Brief Article
Copyright ©2013 Baishideng Publishing Group Co.
World J Gastroenterol. May 7, 2013; 19(17): 2691-2696
Published online May 7, 2013. doi: 10.3748/wjg.v19.i17.2691
Table 1 Inclusion criteria and exclusion criteria
Inclusion criteria
Age ≥ 18 yr and ≤ 60 yr
Positive HCV antibodies and detectable HCV RNA by PCR
Positive liver biopsy for chronic hepatitis with F1 METAVIR score and elevated liver enzymes or F2/F3 METAVIR score
Naïve to treatment with PEG-IFN and RIB
Hepatitis B surface antigen negativity
Normal complete blood count, normal thyroid function, prothrombin concentration ≥ 60%, normal bilirubin, α-fetoprotein < 100 (ng/mL) and antinuclear antibody titer < 1/160
Exclusion criteria
Serious co-morbid conditions such as severe arterial hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes (hemoglobin A1C > 8.5%), chronic obstructive pulmonary disease
Major uncontrolled depressive illness
Solid transplant organ (renal, heart, or lung)
Untreated thyroid disease
History of previous anti-HCV therapy
Body mass index (BMI) > 35 kg/m²
Known human immunodeficiency virus (HIV) coinfection
Hypersensitivity to one of the two drugs (PEG-IFN, RIB)
Concomitant liver disease other than hepatitis C (chronic hepatitis B, autoimmune hepatitis, alcoholic liver disease, hemochromatosis, α-1 antitrypsin deficiency, Wilson’s disease)
Liver biopsy showing severe steatosis (> 66%) and steatohepatitis, decompensated cirrhosis, hepatocellular carcinoma or METAVIR score F4
Table 2 Necroinflammatory activity and fibrosis staging scale
Feature
Grade A0No histologic necroinflammatory activity
Grade A1Mild activity
Grade A2Moderate activity
Grade A3Severe activity
Stage F0No fibrosis
Stage F1Portal fibrosis without septa
Stage F2Portal fibrosis with rare septa
Stage F3Numerous septa without cirrhosis
Stage F4Cirrhosis
Table 3 Baseline characteristics
Schisto + ve (n = 983)Schisto - ve (n = 2613)P value
Age42.59 ± 9.2141.62 ± 9.810.008
Albumin (ref.: 3.5-5.5 mg/dL)4.20 ± 0.474.20 ± 0.470.251
AST (ref.: 40 IU/L)55.91 ± 33.9157.07 ± 46.000.412
ALT (ref.: 40 IU/L)63.19 ± 41.6863.38 ± 43.300.908
HCV RNA, IU/mL1.4 × 106± 6.9 × 1069.5 × 105± 7 × 1060.083
BMI28.12 ± 4.0928.27 ± 4.40.387
Male/female5.3/13.88/10.002
Table 4 Virological response at weeks 12, 24, 48 in relation to schistosomal serology n (%)
Anti-schisto antibody
P value
NegativePositiveTotal
(n = 2613)(n = 983)(n = 3596)
Responders at week 12 (EVR)2335 (89.4)850 (86.5)3185 (88.6)0.015
Responders at week 241768 (67.7)626 (63.7)2394 (66.6)0.024
Responders at week 48 (ETR)1621 (62.0)581 (59.1)2202 (61.2)0.108
Table 5 Multivariate logistic regression analysis in which the failure of treatment is the dependent variable at weeks 48 and 72
FactorsORP value95%CI
LowerUpper
Week 48
Age of > 50 yr1.150.2450.911.50
Female0.650.0000.510.80
Viremia, > 600 × 103 IU/mL1.780.0001.412.30
IFNα2b1.210.0501.011.50
Activity, A2, A30.680.0010.540.90
Fibrosis, > F21.690.0001.352.10
BMI, > 30 kg/m20.860.0090.760.96
Positive schisto status1.290.0151.101.60
Week 72
Age of > 50 yr1.00.9900.71.3
Female0.70.0060.50.9
Viremia, > 600 × 103 IU/mL1.60.0011.22.2
Activity, A2, A30.5< 0.010.40.7
Fibrosis, > F21.9< 0.011.52.5
Positive schisto status1.7< 0.011.32.1