On Dec. 20, the FDA approved Apretude, the first injectable treatment for HIV pre-exposure prevention, or PrEP.
Five notes:
1. The drug was approved for use in at-risk adults and adolescents who weigh at least 77 pounds to reduce the risk of sexually acquired HIV.
2. Apretude is initially administered as two injections, given one month apart. After that, it's administered every two months.
3. The approval marks the first HIV prevention option that doesn't involve a daily pill.
4. Among 4,566 cisgender men and transgender women who have sex with men, a trial measured the rate of HIV infections among participants who recieved either Apretude or Truvada, the daily oral drug. Those who took Apretude were 69 percent less likely to become infected with HIV relative to participants taking Truvada.
5. In a second trial involving 3,224 cisgender women who recieved either of the PrEP drugs, those who took Apretude were 90 perent less likely to develop an HIV infection.
"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," said Debra Birnkrant, MD, director of the division of antivirals in the FDA's Center for Drug Evaluation and Research.
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