Table 1.
Baseline Demographics and Disease Characteristics of GT2 HCV‐Infected Patients Without Cirrhosis Enrolled in Arms A and B of CERTAIN‐2 and GT2 HCV‐Infected Patients With Compensated Cirrhosis Enrolled in Arm C of CERTAIN‐1 Substudy 2
| Characteristic |
CERTAIN‐2 Without Cirrhosis |
CERTAIN‐1 Substudy 2 Compensated Cirrhosis |
|
|---|---|---|---|
|
Arm A G/P 8 weeks (n = 90) |
Arm B SOF + RBV 12 weeks (n = 46) |
Arm C G/P 12 weeks (n = 18) |
|
| Female, n (%) | 48 (53) | 25 (54) | 11 (61) |
| Age, median (range), years | 57 (26‐83) | 58 (21‐84) | 70 (49‐85) |
| Age, n (%) | |||
| ≥65 | 29 (32) | 17 (37) | 13 (72) |
| ≥75 | 10 (11) | 8 (17) | 6 (33) |
| BMI, mean ± SD (kg/m2) | 22.9 ± 3.3 | 23.0 ± 4.2a | 22.2 ± 3.5 |
| IL28B non‐CC genotype, n (%) | 23 (26) | 9 (20) | 3 (17) |
| Treatment‐experienced (IFN‐based with or without RBV), n (%) | 15 (17) | 8 (17) | 7 (39) |
| HCV subtypeb | |||
| 2a, n (%) | 65 (72) | 30 (65) | 10 (56) |
| 2b, n (%) | 25 (28) | 16 (35) | 8 (44) |
| HCV RNA, mean ± SD, log10 IU/mL | 6.0 ± 0.8 | 6.1 ± 0.8 | 5.3 ± 1.0 |
| FIB‐4 index, median (range) | 1.6 (0.6‐7.7) | 2.1 (0.6‐7.3) | 5.1 (1.6‐17.0) |
| Proton pump inhibitor use, n (%) | 12 (13) | 2 (4) | 7 (39) |
| Liver protectant use, n (%) | 15 (17) | 12 (26) | 10 (56) |
| Calcium channel blockers use, n (%) | 23 (26) | 11 (24) | 6 (33) |
a
n = 45.
b
HCV subtype determined by phylogenetic analysis of baseline NS3/4A and/or NS5A sequence.
Abbreviations: BMI, body mass index; IL28B, interleukin 28B; SD, standard deviation.