A noninvasive diagnosis of hepatic fibrosis by BioFibroScore® in chronic hepatitis C patients

Background & Aims The diagnostic accuracy of a novel serological panel (BioFibroScore®) to predict hepatic fibrosis in patients with chronic hepatitis C virus (HCV) infection is unknown. Methods Three markers of BioFibroScore®, including urokinase plasminogen activator (uPA), matrix metalloproteinase-9 (MMP-9), and beta-2 microglobulin (β2M), were retrospectively evaluated in 635 HCV-infected patients who received percutaneous liver biopsy and FibroScan®. The formula of BioFibroScore® to predict the severity of hepatic fibrosis was developed by Adaboost algorithm. The diagnostic accuracy of hepatic fibrosis was assessed both for BioFibroScore® and FibroScan®, taking METAVIR fibrosis score as the reference standard. Results uPA and β2M were positively and MMP-9 was negatively associated with the severity of hepatic fibrosis. Thirty-five (5.5%) patients had failed FibroScan® assessment. By Adaboost model for BioFibroScore® and the established reference ranges for FibroScan®, 85.7% and 89.0% of the patients had an identical result for F0-1, F2, F3 and F4, as compared to liver biopsy. The concordance rate between BioFibroScore® and FibroScan® was 80.7%. BioFibroScore® overestimated and underestimated the stage of hepatic fibrosis in 8.3% and 6.0% patients, and most patients had one stage error. Among patients with failed FibroScan® assessment, 82.9% of them were correctly diagnosed by BioFibroScore®. Bootstrap analysis for BioFibroScore® showed the diagnostic accuracy was 80.9-88.4%. Conclusions BioFibroScore® is accurate to assess the stage of hepatic fibrosis in HCV-infected patients. Applying this noninvasive test can substantially reduce the need for invasive liver biopsy and can play a role for fibrosis evaluation when FibroScan® assessment was unavailable or unreliable.