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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