Comparative effectiveness and safety study of triple therapy with simeprevir or telaprevir for non-cirrhotic patients with chronic hepatitis C virus genotype 1b infection

Eiichi Ogawa, Norihiro Furusyo, Eiji Kajiwara, Hideyuki Nomura, Akira Kawano, Kazuhiro Takahashi, Kazufumi Dohmen, Takeaki Satoh, Koichi Azuma, Makoto Nakamuta, Toshimasa Koyanagi, Kazuhiro Kotoh, Shinji Shimoda, Jun Hayashi

研究成果: ジャーナルへの寄稿記事

9 引用 (Scopus)

抄録

Background and Aim: The addition of hepatitis C virus (HCV) NS3/4A protease inhibitors to pegylated-interferon alpha (PEG-IFNα) and ribavirin (triple therapy) has greatly improved treatment outcome. The aim of this study was to compare the effectiveness and safety of simeprevir-based or telaprevir-based triple therapy for non-cirrhotic patients in real-world clinical practice. Methods: This multicenter study consisted of 835 consecutive Japanese HCV genotype 1b patients treated in a clinical setting, 716 of whom were enrolled (simeprevir=256 and telaprevir=460). Logistic regression was carried out after propensity score matching to assess the sustained virological response at week 12 after the end of treatment (SVR12). Results: In the propensity-matched cohort (253 matched pairs), the SVR12 rates of the patients who underwent simeprevir-based or telaprevir-based triple therapy were 85.0% and 84.2%, respectively, by intention-to-treat analysis. Prior treatment response to PEG-IFNα/ribavirin and IL28B genotype was independently associated with SVR12 in both groups. No significant differences in the SVR12 rates stratified by prior treatment response to PEG-IFNα/ribavirin were found between the simeprevir (treatment-naïve 89.1%, prior relapse 94.3%, prior partial response 65.0%, and prior null response 33.3%) and telaprevir (treatment-naïve 87.8%, prior relapse 90.1%, prior partial response 68.4%, and prior null response 50.0%) groups. The incidence of adverse effects, such as anemia, severe rash, and the elevation of serum creatinine, was markedly higher in the telaprevir group. Conclusions: Considering the effectiveness and safety, simeprevir-based triple therapy will continue to be a useful treatment option in Japan for treatment-naïve or prior relapse patients with a favorable IL28B genotype.

元の言語英語
ページ(範囲)1759-1767
ページ数9
ジャーナルJournal of Gastroenterology and Hepatology (Australia)
30
発行部数12
DOI
出版物ステータス出版済み - 12 1 2015

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Chronic Hepatitis C
Hepacivirus
Genotype
Safety
Infection
Ribavirin
Interferon-alpha
Therapeutics
Recurrence
telaprevir
Simeprevir
Propensity Score
Intention to Treat Analysis
Exanthema
Protease Inhibitors
Multicenter Studies
Anemia
Creatinine
Japan
Logistic Models

All Science Journal Classification (ASJC) codes

  • Hepatology
  • Gastroenterology

これを引用

Comparative effectiveness and safety study of triple therapy with simeprevir or telaprevir for non-cirrhotic patients with chronic hepatitis C virus genotype 1b infection. / Ogawa, Eiichi; Furusyo, Norihiro; Kajiwara, Eiji; Nomura, Hideyuki; Kawano, Akira; Takahashi, Kazuhiro; Dohmen, Kazufumi; Satoh, Takeaki; Azuma, Koichi; Nakamuta, Makoto; Koyanagi, Toshimasa; Kotoh, Kazuhiro; Shimoda, Shinji; Hayashi, Jun.

:: Journal of Gastroenterology and Hepatology (Australia), 巻 30, 番号 12, 01.12.2015, p. 1759-1767.

研究成果: ジャーナルへの寄稿記事

Ogawa, E, Furusyo, N, Kajiwara, E, Nomura, H, Kawano, A, Takahashi, K, Dohmen, K, Satoh, T, Azuma, K, Nakamuta, M, Koyanagi, T, Kotoh, K, Shimoda, S & Hayashi, J 2015, 'Comparative effectiveness and safety study of triple therapy with simeprevir or telaprevir for non-cirrhotic patients with chronic hepatitis C virus genotype 1b infection', Journal of Gastroenterology and Hepatology (Australia), 巻. 30, 番号 12, pp. 1759-1767. https://doi.org/10.1111/jgh.13016
Ogawa, Eiichi ; Furusyo, Norihiro ; Kajiwara, Eiji ; Nomura, Hideyuki ; Kawano, Akira ; Takahashi, Kazuhiro ; Dohmen, Kazufumi ; Satoh, Takeaki ; Azuma, Koichi ; Nakamuta, Makoto ; Koyanagi, Toshimasa ; Kotoh, Kazuhiro ; Shimoda, Shinji ; Hayashi, Jun. / Comparative effectiveness and safety study of triple therapy with simeprevir or telaprevir for non-cirrhotic patients with chronic hepatitis C virus genotype 1b infection. :: Journal of Gastroenterology and Hepatology (Australia). 2015 ; 巻 30, 番号 12. pp. 1759-1767.
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abstract = "Background and Aim: The addition of hepatitis C virus (HCV) NS3/4A protease inhibitors to pegylated-interferon alpha (PEG-IFNα) and ribavirin (triple therapy) has greatly improved treatment outcome. The aim of this study was to compare the effectiveness and safety of simeprevir-based or telaprevir-based triple therapy for non-cirrhotic patients in real-world clinical practice. Methods: This multicenter study consisted of 835 consecutive Japanese HCV genotype 1b patients treated in a clinical setting, 716 of whom were enrolled (simeprevir=256 and telaprevir=460). Logistic regression was carried out after propensity score matching to assess the sustained virological response at week 12 after the end of treatment (SVR12). Results: In the propensity-matched cohort (253 matched pairs), the SVR12 rates of the patients who underwent simeprevir-based or telaprevir-based triple therapy were 85.0{\%} and 84.2{\%}, respectively, by intention-to-treat analysis. Prior treatment response to PEG-IFNα/ribavirin and IL28B genotype was independently associated with SVR12 in both groups. No significant differences in the SVR12 rates stratified by prior treatment response to PEG-IFNα/ribavirin were found between the simeprevir (treatment-na{\"i}ve 89.1{\%}, prior relapse 94.3{\%}, prior partial response 65.0{\%}, and prior null response 33.3{\%}) and telaprevir (treatment-na{\"i}ve 87.8{\%}, prior relapse 90.1{\%}, prior partial response 68.4{\%}, and prior null response 50.0{\%}) groups. The incidence of adverse effects, such as anemia, severe rash, and the elevation of serum creatinine, was markedly higher in the telaprevir group. Conclusions: Considering the effectiveness and safety, simeprevir-based triple therapy will continue to be a useful treatment option in Japan for treatment-na{\"i}ve or prior relapse patients with a favorable IL28B genotype.",
author = "Eiichi Ogawa and Norihiro Furusyo and Eiji Kajiwara and Hideyuki Nomura and Akira Kawano and Kazuhiro Takahashi and Kazufumi Dohmen and Takeaki Satoh and Koichi Azuma and Makoto Nakamuta and Toshimasa Koyanagi and Kazuhiro Kotoh and Shinji Shimoda and Jun Hayashi",
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T1 - Comparative effectiveness and safety study of triple therapy with simeprevir or telaprevir for non-cirrhotic patients with chronic hepatitis C virus genotype 1b infection

