Pegylated interferon α-2a versus standard interferon α-2a for treatment-naïve dialysis patients with chronic hepatitis C: A randomised study
Journal
Gut
Journal Volume
57
Journal Issue
4
Pages
525-530
Date Issued
2008
Author(s)
Liang C.-C.
Chen S.-I.
Tsai H.-B.
Chang C.-S.
Hung P.-H.
Lai M.-Y.
Chen J.-H.
Abstract
Background: Chronic hepatitis C virus (HCV) infection is prevalent in dialysis patients, and standard interferon monotherapy is the current standard of care for such patients. Aim: To investigate whether pegylated interferon has a better therapeutic efficacy and safety profile than standard interferon in dialysis patients with chronic hepatitis C. Methods: 50 such patients were randomly assigned to receive either pegylated interferon α-2a 135 μg subcutaneously once per week or standard interferon α-2a 3 million units subcutaneously thrice per week for 24 weeks. The primary efficacy and safety end points were sustained virological response (SVR) by intention-to-treat analysis and treatment-related withdrawal rate during the study. Results: In univariate analysis, patients receiving pegylated interferon α-2a tended to have a higher sustained virological response (SVR) than those receiving standard interferon α-2a (48% vs 20%, p = 0.07). By using multivariate analysis, treatment with pegylated interferon α-2a (p = 0.02) and pretreatment HCV RNA level <800 000 IU/ml (p = 0.007) were independently predictive of an SVR. All patients failing to achieve a rapid virological response (RVR) could not achieve an SVR. In addition, patients receiving pegylated interferon α-2a had a significantly lower treatment-related withdrawal rate than those receiving standard interferon α-2a (0% vs 20%, p = 0.04). Conclusions: Pegylated interferon α-2a once weekly provides more effective and safer therapy than standard interferon α-2a thrice weekly for treatment-na?ve dialysis patients with chronic hepatitis C.
SDGs
Other Subjects
alpha2a interferon; peginterferon alpha2a; recombinant alpha2a interferon; alpha2a interferon; macrogol derivative; peginterferon alfa-2a; peginterferon alpha2a; unclassified drug; adult; alopecia; anorexia; article; clinical article; clinical trial; constipation; controlled clinical trial; controlled study; coughing; depression; dermatitis; diarrhea; dizziness; drug efficacy; drug fatality; drug safety; drug withdrawal; fatigue; female; fever; headache; hemodialysis patient; hepatitis C; human; injection site reaction; insomnia; irritability; leukopenia; male; monotherapy; multicenter study; multivariate analysis; myalgia; neutropenia; priority journal; randomized controlled trial; retina hemorrhage; rigor; side effect; thrombocytopenia; treatment outcome; univariate analysis; vomiting; comparative study; drug administration; middle aged; pathology; renal replacement therapy; virology; virus load; Adult; Drug Administration Schedule; Female; Hepatitis C, Chronic; Humans; Interferon Alfa-2a; Male; Middle Aged; Polyethylene Glycols; Renal Dialysis; Treatment Outcome; Viral Load
Publisher
BMJ Publishing Group
Type
journal article