Table 1.
Characteristics of the study population 1 (standard IFN therapy, n=37)
| Group 1-A with intake of Aminofeel | Group 1-B without intake of Aminofeel | P value | ||||
|---|---|---|---|---|---|---|
| No. subjects |
n |
24 |
|
13 |
|
|
| Sex |
male/female |
9/15 |
|
6/7 |
|
NS |
| Age |
(mean ± SD), years |
62.3 ± 5.5 |
|
57.5 ± 12.6 |
|
NS |
| Age range |
years |
50 - 74 |
|
26 - 75 |
|
|
| IFN therapy for the first time/retreatment |
n |
14/10 |
|
9/4 |
|
NS |
| Liver diseases |
CH-C |
16 |
66.7% |
11 |
84.6% |
NS |
| |
CH-C & CH-B |
1 |
4.2% |
1 |
7.7% |
NS |
| |
CH-C & post HCV-related HCC |
2 |
8.3% |
0 |
0.0% |
NS |
| |
LC-C |
1 |
4.2% |
0 |
0.0% |
NS |
| |
LC-C & post HCV-related HCC |
4 |
16.7% |
1 |
7.7% |
NS |
| Liver diseases |
Only CH |
17 |
70.8% |
12 |
92.3% |
NS |
| |
LC or post HCC treatment |
7 |
29.2% |
1 |
7.7% |
NS |
| HCV genotype |
1b |
19 |
79.2% |
9 |
69.2% |
NS |
| |
2a |
3 |
12.5% |
4 |
30.8% |
NS |
| |
2b |
2 |
8.3% |
0 |
0.0% |
NS |
| HCV RNA level |
High |
20 |
83.3% |
11 |
84.6% |
NS |
| |
Low |
4 |
16.7% |
2 |
15.4% |
NS |
| Genotype·HCV RNA level |
1b·High |
17 |
70.8% |
9 |
69.2% |
NS |
| |
others |
7 |
29.2% |
4 |
30.8% |
NS |
| Extrahepatic manifestations |
Diabetes millitus (positive %) |
8 |
33.3% |
4 |
30.8% |
NS |
| |
Hypertensiton (positive %) |
6 |
25.0% |
2 |
15.4% |
NS |
| |
Hyperlipidemia (positive %) |
2 |
8.3% |
0 |
0.0% |
NS |
| |
Oral lichen planus (positive %) |
0 |
0.0% |
1 |
7.7% |
NS |
| |
Hyperthyroidism (positive %) |
0 |
0.0% |
1 |
7.7% |
NS |
| |
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% |
|
| |
Peg-IFN alpha 2a/RBV |
0 |
0.0% |
1 |
7.7% |
|
| |
Peg-IFN alpha 2a monotherapy |
0 |
0.0% |
3 |
23.1% |
|
| |
Peg-IFN alpha 2a monotherapy - (change) - Peg-IFN alpha 2a/RBV |
0 |
0.0% |
1 |
7.7% |
|
| |
Peg-IFN alpha 2a monotherapy - (change) - IFN beta |
1 |
4.2% |
0 |
0.0% |
|
| |
Peg-IFN alpha 2b/RBV - (change) - Peg-IFN alpha 2a monotherapy - (change) - Peg-IFN alpha 2b/RBV |
1 |
4.2% |
0 |
0.0% |
|
| |
IFN alpha |
1 |
4.2% |
0 |
0.0% |
|
| Continuation of IFN therapy |
Successful continuation |
20 |
83.3% |
7 |
53.8% |
0.05 |
| |
Discontinuation |
4 |
16.7% |
6 |
46.2% |
0.05 |
| Effect of IFN therapy |
SVR |
12 |
50.0% |
9 |
69.2% |
NS |
| Non-SVR | 12 | 50.0% | 4 | 30.8% | NS |
HCV, hepatitis C virus; CH-C, chronic hepatitis C; CH-B, chronic hepatitis B; LC-C, liver cirrhosis type C; HCC, hepatocellular carcinoma; RBC, red blood cell; Hb, hemoglobin; PLT, platelets; WBC, white blood cell; PT, prothrombin time; AST, aspartate aminotransferase; ALT, alanine aminotransferase; LDH, lactate dehydrogenase; gamma GTP, gamma-glutamyltransferase; ChE, cholinesterase; TP, total protein; Alb, albumin; T.Bil, total bilirubin; FBS, fasting blood glucose; TC, total; cholesterol; IRI, immunoreactive insulin; Zn, zinc; SVR, sustained virological response; NS, not significant; IFN, interferon; RBV, ribavirin.