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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