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Table 4 Adverse events

From: Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort

 

Sofosbuvir + simeprevir

Sofosbuvir + simeprevir+ ribavirin

Fisher P-value

CMH P value (stratification: 12 weeks vs 24 weeks)

CMH P value (stratification: RBV vs no RBV)

12 weeks

24 weeks

12 weeks

24 weeks

Number of patients

485

51

45

18

   

Treatment interruptions n (%)

6 (1)

4 (8)

5 (11)

3 (17)

0.0000

0.0003

0.0130

 ‐ Adverse event

3 (1)

2 (4)

3 (7)

1 (6)

0.0030

0.0074

0.2081

 ‐ Other reasons

3 (1)

2 (4)

2 (4)

2 (11)

0.0014

0.0169

0.0300

All adverse events - any n (%)

312 (64)

35 (69)

32 (71)

15 (83)

0.3185

0.1720

0.3247

(Maximum grade)

 ‐ Grade 1

156 (32)

15 (29)

9 (20)

3 (17)

< 0.0001

0.0043

< 0.0001

 ‐ Grade 2

116 (24)

7 (14)

19 (42)

10 (56)

 ‐ Grade 3

28 (6)

3 (6)

2 (4)

0 (0)

 ‐ Grade 4

11 (2)

8 (16)

2 (4)

1 (6)

 ‐ Grade 5

1 (0)

2 (4)

0 (0)

1 (6)

Deaths

1 (0)

2 (4)

0 (0)

1 (6)

0.0096

0.8684

0.0003

Other serious adverse events

26 (5)

7 (14)

3 (7)

1 (6)

0.1241

0.7697

0.0453

Adverse Events (≥10% in any subgroup)

 ‐ Asthenia

80 (16)

11 (22)

17 (38)

4 (22)

0.0074

0.0023

0.9114

 ‐ Headache

69 (14)

2 (4)

3 (7)

4 (22)

0.0457

0.7803

0.2836

 ‐ Pruritus

42 (9)

1 (2)

3 (7)

3 (17)

0.1653

0.5673

0.3966

 ‐ Hyperbilirubinaemia

28 (6)

5 (10)

7 (16)

5 (28)

0.0015

0.0018

0.1129

 ‐ Fatigue

33 (7)

2 (4)

0 (0)

2 (11)

0.1531

0.2982

0.9563

 ‐ Thrombocytopenia

20 (4)

7 (14)

2 (4)

3 (17)

0.0059

0.7737

0.0007

 ‐ Insomnia

24 (5)

2 (4)

3 (7)

2 (11)

0.4667

0.3140

0.9557

 ‐ Sleep disorder

21 (4)

2 (4)

1 (2)

3 (17)

0.1160

0.6041

0.3077

 ‐ Dry skin

7 (1)

0 (0)

1 (2)

2 (11)

0.0526

0.0711

0.6618

 ‐ Oedema peripheral

4 (1)

2 (4)

0 (0)

2 (11)

0.0117

0.5464

0.0028

 ‐ Eczema

3 (1)

2 (4)

0 (0)

2 (11)

0.0059

0.4760

0.0012

 ‐ Dyspnoea

1 (0)

2 (4)

1 (2)

2 (11)

0.0004

0.0586

0.0019

 ‐ Gastrointestinal disorder

4 (1)

0 (0)

0 (0)

2 (11)

0.0336

0.1701

0.2244

 ‐ Jaundice

0 (0)

1 (2)

2 (4)

2 (11)

0.0001

0.0003

0.0579

  1. RBV Ribavirin
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BMC Infectious Diseases

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