Table 2.
Baseline Characteristics of Patients in the High, Intermediate and Low CRS7 Risk Groups
| CRS7 Risk Group(N = 938) | p-value | ||||||
|---|---|---|---|---|---|---|---|
| High, >0.7 (n= 440)
|
Intermediate, 0.5–0.7 (n= 310)
|
Low, <0.5 (n= 188)
|
|||||
| Mean/% | SD | Mean/% | SD | Mean/% | SD | ||
| Demographics | |||||||
| Age, y | 49.6 | 7.0 | 50.3 | 7.4 | 50.9 | 6.8 | 0.02* |
| Gender, Male | 72.3% | - | 68.7% | - | 70.2% | - | 0.46§ |
| Race/ethnicity | - | - | |||||
| African-American | 19.6% | - | 20.0% | - | 9.0% | ||
| Caucasian | 68.6 | - | 68.1% | - | 87.2% | <0.00 | |
| Hispanic and Other | 11.8 | - | 11.9% | - | 3.7% | - | 1‡ |
| Source of randomization | - | - | 0.53‡ | ||||
| Lead-in | 62.7% | - | 65.2% | - | 61.2% | - | |
| Express | 22.3% | - | 21.9% | - | 23.4% | - | |
| Breakthrough | 3.6% | - | 3.2% | - | 2.7% | - | |
| Relapser | 11.4% | - | 9.7% | - | 12.8% | - | |
| Treatment assignment | - | ||||||
| Peginterferon | 47.7% | - | 49.4% | - | 53.2% | - | 0.22§ |
| Control | 52.3% | - | 50.6% | - | 46.8% | - | |
| Body Mass Index (BMI) | 29.9 | 5.6 | 30.1 | 5.2 | 30.1 | 5.5 | 0.46* |
| Viral Factors | |||||||
| Log10 HCV RNA, IU/mL | 6.45 | 0.50 | 6.39 | 0.55 | 6.40 | 0.55 | 0.19* |
| Duration of infection, y | 28.3 | 8.1 | 27.9 | 8.1 | 28.2 | 7.7 | 0.81* |
| Laboratory Values | |||||||
| Hemoglobin, g/dL | 15.0 | 1.4 | 14.9 | 1.5 | 15.0 | 1.3 | 0.50* |
| White blood cells, x1000/mm3 | 5.82 | 1.98 | 5.69 | 1.80 | 5.85 | 1.80 | 0.99* |
| Platelets, x1000/mm3 | 165.5 | 67.0 | 163.7 | 65.6 | 162.3 | 60.1 | 0.70* |
| Albumin, g/dL | 3.85 | 0.39 | 3.83 | 0.39 | 3.93 | 0.41 | 0.09* |
| AST, U/L | 83.4 | 55.4 | 94.9 | 61.9 | 83.4 | 51.3 | 0.28* |
| ALT, U/L | 102.2 | 77.9 | 115.1 | 81.5 | 101.7 | 63.9 | 0.35* |
| Alkaline Phosphatase, U/L | 100.4 | 42.3 | 104.0 | 48.4 | 92.7 | 46.5 | 0.03* |
| Total bilirubin, mg/dL | 0.79 | 0.40 | 0.81 | 0.41 | 0.78 | 0.42 | 0.82* |
| Prothrombin time, INR | 1.04 | 0.10 | 1.04 | 0.11 | 1.04 | 0.12 | 0.98* |
| AFP, ng/mL | 15.9 | 22.0 | 18.1 | 27.9 | 19.2 | 40.0 | 0.39* |
| Liver histology | |||||||
| Ishak fibrosis score | - | - | - | ||||
| 5 or 6 | 42.5% | - | 40.6% | - | 38.3% | - | 0.32§ |
| <5 | 57.5% | - | 59.4% | - | 61.7% | - | |
| Esophageal varices on EGD | 26.2% | - | 25.9% | - | 25.1% | - | 0.80§ |
| CRS7 | 0.80 | 0.06 | 0.60 | 0.04 | 0.35 | 0.10 | - |
Kendall’s Tau-b Correlation Test,
Cochran-Armitage Trend Test,
Cochran-Mantel-Haenszel Mean Score Test. All p-values are derived from two-sided tests.