TAMPA, Fla. — The FDA has given the green light for a new, injectable medication, to be used for sexually-transmitted HIV prevention. It’s also the first of its kind.
The medicine, Apretude, works by injecting at-risk adults and adolescents with cabotegravir extended-release. Previously, the only drugs available for HIV prevention involved taking a daily pill, like Truvada and Descovy, which can pose a challenge for people who can’t or struggle to take daily medication.
“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 daily to medication has been a major challenge or not a realistic option,” Debra Birnkrant said in a federal press release. She is the director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research.
The PrEP (pre-exposure prophylaxis) medicine is administered first as two initiation injections administered one month apart, and then every two months after, the FDA explains.
What is PrEP?
According to the CDC, pre-exposure prophylaxis is medicine people at risk for HIV take to prevent contracting HIV from sex or injection drug use. The CDC adds when taken correctly, PrEP can be highly effective for HIV prevention.
Trials for Apretude
ViiV Healthcare, the maker of Apretude, said the drug was studied in “one of the most diverse and comprehensive HIV prevention trial programs to date.” According to the company, the trials included some of the largest numbers of transgender women and Black men who have sex with men.
“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,” CEO Deborah Waterhouse said.
The FDA says one trial involved 4,566 cisgender men and transgender women who have sex with men. Participants were given either an injection of Apretude or Truvada, a daily oral pill. The trial showed participants who took Apretude had 69 percent less risk of getting infected with HIV as opposed to participants taking Truvada.
In a separate trial, 3,224 cisgender women took Apretude or Truvada. At the end of the trial, participants taking Apretude had 90 percent less risk of getting infected compared to participants on Truvada.
However, side effects happened more often with Apretude comepared to Truvada. Side effects can include injection site reactions, headache, fever, fatigue, back pain, myalgia, and rash. Additionally, if an individual tests positive for HIV, they must transition to a full HIV treatment regimen. Apretude requires an HIV-negative test before giving the injection.
The FDA says Apretude was granted a priority review and breakthrough therapy designation.