title: Postmarketing surveillance of telaprevir-based triple therapy for chronic hepatitis C in Japan.
abstract: OBJECTIVE
  An observational postmarketing study was conducted to evaluate the real-world safety and efficacy of an NS3-4A protease inhibitor, telaprevir (TVR), in combination with pegylated interferon-α-2b (PEG IFN) and ribavirin (RBV), for patients with chronic hepatitis C (CHC). Here, we report an interim analysis of data from 3563 patients.
  
  
  METHODS
  Patients were treated with TVR, PEG IFN and RBV for 12 weeks, followed by PEG IFN and RBV for 12 weeks (triple therapy). Safety was evaluated throughout the 24-week treatment period. Risk factors for development of the three important adverse drug reactions (ADR), skin disorders, grade 3 anemia (hemoglobin level <8 g/dL) and serious renal dysfunction, were analyzed using a multivariate logistic regression model. Efficacy was assessed on the basis of sustained virological response (SVR) after treatment completion.
  
  
  RESULTS
  Total and serious ADR were observed in 96.5% and 35.7% of patients, respectively. ADR related to skin disorders and anemia were frequently observed in this study and in the phase III clinical studies, whereas those related to serious renal dysfunction were new observations. Concomitantly, various predictive risk factors for development of the three important ADR were identified. The SVR rate was 87.7% in all patients. When patients were grouped by previous treatment history, SVR rates were 91.8% in naive patients, 91.0% in relapsers and 70.6% in non-responders.
  
  
  CONCLUSIONS
  Although many ADR were observed, they can be controllable with appropriate risk management strategies based on the predictive risk factors for important ADR. Furthermore, the efficacy of the triple therapy was found to be favorable.
authors: Pharmacovigilance Department, Pharmacovigilance & Quality Assurance Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
authors: Muneshige
authors: M
authors: Shiraishi
authors: Pharmacovigilance Department, Pharmacovigilance & Quality Assurance Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
authors: Itsuro
authors: I
authors: Umebayashi
authors: Pharmacovigilance Department, Pharmacovigilance & Quality Assurance Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
authors: Hiroaki
authors: H
authors: Matsuda
authors: Pharmacovigilance Department, Pharmacovigilance & Quality Assurance Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
authors: Keisuke
authors: K
authors: Sawamura
authors: Pharmacovigilance Department, Pharmacovigilance & Quality Assurance Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
authors: Aiko
authors: A
authors: Okada
authors: Pharmacovigilance Department, Pharmacovigilance & Quality Assurance Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
authors: Masako
authors: M
authors: Karino
authors: Pharmacovigilance Coordination and Administration Department, Pharmacovigilance and Quality Assurance Division, Mitsubishi Tanabe Pharma Corporation, Osaka, Japan.
authors: Yoshihide
authors: Y
authors: Nogami
keywords: anemia; postmarketing surveillance; serious renal dysfunction; skin disorders; telaprevir