Serum biomarkers in nonalcoholic steatohepatitis: value for assessing drug effects?

Nonalcoholic steatohepatitis (NASH) is a common chronic liver disease throughout the world. In the USA, approximately 3-5% of the population are affected, and the prevalence of this condition is increasing. NASH is associated with an increased risk of liver-related morbidity, such as cirrhosis and fibrosis, as well as cardiovascular disease, and in spite of several clinical studies investigating putative new drugs, no approved treatment is currently available. This is partly due to the nature of the disease. NASH is a complex, slowly progressing disease, and confirmatory clinical trials have long treatment durations and require invasive end points (a liver biopsy). Such invasive assessments are only accepted in confirmatory trials; clinical studies in the exploratory clinical development phase must rely on noninvasive biomarkers as the primary end point. Experimental and clinical research continues to achieve validation and qualification of biomarkers in NASH, which will hopefully assist the development of new treatments for NASH patients.