FDA Approves Twice A Year Injectable PrEP

FDA Approves Twice A Year Injectable PrEP

Hot off the press!  Yesterday, the FDA approved Lenacapavir, a long-acting injectable PrEP option, which now gives us gays little to no excuse to take precautions in our sex life. This drug, known as Yeztugo, is presented by Gilead and can be taken twice a year (every six months) to work towards preventing HIV contraction. Clinical trials reported a 96% risk reduction.

Before you rush out to get one, NBC has reported that it will cost $14,109 per injection. There is no information yet on if insurance will cover it. Popular PrEP distributor, catering to the queer market, is set to distribute the injections at seven of their storefronts. They include:

West Hollywood (Los Angeles)
The Castro (San Francisco)
Hell’s Kitchen (New York City)
Wilton Manors (Fort Lauderdale)
Northalsted (Chicago)
Oaklawn (Dallas)
Las Vegas

Tristan Schukraft, Founder and CEO of MISTR, issued a statement: “Lenacapavir is a true game-changer in HIV prevention. Just two injections a year — that’s it. It’s discreet, effective, and finally makes long-term PrEP adherence simple and practical for more people.” MISTR is leading with the tagline "Two Shots, No Stigma, Full Protection: Lenacapavir Is Here — and MISTR Is Ready."

This version of PrEP went through full trials. The first trial was conducted with cisgender women in sub-Saharan Africa. The second trial expanded its scope to include cis and trans men, trans women, and non-binary folk who were engaging in sex with partners who were assigned male at birth. This trial was conducted in the United States as well as in Argentina, Mexico, Brazil, Peru, Thailand, and South Africa. Only two patients using lenacapavir contracted HIV while using. A comparison group using Truvada was also used in the trial, nine patients were affected by HIV.

The CEO of Gilead released the following statement: “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. 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 first PrEP medication was also released by Gilead in 2012. The ease of taking the medication only twice a year is hoped to make PrEP use even more popular, especially in places where resources and access are limited. The once-daily pill regimen of PrEP remains 99% effective at preventing HIV.

How do you PrEP?

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