Background and aim: To assess the clinical and economic outcomes of non-invasive testing strategies in the diagnosis of significant liver fibrosis (Metavir score >or= 2) compared with liver biopsy.
Methods: We developed a decision analytic model of non-invasive testing strategies in a hypothetical patient population with genotype 1 hepatitis C virus infection, with no contraindications to liver biopsy. The testing strategies included a testing algorithm using the Fibrosure test, a non-invasive measure of fibrosis, followed by liver biopsy for patients with indeterminate results, Fibrospect II, and Fibroscan. The primary outcomes were sensitivity, specificity, diagnostic accuracy (true positive + true negatives/total patients), and costs, evaluated from the health-care payer perspective.
Results: The testing algorithm using Fibrosure was the most accurate non-invasive strategy with a sensitivity, specificity, and overall accuracy of 84%, 87%, and 86%, respectively. In comparison with liver biopsy alone, there was a cost savings of approximately $770/person with the Fibrosure testing algorithm, but a net decrease in accuracy of 14%. Fibrospect II and Fibroscan had poorer accuracy (decreases of 12% and 4%, respectively) and lower costs (-$138 and -$357, respectively) compared with the Fibrosure algorithm. In uncertainty analyses in which biopsy sampling error was considered, the Fibrosure algorithm remained consistently less accurate (5-14% decrease).
Conclusions: The results of our study suggest that compared with liver biopsy, non-invasive testing algorithms can result in short-term cost savings, but the consequences of misdiagnosis in terms of health outcomes and treatment costs might outweigh the short-term gains in cost and convenience.