Chen-Hua Liu, MD; Chung-Feng Huang, MD; Chun-Jen Liu, MD, PhD; Chia-Yen Dai, MD, PhD; Cheng-Chao Liang, MD, MS; Jee-Fu Huang, MD, PhD; Peir-Haur Hung, MD; Hung-Bin Tsai, MD; Meng-Kun Tsai, MD; Shih-I Chen, MD; Jou-Wei Lin, MD, PhD; Sheng-Shun Yang, MD, PhD; Tung-Hung Su, MD; Hung-Chih Yang, MD, PhD; Pei-Jer Chen, MD, PhD; Ding-Shinn Chen, MD; Wan-Long Chuang, MD, PhD; Ming-Lung Yu, MD, PhD; Jia-Horng Kao, MD, PhD
Acknowledgment: The authors thank the nurses and patients involved in the study; Ching-Chuan Chen for central block randomization management; Hui-Ju Lin, Yu-Lin Tan, and Po-Chung Liu for clinical data management; Wan-Ting Yang for host genetic analyses; Yu-Sheng Chiu, PhD, for virology analyses; and the 4th Core Lab of National Taiwan University for instrumental support.
Grant Support: By the National Taiwan University Hospital and the National Center of Excellence for Clinical Trial and Research (NCTRC200721) and the National Science Council and Department of Health, Executive Yuan, Taiwan (NSC 100-2314-B-002-137-MY2).
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M13-0989.
Reproducible Research Statement: Study protocol and statistical code: Available from Dr. C.H. Liu (e-mail, email@example.com). Data set: Not available.
Requests for Single Reprints: Jia-Horng Kao, MD, PhD, National Taiwan University Hospital and College of Medicine, 7 Chung-Shan South Road, Taipei 10002, Taiwan; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. C.H. Liu, C.J. Liu, M.K. Tsai, T.H. Su, H.C. Yang, and D.S. Chen: National Taiwan University Hospital, Chung-Shan South Road, Taipei 10002, Taiwan.
Dr. C.F. Huang: Kaohsiung Medical University and Kaohsiung Municipal Ta-Tung Hospital, Shih-Chuan 1st Road, Kaohsiung 80708, Taiwan.
Drs. C.Y. Dai, J.F. Huang, W.L. Chuang, and M.L. Yu: Kaohsiung Medical University, Shih-Chuan 1st Road, Kaohsiung 80708, Taiwan.
Dr. C.C. Liang: Far Eastern Memorial Hospital, Nan-Ya South Road, Taipei 220, Taiwan.
Dr. P.H. Hung: Chiayi Christian Hospital, Jhong-Siao Road, Chia-Yi, 60002 Taiwan.
Dr. H.B. Tsai: Buddhist Tzu Chi General Hospital, Min-Sheng Road, Chiayi County 622, Taiwan.
Drs. S.I. Chen and J.W. Lin: National Taiwan University Hospital, Yun-Lin Branch, Yun-Lin Road, Yun-Lin 640, Taiwan.
Dr. S.S. Yang: Taichung Veterans General Hospital, Taiwan Boulevard, Taichung, 40705, Taiwan.
Drs. P.J. Chen and J.H. Kao: National Taiwan University Hospital and College of Medicine, Chung-Shan South Road, Taipei 10002, Taiwan.
Author Contributions: Conception and design: C.H. Liu, C.J. Liu, C.Y. Dai, M.K. Tsai, J.W. Lin, D.S. Chen, M.L. Yu, J.H. Kao.
Analysis and interpretation of the data: C.H. Liu, C.J. Liu, C.C. Liang, J.F. Huang, J.W. Lin, D.S. Chen, M.L. Yu, J.H. Kao.
Drafting of the article: C.H. Liu, C.J. Liu, C.Y. Dai, J.W. Lin, M.L. Yu, J.H. Kao.
Critical revision of the article for important intellectual content: C.H. Liu, C.J. Liu, W.L. Chuang, M.L. Yu.
Final approval of the article: C.H. Liu, C.J. Liu, C.Y. Dai, P.H. Hung, J.W. Lin, H.C. Yang, W.L. Chuang, M.L. Yu, J.H. Kao.
Provision of study materials or patients: C.H. Liu, C.J. Liu, J.F. Huang, H.B. Tsai, M.K. Tsai, S.I. Chen, T.H. Su, S.S. Yang, H.C. Yang, P.J. Chen, W.L. Chuang, M.L. Yu, J.H. Kao.
Statistical expertise: C.H. Liu, J.W. Lin.
Obtaining of funding: C.H. Liu, C.J. Liu, M.L. Yu, J.H. Kao.
Administrative, technical, or logistic support: P.J. Chen, J.W. Lin, M.L. Yu, J.H. Kao.
Collection and assembly of data: C.H. Liu, C.F. Huang, C.J. Liu, C.Y. Dai, C.C. Liang, J.F. Huang, P.H. Hung, H.B. Tsai, W.L. Chuang, M.L. Yu, J.H. Kao.
Data are limited on the efficacy and safety of pegylated interferon plus ribavirin for patients with hepatitis C virus genotype 1 (HCV-1) receiving hemodialysis.
To compare the efficacy and safety of combination therapy with pegylated interferon plus low-dose ribavirin and pegylated interferon monotherapy for treatment-naive patients with HCV-1 receiving hemodialysis.
Open-label, randomized, controlled trial. (ClinicalTrials.gov: NCT00491244)
8 centers in Taiwan.
205 treatment-naive patients with HCV-1 receiving hemodialysis.
48 weeks of pegylated interferon-α2a, 135 µg weekly, plus ribavirin, 200 mg daily (n = 103), or pegylated interferon-α2a, 135 µg weekly (n = 102).
Sustained virologic response rate and adverse event–related withdrawal rate.
Compared with monotherapy, combination therapy had a greater sustained virologic response rate (64% vs. 33%; relative risk, 1.92 [95% CI, 1.41 to 2.62]; P < 0.001). More patients receiving combination therapy had hemoglobin levels less than 8.5 g/dL than those receiving monotherapy (72% vs. 6%; risk difference, 66% [CI, 56% to 76%]; P < 0.001). Patients receiving combination therapy required a higher dosage (mean, 13 946 IU per week [SD, 6449] vs. 5833 IU per week [SD, 1169]; P = 0.006) and longer duration (mean, 29 weeks [SD, 9] vs. 18 weeks [SD, 7]; P = 0.004) of epoetin-β than patients receiving monotherapy. The adverse event–related withdrawal rates were 7% in the combination therapy group and 4% in the monotherapy group (risk difference, 3% [CI, −3% to 9%]).
Open-label trial; results may not be generalizable to patients on peritoneal dialysis.
In treatment-naive patients with HCV-1 receiving hemodialysis, combination therapy with pegylated interferon plus low-dose ribavirin achieved a greater sustained virologic response rate than pegylated interferon monotherapy.
National Center of Excellence for Clinical Trial and Research.
Chen-Hua Liu, Chung-Feng Huang, Chun-Jen Liu, Chia-Yen Dai, Cheng-Chao Liang, Jee-Fu Huang, et al. Pegylated Interferon-α2a With or Without Low-Dose Ribavirin for Treatment-Naive Patients With Hepatitis C Virus Genotype 1 Receiving Hemodialysis: A Randomized Trial. Ann Intern Med. 2013;159:729–738. doi: 10.7326/0003-4819-159-11-201312030-00005
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Published: Ann Intern Med. 2013;159(11):729-738.
Gastroenterology/Hepatology, Infectious Disease, Nephrology, Renal Replacement Therapy, Viral Hepatitis.
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