RT Journal Article
SR Electronic
T1 Peginterferon alfa-2a with or without low-dose ribavirin for treatment-naive patients with hepatitis C virus genotype 2 receiving haemodialysis: a randomised trial
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 303
OP 311
DO 10.1136/gutjnl-2014-307080
VO 64
IS 2
A1 Liu, Chen-Hua
A1 Liu, Chun-Jen
A1 Huang, Chung-Feng
A1 Lin, Jou-Wei
A1 Dai, Chia-Yen
A1 Liang, Cheng-Chao
A1 Huang, Jee-Fu
A1 Hung, Peir-Haur
A1 Tsai, Hung-Bin
A1 Tsai, Meng-Kun
A1 Lee, Chih-Yuan
A1 Chen, Shih-I
A1 Yang, Sheng-Shun
A1 Su, Tung-Hung
A1 Yang, Hung-Chih
A1 Chen, Pei-Jer
A1 Chen, Ding-Shinn
A1 Chuang, Wan-Long
A1 Yu, Ming-Lung
A1 Kao, Jia-Horng
YR 2015
UL http://gut.bmj.com/content/64/2/303.abstract
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.