Table 2.
Baseline features of the randomized HALT-CTrial patients with YKL-40 promoter polymorphism data
| Variable | YKL-40 CC genotype | YKL-40 CT genotype | YKL-40 TT genotype | Overall | P-value |
|---|---|---|---|---|---|
| Number | 292 | 119 | 7 | 462 * | |
|
| |||||
| Age (years) | 49.7 (6.9) | 49.5 (6.7) | 48.6 (5.9) | 49.5 (7.0) | 0.71 |
|
| |||||
| Gender (% male) | 201 (68.8%) | 90 (75.6%) | 5 (71.4%) | 325 (70.4%) | 0.21 |
|
| |||||
| Race | 0.003** | ||||
| Caucasian (%) | 199 (68.2%) | 96 (80.7%) | 7 (100%) | 329 (71.2%) | |
| African American (%) | 77 (26.4%) | 17 (14.3%) | 0 (0%) | 110 (23.8%) | |
| Other (%) | 16 (5.5%) | 6 (5.0%) | 0 (0%) | 23 (5.0%) | |
|
| |||||
| Duration of infection (years) | 27.0 (7.4) | 27.8 (7.6) | 26.3 (5.7) | 27.1 (7.4) | 0.51 |
|
| |||||
| Lifetime alcohol (Drinks) | 19,355 (31,039) | 19,139 (24,303) | 15,537 (10,236) | 18,514 (28,054) | 0.83 |
|
| |||||
| Lifetime smoking (pack- years) | 17.0 (18.1%) | 16.0 (16.6%) | 18.9 (22.9%) | 16.5 (17.5%) | 0.75 |
|
| |||||
| Diabetes (%) | 81 (27.7%) | 31 (26.1%) | 4 (57.1%) | 129 (27.9%) | 0.65 |
|
| |||||
| Mean BMI | 30.2 (5.7) | 29.5 (5.2) | 29.2 (4.5) | 29.9 (5.5) | 0.20 |
|
| |||||
| % with esophageal varices | 50 (17.7%) | 24 (20.9%) | 3 (42.9%) | 83 (18.6%) | 0.17 |
|
| |||||
| % Lead-in nonresponders | 181 (62.0%) | 78 (65.6%) | 2 (28.6%) | 288 (62.3%) | 0.83*** |
| % Breakthru/relapsers | 40 (13.7%) | 14(11.8%) | 4 (57.1%) | 63 (13.6%) | |
| % Express | 71 (24.3%) | 27 (22.7%) | 1 (14.3%) | 111 (24.0%) | |
|
| |||||
| Laboratory features | |||||
|
| |||||
| Log10 HCV RNA (IU/ml) | 6.48 (0.48) | 6.53 (0.51) | 6.52 (0.30) | 6.50 (0.47) | 0.45 |
|
| |||||
| % Genotype 1 | 270 (92.5%) | 114 (96.6%) | 6 (85.7%) | 433 (93.9%) | 0.31 |
|
| |||||
| AST (IU/ml) | 85.1 (49.0) | 94.3 (64.8) | 138.3 (141.1) | 90.0 (60.2) | 0.03 |
|
| |||||
| ALT (IU/ml) | 100.8 (63.2) | 119.2 (95.6) | 164.3 (172.2) | 108.7 (79.7) | 0.01 |
|
| |||||
| AST/ALT | 0.89 (0.28) | 0.84 (0.22) | 0.86 (0.18) | 0.88 (0.26) | 0.16 |
|
| |||||
| Total Bilirubin (mg/dL) | 0.75 (0.37) | 0.75 (0.35) | 0.57 (0.25) | 0.74 (0.36) | 0.59 |
|
| |||||
| INR | 1.03 (0.10) | 1.04 (0.09) | 1.10 (0.11) | 1.03 (0.10) | 0.08 |
|
| |||||
| Albumin (g/L) | 3.80 (0.38) | 3.86 (0.34) | 3.64 (0.36) | 3.83 (0.37) | 0.52 |
|
| |||||
| Platelets × 103/mm3 | 177.7 (72.4) | 168.0 (56.3) | 136.5 (62.8) | 174.3 (67.1) | 0.10 |
|
| |||||
| Log10 YKL-40 (ug/L) | 2.50 (0.40) | 2.34 (0.39) | 2.20 (0.57) | 2.45 (0.41) | <0.001 |
|
| |||||
| Baseline histology | |||||
|
| |||||
| Mean Ishak Fibrosis score | 4.05 (1.26) | 4.11 (1.23) | 4.43 (1.40) | 4.08 (1.25) | 0.48 |
|
| |||||
| % Ishak 5/6 | 111 (38.0%) | 50 (42.0%) | 3 (42.9%) | 182 (39.4%) | 0.45 |
|
| |||||
| Mean HAI | 7.66 (2.08) | 7.44 (1.91) | 7.29 (2.29) | 7.56 (2.03) | 0.28 |
|
| |||||
| Steatosis (% ≥ 2) | 130 (44.5%) | 52 (43.7%) | 3 (42.9%) | 204 (44.2%) | 0.87 |
|
| |||||
| Randomized phase outcomes | |||||
|
| |||||
| N (%) Peginterferon | 148 (50.7%) | 56 (47.1%) | 2 (28.6%) | 228 (49.4%) | 0.28 |
|
| |||||
| N (%) Clinical progression | 44 (15.1%) | 20 (16.8%) | 2 (28.6%) | 69 (14.9%) | 0.42 |
|
| |||||
| Duration of follow-up (days) | 1,220 (431) | 1,249 (401) | 1,023 (621) | 1,228 (429) | >0.99 |
Presented as mean (SD) or n (%). T-test for continuous variables and chi-sq p-values for categorical variables.
*
44 missing YKL-40 genotype data
**
p-value tests whether percent Caucasian differs by genotype.
***
p-value tests whether proportion of lead-in nonresponders differs by genotype.