Apretude, a newly approved drug, is administered to patients every two months rather than on a daily basis.
The FDA announced on Monday that the first long-acting injectable medication for HIV pre-exposure prevention, or PrEP, has been approved. The new drug, Apretude, is an injectable that is administered every two months as an alternative to HIV prevention pills such as Truvada and Descovy, which have been found to reduce HIV risk 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 improved efficacy was attributed to the ease with which trial participants followed the every-other-month regimen vs taking a pill daily.
“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. Shee added, “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.” While PrEP use has improved in recent years, just 25% of the 1.2 million people for whom PrEP is advised were administered the treatment last year, according to the Centers for Disease Control and Prevention.