Table 1.
Baseline characteristics of patients
| 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) | |
SOF Sofosbuvir, SMV Simeprevir, RBV Ribavirine, PI Protease inhibitor, SD Standard deviation, BMI Body mass index
P value inferior to 0.05 are in boldface