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Table 1 Baseline characteristics of patients

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

  SOF SMV 12 weeks n = 485 SOF SMV 24 weeks n = 51 SOF SMV RBV 12 weeks n = 45 SOF SMV RBV 24 weeks n = 18 p value
Age (years), mean ± SD 61 ± 11 60 ± 10 59 ± 11 58 ± 13 0.2908
Gender Male n (%) 256 (53) 24 (47) 28 (62) 14 (78) 0.0866
BMI (kg/m2) n (%)
  ≥ 30 74 (15) 10 (20) 7 (16) 2 (11) 0.9531
  < 18.5 12 (2) 2 (4) 0 (0) 0 (0)
 [25–30[ 163 (34) 14 (27) 17 (38) 7 (39)
 [18.5–25[ 233 (48) 25 (49) 21 (47) 9 (50)
Chronic hepatitis duration (years), mean ± SD 16 ± 8 15 ± 7 16 ± 9 11 ± 8 0.0814
HCV genotype n (%)
 1a 110 (23) 11 (22) 14 (31) 6 (33) 0.2543
 4 99 (20) 17 (33) 10 (22) 6 (33)
 1 not subtyped 25 (5) 1 (2) 3 (7) 0 (0)
 1b 251 (52) 22 (43) 18 (40) 6 (33)
Diabetes n (%) 104 (21) 7 (14) 9 (20) 1 (6) 0.2710
Hypertension n (%) 194 (40) 25 (49) 18 (40) 4 (22) 0.2571
Cirrhosis n (%) 259 (54) 33 (65) 27 (60) 16 (89) 0.0117
 •Child-Pugh score B or C 17 (7) 8 (24) 1 (4) 2 (13) 0.0083
 •MELD ≥15 19 (8) 4 (13) 1 (4) 3 (19) 0.2444
 •Elastography ≥14.5 kPa 131 (51) 15 (45) 14 (52) 10 (63) 0.7540
 •Fibrotest ≥0.73 70 (27) 10 (30) 11 (41) 10 (63) 0.0175
 •Liver biopsy > 2 years 148 (57) 20 (61) 14 (52) 7 (44) 0.6618
 •Liver biopsy < 2 years 18 (7) 2 (6) 1 (4) 0 (0) 0.9306
Decompensated cirrhosis n (%) 16 (3) 6 (12) 2 (4) 0 (0) 0.0483
 •Child-Pugh score B or C 6 (38) 4 (67) 1 (50)   0.5589
 •MELD score, mean ± SD 9.7 ± 2.9 12.3 ± 3.9 12.5 ± 0.7   0.1793
Albumin (< 30 g/L) n (%) 12 (3) 5 (11) 1 (3) 1 (6) 0.0415
Prothrombin time (≤70%) n (%) 45 (10) 11 (22) 6 (14) 6 (33) 0.0037
AST (> 5 x ULN) n (%) 28 (6) 4 (8) 3 (7) 2 (12) 0.4951
ALT (> 5 x ULN) n (%) 31 (6) 2 (4) 1 (2) 1 (6) 0.7735
Haemoglobin (≤12 g/dL in women or ≤ 13 g/dL in men) n (%) 58 (12) 8 (16) 5 (11) 1 (6) 0.7365
Platelets < 100,000/mm3 87 (19) 15 (30) 11 (25) 8 (47) 0.0109
Bilirubin conj ≥5 μmol/L 133 (52) 20 (63) 16 (57) 13 (100) 0.0021
Treatment history n (%)
 •Naïve patients 141 (29) 13 (25) 14 (31) 5 (28) 0.0618
 •Experienced patients, last treatment PEG/RBV 324 (67) 35 (69) 25 (56) 10 (56)
 •Experienced patients, last treatment 1rst generation PI/PEG/RBV 20 (4) 3 (6) 6 (13) 3 (17)
Response profile in treatment experienced patients
 •Unknown 164 (48) 20 (53) 17 (55) 6 (46) 0.8370
 •Responders 86 (25) 9 (24) 4 (13) 3 (23)
 •Not responders 94 (27) 9 (24) 10 (32) 4 (31)
  1. SOF Sofosbuvir, SMV Simeprevir, RBV Ribavirine, PI Protease inhibitor, SD Standard deviation, BMI Body mass index
  2. P value inferior to 0.05 are in boldface