Discordance between biochemical markers of liver activity and fibrosis (Actitest®-Fibrotest®) and liver biopsy in patients with chronic hepatitis C

Introduction. - The purpose of this clinical trial was to determine in routine practice and in comparison with liver biopsy the limitations of two blood tests, Actiteste (R) and Fibrotest (R), for the evaluation of hepatic activity and fibrosis in patients with chronic hepatitis C. Methods. - Routine blood tests, Actitest (R) and Fibrotest (R), and liver biopsy were performed in 96 patients with chronic hepatitis C attending routine outpatient clinics. Receiver operating characteristics (ROC) curves were used to assess the diagnostic value of the biochemical tests in comparison-with the METAVIR classification. Results. - The study population was predominantly mate (63.5%) with a mean age of 48 years; 83.3% of the patients had genotype 1 hepatitis C virus infection. Treatment status was naive (62.5%), nonresponders (17.7%), relapsers (7.3%), or unknown (12.5%). The comparison of F0-F2 versus F3-F4 estimated the negative predictive value at 92% and the positive predictive value at 52% for a cut-off of 0.455. Discrepancies in activity score were more frequently due to a higher score of the biochemical test compared to biopsy (18 cases out of 19). Discrepancies for fibrosis were observed in 18 patients with a higher score for biochemical test in eight and a higher score for liver biopsy in 10 cases. A significant increase of gamma-gtutamyt-transferase (GGT) (p=0:0001) and alanine aminotransferase (ALT) (p < 0.0001) was observed in case of biochemical test overestimation of activity, and a significant increase of atpha2-macroglobulin (p=0.006) and GGT (p=0.018) in case of biochemical test overestimation of fibrosis. Conclusion. - This prospective study confirms the good diagnostic value of biochemical tests for necrotico-inflammatory activity and fibrosis as compared with the histological analysis of liver biopsy. Clinicians must interpret Actitest (R) and Fibrotest (R) results with caution in patients with a significant elevation of ALT, and/or GGT and/or alpha2-macrogtobulin which could overestimate hepatic injury. (C) 2008 Elsevier Masson SAS. All rights reserved.