Hepatitis

Pegylated interferon -2a versus standard interferon -2a for treatment-naïve dialysis patients with chronic hepatitis C: a randomised study

C-H Liu¹, C-C Liang², J-W Lin³, S-I Chen³, H-B Tsai⁴, C-S Chang⁴, P-H Hung⁵, J-H Kao⁶, C-J Liu^1,7, M-Y Lai¹, J-H Chen⁸, P-J Chen^1,6,7, J-H Kao^1,6,7, D-S Chen¹

¹ Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
² Department of Internal Medicine, Far Eastern Memorial Hospital, Taipei, Taiwan
³ Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin County, Taiwan
⁴ Division of Nephrology, Department of Medical Affairs, St. Martin De Porres Hospital, Chia-Yi, Taiwan
⁵ Department of Internal Medicine, Chiayi Christian Hospital, Chia-Yi, Taiwan
⁶ Departments of Medical Research, National Taiwan University Hospital, Taipei, Taiwan
⁷ Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan
⁸ Department of Pathology, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin County, Taiwan

Professor J-H Kao, Hepatitis Research Center, National Taiwan University Hospital, 7 Chung-Shan South Road, Taipei 100, Taiwan; kaojh{at}ntu.edu.tw

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 -2a 135 µg subcutaneously once per week or standard interferon -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 -2a tended to have a higher sustained virological response (SVR) than those receiving standard interferon -2a (48% vs 20%, p = 0.07). By using multivariate analysis, treatment with pegylated interferon -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 -2a had a significantly lower treatment-related withdrawal rate than those receiving standard interferon -2a (0% vs 20%, p = 0.04).

Conclusions: Pegylated interferon -2a once weekly provides more effective and safer therapy than standard interferon -2a thrice weekly for treatment-naïve dialysis patients with chronic hepatitis C.

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