Table 1.
Association of quintiles of GGT activity (IU/L)with patient features expressed as means (SD) or percent at time of entry to lead-in phase or randomized phase (for express patients). N=1090 unless otherwise noted.
| Variable | 1st Quintile 10–57 | 2nd Quintile 58–89 | 3rd Quintile 90–139 | 4th Quintile 140–230 | 5th Quintile 231–2000 | p value for trend |
|---|---|---|---|---|---|---|
| N patients | 228 | 216 | 219 | 208 | 219 | |
| Patient characteristics | ||||||
| Age years | 50.4 (7.3) | 50.3 (7.9) | 50.1 (7.3) | 50.0 (7.4) | 49.0 (6.7) | 0.059 |
| Male (%) | 57.9% | 70.4% | 73.5% | 75.5% | 83.1% | <0.0001 |
| Race (%) | <0.0001 | |||||
| White | 82.5% | 78.7% | 74.4% | 72.6% | 62.1% | |
| Black | 9.7% | 10.7% | 11.9% | 19.7% | 25.1% | |
| Hispanic | 4.4% | 7.9% | 10.1% | 5.8% | 11.4% | |
| Other | 3.5% | 2.8% | 3.7% | 1.9% | 1.4% | |
| BMI (kg/m2) | 29.3 (5.8) | 29.6 (5.0) | 29.9 (5.4) | 30.2 (5.8) | 29.8 (5.0) | 0.14 |
| Diabetes (%) | 17.1% | 21.8% | 23.7% | 25.5% | 32.0% | 0.0002 |
| Previous ribavirin treatment (%) | 70.6% | 65.7% | 68.5% | 76.0% | 77.6% | 0.013 |
| Esophageal varices (N=743) | 22.6% | 23.9% | 23.2% | 25.0% | 28.7% | 0.22 |
| Prescription medication use (N=1045) | ||||||
| Any, % | 72.4% | 72.2% | 80.8% | 78.9% | 79.5% | 0.021 |
| Anti-epileptic, % | 3.1% | 4.2% | 4.1% | 3.9% | 2.7% | 0.81 |
| Ever smoked, % (N=1066) | 78.9% | 71.4% | 71.0% | 78.5% | 81.6% | 0.19 |
| Ever drank, % (N=1085) | 78.0% | 80.9% | 83.4% | 88.0% | 89.5% | 0.0001 |
| Drinking at baseline, % | 14.9% | 15.7% | 20.1% | 20.2% | 22.8% | 0.015 |
| Lifetime drinks (N=1085) | 18,451 (35,392) | 16,056 (22,619) | 18,728 (31,667) | 20,013 (36,342) | 19,817 (27,330) | 0.32 |
| Coffee cups per day (%)(N=848) | 0.0011 | |||||
| Non-drinkers | 15.7% | 14.6% | 13.5% | 13.0% | 18.1% | |
| <1, | 20.2% | 30.4% | 31.0% | 27.8% | 33.7% | |
| 1-<3 | 42.7% | 38.0% | 41.5% | 46.3% | 40.4% | |
| ≥ 3 cups/day | 21.4% | 17.0% | 14.0% | 13.0% | 7.8% | |
| Laboratory values | ||||||
| IL28B rs12979860 (N=983) | <0.0001 | |||||
| CC, % | 45.4% | 34.3% | 22.7% | 13.1% | 10.1% | |
| CT, % | 41.0% | 49.0% | 54.0% | 57.4% | 61.8% | |
| TT, % | 13.7% | 16.7% | 23.2% | 29.5% | 28.1% | |
| PNPLA3 rs738409 (N=989 | 0.31 | |||||
| CC, % | 54.9% | 53.5% | 54.0% | 51.6% | 53.2% | |
| CG, % | 39.8% | 36.4% | 37.0% | 41.3% | 35.3% | |
| GG, % | 5.3% | 10.1% | 9.0% | 7.1% | 11.4% | |
| Hemoglobin (g/dL) | 14.6 (1.4) | 15.0 (1.4) | 15.0 (1.4) | 15.2 (1.4) | 15.4 (1.2) | <0.0001 |
| Neutrophils (X103/mm3) | 3.3 (1.4) | 3.3 (1.4) | 3.2 (1.3) | 3.1 (1.3) | 2.9 (1.2) | 0.0013 |
| Platelets (X103/mm3) | 181 (65) | 167 (60) | 169 (66) | 170 (70) | 155 (61) | 0.0002 |
| AST (IU/L) | 63.1 (45) | 74.7 (42) | 90.6 (51) | 97.6 (63) | 126.7 (84) | <0.0001 |
