Circulating Genotypes of Hepatitis C Virus in Italian Patients before and after the Application of Wider Access Criteria to HCV Treatment

Aims: The aims of this study were to report a description of the HCV genotype distribution in adult Italians and non-Italians subjects tested in the Microbiology and Virology Unit of the Padova University Hospital from January 2016 (after about one year from the availability of DAAs) to December 2018 and to compare genotype frequencies in the 12-month period before and after the application of the wider access criteria to HCV treatment. Background: Hepatitis C virus (HCV) infection is a major health problem, but the availability of direct-acting antivirals (DAAs) has dramatically changed HCV disease natural history because these drugs have excellent tolerability and they can eliminate the virus in almost all treated patients. Objective: The objective was to describe the circulating HCV genotypes in high-income countries in order to help health authorities in the future organization of DAAs treatment strategies; this aspect is not limited to drug prescription, but it also includes the identification of infected individuals who are undiagnosed, which is the limiting step to achieve the HCV elimination goal. Methods: Adult patients who had HCV genotype performed from 01/01/16 to 31/12/18 in the Microbiology and Virology Unit of the Padova University Hospital were included in the study: the two 12-month periods were April 2016-March 2017 (before period, BEF) and April 2017-March 2018 (after period, AFT). Results: Italians were 2168 (91.2%) and non-Italians were 208 (8.8%). Italians median age was 55 years, and females were older. Italians had a lower genotype 1 (p=0.0012) and higher genotype 2 frequencies (p<0.0001) with respect to non-Italians. Most patients aged 38-67 years: Italians were more represented in class age 48-57 years (p=0.0138), 68-77 years (p=0.001) and ≥78 years (p<0.0001); subjects with genotype 3 were the youngest and those with genotype 2 the oldest. Italian patients typed in the AFT and BEF were comparable; only a lower frequency of genotype 1 males and younger age in genotype 3 were found in AFT. Conclusion: Italians were older with respect to non-Italians, which implies that a different age based screening program could be applied. Italian genotype 3 subjects represent a cohort to focus on for the risk of therapeutic failure. Patients tested after the extended criteria for HCV treatment were very similar to those tested before, suggesting that HCV burden in Italians is higher than expected.