Table 1 Characteristics of the study population 1 (standard IFN therapy, n=37)
| Â | Â | Group 1-A with intake of Aminofeel | Â | Group 1-B without intake of Aminofeel | Â | P value |
|---|---|---|---|---|---|---|
No. subjects | n | 24 | Â | 13 | Â | Â |
Sex | male/female | 9/15 | Â | 6/7 | Â | NS |
Age | (mean ± SD), years | 62.3 ± 5.5 |  | 57.5 ± 12.6 |  | NS |
Age range | years | 50 - 74 | Â | 26 - 75 | Â | Â |
IFN therapy for the first time/retreatment | n | 14/10 | Â | 9/4 | Â | NS |
Liver diseases | CH-C | 16 | 66.7% | 11 | 84.6% | NS |
| Â | CH-C & CH-B | 1 | 4.2% | 1 | 7.7% | NS |
| Â | CH-C & post HCV-related HCC | 2 | 8.3% | 0 | 0.0% | NS |
| Â | LC-C | 1 | 4.2% | 0 | 0.0% | NS |
| Â | LC-C & post HCV-related HCC | 4 | 16.7% | 1 | 7.7% | NS |
Liver diseases | Only CH | 17 | 70.8% | 12 | 92.3% | NS |
| Â | LC or post HCC treatment | 7 | 29.2% | 1 | 7.7% | NS |
HCV genotype | 1b | 19 | 79.2% | 9 | 69.2% | NS |
| Â | 2a | 3 | 12.5% | 4 | 30.8% | NS |
| Â | 2b | 2 | 8.3% | 0 | 0.0% | NS |
HCV RNA level | High | 20 | 83.3% | 11 | 84.6% | NS |
| Â | Low | 4 | 16.7% | 2 | 15.4% | NS |
Genotype·HCV RNA level | 1b·High | 17 | 70.8% | 9 | 69.2% | NS |
| Â | others | 7 | 29.2% | 4 | 30.8% | NS |
Extrahepatic manifestations | Diabetes millitus (positive %) | 8 | 33.3% | 4 | 30.8% | NS |
| Â | Hypertensiton (positive %) | 6 | 25.0% | 2 | 15.4% | NS |
| Â | Hyperlipidemia (positive %) | 2 | 8.3% | 0 | 0.0% | NS |
| Â | Oral lichen planus (positive %) | 0 | 0.0% | 1 | 7.7% | NS |
| Â | Hyperthyroidism (positive %) | 0 | 0.0% | 1 | 7.7% | NS |
| Â | Hypothyroidism (positive %) | 3 | 12.5% | 1 | 7.7% | NS |
Total of Aminofeel intake (g) | mean ± SD | 1000.0 ± 673.0 |  | 0 |  | <0.0001 |
BMI | mean ± SD | 23.3 ± 3.8 |  | 22.0 ± 1.7 |  | NS |
Obesity (BMI ≥25 kg/m2) | n (%) | 7 | 29.2% | 0 | 0.0% | 0.04 |
RBC (×104/μL) | mean ± SD | 438.8 ± 45.9 |  | 450.2 ± 41.7 |  | NS |
Hb (g/dL) | mean ± SD | 13.7 ± 1.2 |  | 14.1 ± 1.5 |  | NS |
PLT (×104/μL) | mean ± SD | 13.3 ± 4.1 |  | 15.5 ± 7.0 |  | NS |
WBC (μL) | mean ± SD | 4412.5 ± 1348.9 |  | 4853.8 ± 1066.6 |  | NS |
PT (%) | mean ± SD | 86.5 ± 17.9 |  | 92.8 ± 6.4 |  | NS |
AST (U/I) | mean ± SD | 59.6 ± 25.9 |  | 57.6 ± 36.5 |  | NS |
ALT (U/I) | mean ± SD | 64.7 ± 46.9 |  | 73.2 ± 59.2 |  | NS |
LDH (U/I) | mean ± SD | 208.9 ± 42.0 |  | 199.5 ± 54.1 |  | NS |
gamma GTP (U/I) | mean ± SD | 38.4 ± 19.5 |  | 41.8 ± 33.1 |  | NS |
ChE (U/I) | mean ± SD | 206.4 ± 87.1 |  | 262.8 ± 71.1 |  | NS |
TP (g/dL) | mean ± SD | 7.7 ± 0.5 |  | 7.6 ± 0.4 |  | NS |
Alb (g/dL) | mean ± SD | 4.00 ± 0.5 |  | 4.17 ± 0.2 |  | NS |
T.Bil (mg/dL) | mean ± SD | 1.0 ± 0.3 |  | 0.8 ± 0.2 |  | NS |
FBS (mg/dL) | mean ± SD | 117.5 ± 43.7 |  | 99.7 ± 14.9 |  | NS |
HbA1c (%) | mean ± SD | 5.4 ± 0.7 |  | 5.7 ± 1.0 |  | NS |
TC (mg/dL) | mean ± SD | 167.9 ± 26.6 |  | 170.4 ± 13.4 |  | NS |
AFP (ng/dL) | mean ± SD | 8.1 ± 11.5 |  | 5.5 ± 3.0 |  | NS |
IRI (μU/mL) | mean ± SD | 31.3 ± 35.6 |  | 13.2 ± 7.1 |  | NS |
HOMA-beta |  | 216.2 ± 11.9 |  | 203.8 ± 258.8 |  | NS |
HOMA-IR |  | 11.9 ± 21.4 |  | 3.3 ± 2.0 |  | NS |
Zn (μg/dL) | mean ± SD | 68.1 ± 11.5 |  | 73.9 ± 11.4 |  | NS |
Course of IFN therapy | Peg-IFN alpha 2b/RBV | 21 | 87.5% | 8 | 61.5% | Â |
| Â | Peg-IFN alpha 2a/RBV | 0 | 0.0% | 1 | 7.7% | Â |
| Â | Peg-IFN alpha 2a monotherapy | 0 | 0.0% | 3 | 23.1% | Â |
| Â | Peg-IFN alpha 2a monotherapy - (change) - Peg-IFN alpha 2a/RBV | 0 | 0.0% | 1 | 7.7% | Â |
| Â | Peg-IFN alpha 2a monotherapy - (change) - IFN beta | 1 | 4.2% | 0 | 0.0% | Â |
| Â | Peg-IFN alpha 2b/RBV - (change) - Peg-IFN alpha 2a monotherapy - (change) - Peg-IFN alpha 2b/RBV | 1 | 4.2% | 0 | 0.0% | Â |
| Â | IFN alpha | 1 | 4.2% | 0 | 0.0% | Â |
Continuation of IFN therapy | Successful continuation | 20 | 83.3% | 7 | 53.8% | 0.05 |
| Â | Discontinuation | 4 | 16.7% | 6 | 46.2% | 0.05 |
Effect of IFN therapy | SVR | 12 | 50.0% | 9 | 69.2% | NS |
| Â | Non-SVR | 12 | 50.0% | 4 | 30.8% | NS |