Diagnostic performance of collagen IV and laminin for the prediction of fibrosis and cirrhosis in chronic hepatitis C patients: a multicenter study.

Background/aim: To date, liver biopsy has been the gold standard used for the assessment of liver fibrosis in patients with chronic hepatitis C. Our aim was to evaluate the diagnostic performance of a panel of simple blood markers of liver fibrosis and the development a novel score to replace liver biopsy.

Patients And Methods: Liver biochemical profile including transaminases, bilirubin, alkaline phosphatase, and albumin, in addition to platelet count, was evaluated using standard methods in 305 chronic hepatitis C patients. Serum type IV collagen and laminin were assayed using the ELISA technique. Liver biopsies were performed. Statistical analyses were carried out by logistic regression and receiver operating characteristic curves to assess and compare the diagnostic accuracy of blood markers. A stepwise combination algorithm was developed and validated in 317 additional patients.

Results: The Fibrosis Discriminant Score (FDS) was developed combining collagen, laminin, aspartate aminotransferase/platelet ratio index, and albumin. FDS produced an area under receiver operating characteristic curve of 0.831 for significant fibrosis, 0.791 for advanced fibrosis, and 0.881 for cirrhosis. The FDS was correctly classified in 82% of patients with significant fibrosis with 79% sensitivity and 88% specificity at cut-off 0.66 or more. Similar results were obtained in a validation study in which, of 317 patients, liver biopsy could have been avoided in 81%.

Conclusion: A simple fibrosis index can be useful to select hepatitis C virus-infected patients with a very low risk of significant fibrosis in whom the protocol of liver biopsies may be avoided.