Table 2.
Baseline demographics and disease characteristics of GT1 HCV-infected patients without cirrhosis enrolled in Arms A and B, and GT1 HCV-infected patients with compensated cirrhosis enrolled in Arm C of CERTAIN-1
| Characteristic | Substudy 1 | Substudy 2 | |
|---|---|---|---|
| Without cirrhosis | Compensated cirrhosis | ||
| Arm A | Arm B | Arm C | |
| G/P | OBV/PTV/r | G/P | |
| 8 weeks | 12 weeks | 12 weeks | |
| N = 129 | N = 52 | N = 38 | |
| Female, n (%) | 82 (64) | 38 (73) | 21 (55) |
| Age, median (range), years | 64 (21–86) | 67 (31–81) | 73 (48–85) |
| Age distribution, n (%) | |||
| ≥ 65 to < 75 years | 37 (29) | 23 (44) | 15 (40) |
| ≥ 75 years | 26 (20) | 7 (14) | 16 (42) |
| BMI, mean ± SD, kg/m2 | 24 ± 4 | 23 ± 4 | 24 ± 5 |
| IL28B non-CC genotype, n (%) | 50 (39) | 20 (39) | 7 (18) |
| Treatment-naïve, n (%) | 94 (73) | 37 (71) | 26 (68) |
| Treatment-experienced (IFN-based ± RBV), n (%) | 35 (27) | 15 (29) | 12 (32) |
| HCV subtype, n (%) | |||
| 1a | 4 (3) | 0 | 0 |
| 1b | 125 (97) | 52 (100) | 38 (100) |
| NS5A Y93H presenta, n (%) | 23 (18) | 0 | 6 (16) |
| HCV RNA, mean ± SD, log10 IU/ml | 6.1 ± 0.8 | 6.2 ± 0.6 | 6.0 ± 0.8 |
| PPI use, n (%) | 13 (10) | 5 (10) | 6 (16) |
| Liver protectant use, n (%) | 39 (30) | 15 (29) | 23 (61) |
| Calcium channel blockers use, n (%) | 25 (19) | 4 (8) | 14 (37) |
BMI body mass index, G/P glecaprevir/pibrentasvir, OBV/PTV/r ombitasvir/paritaprevir/ritonavir, IL28B interleukin 28B, PPI proton pump inhibitor
a Presence of Y93H in Substudy 1 determined by SRL using population sequencing, which has an approximate detection threshold of 15%. Presence of Y93H in Substudy 2 determined by next generation sequencing at 15% detection threshold