Table 1.
Patient Demographics and Baseline Characteristics
| Arm A (12 Weeks G/P) | Arm B (16 Weeks G/P) | |||
|---|---|---|---|---|
| 1:1 Randomized | ||||
| Characteristic | Treatment‐Naive With Cirrhosis (n = 40) | Treatment‐Experienced Without Cirrhosis (n = 22) | Treatment‐Experienced Without Cirrhosis (n = 22) | Treatment‐Experienced With Cirrhosis (n = 47) |
| Male, n (%) | 24 (60) | 14 (64) | 14 (64) | 36 (77) |
| White race, n (%) | 37 (93) | 17 (77) | 20 (91) | 42 (89) |
| Age, median years (range) | 56 (36‐70) | 56 (35‐68) | 59 (29‐66) | 59 (47‐70) |
| IL28B non‐CC genotype | 20 (50) | 15 (68) | 19 (86) | 34 (72) |
| BMI, median kg/m2 (range) | 29 (21‐51) | 26 (19‐42) | 28 (22‐48) | 27 (21‐42) |
| HCV RNA, median log10 IU/mL (range) | 6.2 (4.2‐7.1) | 6.6 (5.1‐7.5) | 6.1 (4.7‐7.3) | 6.5 (4.6‐7.2) |
| Baseline ALT, mean U/L (±SD) | 127.1 (±94.0) | 92.2 (±54.7) | 78.6 (±65.8) | 120.5 (±82.1) |
| Total bilirubin, mean mg/dL (±SD) | 0.67 (±0.34) | 0.52 (±0.17) | 0.60 (±0.22) | 0.76 (±0.45) |
| Platelets, median × 109/L (range) | 140 (64‐405) | 210 (105‐291) | 235 (132‐365) | 123 (62‐315) |
| Albumin, median g/L (range) | 39 (29‐47) | 41 (35‐45) | 42 (38‐48) | 40 (33‐47) |
| Prior treatment history, n (%) | ||||
| Naive | 40 (100) | 0 | 0 | 0 |
| IFN/pegIFN ± RBV | 0 | 14 (64) | 13 (59) | 22 (47) |
| SOF + RBV ± pegIFN | 0 | 8 (36) | 9 (41) | 25 (53) |
| Baseline fibrosis stage,a n (%) | ||||
| F0‐F1 | 0 | 11 (50) | 15 (68) | 0 |
| F2 | 0 | 4 (18) | 2 (9) | 0 |
| F3 | 0 | 7 (32) | 5 (23) | 0 |
| F4 | 40 (100) | 0 | 0 | 47 (100) |
| Child‐Pugh score, n (%) | ||||
| 5 | 35 (88) | 0 | 0 | 37 (79) |
| 6 | 5 (13) | 0 | 0 | 10 (21) |
| Baseline polymorphisms, n (%)a | ||||
| Any polymorphism | 10 (26) | 6 (27) | 3 (14) | 7 (15) |
| NS3 only | 1 (3) | 0 | 0 | 1 (2) |
| NS5A only | 9 (23) | 6 (27) | 3 (14) | 6 (13) |
| Both NS3 and NS5A | 0 | 0 | 0 | 0 |
a
Data missing for 1 patient in arm A (column 1) and 1 patient in arm B (column 3); percentages calculated with modified numbers reflecting this. Baseline polymorphisms detected by next‐generation sequencing at a 15% threshold in samples that had sequences available for both targets at amino acid positions 155, 156, and 168 in NS3 and 24, 28, 30, 31, 58, 92, and 93 in NS5A.
Abbreviations: BMI, body mass index; IL28B, interleukin 28.