FDA Approves First-Ever Injectable HIV Prevention Treatment

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, the director of the Division of Antivirals in the agency’s Center for Drug Evaluation and Research.

The U.S. Food and Drug Administration (FDA) has approved the first injectable treatment for HIV pre-exposure prevention (PrEP).

In a news release from Monday, the agency announced that it had approved Apretude, a PrEP treatment that can be administered by injection every two months. The treatment helps reduce the risk of acquiring HIV and is considered a more convenient option than current once-daily oral treatments.

“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that does not involve taking a daily pill,” said Debra Birnkrant, the director of the Division of Antivirals in the agency’s Center for Drug Evaluation and Research. “This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option.” 

Based on research from two double-blind trials conducted by FDA researchers, cisgender men and transgender women who have sex with men who took Apretude were 69% less likely to contract HIV than those who were taking Truvada, a once-daily prevention pill. Cisgender women were 90% less likely to contract HIV than those who took Truvada. 

Patients who take Apretude receive an initial injection and a follow-up in the first two months of treatment, followed by subsequent injections every two months. They can also begin treatment with a four-week oral cabotegravir trial to measure their response to the drug. 

The FDA research also reports that frequent side effects in those who took Apretude include headaches, fever, back pain, fatigue, myalgia, rash, and reactions at the injection site. 

While the government announced this year that insurers must cover daily HIV prevention treatments Truvada and Descovy, NBC reports that as of now, they are not required to cover all costs of injectable treatments, which could reach $3,700 per dose. 

The news outlet also reports that Apretude is scheduled to become available “to wholesalers and specialty distributors in the U.S.” in 2022. 


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