Canada, South Africa, and Switzerland, with additional applications underway in Argentina, Mexico, and Peru. To ensure the drug’s accessibility, Gilead’s Advancing Access program will make Yeztugo available at no cost to eligible uninsured individuals in the U.S.
Earlier this month, Gilead announced a landmark partnership with the Global Fund to Fight AIDS, Tuberculosis and Malaria. The agreement will supply enough Yeztugo to reach up to two million people over the next three years in Global Fund-supported nations, all provided at no profit to Gilead. In addition, license-free generics will be produced for use in 120 high-incidence, resource-limited countries, primarily in low- and lower-middle-income regions.
This move marks a bold shift for the pharmaceutical industry—prioritizing global health impact over profit in an effort to curb the HIV epidemic.
Gilead and Global Fund Partner to Provide Yeztugo at No Profit, Aiming to Reach 2 Million People in Low-Income Countries
“The agreement between Gilead and the Global Fund reflects our shared commitment to rapidly reaching as many people as possible with this breakthrough in HIV prevention,” said Gilead CEO Daniel O’Day. “We’re supplying the drug at no profit and in sufficient quantity to serve up to two million people in low-income nations before generic versions become widely available. This is a historic access initiative for a medicine with the power to end HIV.”
The Global Fund is now collaborating with international partners to set up the infrastructure needed to deliver lenacapavir to countries most in need.
“This isn’t just a scientific milestone—it’s a turning point in the fight against HIV/AIDS,” said Peter Sands, Executive Director of the Global Fund. “We finally have a tool that could truly alter the course of the HIV epidemic—but only if we get it to those who need it most. Our goal is to reach two million people with long-acting PrEP, but achieving that requires global commitment and resources.
“This moment matters not just for HIV prevention, but as a powerful statement that lifesaving innovations must be accessible to everyone, regardless of where they live or who they are.”
Read the original article on: New Atlas
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