The Food and Drug Administration has approved the first long-acting injectable medication for use as pre-exposure prevention, or PrEP, against HIV.
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.
While gains have been made in PrEP use over the past several years, only 25 percent of the 1.2 million people for whom PrEP is recommended were prescribed the treatment last year, according to the Centers for Disease Control and Prevention. The CDC estimates that as of 2019, there were approximately 285,000 people using PrEP, the vast majority of them gay and bisexual men.
The hope is that the newly approved, long-acting injectable — made by ViiV Healthcare, which is majority owned by GlaxoSmithKline — will make adherence easier, help increase PrEP usage and drive down the national HIV rate.