Assessment of serum laminin and hyaluronic acid as markers of hepatic fibrosis in patients with chronic hepatitis B.

Abstract

Background: Hepatitis B virus (HBV) is a major cause of chronic liver disease worldwide. Fibrosis of hepatic parenchyma
has been reported as a common pathway to complications of chronic liver disease. There is a need to monitor fibrosis in these
patients to abort or delay disease progression following treatment. Liver biopsy is recognized as the gold standard for disease
monitoring; however, the procedure is invasive and bedeviled with potential complications. For these reasons, non-invasive
biomarkers of fibrosis are now being evaluated as alternatives to liver biopsy. The study aimed to assess the characteristics of
laminin, and hyaluronic acid as markers of hepatic fibrosis in patients with chronic hepatitis B.
Methodology: One hundred participants with HBV-induced chronic liver disease (CLD) were recruited for the study. A liver
biopsy was conducted, and the degree of hepatic fibrosis was scored using the Metavir scoring system. Serum levels of the
biomarkers were determined using enzyme-linked immunosorbent assay (ELISA) technique. Medians and interquartile ranges
were compared using the Mann-Whitney U test. The degree of correlation between continuous variables was determined using
Spearman’s correlation analysis. Statistical significance was set at p ≤ 0.05.
Results: Serum laminin was significantly higher in participants with hepatic fibrosis: 39.09 (27.6-89.4) ng/ml [median
(interquartile range)], vs 24.3 (21.5-31.9) ng/ml, p = 0.001, Hyaluronic acid was significantly higher in participants with
hepatic fibrosis: 45.1 (26.9-94.4) ng/ml vs 23.1 (12.7-35.7) ng/ml, p < 0.001. There was a strong significant positive
correlation of both serum laminin and hyaluronic acid with Metavir score in the study participants (r=0.766, p<0.001; r=0.708,
p<0.001 respectively). At a serum laminin concentration of 44.6 ng/ml, sensitivity and specificity for detecting moderate to
severe hepatic fibrosis were 86.8% and 88.7% respectively, with an area under the curve (AUC) of 0.943 on the Receiver
Operator Characteristic (ROC) curve. The sensitivity and specificity of hyaluronic acid for detecting moderate to severe
hepatic fibrosis were 81.6% and 85.5% at a serum concentration of 53.5 ng/ml. AUC was 0.930 on the ROC curve.
Conclusion: This study underscores the evidence that laminin and hyaluronic acid may be helpful clinically in identifying
patients with moderate to severe hepatic fibrosis. Serum laminin had a slightly better diagnostic ability than hyaluronic acid in
the study participants. Further studies are needed to elucidate our findings.