Table 1.
Baseline demographics and disease characteristics
| Characteristic | GT1 N = 602 |
GT2 N = 297 |
Overall N = 899 |
|---|---|---|---|
| Male, n (%) | 304 (50) | 141 (47) | 445 (49) |
| Race, n (%) | |||
| White | 384 (64) | 171 (59) | 555 (62) |
| Black or African American | 33 (5) | 13 (4) | 46 (5) |
| Asiana | 180 (30) | 107 (36) | 287 (31) |
| Other | 5 (< 1) | 6 (2) | 11 (1) |
| Age, median (range), years | 54 (19–86) | 57 (21–83) | 55 (19–86) |
| Age distribution, n (%) | |||
| ≥ 65 | 113 (19) | 61 (21) | 174 (19) |
| ≥ 75 | 31 (5) | 13 (4) | 44 (5) |
| BMI, median (range), kg/m2 | 24.7 (16.2–41.4) | 25.3 (14.2–65.7) | 24.8 (14.2–65.7) |
| HCV treatment history | |||
| Treatment-naïve | 411 (68) | 262 (88) | 673 (75) |
| Treatment-experiencedb | 191 (32) | 35 (12) | 226 (25) |
| Baseline HCV RNA level, median (range), log10 IU/mL | 6.2 (1.2–7.6) | 6.6 (0.7–7.6) | 6.3 (0.7–7.6) |
| FIB-4 index, median (range) | 1.4 (0.3–7.8) | 1.5 (0.3–7.9) | 1.4 (0.3–7.9) |
| FIB-4 index | |||
| < 1.45 | 317 (53) | 147 (49) | 464 (52) |
| 1.45–3.25 | 244 (41) | 122 (41) | 366 (41) |
| > 3.25 | 41 (7) | 28 (9) | 69 (8) |
| IL28B | |||
| CC | 217 (36) | 165 (56) | 382 (42) |
| Non-CC | 385 (64) | 132 (44) | 517 (58) |
| Presence of key baseline substitutions, n (%) | |||
| NS3 onlyc | 9 (2) | 2 (< 1) | 11 (1) |
| NS5A onlyd | 81 (14) | 26 (9) | 107 (13) |
| NS3 + NS5Ac,d | 1 (< 1) | 1 (< 1) | 2 (< 1) |
| Baseline NS5A Y93H, n (%) | 54 (9) | 0 | 54 (6) |
| History of disorders, n (%) | |||
| Hypertension | 153 (25) | 42 (14) | 195 (22) |
| Gastroesophageal reflux disease | 45 (7) | 7 (2) | 52 (6) |
| Hyperlipidemia | 13 (2) | 14 (5) | 27 (3) |
| Diabetes | 41 (7) | 20 (7) | 61 (7) |
| Cardiovascular disease | 187 (31) | 108 (36) | 295 (33) |
| Chronic kidney disease stage 4 or 5e | 3 (< 1) | 7 (2) | 10 (1) |
| Concomitant medications, n (%) | |||
| Calcium channel blockers | 77 (13) | 46 (15) | 123 (14) |
| Angiotensin II receptor blockers | 67 (11) | 23 (8) | 90 (10) |
| Statins | 32 (5) | 17 (6) | 49 (5) |
| Proton pump inhibitors | 53 (9) | 37 (12) | 90 (10) |
BMI body-mass index, HCV hepatitis C virus, FIB-4 fibrosis-4
aIncludes 132 GT1-infected and 104 GT2-infected Japanese patients from CERTAIN-1 and CERTAIN-2 Phase 3 clinical trials
bPrior treatment experience with interferon (IFN)/pegIFN ± ribavirin (RBV)
cDefined as having any baseline NS3 resistance-associated variant (at amino acid positions 155, 156, and 168) at ≥ 15% NGS detection threshold
dDefined as having any baseline NS5A resistance-associated variant (at amino acid positions 24 (GT2 only), 28, 30, 31 (GT1 only), 92 (GT2 only), and 93) at ≥ 15% NGS detection threshold
eDefined as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 at screening