Elsevier

The American Journal of Medicine

Volume 120, Issue 3, March 2007, Pages 280.e9-280.e14
The American Journal of Medicine

AJM Theme Issue: Gastroenterology
AJM online: Clinical research study
Assessment of FIBROSpect II to Detect Hepatic Fibrosis in Chronic Hepatitis C Patients

https://doi.org/10.1016/j.amjmed.2006.06.044Get rights and content

Abstract

Background

The degree of liver fibrosis in patients with Hepatitis C (HCV) provides important prognostic information; however, the only current method available to obtain this information is by performing a liver biopsy. Liver biopsies are invasive, associated with complications, and costly. There has been recent interest in developing a panel of serum markers that can reliably predict the presence of fibrosis and, thus, obviate the need for a liver biopsy. Our objective was to prospectively validate a panel of serum fibrosis markers (FIBROSpectSM II) that has been recently developed.

Methods

Serum was obtained from 108 consecutive HCV (15% with HCV/ETOH) patients seen in a hepatology clinic at a single tertiary care center at the time of liver biopsy. The performance of FIBROSpect II (consisting of 3 fibrosis markers: hyaluronic acid, tissue inhibitor of metalloproteinases 1, and alpha-2-macroglobulin) in differentiating mild (F0-F1) from significant (F2-F4) fibrosis was assessed by comparing the panel results with performed liver biopsy.

Results

The prevalence of significant fibrosis in the study group was 36.1%. The diagnostic value of the serum marker panel to detect significant fibrosis as assessed by area under the receiver operating characteristic (ROC) curve was 0.826. Performance characteristics are as follows: sensitivity 71.8%, specificity 73.9%, positive predictive value 60.9%, negative predictive value 82.3%, and overall accuracy of 73.1%.

Conclusion

This prospective study supports the clinical utility of serum markers in detecting fibrosis and validates the performance of FIBROSpect II in a prospective cohort of patients. The high negative predictive value of the test provides a reliable alternative to rule out severe fibrosis.

Section snippets

Study Subjects

Consecutive patients with hepatitis C seen in the hepatology clinic at Oregon Health and Science University were asked to participate in this study. All patients were anti-HCV (hepatitis C) positive and had detectable plasma HCV-RNA by polymerase chain reaction. The study was approved by the Institutional Review Board at Oregon Health and Science University. The period of enrollment was between October 2001 and June 2003. All patients at the time of liver biopsy underwent a blood draw for a

Results

One hundred eight consecutive hepatitis C patients seen at the Oregon Health and Science University Hepatology Clinic were enrolled in this prospective validation study. Demographic and baseline characteristics are summarized in Table 1. The mean age of the cohort was 44 ± 7.9 years with a male predominance (65%). Fifteen percent (15%) of the cohort also had a physician-reported diagnosis of alcohol-related liver disease. The mean ALT was 81 IU/L (range 16-519) and mean AST IU/L was 59 (range

Discussion

The current study validates the performance characteristics of the FIBROSpect II assay using a US cohort of HCV patients. Serum was collected prospectively at the time of liver biopsy. The overall performance of the diagnostic test was very good based upon the area under the ROC curve (a value of 0.826). Negative and positive predictive values were good to very good, depending upon the baseline prevalence of significant fibrosis (F2-F4) of the population. In general, the lower the baseline

Cited by (0)

Funding for this study was given by Prometheus Laboratories, which included only the cost of serum fibrosis testing, shipping and handling costs, and statistical support. No other financial support was given.

View full text