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. Author manuscript; available in PMC: 2011 Jun 1.
Published in final edited form as: Gastroenterology. 2010 Mar 6;138(7):2321–2331.e2. doi: 10.1053/j.gastro.2010.02.058

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