FDA Approves Yeztugo: A Global Breakthrough in HIV Prevention with Twice-Yearly Injections

After over four decades, the global HIV epidemic faces a potential turning point. A groundbreaking drug, offering virtually 100% protection with just two injections per year, has received a landmark approval. This represents a monumental leap in public health, poised to save millions of lives worldwide. Crucially, its manufacturers are committed to ensuring widespread, affordable access through royalty-free agreements with generic producers.

The U.S. Food and Drug Administration (FDA) has officially approved lenacapavir, marketed as Yeztugo, for HIV prevention. This novel medication belongs to a class of drugs called capsid inhibitors, demonstrating near 100% effectiveness against HIV infection. Annually, approximately 1.3 million individuals globally are affected by HIV.

Lenacapavir previously earned the ‘Breakthrough Invention of the Year’ title from Science journal in 2024. As a pre-exposure prophylaxis (PrEP), it offers approximately 99% protection for HIV-negative individuals against contracting the virus through sexual contact. Its mechanism as a capsid inhibitor is unique: it targets the protein shell (capsid) of the HIV-1 virus, which is vital for protecting and transporting viral genetic material into host cells. By preventing the capsid from shedding inside the host cell, lenacapavir effectively halts the virus’s replication process.

“This is a historic day in the decades-long fight against HIV,” stated Daniel O’Day, Chairman and CEO of Gilead Sciences, following the FDA approval. He emphasized that “Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.” O’Day highlighted the drug’s potential to transform HIV prevention due to its remarkable clinical outcomes and convenient twice-yearly dosing. He affirmed Gilead’s long-standing commitment to eradicating HIV, now within reach through Yeztugo’s approval and strategic partnerships.

While lenacapavir (marketed as Sunlenca) was approved in 2022 for treating existing HIV infections, achieving a long-acting preventive medication presented a unique challenge. Dr. Carlos del Rio, Distinguished Professor of Medicine at Emory University School of Medicine, described Yeztugo as “the transformative PrEP option we’ve been waiting for.” He noted its potential to significantly increase PrEP uptake and adherence, addressing critical barriers such as stigma and the burden of frequent dosing associated with daily oral PrEP regimens. Research consistently shows a strong preference for less frequent dosing among individuals requiring or desiring PrEP.

Beyond the U.S., Gilead has sought regulatory approvals for Yeztugo in numerous countries, including Australia, Brazil, Canada, South Africa, and Switzerland, with additional applications pending in Argentina, Mexico, and Peru. To ensure affordability and accessibility, particularly for uninsured Americans, Gilead plans to offer the drug free of charge to eligible individuals through its Advancing Access medication assistance program.

Reinforcing its commitment to global health equity, Gilead recently announced a major partnership with the Global Fund to Fight AIDS, Tuberculosis and Malaria. This collaboration aims to supply Yeztugo to up to two million people over three years in Global Fund-supported nations, crucially, at no profit to Gilead. Furthermore, royalty-free generic versions of lenacapavir will be produced for 120 high-incidence, resource-limited countries, predominantly low- and lower-middle-income nations. This unprecedented move underscores a bold corporate responsibility, prioritizing humanitarian need over commercial gain in the fight to end the global HIV epidemic.

“The agreement between Gilead Sciences and the Global Fund is based on our shared intention to benefit as many people as possible, as quickly as possible with this breakthrough in HIV prevention,” reiterated Daniel O’Day. He emphasized that by providing the medicine at no profit and in sufficient supply to reach two million people in low- and lower-middle-income countries before generic versions become widely available, Gilead is demonstrating an “unprecedented approach to access for a medicine that could help end the HIV epidemic.”

The Global Fund is actively collaborating with international organizations to establish the necessary infrastructure for rapid deployment of lenacapavir to the most vulnerable nations. Peter Sands, Executive Director of the Global Fund, proclaimed, “This is not just a scientific breakthrough – it’s a game-changer for HIV/AIDS.” He stressed that while this tool can fundamentally alter the HIV epidemic’s course, its impact hinges on reaching those most in need. Sands highlighted the ambition to provide long-acting PrEP to two million people, contingent on global support and resources. He concluded, “This is a pivotal moment – not just for the fight against HIV, but for the fundamental principle that lifesaving innovations must reach those who need them most – whoever they are, and wherever they live.”

Source: Gilead Sciences