| ALT (IU/L) | 85.2 (66) | 101.9 (61) | 113.3 (76) | 126.0 (88) | 154.6 (102) | <0.0001 |
| Alkaline phosphatase (IU/L) | 79.5 (28) | 86.2 (33) | 100.0 (41) | 104.4 (42) | 118.3 (52) | <0.0001 |
| APRI | 1.04 (1.12) | 1.37 (1.26) | 1.61 (1.49) | 1.75 (1.70) | 2.39 (2.23) | <0.0001 |
| AST/ALT | 0.80 (0.26) | 0.80 (0.28) | 0.87 (0.30) | 0.85 (0.30) | 0.88 (0.29) | 0.0006 |
| AFP (ng/mL) | 6.0 (8.4) | 12.9 (26.4) | 16.5 (26.1) | 16.3 (25.7) | 24.9 (32.0) | <0.0001 |
| Total bilirubin, mg/dL | 0.68 (0.33) | 0.81 (0.44) | 0.79 (0.41) | 0.80 (0.42) | 0.87 (0.42) | <0.0001 |
| Albumin (g/L) | 3.95 (0.38) | 3.96 (0.39) | 3.84 (0.38) | 3.87 (0.38) | 3.82 (0.42) | <0.0001 |
| Prothrombin time (INR) | 1.02 (0.09) | 1.04 (0.13) | 1.04 (0.11) | 1.03 (0.09) | 1.04 (0.11) | 0.23 |
| Ferritin (ng/mL) | 172 (139) | 266 (254) | 294 (261) | 421 (394) | 571 (554) | <0.0001 |
| Serum bile acids (μmol/L) | 11.1 15.3) | 12.3 (13.4) | 19.0 (23.3) | 19.2 (23.3) | 21.5 (22.5) | <0.0001 |
| HOMA IR (N=1087) | 12.5 (21) | 14.1 (22) | 14.7 (18) | 17.0 (30) | 20.0 (26) | 0.0004 |
| HCV genotype | 0.18* | |||||
| Genotype 1, % | 84.7% | 89.8% | 89.5% | 90.9% | 88.6% | |
| Genotype 2, % | 9.7% | 3.7% | 2.3% | 4.3% | 4.1% | |
| Genotype 3, % | 4.8% | 5.6% | 6.9% | 2.9% | 4.6% | |
| Other genotype, % | 0.9% | 0.9% | 1.4% | 1.9% | 2.7% | |
| HCV RNA (Log10 IU/mL) | 6.49 (0.62) | 6.45 (0.56) | 6.37 (0.51) | 6.41 (0.45) | 6.39 (0.47) | 0.023 |
| Histologic Findings (N=1088) | ||||||
| Hepatic Steatosis (%) | <0.0001 | |||||
| <1 | 39.9% | 20.5% | 13.7% | 9.6% | 10.1% | |
| 1–5 | 40.8% | 48.4% | 48.0% | 36.1% | 34.9% | |
| 6–33 | 17.1% | 23.7% | 31.5% | 40.4% | 42.2 | |
| >=34 | 2.2% | 7.4% | 6.9% | 13.9% | 12.8% | |
| Cirrhosis (%) | 25.4% | 35.2% | 43.8% | 42.8% | 42.9% | <0.0001 |
| Ishak fibrosis score | 3.6 (1.2) | 4.0 (1.2) | 4.2 (1.3) | 4.1 (1.3) | 4.3 (1.2) | <0.0001 |
| Ishak inflammation score | 7.0 (2.2) | 7.4 (2.0) | 7.7 (2.0) | 7.6 (2.0) | 7.9 (2.1) | <0.0001 |
| Periportal injury | 2.5 (1.0) | 2.7 (0.9) | 2.8 (1.0) | 2.7 (0.9) | 2.9 (0.9) | <0.0001 |
| Parenchymal injury | 2.7 (0.9) | 2.5 (0.8) | 2.6 (0.9) | 2.7 (0.8) | 2.8 (0.9) | <0.0001 |
| Portal inflammation | 2.2 (0.7) | 2.2 (0.8) | 2.2 (0.8) | 2.2 (0.7) | 2.2 (0.7) | 0.96 |
| Mallory bodies (%) | 6.1% | 7.0% | 13.2% | 16.8% | 25.7% | <0.0001 |
| Hepatocellular iron grade >1 (%) | 7.0% | 8.4% | 8.2% | 10.1% | 11.0% | 0.11 |
| Adherence during lead-in | ||||||
| Pegylated IFN > 80% of prescribed dose | 71.1% | 74.5% | 67.1% | 63.5% | 65.3% | 0.025 |
| Ribavirin > 80% of prescribed dose | 65.4% | 69.9% | 63.5% | 68.8% | 68.0% | 0.67 |
| Pegylated IFN and ribavirin > 80% of prescribed dose | 50.4% | 58.8% | 50.7% | 51.9% | 49.3% | 0.41 |
APRI AST/Platelet ratio index;
*
Genotype 1 versus others