The agency is requiring the labels of these DAA drugs to include a “boxed warning” — the FDA’s strongest warning — detailing the risk of hepatitis B virus reactivation. The warning instructs clinicians to screen and monitor all patients for hepatitis B virus before treating patients with DAA drugs.
The FDA identified 24 reports of hepatitis B virus reactivation based on cases reported to the agency, as well as published literature on the issue, between Nov. 22, 2013 and July 18, 2016. As this number only represents reported occurrences, the FDA said there are probably additional cases it’ not aware of. Out of the 24 reported cases, two patients died and one needed a liver transplant.
It is not known why the reactivation occurs, according to the report.
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