A New Two-Dimensional Shear Wave Elastography for Noninvasive Assessment of Liver Fibrosis in Healthy Subjects and in Patients with Chronic Liver Disease.

PURPOSE: To assess the performance of two-dimensional shear wave elastography (2D-SWE) on the GE LOGIQ E9 ultrasound system in a cohort of healthy subjects and to investigate its accuracy in the staging of liver fibrosis in patients with chronic liver disease (CLD) using liver biopsy as a reference standard. MATERIALS AND METHODS: From October 2014 to June 2016, 54 healthy subjects and 174 patients with CLD were consecutively enrolled. Liver fibrosis stage was assessed by the METAVIR scoring system. 18 (10.3 %) and 17 (9.8 %) patients had advanced fibrosis and cirrhosis, respectively. The correlation of liver stiffness measurement (LSM) and continuous variable was assessed using the Spearman rank correlation. The accuracy of 2D-SWE was evaluated with areas under the receiver operating characteristics curves (AUROC). RESULTS: Reliable LSMs were obtained in all subjects. The interobserver agreement ICC was excellent: 0.847. In healthy subjects, gender, but not anthropometric and biochemical data, were correlated with LSM. In patients with CLD, LSM had a strong positive correlation with fibrosis stage (rho = 0.628; p > 0.001). The AUROC was 0.724 for mild fibrosis (F≥ 1), 0.857 for moderate fibrosis (F≥ 2), 0.946 for severe fibrosis (F≥ 3), and 0.935 for cirrhosis (F4). Likewise, good accuracy was observed in the HCV subgroup. The optimal cut-off value in differentiating healthy subjects from CLD patients with any fibrosis was 5.47 kPa with an AUROC of 0.875. CONCLUSION: 2D-SWE is a reliable and reproducible method to assess LSM with good diagnostic accuracy to assess liver fibrosis in patients with CLD.

Modeling cost-effectiveness and health gains of a "universal" versus "prioritized" hepatitis C virus treatment policy in a real-life cohort.

We evaluated the cost-effectiveness of two alternative direct-acting antiviral (DAA) treatment policies in a real-life cohort of hepatitis C virus-infected patients: policy 1, "universal," treat all patients, regardless of fibrosis stage; policy 2, treat only "prioritized" patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and health care system perspective, was applied to the PITER cohort (representative of Italian hepatitis C virus-infected patients in care). Specifically, 8,125 patients naive to DAA treatment, without clinical, sociodemographic, or insurance restrictions, were used to evaluate the policies' cost-effectiveness. The patients' age and fibrosis stage, assumed DAA treatment cost of €15,000/patient, and the Italian liver disease costs were used to evaluate quality-adjusted life-years (QALY) and incremental cost-effectiveness ratios (ICER) of policy 1 versus policy 2. To generalize the results, a European scenario analysis was performed, resampling the study population, using the mean European country-specific health states costs and mean treatment cost of €30,000. For the Italian base-case analysis, the cost-effective ICER obtained using policy 1 was €8,775/QALY. ICERs remained cost-effective in 94%-97% of the 10,000 probabilistic simulations. For the European treatment scenario the ICER obtained using policy 1 was €19,541.75/QALY. ICER was sensitive to variations in DAA costs, in the utility value of patients in fibrosis stages F0-F3 post-sustained virological response, and in the transition probabilities from F0 to F3. The ICERs decrease with decreasing DAA prices, becoming cost-saving for the base price (€15,000) discounts of at least 75% applied in patients with F0-F2 fibrosis. CONCLUSION: Extending hepatitis C virus treatment to patients in any fibrosis stage improves health outcomes and is cost-effective; cost-effectiveness significantly increases when lowering treatment prices in early fibrosis stages. (Hepatology 2017;66:1814-1825).