Virus World

The FDA on Monday approved ViiV Healthcare’s cabotegravir as the first long-acting injectable for HIV PrEP. The medication, which will be known as Apretude, is administered every 2 months after two initial injections that are given 1 month apart. The FDA approved it for at-risk adults and adolescents weighing at least 77 pounds.  Debra Birnkrant, MD, who heads the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research, said the 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.” “This injection ... 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 in a news release. Anticipating the approval, the CDC included a section on prescribing cabotegravir in its updated clinical practice guideline for HIV PrEP published 2 weeks ago. The CDC also recommended for the first time that clinicians tell all sexually active adult and adolescent patients about HIV PrEP in light of evidence that only around 25% of the 1.2 million people in the United States who met the indication for PrEP in 2020 were prescribed it.

 

The FDA approval was based on study findings that showed cabotegravir administered every 8 weeks prevented HIV infection. Two trials provided the data: one that was conducted among transgender women and cisgender men who have sex with men, and a second trial that included only cisgender women. “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. That’s why ViiV Healthcare is proud 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,” ViiV CEO Deborah Waterhouse said in a statement. Cabotegravir was already part of the first FDA-approved long-acting injectable regimen for HIV treatment, Cabenuva, which also includes rilpivirine.

 

FDA Press Release (Dec. 20, 2021):

https://www.fda.gov/news-events/press-announcements/fda-approves-first-injectable-treatment-hiv-pre-exposure-prevention