Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Dec 3;159(11):729-38.
doi: 10.7326/0003-4819-159-11-201312030-00005.

Pegylated interferon-α2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 1 receiving hemodialysis: a randomized trial

Chen-Hua Liu, Chung-Feng Huang, Chun-Jen Liu, Chia-Yen Dai, Cheng-Chao Liang, Jee-Fu Huang, Peir-Haur Hung, Hung-Bin Tsai, Meng-Kun Tsai, Shih-I Chen, Jou-Wei Lin, Sheng-Shun Yang, Tung-Hung Su, Hung-Chih Yang, Pei-Jer Chen, Ding-Shinn Chen, Wan-Long Chuang, Ming-Lung Yu, Jia-Horng Kao
Randomized Controlled Trial

Pegylated interferon-α2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 1 receiving hemodialysis: a randomized trial

Chen-Hua Liu et al. Ann Intern Med. .

Abstract

Background: 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.

Objective: 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.

Design: Open-label, randomized, controlled trial. (ClinicalTrials.gov: NCT00491244).

Setting: 8 centers in Taiwan.

Patients: 205 treatment-naive patients with HCV-1 receiving hemodialysis.

Intervention: 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).

Measurements: Sustained virologic response rate and adverse event-related withdrawal rate.

Results: 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%]).

Limitation: Open-label trial; results may not be generalizable to patients on peritoneal dialysis.

Conclusion: 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.

Primary funding source: National Center of Excellence for Clinical Trial and Research.

PubMed Disclaimer

Comment in

Summary for patients in

Publication types

MeSH terms

Associated data