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: A total of 50 such patients were randomly assigned to receive either pegylated interferon alfa-2a 135 μg subcutaneously once per week or standard interferon alfa-2a 3 million units subcutaneously thrice per week for 24 weeks. The primary efficacy and safety end points were sustained virologic response (SVR) by intention-to-treat analysis and treatment-related withdrawal rate during the study.
Results: In univariate analysis, patients with pegylated interferon alfa-2a tended to have a higher SVR than those with standard interferon alfa-2a (48% vs. 20%, p = 0.07). By using multivariate analysis, treatment with pegylated interferon alfa-2a (p = 0.02) and pre-treatment HCV RNA level < 800,000 IU/ml (p = 0.007) were independently predictive of SVR. All patients failing to achieve rapid virologic response (RVR) could not achieve SVR. In addition, patients receiving pegylated interferon alfa-2a had a significantly lower treatment-related withdrawal rate than those receiving standard interferon alfa-2a (0% vs. 20%, p = 0.04).
Conclusions: Pegylated interferon alfa-2a once weekly provides more effective and safer therapy than standard interferon alfa-2a thrice weekly for treatment-naïve dialysis patients with chronic hepatitis C. (ClinicalTrials.gov number, NCT00172809)
- chronic hepatitis C
- pegylated interferon
- standard interferon