First fully effective HIV prevention drug approved, set for global rollout

The global battle against HIV may have reached a turning point, as US regulators approve the first drug to offer full protection against the virus with just two injections per year.

The landmark authorisation of lenacapavir – marketed as Yeztugo – could mark the beginning of the end of a 44-year epidemic, Caliber.Az reports, via foreign media.

Developed by Gilead Sciences, the capsid inhibitor has been shown to provide near-total protection for HIV-negative individuals when used as pre-exposure prophylaxis (PrEP). It had already received approval in 2022, under the brand name Sunlenca, to treat those already living with HIV. However, a preventative treatment with long-acting effects had long eluded researchers.

“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences. “Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.”

The US Food and Drug Administration (FDA) granted approval following extensive clinical trials demonstrating Yeztugo’s efficacy. Around 1.3 million people contract HIV in the United States each year, and the new treatment could help bring that number down drastically.

The treatment works by targeting the capsid — a protein shell that shields and transports the virus into human cells. Lenacapavir disrupts this process, preventing the virus from replicating.

“Yeztugo could be the transformative PrEP option we’ve been waiting for – offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” said Carlos del Rio, Professor of Medicine at Emory University and Co-Director of the Emory Centre for AIDS Research. “A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face.”

In a move praised by public health advocates, Gilead has committed to ensuring broad and affordable access to the medicine. Regulatory filings are underway in countries including Australia, Brazil, Canada, South Africa and Switzerland, with further applications expected in Argentina, Mexico and Peru. Gilead’s medication assistance programme also aims to provide free access to eligible uninsured individuals in the US.

In a bold step, Gilead has partnered with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply up to two million doses over the next three years to low- and lower-middle-income countries. This initiative will be delivered on a not-for-profit basis, alongside royalty-free licences granted to six generic manufacturers to ensure widespread production and distribution in 120 high-incidence nations.

“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,” said O’Day.

“We are providing the medicine at no profit to Gilead, and in enough supply to reach up to two million people in low- and lower-middle-income countries ahead of generic lenacapavir becoming available.”

Peter Sands, Executive Director of the Global Fund, underscored the importance of global collaboration: “This is not just a scientific breakthrough – it’s a game-changer for HIV/AIDS. For the first time, we have a tool that can fundamentally change the trajectory of the HIV epidemic – but only if we get it to the people who need it most.”

He added: “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.”

By Aghakazim Guliyev