Liver fibrosis diagnosis by blood test and elastography in chronic hepatitis C: agreement or combination?

Summary Background In chronic hepatitis C, the European Association for the Study of the Liver and the Asociacion Latinoamericana para el Estudio del Higado recommend performing transient elastography plus a blood test to diagnose significant fibrosis; test concordance confirms the diagnosis. Aim To validate this rule and improve it by combining a blood test, FibroMeter (virus second generation, Echosens, Paris, France) and transient elastography (constitutive tests) into a single combined test, as suggested by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Methods A total of 1199 patients were included in an exploratory set ( HCV , n = 679) or in two validation sets ( HCV ± HIV , HBV , n = 520). Accuracy was mainly evaluated by correct diagnosis rate for severe fibrosis (pathological Metavir F ≥ 3, primary outcome) by classical test scores or a fibrosis classification, reflecting Metavir staging, as a function of test concordance. Results Score accuracy : there were no significant differences between the blood test (75.7%), elastography (79.1%) and the combined test (79.4%) ( P = 0.066); the score accuracy of each test was significantly ( P < 0.001) decreased in discordant vs. concordant tests. Classification accuracy : combined test accuracy (91.7%) was significantly ( P < 0.001) increased vs. the blood test (84.1%) and elastography (88.2%); accuracy of each constitutive test was significantly ( P < 0.001) decreased in discordant vs. concordant tests but not with combined test: 89.0 vs. 92.7% ( P = 0.118). Multivariate analysis for accuracy showed an interaction between concordance and fibrosis level: in the 1% of patients with full classification discordance and severe fibrosis, non‐invasive tests were unreliable. The advantage of combined test classification was confirmed in the validation sets. Conclusions The concordance recommendation is validated. A combined test, expressed in classification instead of score, improves this rule and validates the recommendation of a combined test, avoiding 99% of biopsies, and offering precise staging.