Abstract

BackgroundIn patients with chronic hepatitis C virus, liver biopsy is the gold standard for assessing liver disease stage; nevertheless, it is prone to complications, some of them serious. Non-invasive methods have been proposed as surrogate markers for liver fibrosis. It was shown that serum hyaluronic acid (HA) level increases with the development for liver fibrosis. The aim of this study was to evaluate the diagnostic value of HA as well as to determine the HA level cut-off for predicting the presence or absence of fibrosis, severe fibrosis, and cirrhosis.Results405 patients with chronic hepatitis C were prospectively included with biomarker measurement and liver biopsy done the same day: 151 in the training set (only biopsy lengths of 25 mm or more) and 254 in the validation set. For the discrimination of significant fibrosis, severe fibrosis, and cirrhosis in the training set, the areas under curve (AUCs) were 0.75 ± 0.03, 0.82 ± 0.02, and 0.89 ± 0.03, respectively. Absence of significant fibrosis, severe fibrosis, and cirrhosis can be predicted by HA levels of 16, 25, and 50 μg/l, respectively (with negative predictive values of 82%, 89%, and 100%, in the same order). Presence of significant fibrosis, severe fibrosis, and cirrhosis can be predicted by HA levels of 121, 160, and 237 μg/l, respectively (with positive predictive values of 94%, 100%, and 57%, in the same order).ConclusionIn the validation set, HA was accurate in predicting significant fibrosis, severe fibrosis, and cirrhosis with AUCs of 0.73, 0.77, and 0.97, respectively. Moreover, accurate HA level cut-offs were defined for predicting significant fibrosis, severe fibrosis, and cirrhosis. Thus, the study supports that HA level may be clinically useful as a non-invasive marker for liver fibrosis and/or cirrhosis.

Highlights

  • In patients with chronic hepatitis C virus, liver biopsy is the gold standard for assessing liver disease stage; it is prone to complications, some of them serious

  • The first aim of this study was to evaluate the diagnostic value of hyaluronic acid (HA) for significant fibrosis (F2-F4), severe fibrosis, (F3F4) and cirrhosis (F4), in patients with hepatitis C virus (HCV) infection

  • There is an overlap between HA levels and fibrosis determined by liver biopsy, there is a significant increase in HA levels when considering F0 to F4 scores (Kruskal-Wallis – p < 0.0001)

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Summary

Introduction

In patients with chronic hepatitis C virus, liver biopsy is the gold standard for assessing liver disease stage; it is prone to complications, some of them serious. Liver biopsy is currently recommended as the gold standard method of staging fibrosis in patients with chronic hepatitis C [1,2]. The risk of developing cirrhosis depends on the stage (degree of fibrosis) and the grade (degree of inflammation and necrosis) observed in the initial liver biopsy [3,4]. This procedure, is invasive and has potential complications [5,6]. Fibrotest (FT) is a simple non-invasive panel of biochemical markers for fibrosis and activity [15]

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