The U.S. Food and Drug Administration announced Monday that the first injectable medication for use as pre-exposure prevention, or PrEP, against HIV, has been approved. The long-acting drug, Apretude, is intended to reduce the risk of HIV transmission through sex among adults and teenagers who weigh at least 77 pounds (35 kg).
Apretude is an injectable new drug that can be used instead of HIV prevention pills like Truvada and Descovy, which have been demonstrated to reduce HIV risk by 99 percent when taken on a daily basis. On the other hand, the new drug is given first as two administration injections administered one month apart, then every two months after that.
"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 Dr. Debra Birnkrant, director of the Division of Antivirals in the FDA's Center for Drug Evaluation and Research, in a press release.
"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."
The FDA trials analyzed the drug's safety and efficacy
Apretude, developed by ViiV Healthcare, which is majority-owned by GlaxoSmithKline, is exclusively for persons who test negative for HIV immediately before taking the medicine and before each injection -- this is especially important since there could be the risk of treatment-resistant HIV variations.
Overall, Apretude was found to be more likely than daily oral medications to reduce HIV in cisgender men and transgender women who have sex with men. In FDA trials that analyzed the drug's safety and efficacy, this was by 69 percent for cisgender men and transgender women who have sex with men and by 90 percent for cisgender women. Apretude's improved efficacy was attributed to the ease with which trial participants followed the every-other-month routine vs. taking a pill every day.
Currently, insurers are not required to cover all expenses associated with the new injectable version of PrEP, which has a list price of $3,700 per dosage and is expected to start shipping to wholesalers and distributors in the United States in early 2022. If everything goes as expected, the now-licensed long-acting injectable is expected to make adherence simpler, increase PrEP use, and lower the national HIV rate.