Hepatitis C virus clearance after direct-acting antivirals in cirrhotic patients by stages of liver impairment: the ITAL-C network study

Background and Aims: HCV-infected patients with decompensated cirrhosis, and in particular those Child-Pugh-Turcotte (CPT) class C, are usually excluded from studies investigating the sustained virological response (SVR12) to new direct-acting antivirals (DAAs). A more refined classification of cirrhotic patients has been provided by D’Amico et al. In this system stage 1 includes patients without portal hypertension, stage 2 those with esophageal varices, stage 3 patients who bled from varices, stage 4 patients with a single episode of decompensation events, and stage 5 those with multiple decompensation events. To assess the SVR12 after therapy in patients with advanced fibrosis and cirrhosis stratified according to the D’Amico” system. To evaluate the functional outcome during the follow up after treatment. Methods:We investigated a cohort of 2612 patients, from a network of 24 Italian centers, with chronic HCV infection and advanced fibrosis (no. = 575) or cirrhosis (no. = 2037). Different DAAs schedules were administered at the physicians’ choice, in accordance with national and international guidelines. All patients have completed 3 months of follow-up post treatment. Results: At exception of bilirubin levels, numbers of patients with normal albumin and INR values increased significantly in respect to baseline. Circulating platelets and creatinine levels increased significantly in respect to baseline. A remarkable increase in the numbers of CPT class A patients became apparent, whose frequency increased from 35.9% to 80.3% (p < 0.001). During the 3 month post-treatment follow up, no decompensation events were detected in patients with advanced hepatic fibrosis; a single patient developed HCC, and one patient died for acute leukemia. Of the 1739 stage 1 and 2 cirrhotics, 33 patients (1.9%) manifested events of decompensation or a HCC, and 1 of them died for uncontrolled esophageal bleed. Among the 277 decompensated cirrhotics (stage 3 to 5), 25 subjects (9.0%) experienced single or multiple events or a HCC, 4 were transplanted being HCVRNA negative at the time of the OLT,1 died for acute hepatic failure and 1 for diabetic complications. Results are shown in the Table. Conclusions: Our findings support the safety and the efficacy of DAAs treatment even in patients with portal hypertension and decompensated liver disease (stages 3–5 or CPT class C).