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Table 4 On-treatment and post-treatment failure by trial phase (ITT population)

From: Simeprevir with peginterferon α-2a/ribavirin for chronic hepatitis C virus genotype 1 infection in treatment-experienced patients: an open-label, rollover study

n/N (%) Phase 2/3 group (N = 125) Phase 1 group (N = 16)
Failure 38/125 (30.4) 10/16 (62.5)
 On-treatment failure 20/125 (16.0) 3/16 (18.8)
  Met stopping rule at Week 4/12/24/36 13/125 (10.4) 0/16
  Other (detectable at EOT) 5/125 (4.0) 2/16 (12.5)
  Viral breakthrough 2/125 (1.6) 1/16 (6.3)
 Completed PegIFNα-2a and/or RBV 3/125 (2.4) 0/16
  Met stopping rule at Week 4/12/24/36 1/125 (0.8) 0/16
  Other (detectable at EOT) 1/125 (0.8) 0/16
  Viral breakthrough 1/125 (0.8) 0/16
 Discontinued PegIFNα-2a and RBV 17/125 (13.6) 3/16 (18.8)
  Met stopping rule at Week 4/12/24/36 12/125 (9.6) 0/16
  Other (detectable at EOT) 4/125 (3.2) 2/16 (12.5)
  Viral breakthrough 1/125 (0.8) 1/16 (6.3)
 Post-treatment failure 18/125 (14.4) 7/16 (43.8)
  Viral relapse 15/125 (12.0) 5/16 (31.3)
   Discontinued PegIFNα-2a and RBV 3/125 (2.4) 3/16 (18.8)
   Completed PegIFNα-2a and/or RBV 12/125 (9.6) 2/16 (12.5)
  Missing at time point of SVR12 3/125 (2.4) 2/16 (12.5)
  1. EOT end of treatment, ITT intent-to-treat, PegIFNα-2a/RBV peginterferon α-2a with ribavirin, SVR12 sustained virologic response 12 weeks after planned end of treatment