Table 1. Baseline Characteristics of Studied Patients a, b.
Group A | Group B | P value | |
Patients, No. | 199 | 81 | |
Gender | 0.1 | ||
Male, No. | 123 | 42 | |
Female, No. | 76 | 39 | |
Mean, % | 62 | 60 | |
Mean Age , Mean ± SD | 24 ± 5.5 | 25 ± 7.2 | 0.3 |
range | 11-43 | 12-54 | |
BMI c, Mean ± SD | 20.4 ± 0.2 | 20.2 ± 0.2 | |
range | 14-28 | 15-25 | |
ALT c (U/L) , Mean ± SD | 91 ± 56 | 79 ± 60 | 0.06 |
range | 12-994 | 15-338 | |
Normal (< 40 U/L), No. (%) | 35 (18) | 24 (30) | 0.02 |
Elevated, No. (%) | 164 (82) | 57 (70) | 0.02 |
AST c (U/L) , Mean ± SD | 77 ± 61 | 64 ± 41 | 0.08 |
range | 17-638 | 13-206 | |
Normal (< 40 U/L), No. (%) | 43 (22) | 29 (36) | 0.01 |
Elevated, No. (%) | 156 (78) | 62 (64) | 0.01 |
Hb c, Mean ± SD | 10 ± 1.5 | 9.5 ± 1.3 | 0.4 |
HCV c viral load d (IU/mL) , Mean ± SD | 800000 ± 11000 | 799000 ± 88000 | |
range | 2000-8000000 | 7540-4090000 | |
Log10 Serum HCV Viral Load (IU/mL) , Mean ± SD | 5.5 ± 0.7 | 5.5 ± 0.6 | 0.5 |
> 6 (copy/ml), No. (%) | 85 (43) | 31 (38) | |
Serum ferritin (ng/mL) , Mean ± SD | 2130 ± 1777 | 1710 ± 1498 | 0.06 |
range | 210-8132 | 300-6650 | |
History of Splenectomy, y, No.(%) | |||
Yes/No | 135/64 (68) | 49/32 (60) | 0.2 |
HCV Type | |||
Genotype 1, No. (%) | 119 (60) | 41 (51) | 0.1 |
Genotype 2, No. (%) | 1 (0.5) | 2 (2.5) | 0.1 |
Genotype 3, No. (%) | 65 (33) | 33 (41) | 0.1 |
Mixed infection, No. (%) | 10 (5) | 2 (2.5) | 0.1 |
Untypable, No. (%) | 4 (2) | 3 (4) | 0.1 |
Stage of liver fibrosis , Mean ± SD | 3.2 ± 1.6 | 3.3 ± 1.4 | 0.5 |
0-2, No. (%) | 50 (31) | 16 (20) | 0.3 |
3-4, No. (%) | 69 (43) | 37 (53) | 0.3 |
5-6, No. (%) | 41 (26) | 17 (24) | 0.3 |
Grade of liver inflammation , Mean ± SD | 6.3 ± 0.2 | 6.3 ± 0.4 | 0.9 |
0-6, No. (%) | 92 (59) | 43 (63) | 0.7 |
7-12, No. (%) | 58 (37) | 23 (34) | 0.7 |
13-18, No. (%) | 7 (4.5) | 2 (3) | 0.7 |
Stage of liver sidrosis , Mean ± SD | 3 ± 1 | 2.9 ± 1 | |
0-2 | 37 (19) | 16 (20) | 0.2 |
3-4 | 118 (59) | 34 (42) | 0.2 |
Previous treatment | 136 (68) | 38 (47) | 0.001 |
Naïve | 61 (31) | 43 (53) | 0.0006 |
Standard IFN c | 62 (31) | 24 (30) | 0.8 |
Standard IFN + RVB c | 74 (37) | 14 (17) | 0.001 |
a Except for liver enzymes and serum ferritin there were no significant differences among the two treatment groups with regard to baseline characteristics.
b Percutaneous liver-biopsy specimens obtained before treatment were evaluated according to modified knodell score scaling system. The modified knodell scoring system classifies fibrosis according to a 6-point scale: 0, no fibrosis; 1, Fibrous expansion of some portal areas; 2, Fibrous expansion of most portal areas; 3, Fibrous expansion of most portal areas with occasional portal to portal bridging; 4, Fibrous expansion of portal areas with marked bridging of portal to portal as well as portal to central; 5, Marked bridging with occasional nodules; 6, Cirrhosis.
c Abbreviations: ALT, denotes alanine aminotransferase; AST, aspartat aminotransferase; BMI, body mass index; Hb, hemoglobin; HCV, hepatitis C virus; IFN, interferon; RVB, ribavirin
d Hepatitis C virus level was determined with the use of the amplicor assay version II (Roche), for which the lower limit of quantitation is 50 IU per milliliter.