A 44-year-long epidemic could soon be brought under control, following the groundbreaking approval of the first HIV drug offering 100% protection through twice-yearly injections. This landmark medical achievement holds the potential to save millions of lives worldwide. Furthermore, its manufacturers are ensuring affordable global access by entering into royalty-free licensing agreements with six generic drug producers for its manufacture and distribution.
In the United States, the Food and Drug Administration (FDA) recently granted approval to lenacapavir, marketed as Yeztugo. This innovative drug belongs to a class called capsid inhibitors, offering near-complete protection against HIV infection, a condition that currently impacts 1.3 million individuals annually in the US.
Recognized as the “Breakthrough Invention of the Year” by the journal Science in 2024, lenacapavir has garnered significant attention during its development. As a pre-exposure prophylaxis (PrEP) medication, it offers approximately 99% protection for HIV-negative individuals against contracting the virus through sexual contact.
Lenacapavir functions as a capsid inhibitor. Within the HIV-1 virus, the capsid is a protective protein shell enclosing the viral genetic material; it is essential for transporting the virus into a host cell. Once inside, the capsid disassembles, allowing the virus to replicate. Lenacapavir prevents this crucial step.
Upon news of the FDA’s approval, Daniel O’Day, Chairman and CEO of Gilead Sciences, hailed it as “a historic day in the decades-long fight against HIV.” He emphasized that Yeztugo represents “one of the most important scientific breakthroughs of our time,” offering a tangible chance to “help end the HIV epidemic.” O’Day further noted the drug’s potential to “transform HIV prevention,” given its remarkable clinical trial outcomes and twice-yearly dosing schedule. “Gilead scientists have made it their life’s work to end HIV,” he added, expressing confidence that, with FDA approval and collaborative partnerships, this objective can now become a reality.
Previously, in 2022, lenacapavir was approved under the brand name Sunlenca for treating individuals already infected with HIV. However, developing a long-acting medication specifically for prevention has posed a significantly greater challenge.
Dr. Carlos del Rio, Distinguished Professor of Medicine at Emory University School of Medicine and Co-Director of the Emory Center for AIDS Research, stated that “Yeztugo could be the transformative PrEP option we’ve been waiting for.” He believes it will “boost PrEP uptake and persistence,” providing a vital new instrument in the fight against HIV. Dr. del Rio underscored that a twice-yearly injection could overcome major obstacles such as adherence issues and the stigma associated with more frequent PrEP regimens, particularly daily oral pills. He also noted that research shows a strong preference for less frequent dosing among individuals seeking PrEP.
Beyond the US, Gilead has sought regulatory approval in Australia, Brazil, Canada, South Africa, and Switzerland, with further applications planned for Argentina, Mexico, and Peru. Domestically, the company has taken steps to ensure Yeztugo’s affordability; eligible uninsured individuals may receive the drug free of charge via its Advancing Access medication assistance program.
Earlier this month, Gilead announced a collaboration with the Global Fund to Fight AIDS, Tuberculosis, and Malaria (Global Fund). This partnership aims to supply sufficient doses of the drug to reach up to two million people over three years in Global Fund-supported nations, with Gilead providing the medication at no profit. Additionally, license-free generic versions of the drug will be produced for distribution in 120 “high-incidence, resource-limited countries,” primarily low- and lower-middle-income nations.
This vital commitment to prioritizing widespread access over corporate profit represents a bold and commendable strategy for a pharmaceutical company, acknowledging the urgent global need to eradicate the HIV epidemic.
Daniel O’Day, Gilead Sciences’ Chairman and CEO, reaffirmed that the agreement with the Global Fund stems from a “shared intention to benefit as many people as possible, as quickly as possible” with this preventive breakthrough. He stated that Gilead is supplying the medicine “at no profit” and in quantities sufficient to reach up to two million individuals in low- and lower-middle-income countries before generic versions become available. O’Day characterized this as an “unprecedented approach to access for a medicine that could help end the HIV epidemic.”
The Global Fund is now collaborating with various international organizations to swiftly establish the necessary infrastructure and resources for delivering lenacapavir to countries most in need, particularly middle- and low-income nations. Peter Sands, Executive Director of the Global Fund, declared, “This is not just a scientific breakthrough – it’s a game-changer for HIV/AIDS.” He further emphasized, “For the first time, we have a tool that can fundamentally change the trajectory of the epidemic.”
Source: Gilead Sciences
