Biochemical markers of liver fibrosis in patients with hepatitis C virus infection: a prospective study

Background Liver biopsy is thought mandatory for management of patients wit h hepatitis C virus (HCV) infection, especially for staging fibrosis. We ai med, in our prospective study, to assess the predictive value of a combinat ion of basic serum biochemical markers for diagnosis of clinically signific ant fibrosis (Including early stages). Methods We assessed liver-biopsy patients with detectable HCV by PCR, for e ligibility, and took a blood sample on the day of the procedure. The analys is was done in a first-year period for 205 patients and then tested in a se cond period on 134 patients. We devised a fibrosis index that included the most informative markers (combined with age and sex) for the first-year gro up. 11 serum markers were assessed as well as fibrosis stage: F0=no fibrosi s and F1=portal fibrosis; and for clinically significant fibrosis, F2=few s epta, F3=many septa, and F4=cirrhosis. Statistical analysis was by logistic regression, neural connection,and receiver-operating characteristic (ROC) curves. Findings First-year and second-year patient-group characteristics and bioch emical markers did not differ. The overall frequency of clinically signific ant fibrosis was 40% (138 patients). The most informative markers were: alp ha (2) macroglobulin, alpha (2) globulin (or haptoglobin), gamma globulin, apolipoprotein A(1). gamma glutamyltranspeptidase, and total bilirubin. The areas (SD) under the ROC curves for the first-year (0.836 [0.430]) and sec ond-year groups (0.870 [0.340]) did not differ (p=0.44). With the best inde x, a high negative predictive value (100% certainty of absence of F2, F3, o r F4) was obtained for scores ranging from zero to 0.10 (12% [41] of all pa tients), and high positive predictive value (>90% certainty of presence of F2, F3, or F4) for scores ranging from 0.60 to 1.00 (34% [115] of all patie nts). Interpretation A combination of basic serum markers could be used to substa ntially reduce the number of liver biopsies done in patients with chronic H CV infection.