Non Invasive Biomarkers Of Non-Alcoholic Steatohepatitis And Liver Fibrosis

By Nerea Hermida, Associate Director, Medpace Central Laboratories

The dramatic increase in the prevalence of non-alcoholic steatohepatitis (NASH) world-wide1-2 and the invasive nature of the liver biopsy as a diagnostic procedure, has necessitated the development of new non-invasive biomarkers.

Although liver biopsy is still considered the gold standard method for diagnosing NASH, the dramatic rise in NASH prevalence means that the resources needed to perform liver biopsies on every patient would be enormous and impractical. The biopsy procedure is invasive for the patient and may be associated with clinical complications such as trauma and bleeding. Additionally, it presents several limitations in terms of accuracy, reproducibility and poor diagnostic performance since a small sample of the liver parenchyma may not be representative of the pathology in the rest of the liver tissue. 3-4 Therefore, the development and validation of noninvasive biomarkers, has become a main focus of interest for screening, stratifying severity and monitoring progression of NASH and liver fibrosis in recent years.

Plasma biomarkers of inflammation, fibrosis, apoptosis and oxidative stress associated with the pathophysiological processes in NASH have been studied and validated in recent years.5-7 One of the main determinants of NASH prognosis is the identification of fibrosis stage and rate of progression.8-10 In this sense, the classification of no/minimal fibrosis, significant fibrosis, severe fibrosis or cirrhosis is very useful for selecting patients for treatment studies and monitoring progression/regression of the disease. Current non-invasive methods for assessing fibrosis range from biomarker assays to advanced imaging techniques such as transient elastography.