U.S. FDA Approves First Injectable HIV Prevention Drug

The United States Food and Drug Administration (FDA) approved on Dec. 20 the first injectable medication for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquiring HIV.

FDA approved Apertude as an alternative to oral HIV prevention pills taken daily, such as Truvada and Descovy, for at-risk adults and teens who weigh at least 35 kilograms.

Apertude is given first as two shots a month apart, then every two months afterward, according to the FDA.

FDA said that two clinical trials showed that Apertude was more likely to reduce HIV than the oral pills.

The risk was 69% lower for cisgender men and transgender women who have sex with men and 90% lower for cisgender women.

“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,” Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said.

“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,” Birnkrant further said.

Kenyan Farrow, the managing director of advocacy group PrEP4All told NBC News in an emailed statement that they were “definitely happy to see the FDA approval of another option for people who want to use PrEP.”

However, Farrow added that he fears the “implementation of this option will likely take years to make it real for most people.”

“Due to COVID, public health systems are already overburdened and much of the workforce needed to implement this large scale are leaving the field due to burnout,” Farrow said.


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