infliximab treatment along with pegylated interferon and ribavirin in the treatment of hepatitis c

Conditions: Hepatitis C

Summary: the aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic hcv infection

the aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic hcv infection (genotype 1) whether the addition of infliximab to a standard regimen of pegylated interferon α-2b in combination with ribavirin: * increases the proportion of subjects attaining a sustained virological response svr (undetectable blood hepatitis c viral load 6 months after treatment) * improves the safety profile compared to the same regimen without infliximab

Eligibility criteria:
inclusion criteria: * male or female subjects, \>18 years of age with proven chronic (greater than 6 months) hepatitis c infection (genotype 1) who have never been treated with pegylated interferon α-2b and /or ribavirin. criteria for inclusion in this trial are as follows: * male or female, 18 years of age or older * positive hcv rna, genotype 1, treatment naïve (never received pegylated interferon and / or ribavirin) * evidence of chronic hcv infection for at least six months prior to screening * findings on liver biopsy within the past 36 months that are consistent with the presence of chronic hepatitis c infection. * negative hepatitis b surface antigen * no evidence of hemochromatosis * hemoglobin ≥12 g/dl for females and ≥13 g/dl for males * wbc ≥3.0 x 109/l and neutrophils ≥1.5 x 109/l * platelets ≥80 x109/l * direct bilirubin wnl +/- 50% of central laboratory normal range. total bilirubin ≤1.6. * albumin within normal limits * serum creatinine within normal limits. * serum thyroid stimulating hormone (tsh) levels within normal limits * men and women of childbearing potential must use two forms of adequate birth control measures for the duration of the study and should continue such precautions for 6 months after receiving the last infusion. * subjects with a history of mild depression may be considered for entry into this study. * no history of latent or active tb. exclusion criteria: * women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion and men with partners who are pregnant at baseline or intend to become pregnant within 6 months after the last infusion. * known allergy against infliximab, ribavirin, or pegylated interferon * decompensated liver disease characterized as decreased hepatic synthetic functioning with abnormal albumin and bilirubin levels, prolonged prothrombin time or complications including ascites or recent variceal bleeding * have a history of latent or active granulomatous infection, including tb, histoplasmosis, or coccidiomycosis (valley fever) * history of autoimmune hepatitis or a history of poorly controlled autoimmune disease * use of other systemic anti-inflammatory medication except nsaids and low dose systemic steroids * previous treatment with monoclonal antibodies or antibody fragments * history of receiving human/murine recombinant products or a known allergy to murine products * documentation of seropositive for human immunodeficiency virus (hiv) * history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results * history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months * opportunistic infection within 6 months prior to screening * history of lymphoproliferative disease * currently have any known malignancy or have a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence * current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease * treatment with any other therapeutic agent targeted at reducing tnf within 3 months of screening * presence of a transplanted solid organ * concomitant diagnosis or history of congestive heart failure

Keywords: hepatitis hcv hepatitis c