Characteristics of patients with hepatitis C virus-related chronic liver diseases just before the era of oral direct-acting antiviral therapy in Italy

Background In 2017, oral direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection became available free of charge for all HCV-RNA-positive patients, irrespective of their fibrosis stage. Aim The aim of this study was to evaluate the characteristics of HCV-related chronic liver disease (CLD) in Italy just before the introduction of DAA therapy. Patients and methods Patients with CLD were enrolled in two national surveys conducted in 2001 and in 2014. The two surveys prospectively enrolled patients aged older than 18 years referring to Italian liver units throughout the country using a similar clinical approach and analytical methods. Results Out of the 12 564 patients enrolled, 8447 (67.3%) were anti-HCV-positive, with a decreasing trend from 69.0% in 2001 to 60.4% in 2014. During this period, an increasing trend over time was observed in the mean age of patients (55.6 vs. 59.1 years; P<0.01), in the proportion of patients with liver cirrhosis (19.4 vs. 28.2%; P<0.01), and in the circulation of genotype 4 (0 vs. 6.1%). The multiple logistic analysis showed that age older than 60 years, birth in southern Italy, and multiple etiology (HCV+hepatitis B virus or HCV+alcohol) are independent predictors of a likelihood of liver cirrhosis, whereas a higher level of education plays a protective role (odds ratio: 0.65; 95% confidence interval=0.57-0.76). Conclusion Currently, in Italy, chronic HCV infection plays a decreasing role in CLD, showing a shift toward older age groups and a more severe disease stage. These data, relating to just before the era of DAA therapy for this infection, represent up-to-date reference data for evaluating the effectiveness of DAAs in the future.