Table 1.
Selected demographic and historical features of participants
| All Patients (n=1,049) | Patients with Noncirrhotic Fibrosis at Baseline (n=622) | Patients with Cirrhosis at Baseline (n=427) | p-value* | |
|---|---|---|---|---|
| % or mean ± SD | % or mean ± SD | % or mean ± SD | ||
| DEMOGRAPHICS | ||||
| Age (years) | 50.1 ± 7.2 | 50.1 ± 7.3 | 50.1 ± 7.0 | 0.99 |
| Gender (% female) | 29 | 29 | 28 | 0.60 |
| Marital status (% married or living as married) | 55 | 57 | 53 | 0.20 |
| Education level (% college graduate) | 21 | 22 | 19 | 0.33 |
| Race/Ethnicity (% White, non-Hispanic) | 72 | 72 | 71 | 0.81 |
| Body Mass Index (kg/m2) | 29.9 ± 5.5 | 29.5 ± 5.6 | 30.3 ± 5.3 | 0.03 |
| MEDICAL DISORDERS | ||||
| History of diabetes mellitus (% of patients) | 17 | 16 | 20 | 0.08 |
| History of serious or other heart disease (% of patients) | 13 | 13 | 13 | 0.97 |
| History of major depression (% of patients) | 7 | 7 | 7 | 0.57 |
| Anxiolytic/antidepressant use at baseline (% of patients) | 34 | 34 | 35 | 0.76 |
| HEPATITIS FACTORS | ||||
| HCV genotype 1 (% of patients) | 94 | 94 | 93 | 0.34 |
| HCV RNA level at baseline (log10 of IU/ml) | 6.4 ± 0.5 | 6.5 ± 0.5 | 6.3 ± 0.6 | <0.001 |
| SMOKING AND ALCOHOL USE | ||||
| Ever drank alcohol regularly (% of patients) | 83 | 83 | 84 | 0.63 |
| Lifetime alcohol consumption (number of drinks) | 18,159 ± 30,881 | 17,339 ± 30,536 | 19,359 ± 31,378 | 0.30 |
| Regular alcohol user at baseline (% of patients) | 17 | 19 | 14 | 0.08 |
| Ever smoked cigarettes (% of patients) | 76 | 75 | 78 | 0.24 |
| Current smoker at baseline (% of patients) | 30 | 29 | 31 | 0.56 |
| BASELINE HRQOL & SYMPTOM SCORES ** | ||||
| SF-36 Vitality Subscale Score | 54.2 ± 23.0 | 55.4 ± 22.3 | 52.5 ± 23.9 | 0.05 |
| SF-36 Physical Summary Score | 44.5 ± 11.3 | 45.3 ± 11.1 | 43.4 ± 11.5 | 0.009 |
| SF-36 Mental Summary Score | 50.5 ± 9.0 | 51.1 ± 8.3 | 49.5 ± 9.9 | 0.005 |
| Sexual Health Score (Men only) | 74.3 ± 28.4 | 76.5 ± 27.2 | 71.2 ± 29.7 | 0.01 |
| Sexual Health Score (Women only) | 62.9 ± 35.4 | 64.0 ± 35.8 | 61.3 ± 34.8 | 0.53 |
| Fatigue | 3.4 ± 2.7 | 3.3 ± 2.6 | 3.5 ± 2.8 | 0.11 |
| General Well-Being | 2.7 ± 2.2 | 2.6 ± 2.2 | 2.9 ± 2.3 | 0.13 |
*
p value for a t-test or chi-square comparison of participants with baseline noncirrhotic fibrosis vs. participants with baseline cirrhosis.
**
SF-36 and Sexual Health scores have a 100 point scale (0=worst; 100=best); Fatigue scores have a 10 point scale (none = 0 to worst ever = 10); and General Well-Being scores have a 10 point scale (very good = 0 to very bad = 10).