Table 4.
Baseline characteristics in patients with hepatic disease progression or new HCC
| Parameter, n (%)a | All patients | Hepatic disease progressionc | HCC | ||
|---|---|---|---|---|---|
| SVR | Non‐SVR | SVR | Non‐SVR | ||
| N = 1503b | N = 8 | N = 7 | N = 20 | N = 3 | |
| Age, median, years (range) | 56 (21‐83) | 61 (50‐72) | 56 (43‐71) | 66 (52‐78) | 62 (58‐71) |
| Male | 898 (60) | 6 (75) | 4 (57) | 14 (70) | 1 (33) |
| HCV genotype | |||||
| 1 (not subtyped) | 4 (<1) | 0 | 0 | 0 | 0 |
| 1a | 628 (42) | 3 (38) | 4 (57) | 6 (30) | 1 (33) |
| 1b | 671 (45) | 4 (50) | 3 (43) | 14 (70) | 2 (67) |
| 2 | 41 (3) | 0 | 0 | 0 | 0 |
| 3 | 91 (6) | 1 (13) | 0 | 0 | 0 |
| 4 | 67 (4) | 0 | 0 | 0 | 0 |
| 6 | 1 (<1) | 0 | 0 | 0 | 0 |
| Regimen | |||||
| DAA‐only | 893 (59) | 7 (88) | 1 (14) | 16 (80) | 2 (67) |
| IFN‐containing | 610 (41) | 1 (13) | 6 (86) | 4 (20) | 1 (33) |
| Cirrhoticd | 269 (18) | 5 (63) | 5 (71) | 9 (45) | 1 (33) |
| Laboratory data, mean | |||||
| Total bilirubine (mg/dL) | 0.55 | 0.54 | 0.89 | 0.65 | 0.63 |
| INRe (fraction) | 1.09 | 1.44 | 1.15 | 1.21 | 1.13 |
| Plateletsf (×109 cells/L) | 192 | 115 | 127 | 145 | 130 |
| Creatininef (mg/dL) | 0.83 | 1.06 | 0.68 | 0.86 | 0.76 |
INR, international normalized ratio.
a
Unless otherwise stated.
b
SVR (n = 1329, 88%); non‐SVR (n = 160, 11%); missing data (n = 14, 1%).
c
Bleeding and non‐bleeding oesophageal or gastric varices, ascites, hepatic encephalopathy, spontaneous bacteria peritonitis, hepatorenal syndrome, and liver transplant.
d
Reported in the medical histories prior to parent study EOT (n = 261), or between parent study EOT and Day 1 of this study (n = 8).
e
Measured upon entry to this study.
f
Last available parent study measurements (measurements during this study only taken in cirrhotic and post‐transplant patients enrolled from the ALLY‐1 study12).