Three direct-acting antiviral drugs have been tied to liver problems in certain people being treated for hepatitis C, according to an Aug. 28 FDA drug safety communication. The agency said 63 cases involving AbbVie Inc.’s Mavyret (glecaprevir/pibrentasvir), Gilead Sciences, Inc.’s Vosevi (sofosbuvir/velpatasvir/voxilaprevir) and Merck & Co., Inc.’s Zepatier (elbasvir/grazoprevir) were reported to the FDA Adverse Event Reporting System. Most of the people had moderate to severe liver impairment before treatment and experienced a worsening of liver function or liver failure. Mavyret’s label says the drug is contraindicated in people with severe hepatic impairment (Child-Pugh C), Zepatier’s label says the drug is contraindicated in people with moderate (Child-Pugh B) or severe hepatic impairment, and Vosevi’s label says the drug is not recommended for people with Child-Pugh B or C. The symptoms occurred within four weeks of starting treatment in most of the cases and resolved or improved once treatment stopped. The FDA noted that the cases were rare and that approximately 72,000 people received dispensed prescriptions for the drugs last year. Read the FDA drug safety communication at www.fda.gov/media/130351/download.
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