The FDA has issued a warning about rare cases of liver injury in HCV patients receiving either AbbVie's (ABBV +0.4%) Mavyret (glecaprevir/pibrentasvir), Merck's (MRK +0.9%) Zepatier (elbasvir/grazoprevir) or Gilead Sciences' (GILD +0.6%) Vosevi (sofosbuvir/velpatasvir/voxilaprevir).
63 cases of worsening liver function have been reported, some leading to liver failure and death.
All contain a protease inhibitor and are contraindicated for patients with moderate-to-severe liver impairment. Many of the reported cases were from this population. Others involved patients with no reported cirrhosis or compensated cirrhosis with mild liver impairment (despite evidence of decreased platelets or elevated portal vein pressure). Some cases involved 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 medications as indicated, assess the severity of liver disease at baseline and closely monitor their patients for signs and symptoms of worsening liver function.
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