Liver Biopsy Reliability in Clinical Trials: Thoughts from a Liver Pathologist

There is no question that nonalcoholic steatohepatitis (NASH) remains a significant unmet need for therapeutic intervention. Large meta-analyses document the increase in mortality, specifically liver-related mortality, and liver transplant with biopsy-proven advanced fibrosis (1, 2). The impact of NASH on healthcare systems worldwide is detailed (3, 4). Pharmaceutical industry trials address growing evidence of inter-related mechanistic molecular processes on cellular and organelle functions by exogenous and endogenous energy excess, storage and disposal that culminate in hepatic histopathologic phenotypes of fatty liver disease (5).