Noninvasive biomarkers FibroTest and ActiTest versus liver biopsy in chronic hepatitis C patients: the Middle East experience.

BACKGROUND: The aim of this study was to compare noninvasive biomarkers, FibroTest and ActiTest in predicting fibrosis stage and inflammation grade in chronic hepatitis C (CHC) patients with liver biopsy (LB). METHODS: In 107 patients with CHC, levels of six serum biomarkers (alanine aminotransferase, γ-glutamyl transpeptidase, total bilirubin, haptoglobin, apolipoprotein, α-2 macroglobulin) were determined at the time of LB. LB was evaluated by Metavir score for fibrosis and inflammation. Voluntary blood donors (n=106) were taken as controls for the study. RESULTS: Fibrosis estimated by Fibrotest was significantly higher in patients compared to control group. The observed area under the receiver operating characteristic curve (AUROC) for advanced fibrosis (F3, F4) adjusted according to the observed difference between advanced and non-advanced fibrosis prevalence (DANA) was 0.80 (0.69-0.88) and the AUROC for cirrhosis (F4) was 0.94 (0.86-0.98). ActiTest AUROC for moderate to severe activity (A2A3) was 0.72 (0.61-0.81), and for severe activity (A3) was 0.88 (0.78-0.93). The diagnostic values in the group of good quality biopsy (n=41) showed Fibrotest AUROC (DANA-adjusted): for advanced fibrosis 0.90 (0.72-0.99); for cirrhosis 0.93 (0.76-0.98); and ctiTest AUROC: for moderate/severe activity 0.86 (0.67-0.94); and for severe activity 0.90 (0.76-0.93). There was good concordance between FibroTest and LB (with discordance for two or more stages in <20% for advanced fibrosis and <10% for cirrhosis) and between ActiTest and LB. Specificity for FibroTest and ActiTest in the control population were 95% and 100% respectively. CONCLUSIONS: Fibrotest and ActiTest had high observed and standardized diagnostic values for predicting fibrosis and activity respectively.