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Table 1 Baseline demographics and clinical characteristics
| Characteristic | Phase 2/3 group (N = 125) | Phase 1 group (N = 16) |
|---|---|---|
| Male, n (%) | 80 (64.0) | 13 (81.3) |
| Age (years), median (range) | 51.0 (22–72) | 52.5 (33–65) |
| BMI (kg/m2), median (range) | 27.4 (18.9–45.8) | 27.1 (20.4–35.3) |
| Race, n (%) | ||
| White | 121 (96.8) | 14 (87.5) |
| Black/African American | 3 (2.4) | 1 (6.3) |
| American Indian/Alaskan native | 0 | 1 (6.3) |
| Native Hawaiian or other Pacific Islander | 1 (0.8) | 0 |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 7 (5.6) | 1 (6.3) |
| Not Hispanic or Latino | 118 (94.4) | 15 (93.8) |
| Time since diagnosis (years), median (range) | 7.1 (2.1–35.4) | 6.1 (0.7–20.4) |
| SMV therapy-experienced, yes, n (%) | 125 (100) | 8 (50) |
| PegIFN/RBV therapy-experienced, yes, n (%) | 125 (100) | 9 (56.2) |
| Response to last course of PegIFN/RBV therapy, n (%) | ||
| Viral relapser | 55 (44.0) | – |
| Viral breakthrough | 10 (8.0) | – |
| Non-responder | 60 (48.0) | – |
| Partial responder | 28 (22.4) | – |
| Null responder | 30 (24.0) | – |
| Other (non-classifiable non-responder) | 2 (1.6) | – |
| Baseline HCV RNA (log10 IU/ml), median (range) | 6.53 (4.9–7.8) | 6.68 (5.6–7.2) |
| IL28B genotype, n (%) | ||
| CC | 20 (16.0) | 1 (6.3) |
| CT | 87 (69.6) | 9 (56.3) |
| TT | 18 (14.4) | 6 (37.5) |
| HCV geno/subtype | ||
| 1a | 50 (40.0) | 14 (87.5) |
| 1a with Q80K | 12/50 (24.0) | 3/14 (21.4) |
| 1a without Q80K | 38/50 (76.0) | 11/14 (78.6) |
| 1b | 75 (60.0) | 2 (12.5) |
| HOMA-IR,a n (%) | ||
| <2 | 46/120 (38.3) | 4/14 (28.6) |
| ≥2 to ≤4 | 43/120 (35.8) | 7/14 (50.0) |
| >4 | 31/120 (25.8) | 3/14 (21.4) |
| METAVIR fibrosis score, n (%) | ||
| F0, 1, or 2 | 85 (68.0) | 13 (81.3) |
| F3 | 18 (14.4) | 3 (18.8%) |
| F4 | 22 (17.6) | 0 |
| Baseline ALT WHO toxicity grade, n (%) | ||
| Grade 0 | 66 (52.8) | 10 (62.5) |
| Grade 1/2 | 56 (44.8) | 6 (37.5) |
| Grade 3 | 3 (2.4) | 0 |
| Grade 4 | 0 | 0 |
