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

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.