The Food and Drug Administration approved the first injectable treatment for use by HIV-negative people to prevent infection, allowing people to ditch a daily pill in exchange for a shot 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 Dr. Debra Birnkrant, the director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research.
MODERNA BOOSTER PROVIDES STRONG PROTECTION AGAINST OMICRON, COMPANY SAYS
The injectable drug, marketed under the name Apretude, was found to perform just as well in two clinical trials as the daily pill Truvada for PrEP, a combination of two drugs used to prevent HIV infection that was approved by the FDA in 2012. In the first trial, made up of 4,566 men and transgender women who have sex with men, participants who took Apretude had 69% less risk of getting infected with HIV when compared to participants who took Truvada. In the second trial of 3,224 women, researchers found that participants who took Apretude had 90% less risk of getting infected when compared with those who took Truvada.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
“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,” Birnkrant said.