Direct-Acting Antivirals Slapped With Black Box On Hepatitis B Risk
FDA imposes boxed warning on labels for hepatitis C drugs in response to reports of hepatitis B reactivation, including fatal cases.
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A US FDA warning of serious liver injuries in hepatitis C patients treated with combo pills from AbbVie, Gilead and Merck may impact AbbVie's Mavyret most, since it's one of the company's top sellers.
Bringing three-drug, single-tablet regimen to market means Gilead has an answer for every hepatitis C patient, company says. It still lacks an answer, however, for its future business direction as HCV revenue wanes.
The European Medicines Agency’s pharmacovigilance committee wants manufacturers of the direct-acting antivirals for hepatitis C to include a warning about the possibility of hepatitis B reactivation in patients who carry both viruses.