FDA Wants Boxed Warnings About HBV Reactivation
The FDA is calling on the manufacturers of direct-acting antiviral (DAA) agents to add boxed warnings on their medication labels in the wake of recent reports of hepatitis B virus (HBV) resurfacing in patients who take the drugs. The agency has received at least 24 reports of HBV reactivation in patients treated with DAAs between Nov. 22, 2013, and July 18, 2016. Reactivation occurred within four to eight weeks of starting therapy, according to the agency. Of those cases, two patients died and one required a liver transplant, officials said.