Table 1.
Baseline characteristics of patients
| Parameter | Boceprevir | Telaprevir | Total |
|---|---|---|---|
| Number of patients, n | 82 | 45 | 127 |
| Female/male, n/n | 48/34 | 22/23 | 70/57 |
| Age, mean ± SEM (range), years | 59.4 ± 5.2 (45-74) | 57.6 ± 5.8 (34-70) | 58.8 ± 5.4 (34-74) |
| Body weight, mean ± SEM (range), kg | 79.8 ± 10.9 (54-116) | 81.3 ± 14.1 (54-119) | 80.4 ± 12.8 (54-119) |
| BMI, mean ± SEM (range), kg/m2 | 28.3 ± 3.6 (20.5-48.9) | 28.2 ± 3.8 (20.8-49.5) | 28.2 ± 4.0 (20.5-49.5) |
| Liver stiffness, mean ± SEM (range), kPa | 29.7 ±11.0 (6.9-73.5) | 27.8 ± 11.9 (8.5-75.0) | 28.9 ± 11.1 (6.9-75.0) |
| Oesophageal varices reported, n | 4 | 1 | 5 |
| Platelet count < 75.0 × 109/l, n (%) | 19 (25.6) | 9 (20.0) | 28 (22.0) |
| Fibrosis stage (METAVIR or FibroScan) | |||
| < F3, n | 5 | 3 | 8 |
| F3, n | 3 | 5 | 8 |
| F4 (cirrhosis), n (%) | 74 (90.2) | 37 (82.2) | 111 (87.4) |
| Liver function tests | |||
| Elevated baseline ALT, n (%) | 73 (89.0) | 42 (93.3) | 115 (90.6) |
| Elevated baseline GGT, n/available (%) | 44/67 (65.7) | 24/39 (61.5) | 68/106 (64.2) |
| HCV subtype | |||
| GT1b, n (%) | 74 (90.2) | 43 (95.6) | 117 (92.1) |
| GT1 non-1b, total, n (%) | 8 (9.8) | 2 (4.4) | 10 (7.9) |
| GT1a, n | 2 | 2 | 4 |
| GT1a+1b, n | 2 | 0 | 2 |
| GT1, subtype untypable, n | 4 | 0 | 4 |
| HCV baseline viral load | |||
| HCV RNA, median (range), MIU/ml | 0.94 (< 0.1-19.2) | 1.27 (< 0.1-12.1) | 0.99 (<0.1-19.2) |
| HCV RNA viral load ≤ 0.8 MIU/ml, n (%) | 37 (45.1) | 17 (37.8) | 54 (42.5) |
| HCV RNA viral load > 0.8 – ≤ 2 MIU/ml, n (%) | 22 (26.9) | 14 (31.1) | 36 (28.4) |
| HCV RNA viral load > 2 MIU/ml, n (%) | 23 (28.0) | 14 (31.1) | 37 (29.1) |
| Response to previous therapy | |||
| Non-response, n (%) | 47 (57.3) | 17 (37.8) | 64 (50.4) |
| Breakthrough, n (%) | 0 | 5 (1.1) | 5 (3.9) |
| Relapse, n (%) | 21 (25.6) | 12 (26.7) | 33 (26.0) |
| Unknown/early termination, n (%) | 14 (17.1) | 11 (24.4) | 25 (19.7) |
| Relevant reported co-morbidities | |||
| Other liver diseases, n | 3 | 1 | 4 |
| HBV co-infection, n | 0 | 0 | 0 |
| HIV co-infection, n | 0 | 2 | 2 |
| Hypertension, n (%) | 34 (41.5) | 20 (44.4) | 54 (42.5) |
| Diabetes mellitus, n (%) | 23 (28.0) | 7 (15.6) | 30 (23.6) |
| Coronary artery disease, n (%) | 9 | 4 | 13 (10.2) |
| Thyroid disease, n (%) | 9 | 4 | 13 (10.2) |
| GERD, n (%) | 7 | 4 | 11 (8.7) |
| Depression, n | 6 | 3 | 9 (7.1) |
| Cryoglobulinemia ± vasculitis, n (%) | 6 | 1 | 7 (5.5) |
| End stage kidney disease (PD), n | 1 | 2 (1) | 3 (1) |
n – number of patients, SEM – standard error of mean, HCV – hepatitis C virus, ALT – alanine aminotransferase, GGT – gamma-glutamyl transpeptidase, GT – genotype, RNA – ribonucleic acid, HBV – hepatitis B virus, HIV – human immunodeficiency virus, GERD – gastroesophageal reflux disease, PD – peritoneal dialysis