Evaluation of the adverse effect of premature discontinuation of pegylated interferon α-2b and ribavirin treatment for chronic hepatitis C virus infection: Results from Kyushu University Liver Disease Study

Background and Aims: Pegylated interferon (PEG-IFN) α-2b and ribavirin (RBV) treatment of chronic hepatitis C virus (HCV) infection is associated with a substantially elevated risk of discontinuation. The aim of this study is to evaluate the reason for premature discontinuation during PEG-IFN α-2b and RBV treatment due to adverse effects in patients with chronic HCV infection. Methods: A total of 2871 Japanese patients who had chronic HCV infection treated with PEG-IFN α-2b and RBV were screened. We prospectively investigated the reasons for premature discontinuation of treatment classified by sex and age, and analyzed the timing of discontinuation. Results: Of the 2871 patients, 250 (8.7%) discontinued treatment because of adverse effects. The main reasons for premature discontinuation were neurovegetative symptoms (n=77, 30.8%), depression-related syndrome (n=46, 18.4%), hematologic effects (n=41, 16.4%) and dermatologic effects (n=27, 10.8%). The rate of discontinuation of treatment for patients aged ≥65years was significantly higher than for patients aged <65years, for both men (P<0.0001) and women (P=0.0121). Moreover, the frequency of discontinuation due to neurovegetative symptoms, depression-related syndrome, and hematologic effects for men aged ≥65years was significantly higher than for those aged <65years (P=0.0001, P=0.0016, and P=0.0170, respectively), but not for women. Conclusion: Premature discontinuation due to the adverse effects of PEG-IFN α-2b and RBV treatment by patients with chronic HCV infection is mainly due to neuropsychiatric symptoms and is more common for older than for younger patients.