The US Food and Drug Administration announced Monday that it has approved the first injectable medicine for pre-exposure prophylaxis (PrEP) to reduce the risk of contracting HIV through sex.
Apretude is licensed for adults and teens who are at least 77 pounds and are at risk of contracting HIV through intercourse. It’s given twice a month at first, then every two months after that.
Previously, PrEP was only accessible as pills, Truvada and Descovy.
Dr. Debra Birnkrant, director of the FDA’s Center for Drug Evaluation and Research’s Division of Antivirals, said, “Today’s approval adds a vital tool in the quest to end the HIV epidemic by giving the first option to prevent HIV that does not need taking a daily tablet.”
The new drug’s approval “will be essential in managing the HIV epidemic in the United States,” according to Birnkrant, “particularly helping high-risk persons and specific populations whose adherence to daily medicine has been a huge difficulty or not a practical choice.”
In 2019, the most recent year for which official statistics are available, an estimated 34,800 new HIV cases were detected.
This compares to the 37,800 in 2015. According to the Centers for Disease Control and Prevention, PrEP was recommended for approximately 1.2 million people in 2020, although only a few got it.
Apretude was also shown to be more likely than Truvada to produce injection site responses, headache, fatigue, back discomfort, myalgia, and rash, according to research.
Apretude is exclusively for persons who test negative for HIV immediately before taking the medicine and before each injection because of the risk of treatment-resistant HIV variations. Hypersensitivity responses, liver damage, and depression disorders are all included on the label.