Role of Liver Biopsy in Clinical Trials and Clinical Management of Nonalcoholic Fatty Liver Disease

Nonalcoholic fatty liver disease and nonalcoholic steatohepatitis constitute a spectrum of histologic lesions characterized by varying degrees of hepatocellular injury and fat accumulation with inflammation and scarring. Fibrosis associated with this disease may progress to cirrhosis and its complications. As there are no approved therapies , clinical trials to assess potential forms of drug therapy are conducted to assess drugs for efficacy and safety before submission to regulatory review. Liver biopsies are performed and evaluated to confirm the diagnosis of nonalcoholic steatohepatitis and to assess fibrosis stage for inclusion in trials.