Gilead’s new twice-yearly HIV prevention injection gets FDA approval

The U.S. Food and Drug Administration (FDA) approved a new, twice-yearly shot — the first and only of its kind — to prevent HIV, the creator of the drug, Gilead Sciences, announced on Wednesday.

Sold under the name Yeztugo, the company’s injectable HIV-1 capsid inhibitor (lenacapavir) reduces the risk of sexually acquired HIV in adults and adolescents.

“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, chairman and CEO of California-based Gilead Sciences, in a press release.

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The medicine, which only needs to be administered twice a year, has shown “remarkable outcomes in clinical studies,” as Gilead claims it could transform HIV prevention.

The drug is given as an injectable under the skin that the body then slowly absorbs. Individuals must have a negative HIV-1 test prior to starting the treatment.

In large trials last year, the drug was not only nearly 100% effective in its prevention of HIV, but proved superior to once-daily oral medication like Truvada, another drug by Gilead.

The journal Science named lenacapavir its 2024 “Breakthrough of the Year.”

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Lenacapavir uses a multi-stage approach that distinguishes it from other approved antiviral medications. 

“While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle,” states the press release from Gilead.

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“Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,” O’Day said in the press release.

The most commonly reported adverse reactions during clinical trials included injection site reactions, headache and nausea, according to the company.