Table 1.
Baseline data for patients with and without elevated HCC biomarkers at least once during months 13-48 [data presented as mean (SD) or percent].
| AFP mg/dL | DCP mAU/mL | |||||
|---|---|---|---|---|---|---|
| Baseline Variables | <20 (N = 613) |
≥20 (N = 242) |
P value* | <90 (N = 616) |
≥90 (N = 239) |
P value** |
| Age | 50.2 (7.3) | 49.5 (6.7) | 0.22 | 50.1 (7.1) | 49.9 (7.3) | 0.20 |
| Female, % | 26% | 36% | 0.003 | 31% | 23% | 0.03 |
| White-non-hispanic, % | 78% | 57% | <0.0001 | 72% | 72% | 0.54 |
| Hispanic, % | 6% | 12% | 7% | 10% | ||
| Black, % | 14% | 28% | 19% | 16% | ||
| Other race/ethnicity, % | 2% | 3% | 2% | 2% | ||
| Body Mass Index, kg/m2 | 29.6 (5.3) | 30.6 (5.7) | 0.03 | 29.8 (5.2) | 30.1 (6.1) | 0.28 |
| Diabetes, % | 23% | 28% | 0.16 | 25% | 24% | 0.84 |
| Log HCV RNA (IU/mL) | 6.46 (0.51) | 6.38 (0.54) | 0.05 | 6.46 (0.50) | 6.36 (0.56) | 0.002 |
| Platelets ×1000/mm3 | 175 (66) | 145 (57) | <0.0001 | 172 (63) | 153 (67) | <0.0001 |
| Albumin, g/dL | 3.9 (0.4) | 3.8 (0.4) | <0.0001 | 3.9 (0.35) | 3.8 (0.45) | <0.0001 |
| AST, U/L | 79 (57) | 104 (59) | <0.0001 | 83 (56) | 96 (65) | 0.002 |
| ALT, U/L | 103 (78) | 118 (76) | 0.01 | 106 (72) | 109 (92) | 0.55 |
| Alkaline phosphatase, U/L | 94 (42) | 113 (52) | <0.0001 | 95 (44) | 109 (49) | <0.0001 |
| Total bilirubin, mg/dL | 0.76 (0.40) | 0.85 (0.42) | 0.005 | 0.76 (0.37) | 0.85 (0.48) | 0.0001 |
| Prothrombin time, INR | 1.03 (0.10) | 1.05 (0.10) | 0.009 | 1.02 (0.10) | 1.06 (0.11) | <0.0001 |
| AST/ALT ratio | 0.83 (0.27) | 0.95 (0.30) | <0.0001 | 0.83 (0.26) | 0.95 (0.31) | <0.0001 |
| APRI | 1.34 (1.35) | 2.14 (1.80) | <0.0001 | 1.44 (1.43) | 1.88 (1.75) | <0.0001 |
| MELD | 6.9 (1.4) | 7.2 (1.4) | 0.03 | 6.89 (1.26) | 7.29 (1.61) | <0.0001 |
| AFP, ng/mL | 6.0 (8.9) | 38.4 (50.8) | <0.0001 | 13.8 (28.5) | 18.9 (38.2) | 0.004 |
| DCP, mAU/mL | 28.3 (174) | 23.0 (38.2) | 0.16 | 15.3 (17.7) | 56.2 (277) | <0.0001 |
| Cirrhosis on biopsy, % | 35% | 55% | <0.0001 | 37% | 51% | <0.0001 |
| Esophageal varices, % | 24% | 26% | 0.45 | 21% | 35% | <0.0001 |
| Treatment group ***, % | 51% | 49% | 0.60 | 49% | 56% | 0.07 |
| HCC, % | 3% | 10% | <0.0001 | 3% | 11% | <0.0001 |
APRI = AST to platelet ratio index; MELD = Model for End Stage Liver Disease; HCC = hepatocellular carcinoma
*
Cox proportional hazards regression comparing those with AFP <20 and ≥ 20 ng/mL,
**
Cox proportional hazards regression comparing those with DCP <90 and ≥ 90 mAU/mL
***
Patients randomized to long-term treatment with peginterferon alfa-2a monotherapy at a dose of 90 μg weekly