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Peginterferon alfa-2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 2 receiving haemodialysis: a randomised trial
  1. Chen-Hua Liu1,2,3,
  2. Chun-Jen Liu1,2,3,
  3. Chung-Feng Huang4,5,6,
  4. Jou-Wei Lin7,
  5. Chia-Yen Dai5,8,
  6. Cheng-Chao Liang9,
  7. Jee-Fu Huang5,8,
  8. Peir-Haur Hung10,
  9. Hung-Bin Tsai11,12,
  10. Meng-Kun Tsai13,
  11. Chih-Yuan Lee13,
  12. Shih-I Chen7,
  13. Sheng-Shun Yang14,
  14. Tung-Hung Su1,2,3,
  15. Hung-Chih Yang2,3,15,
  16. Pei-Jer Chen1,2,3,
  17. Ding-Shinn Chen1,2,3,16,
  18. Wan-Long Chuang5,8,
  19. Ming-Lung Yu5,8,
  20. Jia-Horng Kao1,2,3
  1. 1Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
  2. 2Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan
  3. 3Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan
  4. 4Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
  5. 5Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
  6. 6Department of Occupational Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan
  7. 7Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan
  8. 8Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
  9. 9Department of Internal Medicine, Far Eastern Memorial Hospital, Taipei, Taiwan
  10. 10Department of Internal Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chia-Yi, Taiwan
  11. 11Department of Traumatology, National Taiwan University Hospital, Taipei, Taiwan
  12. 12Department of Internal Medicine, Buddhist Tzu Chi General Hospital, Chia-Yi, Taiwan
  13. 13Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan
  14. 14Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan
  15. 15Department of Microbiology, National Taiwan University College of Medicine and National Taiwan University Hospital, Taipei, Taiwan
  16. 16Genomics Research Center, Academia Sinica, Taipei, Taiwan
  1. Correspondence to Professor Jia-Horng Kao, Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine and Hospital, 7 Chung-Shan South Road, Taipei 10002, Taiwan; kaojh{at}ntu.edu.tw

Abstract

Objective Data comparing the efficacy and safety of combination therapy with peginterferon plus low-dose ribavirin and peginterferon monotherapy in treatment-naive haemodialysis patients with hepatitis C virus genotype 2 (HCV-2) infection are limited.

Design In this randomised trial, 172 patients received 24 weeks of peginterferon alfa-2a 135 μg/week plus ribavirin 200 mg/day (n=86) or peginterferon alfa-2a 135 μg/week (n=86). The efficacy and safety endpoints were sustained virological response (SVR) rate and adverse event (AE)-related withdrawal rate.

Results Compared with monotherapy, combination therapy had a greater SVR rate (74% vs 44%, relative risk (RR): 1.68 [95% CI 1.29 to 2.20]; p<0.001). The beneficial effect of combination therapy was more pronounced in patients with baseline viral load ≥800 000 IU/mL than those with baseline viral load <800 000 IU/mL (RR: 3.08 [95% CI 1.80 to 5.29] vs RR: 1.11 [95% CI 0.83 to 1.45]; interaction p=0.001). Patients receiving combination therapy were more likely to have a haemoglobin level of <8.5 g/dL (70% vs 8%, risk difference (RD): 62% [95% CI 50% to 73%]; p<0.001) and required a higher dosage [mean: 13 417vs 6667 IU/week, p=0.027] of epoetin β to manage anaemia than those receiving monotherapy. The AE-related withdrawal rates were 6% and 3% in combination therapy and monotherapy groups, respectively (RD: 2% [95% CI −4% to 9%]).

Conclusions In treatment-naive haemodialysis patients with HCV-2 infection, combination therapy with peginterferon plus low-dose ribavirin achieved a greater SVR rate than peginterferon monotherapy. Most haemodialysis patients can tolerate combination therapy.

Trial registration number ClinicalTrial.gov number, NCT00491244.

  • HEPATITIS C

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