All patients | Telaprevir | Boceprevir | |
---|---|---|---|
(N = 102) | (N = 65) | (N = 37) | |
N (%); median (range) | N (%); median (range) | N (%); median (range) | |
Male sex | 63 (62%) | 43 (66%) | 20 (54%) |
Exclusion criteria for appropriate phase III trials | 65 (64%) | 42 (65%) | 23 (62%) |
Treatment naïve | 47 (46%) | 23 (35%) | 24 (65%) |
Treatment experienced | 55 (54%) | 42 (65%) | 13 (35%) |
Relapse | 25 (25%) | 18 (28%) | 7 (19%) |
Null/partial response | 15 (15%) | 13 (20%) | 2 (5%) |
Breakthrough | 6 (6%) | 5 (8%) | 1 (3%) |
Discontinuation § | 5 (5%) | 3 (5%) | 2 (5%) |
Unknown outcome | 4 (4%) | 3 (5%) | 1 (3%) |
DAA experienced | 10 (10%) | 9 (14%) | 1 (3%) |
RVR | 38 (37%) | 21 (32%) | 17 (46%) |
Genotype | |||
Genotype 1a | 39 (38%) | 20 (31%) | 19 (51%) |
Genotype 1b | 53 (52%) | 37 (57%) | 16 (43%) |
No subtype provided | 9 (9%) | 7 (11%) | 2 (5%) |
Unknown | 1 (1%) | 1 (2%) | 0 |
IL28B (N = 70) | |||
C/C | 16 (24%) | 10 (20%) | 6 (29%) |
C/T | 42 (60%) | 32 (65%) | 10 (48%) |
T/T | 12 (17%) | 7 (14%) | 5 (24%) |
Stage of fibrosis (N = 92) | |||
No or mild fibrosis (F0-F2) | 51 (55%) | 32 (49%) | 19 (59%) |
Bridging fibrosis (F3) | 12 (13%) | 6 (10%) | 6 (19%) |
Liver cirrhosis | 29 (32%) | 22 (37%) | 7 (22%) |
Hemoglobin [g/dl] | 14.7 (10.3-18.8) | 14.7 (11.1-18.8) | 14.6 (10.3-17.6) |
Leukocytes [x10^9/l] | 6.1 (2.7-13.1) | 5.9 (2.7-13.1) | 6.3 (3.9-12.4) |
Platelets [x10^9/l] | 188 (48–377) | 180 (48–377) | 203 (67–338) |
ASAT [U/l] | 50.5 (16–328) | 52 (16–328) | 44 (19–156) |
ALAT [U/l] | 75.5 (16–271) | 87 (16–271) | 72 (19–227) |
γGT [U/l] | 66.5 (25–1274) | 67 (25–1274) | 62 (25–217) |
Bilirubin [mg/dl] | 0.5 (0.2-2.2) | 0.6 (0.3-2.2) | 0.5 (0.2-1.4) |
Albumin [g/l] | 40 (25–50) | 40 (25–47) | 39 (30–50) |
Prothrombin time [INR] | 1.00 (0.90-3.29) | 1.02 (0.90-3.29) | 1.00 (0.92-2.33) |
Creatinine [mg/dl] | 0.8 (0.5-5.8) | 0.8 (0.5-1.1) | 0.8 (0.5-5.8) |
Viral load undetectable at | |||
EOT | 82 (80%) | 51 (78%) | 31 (84%) |
SVR12 | 62 (61%) | 40 (62%) | 22 (59%) |