The first 100% effective HIV prevention drug is approved and going global

Summary

An epidemic that's been sustained for 44 years might finally be quelled, with the milestone approval of the first HIV drug that offers 100% protection with its twice-yearly injections. It's a landmark achievement that stands to save millions of lives across the globe. The makers are also providing affordable access to the drug in the US and beyond, signing royalty-free licensing agreements with six generic manufacturers to produce and supply it.In the US, the Food and Drug Administration (FDA) has approved the novel lenacapavir – sold under the brand name Yeztugo – a class of drugs known as capsid inhibitors, which provide almost 100% protection against HIV infection, which currently affects 1.3 million people every year. In 2024, the journal Science named lenacapavir the Breakthrough Invention of the Year, and we've extensively covered it on its way to market. The pre-exposure prophylaxis (PrEP) provides HIV-negative individuals around 99% protection from contracting the devastating virus through sex.As we detailed last year, lenacapavir is a capsid inhibitor. In the HIV type 1 (HIV-1) virus, the capsid is a protein shell that houses and protects viral genetic material and is crucial for transporting the virus into a host cell. Once inside the host cell, the capsid is shed, and the virus begins copying itself. Lenacapavir stops that from happening.“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences on news of the FDA's approval. "Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.“This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life’s work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can hel...