Efficacy and Safety of Sofosbuvir and Ribavirin in an Italian Cohort of HCV Genotype 2 Elderly Cirrhotic Patients

Objective: Sofosbuvir and ribavirin represented until recently the standard of care in hepatitis C virus genotype 2 cirrhotic patients. In registration trials, 12-16 week durations were associated with 90% sustained virological responses, although not confirmed by real-life studies. In Italy, various durations (12,16, 20, and 24 weeks) represent lawfully reimbursable healthcare practice. The aim is, therefore, to study the behavior of Italian clinicians and the possible impact of therapy durations on sustained virological responses and patient safety. Materials and Methods: Data of all consecutive genotype 2 cirrhotic patients who started sofosbuvir plus ribavirin therapy between January 2015 and March 2017 in 7 Italian liver clinics were collected retrospectively. Results: Overall, 147 patients (138 Child-Pugh A, mean age: 71 years) were treated. The median treatment duration was 16 weeks, but marked differences were found among the clinicians; however, the 12-week duration was not considered by the vast majority of them. Rates of intention-to-treat and per-protocol sustained virological responses were 95.9% and 97.1%, respectively, and neither showed differences between the various durations. No independent, sustained virological response predictors could be found, but the median baselines for Child-Pugh and Model For End-Stage Liver Disease scores were higher in non-responders. Anemia was not associated with treatment duration. One case of acute kidney injury attributed to the possible sofosbuvir effect was reported. Conclusion: In genotype 2 cirrhotic patients, sofosbuvir plus ribavirin was associated with real-life-sustained virological response rates of almost 96%, without a significant impact on treatment duration provided it was longer than 12 weeks.