Table 1.
Baseline characteristics.
| Patients characteristics | Patients only screened | % of patients only screened | Safety population (ITT 1) | % of patients (safety population) | Effectiveness population (ITT 3) | % of patients (effectiveness c population) | Per-protocol analysis | % of patients (per-protocol analysis) |
|---|---|---|---|---|---|---|---|---|
| Total | 498 | 6108 | 4846 | 4609 | ||||
| Male | 304 | 61.0 | 3458 | 56.6 | 2700 | 55.7 | 2550 | 55.3 |
| Age, years (mean) | 52.1 ± 13.5 | 54.2 ± 12.5 | 54.3 ± 12.6 | 54.5 ± 12.4 | ||||
| Treatment-naïve | 361 | 72.5 | 3070 | 50.3 | 2397 | 49.5 | 2238 | 48.6 |
| IFN pretreatment | 133 | 26.7 | 2929 | 48.0 | 2365 | 48.8 | 2292 | 49.7 |
| DAA pretreatment | 13 | 2.6 | 704 | 11.5 | 590 | 12.2 | 564 | 12.2 |
| MELD score (mean, min–max; cirrhotic patients)a | n.a. | 8.7 ± 3.0/(6–32) | 8.7 ± 2.9/(6–32) | 8.7 ± 2.9/(6–32) | ||||
| Cirrhosis | 37 | 7.4 | 1697 | 27.8 | 1378 | 28.4 | 1316 | 28.6 |
| CHILD Ab | 28 | 82.4 | 1175 | 86.7 | 955 | 86.9 | 916 | 87.2 |
| CHILD B | 4 | 11.8 | 156 | 11.5 | 126 | 11.5 | 119 | 11.3 |
| CHILD C | 2 | 5.9 | 24 | 1.8 | 18 | 1.6 | 15 | 1.4 |
| Any comorbidities | 394 | 79.1 | 4615 | 75.6 | 3690 | 76.1 | 3513 | 76.2 |
| GFR <30 ml/minc | n.a. | 43 | 0.8% | 36 | 0.8 | 36 | 0.9 | |
| Diabetes mellitus | 36 | 7.2 | 617 | 10.1 | 500 | 10.3 | 485 | 10.5 |
| Opioid substitution therapy (OST) | 111 | 22.3 | 499 | 8.2 | 366 | 7.6 | 327 | 7.1 |
| Solid organ transplantation | 11 | 2.2 | 131 | 2.1 | 105 | 2.2 | 102 | 2.2 |
| HIV | 60 | 12.0 | 499 | 8.2 | 378 | 7.8 | 366 | 7.9 |
| Plateletsd/nl (mean) | 202.9 ± 85.0 | 192.9 ± 78.7 | 192.3 ± 78.5 | 193.7 ± 78.9 | ||||
| Platelets <90/nld | 18 | 6.9 | 550 | 9.7 | 457 | 9.9 | 438 | 10.0 |
| Albumin g/l (mean) | n.a. | 40.4 ± 7.9 | 40.7 ± 7.5 | 40.7 ± 7.5 | ||||
| Albumin <35 g/le | 313 | 12.1 | 244 | 11.2 | 233 | 11.2 | ||
| HCV-RNA <800,000 IU/ml | 197 | 39.6 | 2368 | 38.8 | 1899 | 39.2 | 1803 | 39.1 |
| HCV-RNA >800,000–2 × 106 IU/ml | 106 | 21.3 | 1435 | 23.5 | 1151 | 23.8 | 1099 | 23.8 |
| HCV-RNA > 2 × 106–6 × 106 IU/ml | 96 | 19.3 | 1464 | 24.0 | 1210 | 25.0 | 1154 | 25.0 |
| HCV-RNA > 6 × 106 IU/ml | 47 | 9.4 | 647 | 10.6 | 516 | 10.6 | 487 | 10.6 |
Data for MELD were available from 477 treated patients (ITT1), patients with follow-up (ITT3) and 373 pts in the per-protocol analysis
Data for Child-Pugh score were available for 34 screened patients, 1355 treated patients (ITT1), 1099 patients in the follow-up (ITT3) group and 1050 patients in the per-protocol analysis
Data for glomerular filtration rate (GFR) were available for 5355 treated patients (ITT1), 4405 patients in the follow-up (ITT3) group and 4200 patients in the per-protocol analysis
Data on platelet count were available for 263 screened and 5653 treated patients (ITT 1), 4613 patients with follow-up (ITT 3) and 4393 in the per-protocol analysis
Data on albumin were available for 2592 treated patients (ITT 1), 2182 patients with follow-up (ITT3) and 2085 in the per-protocol analysis
ITT: intention-to-treat; IFN: interferon; DAA: direct-acting antivirals; MELD: Model for End-Stage Liver Disease; HIV: human immunodeficiency virus; HCV: hepatitis C virus; n.a.: not available.