AU - Ogawa, Eiichi

AU - Furusyo, Norihiro

AU - Kajiwara, Eiji

AU - Nomura, Hideyuki

AU - Kawano, Akira

AU - Takahashi, Kazuhiro

AU - Dohmen, Kazufumi

AU - Satoh, Takeaki

AU - Azuma, Koichi

AU - Nakamuta, Makoto

AU - Koyanagi, Toshimasa

AU - Kotoh, Kazuhiro

AU - Shimoda, Shinji

AU - Hayashi, Jun

PY - 2015/12/1

Y1 - 2015/12/1

N2 - Background and Aim: The addition of hepatitis C virus (HCV) NS3/4A protease inhibitors to pegylated-interferon alpha (PEG-IFNα) and ribavirin (triple therapy) has greatly improved treatment outcome. The aim of this study was to compare the effectiveness and safety of simeprevir-based or telaprevir-based triple therapy for non-cirrhotic patients in real-world clinical practice. Methods: This multicenter study consisted of 835 consecutive Japanese HCV genotype 1b patients treated in a clinical setting, 716 of whom were enrolled (simeprevir=256 and telaprevir=460). Logistic regression was carried out after propensity score matching to assess the sustained virological response at week 12 after the end of treatment (SVR12). Results: In the propensity-matched cohort (253 matched pairs), the SVR12 rates of the patients who underwent simeprevir-based or telaprevir-based triple therapy were 85.0% and 84.2%, respectively, by intention-to-treat analysis. Prior treatment response to PEG-IFNα/ribavirin and IL28B genotype was independently associated with SVR12 in both groups. No significant differences in the SVR12 rates stratified by prior treatment response to PEG-IFNα/ribavirin were found between the simeprevir (treatment-naïve 89.1%, prior relapse 94.3%, prior partial response 65.0%, and prior null response 33.3%) and telaprevir (treatment-naïve 87.8%, prior relapse 90.1%, prior partial response 68.4%, and prior null response 50.0%) groups. The incidence of adverse effects, such as anemia, severe rash, and the elevation of serum creatinine, was markedly higher in the telaprevir group. Conclusions: Considering the effectiveness and safety, simeprevir-based triple therapy will continue to be a useful treatment option in Japan for treatment-naïve or prior relapse patients with a favorable IL28B genotype.

AB - Background and Aim: The addition of hepatitis C virus (HCV) NS3/4A protease inhibitors to pegylated-interferon alpha (PEG-IFNα) and ribavirin (triple therapy) has greatly improved treatment outcome. The aim of this study was to compare the effectiveness and safety of simeprevir-based or telaprevir-based triple therapy for non-cirrhotic patients in real-world clinical practice. Methods: This multicenter study consisted of 835 consecutive Japanese HCV genotype 1b patients treated in a clinical setting, 716 of whom were enrolled (simeprevir=256 and telaprevir=460). Logistic regression was carried out after propensity score matching to assess the sustained virological response at week 12 after the end of treatment (SVR12). Results: In the propensity-matched cohort (253 matched pairs), the SVR12 rates of the patients who underwent simeprevir-based or telaprevir-based triple therapy were 85.0% and 84.2%, respectively, by intention-to-treat analysis. Prior treatment response to PEG-IFNα/ribavirin and IL28B genotype was independently associated with SVR12 in both groups. No significant differences in the SVR12 rates stratified by prior treatment response to PEG-IFNα/ribavirin were found between the simeprevir (treatment-naïve 89.1%, prior relapse 94.3%, prior partial response 65.0%, and prior null response 33.3%) and telaprevir (treatment-naïve 87.8%, prior relapse 90.1%, prior partial response 68.4%, and prior null response 50.0%) groups. The incidence of adverse effects, such as anemia, severe rash, and the elevation of serum creatinine, was markedly higher in the telaprevir group. Conclusions: Considering the effectiveness and safety, simeprevir-based triple therapy will continue to be a useful treatment option in Japan for treatment-naïve or prior relapse patients with a favorable IL28B genotype.

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