HIV Prevention
HIV Prevention
HIV Prevention
HIV Prevention

The Food and Drug Administration (FDA) has approved the first injectable treatment for HIV pre-exposure prophylaxis, giving individuals at risk another option for avoiding sexually transmitted HIV.

The FDA announced on Monday that the drug, called Apretude, will be available to at-risk adults and adolescents who weigh at least 77 pounds and have previously tested negative for HIV.

The agency’s approval allows patients to receive the injectable drug instead of daily HIV prevention oral medication, such as Truvada. Apretude, on the other hand, necessitates two initiation injections, one month apart, followed by shots every two months.

“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 Debra Birnkrant, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. 

Apretude was found to be more effective than Truvada at preventing HIV infection in two trials conducted in 13 countries. Participants who took the injectable medicine after the oral drug cabotegravir were 69 percent less likely to become infected with HIV in a study of over 4,500 cisgender men and transgender women who have sex with men.

The other study, which included over 3,200 cisgender women at risk of HIV, found that those who took Apretude and cabotegravir had a 90% lower risk of getting HIV than those who took Truvada.

The FDA noted it hopes the injectable option will improve uptake among high-risk groups such as young men who have sex with men and those dealing with substance use disorders, depression and poverty, who are less likely to keep up with daily medication. Men who have sex with men made up 66 percent of all new HIV cases in 2019, according to Centers for Disease Control and Prevention data. 

The FDA expressed hope that the injectable option will increase uptake among high-risk groups, such as young men who have sex with men and those dealing with substance use disorders, depression, and poverty, who are less likely to adhere to daily medication. According to data from the Centers for Disease Control and Prevention, men who have sex with men accounted for 66 percent of all new HIV cases in 2019.

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