Table 1.
Baseline characteristics of the 456 HALT-C Lead-in patients enrolled in serum fibrosis marker study
| Parameter | Total patients | Wk 20 Complete responder | Wk 20 Partial responder | Wk 20 Non-responder | P value (across 3 groups) |
|---|---|---|---|---|---|
| n | 456 | 169 | 143 | 144 | |
| Age (yrs) | 49.2 + 7.1 | 47.9 + 5.9 | 50.5 + 8.0 | 49.4 + 7.1 | 0.07 |
| Male | 71% | 75% | 73% | 65% | 0.0424 |
| White (non-hispanic) Black or Black + hispanic Hispanic |
74% 20% 4% |
86% 7% 5% |
74% 20% 3% |
60% 36% 3% |
< 0.0001 |
| Lifetime alcohol (drinks) | 17,440 + 27,778 | 18, 173 + 23,813 | 14,576 + 17,620 | 19,434 + 38,275 | 0.72 |
| Lifetime smoking (pack-yrs) | 15 + 17 | 16 + 17 | 16 + 18 | 13 + 16 | 0.19 |
| Diabetes | 26% | 19% | 24% | 35% | 0.001 |
| BMI > 30 kg/m2 | 41% | 41% | 42% | 39% | 0.75 |
| Prior IFN + rib | 68% | 59% | 76% | 71% | 0.0105 |
| Log HCV RNA (IU/ml) | 6.44 + 0.54 | 6.41 + 0.63 | 6.53 + 0.43 | 6.39 + 0.51 | 0.83 |
| Genotype 1 | 89% | 78% | 94% | 97% | < 0.0001 |
| AST (U/l) | 93 + 70 | 96 + 90 | 85 + 52 | 99 + 58 | 0.77 |
| ALT (U/l) | 115 + 81 | 130 + 103 | 104 + 63 | 107 + 63 | 0.0056 |
| AST/ALT ratio | 0.85 + 0.27 | 0.75 + 0.24 | 0.86 + 0.27 | 0.97 + 0.27 | < 0.0001 |
| Alk phosphatase (x ULN) | 0.87 + 0.41 | 0.77 + 0.3 | 0.87 + 0.4 | 0.98 + 0.5 | < 0.0001 |
| Total bilirubin (mg/dl) | 0.77 + 0.43 | 0.77 + 0.43 | 0.74 + 0.39 | 0.79 + 0.46 | 0.80 |
| INR | 1.03 + 0.1 | 1.03 + 0.1 | 1.03 + 0.1 | 1.04 + 0.1 | 0.23 |
| Albumin (g/dl) | 3.87 + 0.36 | 3.98 + 0.31 | 3.88 + 0.37 | 3.72 + 0.37 | < 0.0001 |
| Platelets (1000/mm3) | 174 + 66 | 180 + 59 | 179 + 74 | 162 + 63 | 0..0272 |
| APRI | 1.6 + 1.8 | 1.5 + 2.2 | 1.5 +1.4 | 1.8 + 1.6 | 0.16 |
| Log YKL-40 (ug/l) | 2.39 + 0.44 | 2.20 + 0.38 | 2.46 + 0.44 | 2.55 + 0.43 | < 0.0001 |
| Log HA (ng/ml) | 1.93 + 0.47 | 1.79 + 0.45 | 1.97 + 0.45 | 2.06 + 0.48 | < 0.0001 |
| Serum PIIINP (ug/l) | 6.14 + 2.73 | 5.45 + 2.43 | 6.28 + 2.66 | 6.81 + 2.97 | < 0.0001 |
| Serum TIMP-1 (ng/ml) | 237.9 + 71.0 | 221.2 + 63.9 | 239.0 + 65.0 | 256.7 + 79.8 | < 0.0001 |
| Algorithm score* | −0.7 + 1.39 | −1.13 + 1.22 | −0.68 + 1.33 | −0.24 + 1.5 | < 0.0001 |
| Mean Ishak fibrosis score | 4.0 + 1.2 | 3.8 + 1.2 | 4.1 + 1.2 | 4.2 + 1.3 | 0.0013 |
| Ishak 5/6 (cirrhosis) | 37% | 27% | 40% | 45% | 0.0010 |
| Took > 80% Peg and rib to wk 20 | 59% | 68% | 57% | 50% | 0.0011 |
*
consists of HA, TIMP-1, and platelets per baseline paper (ref 8).
All results reported as mean +/− standard deviation.