title: Efficacy and safety of telaprevir with pegylated interferon α-2a and ribavirin in Japanese patients.
abstract: OBJECTIVE
  To assess the efficacy and safety of telaprevir (TVR) in combination with pegylated interferon α-2a (PEG-IFNα-2a) and ribavirin (RBV) for treatment-naïve patients and relapsed patients compared to previous TVR-based triple therapy in Japan.
  
  
  METHODS
  The study group included 35 treatment-naïve (median age, 55 years) and 19 relapsed (median age, 55 years) patients with genotype 1 hepatitis C virus infection. Patients received TVR (750 mg every 8 h) for 12 weeks, in combination with PEG-IFNα-2a and RBV.
  
  
  RESULTS
  The sustained virological response (SVR24) rates for naïve and relapsed patients were 85.7% (30/35) and 94.7% (18/19), respectively. The discontinuation rate of all study drugs due to adverse events was 5.6% (3/54). Among the 54 patients, grade 3 skin disorders and grade 3 anemia (<8.0 g/dL) were reported in 2 (3.7%) and 6 patients (11.1%), respectively. Although the overall safety profiles were similar for the TVR/PEG-IFNα-2a/RBV and TVR/PEG-IFNα-2b/RBV regimens (previous study), the proportion of patients discontinuing all study drugs due to adverse events was lower in the patients treated with the TVR/PEG-IFNα-2a/RBV regimen (3/54, 5.6%) than TVR/PEG-IFNα-2b/RBV regimen (44/267, 16.5%).
  
  
  CONCLUSIONS
  Telaprevir in combination with PEG-IFNα-2a/RBV provided a high sustained virological response rate for the treatment of genotype 1 hepatitis C virus in both treatment-naïve and relapsed patients in Japan. Telaprevir-based therapy may provide a useful treatment option for patients who are difficult to treat due to NS5A (Y93, L31) and NS3/4A (D168) variants.
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kumada
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Fumitaka
authors.initials: F
authors.lastname: Suzuki
authors.affiliation: SOUYAKU, Innovative Research Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
authors.forename: Naohiro
authors.initials: N
authors.lastname: Kamiya
authors.affiliation: SOUYAKU, Innovative Research Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
authors.forename: Madori
authors.initials: M
authors.lastname: Orihashi
authors.affiliation: SOUYAKU, Innovative Research Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Nakayasu
authors.affiliation: IKUYAKU, Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
authors.forename: Ichimaro
authors.initials: I
authors.lastname: Yamada
keywords: Japan; hepatology; peginterferon α-2a; ribavirin; telaprevir