Pegylated Interferon Alfa-2a versus Standard Interferon Alfa-2a for Treatment-Naïve Dialysis Patients with Chronic Hepatitis C: A Randomized Study

Chen-Hua Liu ¹, Cheng-Chao Liang ², Jow-Wei Lin ³, Shih-I Chen ³, Hung-Bin Tsai ⁴, Chyi-Sen Chang ⁴, Peir-Haur Hung ⁵, Chun-Jun Liu ¹, Ming-Yang Lai ¹, Jun-Herng Chen ⁶, Pei-Jer Chen ¹, Jia-Horng Kao ^1* and Ding-Shinn Chen ¹

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 Department of Pathology, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin County, Taiwan

^* To whom correspondence should be addressed. E-mail: kaojh{at}ntu.edu.tw.

Accepted 28 August 2007

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: 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)

Keywords: chronic hepatitis C, dialysis, pegylated interferon, standard interferon

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