Comparison of the Safety Profiles of Pegylated Interferon alpha-2a and alpha-2b Administered in Combination with Ribavirin for Chronic Hepatitis C Infection: A Real-World Retrospective Cohort Study

作者：Ide Kazuki; Sato Izumi; Imai Takumi; Hawke Philip; Yamada Hiroshi; Kawasaki Yohei^*; Masaki Naohiko

来源：Biological & Pharmaceutical Bulletin, 2016, 39(12): 2060-2065.

DOI：10.1248/bpb.b16-00617

• hepatitis C virus (HCV)
• interferon
• ribavirin
• regional difference
• nationwide database

This study compares the safety profiles of pegylated interferon (PEG-IFN) alpha-2a and alpha-2b administered in combination with ribavirin, based on the variable of time to withdrawal from treatment due to adverse events. We conducted a real-world retrospective cohort study using the Japanese interferon database. Based on eligibility criteria, individuals with chronic hepatitis C virus (HCV) infection were identified in the database covering the period December 2009 to August 2015. The primary outcome measure was defined as difference in time to withdrawal from treatment due to adverse events between patients receiving PEG-IFN alpha-2a combined with ribavirin and those receiving PEG-IFN alpha-2b combined with ribavirin. The difference was analyzed using the multivariate Cox proportional hazards regression model. A frailty model was also applied to consider regional (prefectural) variation. After eligibility evaluation, 11058 individuals were included in the analysis. 3774 were treated with PEG-IFN alpha-2a, and 6764 with PEG-IFN alpha-2b, with 11.84 and 12.30% respectively withdrawing from treatment due to adverse events. The Cox model showed no significant difference between the two groups (hazard ratio (HR), 95%CI; 0.918, 0.817 to 1.031; p=0.1475). The results were consistent even when regional variation and other confounding variables were adjusted in the frailty model. In conclusion, there may be no difference in time to withdrawal from treatment due to adverse events between PEG-IFN alpha-2a and PEG-IFN alpha-2b combined with ribavirin. Applying the method used here to future studies using novel treatment regimens may also provide important information for the treatment of chronic HCV infection in clinical practice.

• 出版日期2016-12