FDA Approves Gilead’s Twice-Yearly Injection for HIV Prevention

WASHINGTON — The Food and Drug Administration on Wednesday approved Gilead Sciences’ lenacapavir, a twice-yearly injection for preventing HIV infection in adults and adolescents.

The drug, part of a class of drugs known as capsid inhibitors, will be sold under the brand name Yeztugo.

In two large trials last year, lenacapavir proved nearly 100% effective at preventing HIV infection with just a single administration every six months.

“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, chairman and chief executive officer of Gilead Sciences, in a written statement.

“Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” he continued.

“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,” O’Day said.

“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,” he added.

The first pre-exposure prophylaxis (PrEP) medication, which was also developed by Gilead, was approved in the U.S. in 2012. 

However, data from the Centers for Disease Control and Prevention show that, in 2022, the most recent year with available data, only about one in three people in the U.S. who met the CDC’s eligibility criteria for PrEP were prescribed it. 

Other CDC data have shown notable gaps in usage among women, Blacks, Hispanic and Latino people, as well as residents of the southeastern United States.

Data also show that barriers including adherence challenges, stigma and low awareness of existing PrEP options — by both health care providers and consumers — contribute to the low uptake of PrEP across multiple populations. 

Currently more than 100 people are diagnosed with HIV every day across the United States.

“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 Dr. Carlos del Rio, co-director of the Emory Center for AIDS Research in Atlanta, Georgia, in a written statement. 

“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. We also know that, in research, many people who need or want PrEP preferred less frequent dosing,” del Rio said.

Of course, breakthroughs don’t come cheap.

Lenacapavir has an annual list price of $28,218 in the U.S. before insurance, according to a Gilead spokesperson. 

While that might seem high at first glance, it is actually very much in line with existing branded medications approved for the same use.

A month’s supply of Truvada and Descovy, Gilead’s daily pills for PrEP, are both around $2,000 without insurance, which amounts to around $24,000 per year. 

One dose of GlaxoSmithKline’s Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs roughly $4,000 before insurance.

Gilead said Wednesday that it is working closely with insurers, health care systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo.

It already has a copay savings program for eligible insured patients — Advancing Access® Co-Pay Savings Program — that may reduce out-of-pocket payments for Yeztugo to as little as zero dollars. 

The company also has a program for eligible uninsured people to receive the injection free of charge.

Dan can be reached at [email protected] and @DanMcCue