Regional Differences in the Safety of Telaprevir-Based Triple Therapy for Chronic Hepatitis C in Japan:

Ryo Iketani; Kazuki Ide; Hiroshi Yamada; Yohei Kawasaki; Naohiko Masaki

Return

Regional Differences in the Safety of Telaprevir-Based Triple Therapy for Chronic Hepatitis C in Japan:

VernacularTitle:Regional Differences in the Safety of Telaprevir-Based Triple Therapy for Chronic Hepatitis C in Japan:
Author: Ryo IKETANI ¹ ; Kazuki IDE ¹ ; Hiroshi YAMADA ² ; Yohei KAWASAKI ³ ; Naohiko MASAKI ¹
Author Information

1. Department of Drug Evaluation and Informatics,Graduate School of Pharmaceutical Sciences,University of Shizuoka
2. Department of Pharmacoepidemiology,Graduate School of Medicine and Public Health
3. Center for the Promotion of Interdisciplinary Education and Research,Kyoto University
Keywords: telaprevir; chronic hepatitis C; real world database; retrospective cohort study
From:Japanese Journal of Drug Informatics 2018;20(2):57-65
CountryJapan
Language:English
Abstract: Objective:The objectives were to assess regional differences in the safety outcomes of telaprevir-based triple therapy(T/PR) in Japan and evaluate a suitable generalized linear mixed model for estimating regional differences.Design and Methods:This study targeted individuals infected with genotype 1 chronic hepatitis C virus registered in a nationwide Japanese interferon database from December 2009 to August 2015. The rate of dropout from treatmentattributable to adverse events was calculated in every prefecture where ≥ 20 cases were reported. We constructed the following four models and evaluated the best-fit model based on Akaike information criterion (AIC) and Bayesian information criterion (BIC):1)prefecture as a fixed-effect,2)prefecture and identified confounding factors as fixed-effects,3)prefecture as a random-effect,and 4)prefecture as a random-effect and identified confounding factors as fixed-effects.Results:A total of 25,989 individuals from 38 prefectures were registered during the study period;among them,1,591 from18 prefectures were included as the study population. The dropout rate ranged from 7.0 to 23.1%among 17 prefectures.The model considering prefecture as a random-effect and confounding factors as fixed-effects showed the best-fit for the databased on both the AIC (1,108.06)and BIC (1,113.41).Conclusion:It is difficult to determine if regional differences exist in the safety outcomes of T/PR in Japan because of the limited number of cases. However, the model using prefecture as a random-effect and other confounding factors as fixed-effects would be suitable for estimating parameters that reflect the influence of the prefecture. Further studies using the model would help inform chronic hepatitis C treatment.