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FDA Warns Of Rare Liver Injury With Leading HCV Medicines – AbbVie Inc. (NYSE: ABBV)



FDA Warns Rare Injuries In Patients With HCV Receiving Or AbbVie's (ABBV + 0.4% ) Mavyret (glecaprevir / pibrentasvir), Merck & # 39; s (MRK + 0.9% ) Zepatier (elbasvir / grazoprevir) or Gilead Sciences & # 39; (GILD + 0.6% ) Vose (sofosbuvir / velpatasvir / voxilaprevir).

63 cases of impaired liver function have been reported. liver failure and death.

All contain a protease inhibitor and are contraindicated in patients with moderate to severe hepatic impairment. Many of the reported cases are from this population. Others include patients with unreported cirrhosis or compensated cirrhosis with mild hepatic impairment (despite evidence of decreased platelets or increased portal venous pressure). Some cases include patients with known risk factors such as liver cancer, alcohol abuse, or other medical conditions associated with serious liver disorders.

The Agency recommends that healthcare providers continue to prescribe the three drugs, as indicated, to evaluate the severity of liver disease at baseline and closely monitor their patients for signs and symptoms of impaired liver function.

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