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Table 2 Summary of adverse events during the treatment phase (intent-to-treat population)

From: Efficacy, safety and pharmacokinetics of simeprevir and TMC647055/ritonavir with or without ribavirin and JNJ-56914845 in HCV genotype 1 infection

  Simeprevir 75 mg + TMC647055/ritonavir 450/30 mg Simeprevir 75 mg + TMC647055/ritonavir 600/50 mg Simeprevir 75 mg + TMC647055/ritonavir 450/30 mg + JNJ-56914845 30 mg Simeprevir 75 mg + TMC647055/ritonavir 450/30 mg + JNJ-56914845 60 mg
  Panel 1 Panel 2 Panel 3 Panel 4
  GT1a/with ribavirin (n = 10) GT1b/with ribavirin (n = 12) GT1b/without ribavirin (n = 9) GT1a/with ribavirin (n = 7) GT1b/without ribavirin (n = 8) GT1a/b/other (n = 22)a GT1a/b/other (n = 22)b
Any AE, n (%) 10 (100) 12 (100) 7 (78) 6 (86) 6 (75) 20 (91) 22 (100)
Worst Grade 1, n (%) 6 (60) 7 (58) 4 (44) 5 (71) 3 (38) 15 (68) 15 (68)
Worst Grade 2, n (%) 4 (40) 5 (42) 3 (33) 1 (14) 2 (25) 5 (23) 6 (27)
Worst Grade 3, n (%) 0 (0) 0 (0) 0 (0) 0 (0) 1 (13)c 0 (0) 1 (5)d
Worst Grade 4, n (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Leading to permanent stop of study drugs, n (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Serious AE, n (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
Death, n (%) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)
  1. AE adverse event, GT genotype
  2. aGT1a/other, n = 14; GT1b, n = 8. GT1a/other includes one patient with HCV GT1c and one patient with GT1l, as determined by NS5B sequencing
  3. bGT1a/other, n = 15; GT1b, n = 7
  4. cHypercholesterolaemia, not related to any study drug
  5. dIncrease in white blood cell count, not related to any study drug