title: Relative efficacy and safety of simeprevir and telaprevir in treatment-naïve hepatitis C-infected patients in a Japanese population: A Bayesian network meta-analysis.
abstract: OBJECTIVE
  Simeprevir (SMV) is an oral, once-daily protease inhibitor for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. In phase II/III randomized controlled trials (RCT) conducted in Japan, SMV, in combination with peginterferon-α and ribavirin (PEG IFN/RBV), demonstrated potent efficacy in HCV genotype 1-infected patients relative to PEG IFN/RBV and was generally well tolerated. Telaprevir (TVR) in combination with PEG IFN/RBV is licensed for the treatment of HCV in Japan. In the absence of head-to-head comparisons of TVR and SMV in a Japanese population, we undertook a network meta-analysis (NMA) to examine the relative efficacy and safety of SMV and TVR in combination with PEG IFN/RBV.
  
  
  METHODS
  A systematic review identified SMV and TVR RCT in Japanese treatment-naïve patients. Bayesian NMA was performed assuming fixed study effects.
  
  
  RESULTS
  Three studies met our inclusion criteria: two SMV and one TVR. SMV showed a higher mean odds ratio (OR) of achieving SVR versus TVR (OR, 1.68 (95% credible interval 0.66-4.26)). SMV showed a lower mean OR of discontinuation: overall, 0.35 (0.12-1.00); and due to AE, 0.87 (0.23-3.34) versus TVR. SMV showed a lower mean OR of experiencing anemia 0.20 (0.07-0.56) and rash 0.41 (0.17-0.99) but a higher mean OR of experiencing pruritus 1.26 (0.46-3.47) versus TVR.
  
  
  CONCLUSIONS
  In this indirect treatment comparison, SMV, in combination with PEG IFN/RBV, showed a favorable risk-benefit profile compared with TVR with PEG IFN/RBV in Japanese treatment-naïve HCV patients.
authors.affiliation: ICON Health Economics, Oxford, UK.
authors.forename: Joan M
authors.initials: JM
authors.lastname: Quigley
authors.affiliation: School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Bryden
authors.affiliation: ICON Health Economics, Oxford, UK.
authors.forename: David A
authors.initials: DA
authors.lastname: Scott
authors.affiliation: Janssen Pharmaceutical, Tokyo, Japan.
authors.forename: Hiroyo
authors.initials: H
authors.lastname: Kuwabara
authors.affiliation: London School of Economics and Political Sciences, London, UK.|Janssen Pharmaceutica, Beerse, Belgium.
authors.forename: Karin
authors.initials: K
authors.lastname: Cerri
keywords: hepatitis C; network meta-analysis; simeprevir; telaprevir