Journal
DIGESTIVE DISEASES AND SCIENCES
Volume 60, Issue 4, Pages 1031-1035Publisher
SPRINGER
DOI: 10.1007/s10620-014-3422-x
Keywords
Drug-induced liver injury; Cholestasis; Hepatitis C; Protease inhibitors; Liver transplantation
Categories
Funding
- National Institutes of Health via the National Institute of Diabetes and Digestive and Kidney Diseases
Ask authors/readers for more resources
Background Hyperbilirubinemia is a common side effect of protease inhibitors used to treat chronic hepatitis C (HCV), and most patients do not experience without clinically overt hepatotoxicity. The safety of second-wave protease inhibitors, including simeprevir, has not been well studied in patients with advanced cirrhosis. Materials & Methods We report two cases of suspected drug-induced liver injury leading to hepatic decompensation in patients with advanced HCV cirrhosis treated with the combination of simeprevir and sofosbuvir on a compassionate basis. Both patients developed marked hyper-bilirubinemia out of proportion to their aminotransferases, despite clearance of hepatitis C RNA. RUCAM scoring was probable and possible, respectively. While other factors may have contributed to the liver injury, including infection and concurrent administration of other medications, we believe that the potentially deleterious hepatic effects of simeprevir on transporters or other key functional components were the main reason for their decompensation. Conclusions Protease inhibitors should be used with caution, if at all, in patients with cirrhosis, especially in those with the most advanced disease. We await newer, safer, direct-acting antiviral therapies for such patients, especially those on our transplant list.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available