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Table 6 Summary of AEs (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

  SMV + PegIFNα-2a/RBV treatment phase Entire treatment phase
n (%) (N = 141) (N = 141)
Any AE 128 (90.8) 131 (92.9)
 Worst Grade 1 or 2 87 (61.7) 81 (57.4)
 Worst Grade 3 36 (25.5) 45 (31.9)
 Worst Grade 4 5 (3.5) 5 (3.5)
 Worst Grade 3/4, at least possibly related to SMV 9 (6.4) 9 (6.4)
Treatment-related AE 127 (90.1) 131 (92.9)
 At least possibly related to SMV 93 (66.0) 93 (66.0)
 At least possibly related to RBV 99 (70.2) 109 (77.3)
 At least possibly related to PegIFNα-2a 123 (87.2) 126 (89.4)
Any AE with fatal outcome 0 0
Any SAE 5 (3.5) 9 (6.4)
 At least possibly related to SMV 0 0
AE leading to permanent stop of at least one drug 6 (4.3) 9 (6.4)
 SMVa 3 (2.1) 3 (2.1)
 PegIFNα-2a and/or RBV 3 (2.1) 6 (4.3)
Events of special interest 17 (12.1) 17 (12.1)
 Increased bilirubin 17 (12.1) 17 (12.1)
Events of clinical interest 78 (55.3) 87 (61.7)
 Rash (any type)b 31 (22.0) 36 (25.5)
 Pruritus 25 (17.7) 26 (18.4)
 Photosensitivity conditions 8 (5.7) 8 (5.7)
 Neutropenia 33 (23.4) 38 (27.0)
 Anemia 11 (7.8) 23 (16.3)
 Dyspnea 15 (10.6) 17 (12.1)
  1. aWithout regard to PegIFNα-2a and RBV
  2. bIncludes photosensitivity conditions
  3. AE adverse event; ITT intent-to-treat, PegIFNα-2a/RBV peginterferon α-2a with ribavirin, SAE serious adverse event, SMV simeprevir