Eiichi Ogawa1, Norihiro Furusyo1, Eiji Kajiwara2, Hideyuki Nomura3, Akira Kawano4, Kazuhiro Takahashi5, Kazufumi Dohmen6, Takeaki Satoh7, Koichi Azuma8, Makoto Nakamuta9, Toshimasa Koyanagi10, Kazuhiro Kotoh11, Shinji Shimoda12, Jun Hayashi13. 1. Department of General Internal Medicine, Kyushu University Hospital, Fukuoka, Japan. 2. Department of Hepatology, Steel Memorial Yawata Hospital, Kitakyushu, Japan. 3. The Center for Liver Disease, Shin-Kokura Hospital, Kitakyushu, Japan. 4. Department of Medicine, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. 5. Department of Medicine, Hamanomachi Hospital, Fukuoka, Japan. 6. Department of Internal Medicine, Chihaya Hospital, Fukuoka, Japan. 7. Center for Liver Disease, National Hospital Organization Kokura Medical Center, Kitakyushu, Japan. 8. Department of Medicine, Kyushu Central Hospital, Fukuoka, Japan. 9. Department of Gastroenterology, Kyushu Medical Center, National Hospital Organization, Fukuoka, Japan. 10. Department of Medicine, Fukuoka City Hospital, Fukuoka, Japan. 11. Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 12. Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 13. Kyushu General Internal Medicine Center, Haradoi Hospital, Fukuoka, Japan.
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-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.
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.