PT  - JOURNAL ARTICLE
AU  - Liu, Chen-Hua
AU  - Liu, Chun-Jen
AU  - Huang, Chung-Feng
AU  - Lin, Jou-Wei
AU  - Dai, Chia-Yen
AU  - Liang, Cheng-Chao
AU  - Huang, Jee-Fu
AU  - Hung, Peir-Haur
AU  - Tsai, Hung-Bin
AU  - Tsai, Meng-Kun
AU  - Lee, Chih-Yuan
AU  - Chen, Shih-I
AU  - Yang, Sheng-Shun
AU  - Su, Tung-Hung
AU  - Yang, Hung-Chih
AU  - Chen, Pei-Jer
AU  - Chen, Ding-Shinn
AU  - Chuang, Wan-Long
AU  - Yu, Ming-Lung
AU  - Kao, Jia-Horng
TI  - Peginterferon alfa-2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 2 receiving haemodialysis: a randomised trial
AID  - 10.1136/gutjnl-2014-307080
DP  - 2015 Feb 01
TA  - Gut
PG  - 303--311
VI  - 64
IP  - 2
4099  - http://gut.bmj.com/content/64/2/303.short
4100  - http://gut.bmj.com/content/64/2/303.full
SO  - Gut2015 Feb 01; 64
AB  - 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.