Comparative effectiveness and safety study of triple therapy with simeprevir or telaprevir for non‐cirrhotic patients with chronic hepatitis C virus genotype 1b infection. Issue 12 (December 2015)

• Record Type: Journal Article
• Authors: 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
• Is Part Of: Journal of gastroenterology and hepatology. Volume 30:Issue 12(2015:Dec.)
• Page Start: 1759
• Page End: 1767
• Publication Date: 2015-12
• Subjects: adverse effect -- hepatitis C virus -- pegylated interferon -- simeprevir -- telaprevir; Gastroenterology -- Periodicals; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; Gastroenterology -- Periodicals; Liver Diseases -- Periodicals; 616.33
• DOI: 10.1111/jgh.13016
• Languages: English
• ISSNs: 0815-9319

Abstract

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.