The US Food and Drug Administration has approved the first injectable pre-exposure prophylaxis (PrEP) drug to reduce the risk of contracting HIV through sex. it announced Monday.
Apretude is approved for adults and teenagers who are at risk of contracting HIV through sex and who weigh at least 77 pounds. It is given first every two injections per month and then every two months.
Previously, PrEP was only available in pill, Truvada, and Descovy form.
“Today’s approval is an important tool in our efforts to end the HIV epidemic by providing the first non-daily pill prevention option for HIV prevention,” said Dr. Debra Birnkrant, director of the antiviral division at the FDA’s Center for Drugs, Drug Evaluation and Research.
The approval of the new drug “will be critical to tackling the HIV epidemic in the US, including helping high-risk people and certain groups where adherence to daily medication was a major challenge or not a realistic option,” added Birnkrant.
In 2019, the last year for which federal statistics are available, an estimated 34,800 new HIV cases were diagnosed. That’s a decrease from 37,800 in 2015. Data from the Centers for Disease Control and Prevention shows that in 2020 PrEP was recommended to about 1.2 million people, but only a quarter received a prescription for it.
Two double-blind clinical trials that compared Apretude with Truvada found significantly lower risk of HIV in people who received the injection, the FDA found. The risk was 69 percent lower in HIV-negative cis men and transgender women who had sex with men in the first study and 90 percent lower in the second study that included cis women.
Research has also found that Apretude is more likely than Truvada to cause side effects such as injection site reactions, headache, fatigue, back pain, myalgia, and rash.
Because of the risk of drug-resistant variants of HIV, Apretude is only intended for people who test negative for HIV immediately before starting the drug and before each injection. The label also contains warnings about hypersensitivity reactions, liver damage, and depressive disorders.