Revolutionary Drug That's “Closest Thing” To HIV Vaccine Gets FDA Approval

The Food and Drug Administration (FDA) has approved lenacapavir, an injectable drug that has been shown to act as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV. The drug, which is being marketed by Gilead Sciences as Yeztugo, has shown a 99.9 percent prevention rate in a clinical trial involving people of all genders.

The creation of an HIV vaccine has been difficult due to the complex nature of the virus, but the development of PrEP has given people a tool to protect themselves from HIV infections. Lenacapavir comes as two injections given six months apart, unlike PrEP, which is usually taken as daily pills.

PrEP and now lenacapavir have come along during a momentous progression in the prevention and treatment of HIV in recent decades. A crucial breakthrough has been the ability of new drugs to lead to undetectable levels of the virus, making it impossible for it to be passed along.

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

“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 help to make that goal a reality.”

The revolutionary drug comes with a very high price tag of $14,109 per injection. While Gilead stated that it is working with insurers and healthcare providers to ensure broad insurance coverage for the drug, many have pointed out that there is research showing that lenacapavir could be made up to 1,000 times cheaper than its current market price.

“This is a breakthrough moment. The approval of lenacapavir is a testament to decades of public investment, scientific excellence, and the contributions of trial participants and communities. I congratulate Gilead and US partners for advancing this important innovation. Lenacapavir could be the tool we need to bring new infections under control – but only if it is priced affordably and made available to everyone who could benefit,” Winnie Byanyima, Executive Director of UNAIDS and United Nations Undersecretary-General, said in a statement.

“UNAIDS has seen research that lenacapavir can be produced for just $40 per person per year, falling to $25 within a year of roll out. It is beyond comprehension how Gilead can justify a price of $28,218. If this game-changing medicine remains unaffordable, it will change nothing. I urge Gilead to do the right thing. Drop the price, expand production, and ensure the world has a shot at ending AIDS.”

HIV and AIDS are responsible for the deadliest pandemic in living memory, which has claimed the lives of 42.3 million people since the 1980s. About 39.9 million people across the globe were living with HIV in 2023, but thanks to improved medicine and improved equitable access to it, annual AIDS-related fatalities have declined by 51 percent since 2010.

Breakthrough drugs show that it is very possible to end HIV in a matter of years, as long as there is an interest in creating equal access to those very drugs.