The FDA will require boxed warnings on labels for certain direct-acting antiviral medications used to treat hepatitis C virus (HCV) infection following reports that the drugs reactivated hepatitis B virus (HBV) infection.
“Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with [direct-acting antivirals], and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up,” agency officials said in a drug safety communication. “It is currently unknown why the reactivation occurs.”
Voelker R. HCV Drug Warning. JAMA. 2016;316(19):1957. doi:10.1001/jama.2016.16352