Pretreatment baseline characteristics of the 462 HALT-C Trial patients
| Characteristic | All patients, N=462 | With clinical progression, n=69 | Without clinical progression, n=393 | p Value* | HR (95% CI) | ||
| Demographics | |||||||
| Age (years) | 49.5 (6.95) | 50.0 (6.58) | 49.5 (7.02) | 0.78 | 1.05 (0.75 to 1.47)† | ||
| % Male | 70.3% | 72.5% | 70% | 0.74 | 1.09 (0.65 to 1.86) | ||
| Race | 0.63 | ||||||
| % Hispanic | 3.7% | 1.4% | 4.1% | 0.40 (0.06 to 2.87) | |||
| % Black | 23.8% | 23.2% | 23.9% | 0.90 (0.52 to 1.58) | |||
| % Caucasian | 72.5% | 75.4% | 72% | Ref | |||
| Co-morbidities | |||||||
| % Diabetes mellitus | 27.9% | 42% | 25.4% | 0.0042 | 2.01 (1.25 to 3.24) | ||
| BMI (kg/m2) | 29.9 (5.55) | 29.9 (5.48) | 30 (5.57) | 0.97 | 1.00 (0.80 to 1.25)‡ | ||
| % Truncal obesity | 51.1% | 48.5% | 51.6% | 0.64 | 0.89 (0.55 to 1.43) | ||
| % Current smoker | 31.1% | 36.2% | 30.2% | 0.19 | 1.39 (0.85 to 2.27) | ||
| Total lifetime drinks | 18514 (28053) | 19097 (23846) | 18412 (28757) | 0.66 | 1.02 (0.93 to 1.12)§ | ||
| HCV parameters | |||||||
| Prior HALT-C status | 0.114 | 0.90 (0.53 to 1.53) | |||||
| % Non-responder | 62.3% | 66.7% | 61.6% | ||||
| % Breakthrough/relapse | 13.6% | 5.8% | 15% | 0.32 (0.11 to 0.95) | |||
| % Expressor | 24% | 27.5% | 23.4% | Ref | |||
| Log HCV RNA (IU/ml) | 6.46 (0.51) | 6.24 (0.45) | 6.5 (0.51) | <0.0001 | 0.46 (0.32 to 0.66) | ||
| % HCV genotype 1 | 93.9% | 95.7% | 93.6% | 0.74 | 1.21 (0.38 to 3.86) | ||
| % Peginterferon arm | 49.4% | 52.2% | 48.9% | 0.62 | 1.13 (0.70 to 1.81) | ||
| Laboratory parameters | |||||||
| Serum AST/ALT | 0.90 (0.28) | 1.09 (0.33) | 0.86 (0.26) | <0.0001 | 6.54 (3.63 to 11.77) | ||
| Alkaline phoshatase ratio (ULN) | 0.91 (0.46) | 1.14 (0.55) | 0.87 (0.43) | <0.0001 | 2.14 (1.55 to 2.96) | ||
| Total bilirubin (mg/dl) | 0.74 (0.37) | 0.90 (0.48) | 0.71 (0.35) | <0.0001 | 2.68 (1.64 to 4.38) | ||
| INR (% >1) | 33.1% | 63.8% | 27.7% | <0.0001 | 0.24 (0.15 to 0.40) | ||
| Albumin (g/dl) | 3.83 (0.37) | 3.53 (0.41) | 3.88 (0.33) | <0.0001 | 0.091 (0.05 to 0.16) | ||
| Serum creatinine (mg/dl) | 0.84 (0.16) | 0.84 (0.18) | 0.84 (0.16) | 0.91 | 0.92 (0.20 to 4.16) | ||
| Platelets (109/l) | 170.6 (67.5) | 131.1 (70) | 177.6 (64.7) | <0.0001 | 0.98 (0.98 to 0.99) | ||
| Log YKL-40 (μg/l) | 2.45 (0.41) | 2.69 (0.38) | 2.40 (0.40) | <0.0001 | 4.82 (2.69 to 8.63) | ||
| PIIINP (μg/l) | 6.19 (2.64) | 7.36 (2.94) | 5.99 (2.53) | <0.0001 | 1.16 (1.08 to 1.24) | ||
| TIMP-1 (ng/ml) | 237.34 (65.7) | 267.28 (79.4) | 232.01 (61.6) | <0.0001 | 1.08 (1.04 to 1.11)¶ | ||
| Log HA (ng/ml) | 1.96 (0.43) | 2.23 (0.46) | 1.91 (0.41) | <0.0001 | 4.79 (2.82 to 8.13) | ||
| % Cirrhosis (Ishak 5/6) | 39.4% | 72.5% | 33.6% | <0.0001 | 4.48 (2.64 to 7.61) | ||
| % Hepatic steatosis ≥2 | 44.2% | 46.4% | 43.8% | 0.65 | 1.12 (0.70 to 1.79) | ||
Data reported as mean ± SD (in parentheses) or %.
↵* Comparing clinical progressors vs non-progressors.
↵† HR for age is per 10 years.
↵‡ HR for BMI is per 5 kg/m2.
↵§ HR for lifetime drinks is for a change of 10 000 units.
↵¶ HR for TIMP-1 is for every 10 ng/ml.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; HA, hyaluronic acid; HCV, hepaptits C virus; INR, international normalised ratio; PIIINP, N-terminal peptide of procollagen type 3; TIMP-1, tissue inhibitor of matrix metalloproteinase-1; ULN, upper limit of normal.