CHEN-HUA LIUCHUN-JEN LIUHuang C.-FJOU-WEI LINDai C.-YLiang C.-CHuang J.-FHung P.-HHUNG-BIN TSAIMENG-KUN TSAICHIH-YUAN LEEChen S.-IYang S.-STUNG-HUNG SUHUNG-CHIH YANGPEI-JER CHENDING-SHINN CHENChuang W.-LYu M.-LJIA-HORNG KAO2019-12-042019-12-0420150017-5749https://www.scopus.com/inward/record.uri?eid=2-s2.0-84920999772&doi=10.1136%2fgutjnl-2014-307080&partnerID=40&md5=4f3189bd1469820c4207c437125fcf88https://scholars.lib.ntu.edu.tw/handle/123456789/434606Objective: 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.[SDGs]SDG3hemoglobin; peginterferon alpha2a; ribavirin; alpha interferon; antivirus agent; erythropoietin; hemoglobin; macrogol derivative; peginterferon alpha2a; recombinant erythropoietin; recombinant protein; ribavirin; adult; adverse outcome; alopecia; anemia; anorexia; Article; chronic kidney disease; comparative effectiveness; constipation; controlled study; coughing; depression; dermatitis; diarrhea; drug dose reduction; drug efficacy; drug safety; drug withdrawal; fatigue; female; flu like syndrome; follow up; hair loss; headache; hemodialysis; hepatitis C; Hepatitis C virus genotype 2 infection; Hepatitis C virus genotype 2 infection; human; injection site reaction; insomnia; major clinical study; male; medication compliance; monotherapy; multicenter study; neutropenia; outcome assessment; patient compliance; randomized controlled trial; thrombocytopenia; treatment response; virus load; aged; anemia; blood; chemically induced; clinical trial; dose response; drug combination; genetics; genotype; Hepacivirus; Hepatitis C, Chronic; isolation and purification; metabolism; middle aged; renal replacement therapy; treatment outcome; virology; young adult; Adult; Aged; Anemia; Antiviral Agents; Dose-Response Relationship, Drug; Drug Therapy, Combination; Erythropoietin; Female; Genotype; Hemoglobins; Hepacivirus; Hepatitis C, Chronic; Humans; Interferon-alpha; Male; Middle Aged; Polyethylene Glycols; Recombinant Proteins; Renal Dialysis; Ribavirin; Treatment Outcome; Viral Load; Young Adultjournal article10.1136/gutjnl-2014-307080247478672-s2.0-84920999772