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Biol Pharm Bull. 2017 May 1;40(5):645-649. doi: 10.1248/bpb.b16-00941. Epub 2017 Feb 17.

Risk Factors for Treatment Discontinuation Caused by Adverse Events When Using Telaprevir, Peginterferon, and Ribavirin to Treat Chronic Hepatitis C: A Real-World Retrospective Cohort Study.

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Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University.
Center for the Promotion of Interdisciplinary Education and Research, Kyoto University.
Department of Drug Evaluation & Informatics, Graduate School of Pharmaceutical Sciences, University of Shizuoka.
The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine.


In this study, a nationwide database was used to identify the risk factors for treatment discontinuation due to adverse events during telaprevir, peginterferon, and ribavirin (T/PR) treatment, and estimate the increase in the occurrence of adverse events when patients have multiple risk factors at the same time. The risk factors were identified using univariate logistic regression analysis, and a Cochran-Armitage trend test was used to analyze the correlation between the number of risk factors and treatment discontinuation due to adverse events. Of the 25989 individuals registered in the database, 1668 (age, mean┬▒standard deviation (S.D.): 58.0┬▒9.9) were included in the study. Of these, 188 (11.3%) discontinued T/PR therapy due to adverse events. In the univariate logistic regression analysis, sex, age, aspartate aminotransferase (AST) level, and platelet count were found to significantly affect the incidence of T/PR treatment discontinuation (p<0.05). Furthermore, the incidence of treatment discontinuation gradually increased from 4.6 to 27.2% as the number of risk factors increased from 0 to 4, and the Cochran-Armitage trend test showed a significant correlation (p<0.001). In conclusion, this study not only revealed the risk factors for treatment discontinuation but also showed that patients with multiple risk factors are more likely to discontinue treatment due to adverse events compared to patients with fewer risk factors.


hepatitis C; interferon; nationwide database; regional difference; ribavirin; telaprevir

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