The Food and Drug Administration has approved the first long-acting injectable medication for use as pre-exposure prevention, or PrEP, against HIV, the agency announced Monday.
Apretude, the new drug, is an injectable given every two months as an alternative to HIV prevention pills, like Truvada and Descovy, which have been shown to reduce the risk of HIV by 99 percent when taken daily.
Two FDA trials analyzing the safety and efficacy of the novel drug found that Apretude was more likely to reduce HIV than the daily oral medications — by 69 percent for cisgender men and transgender women who have sex with men and by 90 percent for cisgender women. Apretude’s superior efficacy was apparently driven by the greater ease with which study participants adhered to the every-other-month regimen compared with taking a pill every day.
“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,” Dr. Debra Birnkrant, the director of antivirals division at the FDA’s Center for Drug Evaluation and Research, said in a statement.