Table 2.
Characteristics of the 210 HALT-C Trial patients with gastroesophageal varices at pretreatment screening endoscopy
| Characteristic | All patients N=210 |
Variceal progressors n=74 |
Non- progressors n=136 |
p-value * |
OR (95% CI) |
|---|---|---|---|---|---|
| Demographics | |||||
| Age (yrs) | 50.8 (7.0) | 51.5 (7.6) | 50.5 (6.7) | 0.35 | 1.02 (0.98, 1.06) |
|
| |||||
| % Male | 78% | 77% | 79% | 0.78 | 0.91 (0.46, 1.79) |
|
| |||||
| Race | 0.188 | ||||
| % Hispanic | 10% | 15% | 8% | 1.88 (0.77, 4.60) |
|
| % Black | 9% | 5% | 10% | 0.54 (0.17, 1.71) |
|
| % Caucasian | 81% | 80% | 82% | 1 Ref | |
|
| |||||
| Co-morbidities | |||||
|
| |||||
| % Diabetes mellitus | 26% | 28% | 25% | 0.60 | 1.19 (0.63, 2.25) |
|
| |||||
| BMI (kg/m2) | 29.8 (4.5) | 29.5 (4.4) | 30 (4.6) | 0.44 | 0.94 (0.80, 1.10) |
|
| |||||
| % Truncal obesity | 50% | 47% | 52% | 0.52 | 0.83 (0.47, 1.47) |
|
| |||||
| % Current smoker | 26% | 30% | 24% | 0.33 | 1.38 (0.73, 2.60) |
|
| |||||
| Total lifetime drinks | 20113 (36096) | 25283 (52592) | 17300 (22336) | 0.155 | 1.00 (1.00, 1.00) |
|
| |||||
| % Baseline NSAID/ Cox-2 Inhibitor |
4% | 3% | 4% | 0.54 | 0.60 (0.12, 3.06) |
|
| |||||
| % B-Blocker at baseline |
15% | 19% | 13% | 0.28 | 1.53 (0.71, 3.29) |
|
| |||||
| % Statins at baseline | 1% | 0% | 1.5% | 0.54 | NA |
|
| |||||
| HCV parameters | |||||
|
| |||||
| Prior HALT-C status | 0.28 | ||||
| % Non-responder | 63% | 69% | 60% | 1.29 (0.67, 2.51) |
|
| % Breakthru/relapse | 11% | 7% | 13% | 0.57 (0.18, 1.79) |
|
| % Express | 26% | 24% | 27% | 1 Ref | |
|
| |||||
| Log HCV RNA (IU/ml) | |||||
|
| |||||
| % HCV genotype 1 | 93% | 97% | 90% | 0.086 | 3.78 (0.83, 17.24) |
|
| |||||
|
Laboratory
parameters |
|||||
|
| |||||
| Hemoglobin (g/dl) | 15.1 (1.4) | 14.8 (1.4) | 15.2 (1.4) | 0.068 | 0.83 (0.67, 1.01) |
|
| |||||
| Serum AST/ALT | 0.94 (0.3) | 1.03 (0.3) | 0.89 (0.3) | 0.0014 | 5.19 (1.87,14.27) |
|
| |||||
| Alk phos ratio (ULN) | 0.87 (0.4) | 0.92 (0.4) | 0.84 (0.4) | 0.189 | 1.65 (0.78, 3.50) |
|
| |||||
| Total bilirubin (mg/dl) | 0.97 (0.5) | 1.10 (0.5) | 0.90 (0.5) | 0.0065 | 2.25 (1.26, 4.04) |
|
| |||||
| INR | 0.0811 | ||||
| % > 1.0 | 60% | 68% | 55% | 1.69 (0.94, 3.06) |
|
| % ≤ 1.0 | 40% | 32% | 45% | ||
|
| |||||
| Albumin (g/dl) | 3.8 (0.5) | 3.7 (0.4) | 3.8 (0.5) | 0.0487 | 0.52 (0.27, 1.00) |
|
| |||||
| Platelets (103/ml) | 132.5 (60.7) | 107.8 (44.1) | 146.0 (64.3) | <0.0001 | 0.24 (0.12, 0.47) |
|
| |||||
| Total Bile acids (umol/L) |
22.4 (22) | 26.7 (23.7) | 20.2 (20.8) | 0.0524 | 1.01 (1.00, 1.03) |
|
| |||||
| HOMA-IR | 20.6 (29.8) | 25.8 (33.6) | 17.6 (27.2) | 0.116 | 1.01 (1.00, 1.02) |
|
| |||||
| Log HA (ng/ml) | 2.18 (0.5) | 2.37 (0.4) | 2.09 (0.5) | <0.0001 | 2.12 (1.47, 3.07) |
|
| |||||
| % Splenomegaly on ultrasound |
49% | 62% | 42% | 0.0062 | 2.28 (1.26, 4.12) |
|
| |||||
| Baseline Endoscopy | |||||
|
| |||||
| % Gastric varices | 10% | 29% | 3% | <0.0001 | 13.2 (4.17, 41.74) |
|
| |||||
| Esophageal varix size | 0.30 | ||||
| % Grade 1 | 76% | 70% | 79% | 1.03 (0.25, 4.14) |
|
| % Grade 2 | 19% | 25% | 16% | 1.80 (0.41, 8.03) |
|
| % Grade 3 | 5% | 5% | 5% | 1 Ref | |
|
| |||||
| Baseline Histology | |||||
|
| |||||
| % Cirrhosis (Ishak 5/6) |
64% | 78% | 56% | 0.0015 | 2.86 (1.50, 5.48) |
|
| |||||
| Mean HAI Baseline | 7.90 (2) | 8.07 (2.1) | 7.82 (2) | 0.39 | 1.06 (0.92, 1.23) |
|
| |||||
| % Hepatic steatosis ≥ 2 |
40% | 31% | 46% | 0.0420 | 0.54 (0.30, 0.98) |
|
| |||||
| % Mallory Bodies | 16% | 14% | 18% | 0.44 | 0.73 (0.33, 1.62) |
|
| |||||
| % Zone 3 fibrosis | 0.40 | ||||
|
| |||||
| 0 | 65% | 68% | 64% | 2.43 (0.66, 8.98) |
|
|
| |||||
| 1 | 27% | 28% | 26% | 2.50 (0.63, 9.88) |
|
|
| |||||
| 2 | 8% | 4% | 10% | 1 Ref | |
|
| |||||
| Randomized phase | |||||
|
| |||||
| % Peginterferon arm | 47% | 41% | 51% | 0.1584 | 0.66 (0.37, 1.17) |
|
| |||||
| % Clinical outcome | 27% | 49% | 15% | < 0.0001 |
5.50 (2.85, 10.61) |
|
| |||||
| % Two-point increase in Ishak fibrosis score |
40% | 69% | 32% | 0.0119 | 4.64 (1.40, 15.39) |
Data reported as mean + std dev or %
*
comparing de novo vs non-progressors