Table 1.
Characteristics of the 598 HALT-C Trial patients without gastroesophageal varices at pretreatment screening endoscopy
| Characteristic | All patients N=598 |
De Novo varices n=157 |
Non- progressors n=441 |
p-value * | OR (95% CI) |
|---|---|---|---|---|---|
| Demographics | |||||
|
| |||||
| Age (yrs) | 50.1 (7.1) | 50.9 (7.2) | 49.8 (7.1) | 0.10 | 1.02 (1.00,1.05) |
|
| |||||
| % Male | 69% | 68% | 69% | 0.77 | 0.94 (0.64,1.40) |
|
| |||||
| Race | 0.0003 | ||||
| % Hispanic | 6% | 13% | 4% | 3.72 (1.89,7.31) |
|
| % Black | 22% | 19% | 23% | 0.86 (0.54,1.37) |
|
| % Caucasian | 72% | 68% | 73% | 1 Ref | |
|
| |||||
| Co-morbidities | |||||
|
| |||||
| % Diabetes mellitus | 23% | 28% | 22% | 0.11 | 1.40 (0.92,2.12) |
|
| |||||
| BMI (kg/m2) | 29.8 (5.3) | 30.6 (5.5) | 29.5 (5.2) | 0.0330 | 1.04 (1.00,1.07) |
|
| |||||
| % Truncal obesity | 51% | 56% | 49% | 0.1524 | 1.31 (0.91,1.90) |
|
| |||||
| % Current smoker | 28% | 24% | 29% | 0.25 | 0.78 (0.51,1.19) |
|
| |||||
| Total lifetime drinks | 15358 (23940) | 12793 (18289) |
16273 (25614) | 0.12 | 1.00 (1.00,1.00) |
|
| |||||
| % Baseline NSAID/Cox- 2 Inhibitor |
5% | 4% | 5% | 0.43 | 0.69 (0.28,1.72) |
|
| |||||
| % B-Blocker at baseline | 7% | 7% | 8% | 0.84 | 0.93 (0.46,1.89) |
|
| |||||
| % Statins at baseline | 1.3% | 2% | 1% | 0.44 | 1.70 (0.40,7.19) |
|
| |||||
| HCV parameters | |||||
|
| |||||
| Prior HALT-C status | 0.37 | ||||
| % Non-responder | 63% | 67% | 62% | 1.09 (0.68,1.74) |
|
| % Breakthru/ relapser | 17% | 13% | 18% | 0.75 (0.40,1.40) |
|
| % Express | 20% | 20% | 20% | 1 Ref | |
|
| |||||
| Log HCV RNA (IU/ml) | 6.5 (0.5) | 6.37 (0.5) | 6.54 (0.5) | 0.0004 | 0.52 (0.37,0.75) |
|
| |||||
| % HCV genotype 1 | 94% | 90% | 95% | 0.0253 | 0.45 (0.23,0.91) |
|
| |||||
| Laboratory parameters | |||||
|
| |||||
| Hemoglobin (g/dl) | 15.0 (1.4) | 14.9 (1.6) | 15.1 (1.4) | 0.25 | 0.93 (0.82, 1.05) |
|
| |||||
| Serum AST/ALT | 0.85 (0.3) | 0.91 (0.3) | 0.83 (0.3) | 0.0027 | 2.55 (1.38, 4.70) |
|
| |||||
| Alk phos ratio (ULN) | 0.82 (0.4) | 0.91 (0.4) | 0.79 (0.4) | 0.0011 | 2.12 (1.35, 3.33) |
|
| |||||
| Total bilirubin (mg/dl) | 0.73 (0.4) | 0.81 (0.4) | 0.7 (0.4) | 0.0014 | 2.29 (1.38, 3.82) |
|
| |||||
| INR | 0.0005 | ||||
| % >1.0 | 31% | 42% | 27% | 1.96 (1.34-2.87) |
|
| % ≤ 1.0 | 69% | 58% | 73% | 1 Ref | |
|
| |||||
| Albumin (g/dl) | 3.93 (0.4) | 3.83 (0.4) | 3.96 (0.3) | <.0001 | 0.33 (0.20, 0.57) |
|
| |||||
| Platelets (103/ml) | 177 (61.5) | 159 (67.9) | 183 (57.8) | <.0001 | 0.50 (0.36, 0.70) |
|
| |||||
| Total Bile acids (umol/l) | 14.1 (16.5) | 20.5 (24) | 11.7 (12) | <.0001 | 1.03 (1.02, 1.04) |
|
| |||||
| HOMA-IR | 14.1 (17.7) | 15.2 (17.3) | 13.7 (17.9) | 0.42 | 1.00 (0.99, 1.02) |
|
| |||||
| Log HA (ng/ml) | 1.89 (0.5) | 2.12 (0.5) | 1.81 (0.4) | <.0001 | 4.69 (2.98, 7.37) |
|
| |||||
| % Splenomegaly on ultrasound |
28% | 38% | 25% | 0.0018 | 1.87 (1.26, 2.76) |
|
| |||||
| Baseline Histology | |||||
|
| |||||
| % Cirrhosis (Ishak 5/6) | 32% | 42% | 29% | 0.0025 | 1.79 (1.23, 2.62) |
|
| |||||
| Mean HAI Baseline | 7.4 (2.1) | 7.5 (2) | 7.4 (2.1) | 0.49 | 1.03 (0.94, 1.13) |
|
| |||||
| % Hepatic steatosis ≥ 2 | 42% | 54% | 37% | 0.0005 | 1.93 (1.33, 2.78) |
|
| |||||
| % Mallory Bodies | 14% | 21% | 12% | 0.0064 | 1.95 (1.21, 3.15) |
|
| |||||
| % Zone 3 fibrosis | 0.15 | ||||
|
| |||||
| 0 | 64% | 67% | 63% | 0.64 (0.30,1.36) |
|
|
| |||||
| 1 | 30% | 25% | 32% | 0.47 (0.21,1.06) |
|
|
| |||||
| 2 | 6% | 38% | 5% | 1 Ref | |
|
| |||||
| Randomized phase | |||||
|
| |||||
| % Peginterferon arm | 50% | 50% | 49% | 0.81 | 1.05 (0.73,1.51) |
|
| |||||
| % Clinical outcome | 8% | 20% | 4% | <0.0001 | 5.46 (2.99,10.01) |
|
| |||||
| % Two-point increase in Ishak fibrosis score |
26% | 53% | 18% | <0.0001 | 5.20 (3.11,8.68) |
Data reported as mean + std dev or %
*
comparing de novo vs non-progressors