FDA approves injectable PrEP

Truvada pills

On Monday, the U.S. Food and Drug Administration (FDA) approved Apretude for use as pre-exposure prophylaxis (PrEP).

According to an FDA statement, Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter.

“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, M.D., director of the Division of Antivirals in the FDA’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.”

According to the U.S. Centers for Disease Control and Prevention, notable gains have been made in increasing PrEP use for HIV prevention in the U.S. and preliminary data show that in 2020, about 25% of the 1.2 million people for whom PrEP is recommended were prescribed it, compared to only about 3% in 2015. However, sticking to the daily pill has been a challenge for many.

Approval came after a trial that included cisgender men, cisgender women and transgender woman. For cis men and trans women, those on Apretude had a 69% lower risk for HIV. With cis women, that risk went down 90%.

The generic name for Apretude is cabotegravir extended-release injectable suspension. It is approved for adults and adolescents.