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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