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Pegylated Interferon Alfa-2a versus Standard Interferon Alfa-2a for Treatment-Naïve Dialysis Patients with Chronic Hepatitis C: A Randomized Study
  1. Chen-Hua Liu (jacque_liu{at}mail2000.com.tw)
  1. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
    1. Cheng-Chao Liang
    1. Department of Internal Medicine, Far Eastern Memorial Hospital, Taipei, Taiwan
      1. Jow-Wei Lin
      1. Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin County, Taiwan
        1. Shih-I Chen
        1. Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin County, Taiwan
          1. Hung-Bin Tsai
          1. Division of Nephrology, Department of Medical Affairs, St. Martin De Porres Hospital, Chia-Yi, Taiwan
            1. Chyi-Sen Chang
            1. Division of Nephrology, Department of Medical Affairs, St. Martin De Porres Hospital, Chia-Yi, Taiwan
              1. Peir-Haur Hung
              1. Department of Internal Medicine, Chiayi Christian Hospital, Chia-Yi, Taiwan
                1. Chun-Jun Liu
                1. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
                  1. Ming-Yang Lai
                  1. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
                    1. Jun-Herng Chen
                    1. Department of Pathology, National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin County, Taiwan
                      1. Pei-Jer Chen
                      1. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
                        1. Jia-Horng Kao (kaojh{at}ntu.edu.tw)
                        1. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
                          1. Ding-Shinn Chen
                          1. Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan

                            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)

                            • chronic hepatitis C
                            • dialysis
                            • pegylated interferon
                            • standard interferon

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