FDA Approves First Injectable HIV Prevention Drug

The Food and Drug Administration has approved the first injectable HIV prevention drug. Two studies showed that Apretude, which was developed by ViiV Healthcare, was more likely to reduce HIV infection in high-risk individuals than oral medications, which must be taken daily. The drug was approved for adults and adolescents who weigh more than 77 pounds. They must test negative for HIV before beginning the treatment.

The first two injections are given one month apart and must be followed with injections every two months.

The studies suggested that the injections worked better than the oral medications because it was easier for people to get a single shot every two months than remember to take 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. “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.”

Health experts hope the newly approved drug will reduce the rate of HIV, especially in minority communities.

“People who are vulnerable to acquiring HIV, especially those in Black and Latinx communities who are disproportionately impacted in the U.S., may want options beyond daily oral pills,” Deborah Waterhouse, ViiV Healthcare’s CEO, said in a statement, adding that “Apretude was studied in one of the most diverse and comprehensive HIV prevention trial programs to date, which also included some of the largest numbers of transgender women and Black men who have sex with men ever enrolled in an HIV prevention trial.”

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