Retrospective Cohort Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Dec 8, 2015; 7(28): 2841-2848
Published online Dec 8, 2015. doi: 10.4254/wjh.v7.i28.2841
Comparison of peg-interferon, ribavirin plus telaprevir vs simeprevir by propensity score matching
Hideki Fujii, Takeshi Nishimura, Atsushi Umemura, Taichiro Nishikawa, Kanji Yamaguchi, Michihisa Moriguchi, Yoshio Sumida, Hironori Mitsuyoshi, Chihiro Yokomizo, Saiyu Tanaka, Hiroki Ishikawa, Kenichi Nishioji, Hiroyuki Kimura, Shiro Takami, Yasuyuki Nagao, Takayuki Takeuchi, Toshihide Shima, Yoshihiko Sawa, Masahito Minami, Kohichiroh Yasui, Yoshito Itoh
Hideki Fujii, Takeshi Nishimura, Atsushi Umemura, Taichiro Nishikawa, Kanji Yamaguchi, Michihisa Moriguchi, Yoshio Sumida, Hironori Mitsuyoshi, Masahito Minami, Kohichiroh Yasui, Yoshito Itoh, Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan
Hideki Fujii, Hiroyuki Kimura, Department of Gastroenterology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto 605-0981, Japan
Takeshi Nishimura, Department of Gastroenterology and Hepatology, North Medical Center, Kyoto Prefectural University of Medicine, Kyoto 629-2261, Japan
Chihiro Yokomizo, Department of Gastroenterology, Osaka General Hospital of West Japan Railway Company, Osaka 545-0053, Japan
Saiyu Tanaka, Center for Digestive and Liver Diseases, Nara City Hospital, Nara 630-8305, Japan
Hiroki Ishikawa, Department of Gastroenterology and Hepatology, Omihachiman Community Medical Center, Shiga 523-0082, Japan
Kenichi Nishioji, Health Care Division, Kyoto Second Red Cross Hospital, Kyoto 602-8026, Japan
Shiro Takami, Department of Gastroenterology, Otsu Municipal Hospital, Otsu 520-0804, Japan
Yasuyuki Nagao, Department of Gastroenterology, Matsushita Memorial Hospital, Moriguchi 570-8540, Japan
Takayuki Takeuchi, Higashiomicity Notogawa Hospital, Higashiomi 521-1223, Japan
Toshihide Shima, Center of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Suita 564-0013, Japan
Yoshihiko Sawa, Masahito Minami, Department of Internal Medicine, Aiseikai Yamashina Hospital, Kyoto 607-8086, Japan
Author contributions: Fujii H, Nishimura T and Itoh Y designed the research; Umemura A, Nishikawa T, Yamaguchi K, Moriguchi M, Sumida Y, Mitsuyoshi H, Yokomizo C, Tanaka S, Ishikawa H, Nishioji K, Kimura H, Takami S, Nagao Y, Takeuchi T, Shima T, Sawa Y, Minami M and Yasui K performed the research; Fujii H analyzed the data; Fujii H and Itoh Y wrote the paper.
Institutional review board statement: The study was reviewed and approved by the Kyoto Prefectural University of Medicine Institutional Review Board.
Informed consent statement: All study participants provided informed written consent prior to study enrollment.
Conflict-of-interest statement: Yoshito Itoh receives honoraria from Bristol-Myers K.K., MSD K.K.. Yoshito Itoh receives research grant from MSD K.K., Chugai Phram, Bristol-Myers K.K., Gilead Sciences, Inc., Mitsubishi Tanabe Pharma Corporation, Dainippon Sumitomo Pharma Co., Ltd.
Data sharing statement: No additional data are available. Responses to the request for the raw data will be judged by the IRB.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Hideki Fujii, MD, PhD, Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Hirokoji Agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan. hidekifuiii710810@yahoo.co.jp
Telephone: +81-75-2515519 Fax: +81-75-2510710
Received: August 16, 2015
Peer-review started: August 18, 2015
First decision: October 14, 2015
Revised: October 22, 2015
Accepted: November 10, 2015
Article in press: November 11, 2015
Published online: December 8, 2015
Processing time: 109 Days and 17.5 Hours
Abstract

AIM: To compare efficacy of telaprevir (TVR) and simeprevir (SMV) combined with pegylated interferon (PEG-IFN) and ribavirin (RBV) while treating chronic hepatitis C (CHC).

METHODS: In all, 306 CHC patients were included in this study. There were 159 patients in the TVR combination therapy group and 147 patients in the SMV combination therapy group. To evaluate pretreatment factors contributing to sustained virological response at 12 wk (SVR12), univariate and multivariate analyses were performed in TVR and SMV groups. To adjust for patient background between TVR and SMV groups, propensity score matching was performed. Virological response during treatment and SVR12 were evaluated.

RESULTS: Overall rates of SVR12 [undetectable serum hepatitis C virus (HCV) RNA levels] were 79.2% and 69.4% in TVR and SMV groups, respectively. Patients in the SMV group were older, had higher serum HCV RNA levels, lower hemoglobin, higher prevalence of unfavorable interleukin-28B (IL28B) genotype (rs8099917), and poorer response to previous PEG-IFN and RBV treatment. Propensity score matching was performed to adjust for backgrounds (n = 104) and demonstrated SVR12 rates of 74.0% and 73.1% in the TVR and SMV groups, respectively. In the TVR group, discontinuation rates were higher because of adverse events; however, breakthrough and nonresponse was more frequent in the in SMV group. Multivariate analysis revealed IL28B genotype (rs8099917) as the only independent predictive factor of SVR12 in both groups.

CONCLUSION: SVR12 rates were almost identical following propensity score matching.

Keywords: Chronic hepatitis C; Combination therapy; Pegylated interferon; Simeprevir; Telaprevir; Propensity score matching; Protease inhibitor

Core tip: We evaluated and compared the efficacy of telaprevir (TVR) and simeprevir (SMV) in combination with pegylated interferon and ribavirin in the treatment of chronic hepatitis C. patients in real-world clinical settings. In the TVR group, the proportion of patients achieving a virological response was higher than that in the SMV group according to the original data. After propensity score matching, the proportion of patients achieving a virological response during treatment and after 12 wk was almost identical between the two groups with no significant difference observed.