title: Peginterferon plus weight-based ribavirin for treatment-naïve hepatitis C virus genotype 2 patients not achieving rapid virologic response: a randomized trial.
abstract: Hepatitis C virus genotype 2 (HCV-2) slow responders poorly respond to 24 weeks of peginterferon (Peg-IFN) plus ribavirin (RBV). We evaluated the efficacy of extended 48-week regimen and the role of interleukin-28B (IL-28B) genotype in this clinical setting. Treatment-naïve HCV-2 patients not achieving rapid virologic response (RVR) by Peg-IFN alfa-2a 180 μg/week plus weight-based RBV (1,000-1,200 mg/day, cutoff body weight of 75 kg) were randomly assigned to receive a total duration of 48 (n = 94) or 24 (n = 93) weeks of therapy. The primary endpoint was sustained virologic response (SVR). Baseline patient characteristics to predict SVR were analyzed. Patients receiving 48 weeks of treatment had a greater SVR rate than those receiving 24 weeks of treatment (70.2% versus 46.2%, P = 0.001). Compared to patients treated for 24 weeks, the SVR rate in those treated for 48 weeks increased by 10.9% [95% CI: -5.9% to 27.7%] and 65.6% [95% CI: 44.5% to 86.7%] if they had IL-28B rs8099917 TT genotype, and GT/GG genotype, respectively (interaction P = 0.002). In conclusion, 48-week treatment with Peg-IFN plus weight-based RBV provides a greater SVR rate than 24-week treatment in treatment-naïve HCV-2 patients with unfavorable IL-28B genotypes who fail to achieve RVR.
authors.affiliation: 1] Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan [2] Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan [3] Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan [4] Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan.
authors.forename: Chen-Hua
authors.initials: CH
authors.lastname: Liu
authors.affiliation: 1] Institute of Clinical Medicine and Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan [2] Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan [3] Department of Occupational Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan.
authors.forename: Chung-Feng
authors.initials: CF
authors.lastname: Huang
authors.affiliation: 1] Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan [2] Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan [3] Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Chun-Jen
authors.initials: CJ
authors.lastname: Liu
authors.affiliation: 1] Institute of Clinical Medicine and Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan [2] Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
authors.forename: Chia-Yen
authors.initials: CY
authors.lastname: Dai
authors.affiliation: 1] Institute of Clinical Medicine and Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan [2] Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
authors.forename: Jee-Fu
authors.initials: JF
authors.lastname: Huang
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Douliou, Taiwan.
authors.forename: Jou-Wei
authors.initials: JW
authors.lastname: Lin
authors.affiliation: Department of Internal Medicine, Far Eastern Memorial Hospital, Taipei, Taiwan.
authors.forename: Cheng-Chao
authors.initials: CC
authors.lastname: Liang
authors.affiliation: Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
authors.forename: Sheng-Shun
authors.initials: SS
authors.lastname: Yang
authors.affiliation: Department of Gastroenterology, Taipei City Hospital, Ren-Ai Branch, Taipei, Taiwan.
authors.forename: Chih-Lin
authors.initials: CL
authors.lastname: Lin
authors.affiliation: 1] Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan [2] Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan [3] Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Tung-Hung
authors.initials: TH
authors.lastname: Su
authors.affiliation: 1] Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan [2] Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan [3] Department of Microbiology, National Taiwan University College of Medicine and National Taiwan University Hospital, Taipei.
authors.forename: Hung-Chih
authors.initials: HC
authors.lastname: Yang
authors.affiliation: 1] Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan [2] Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan [3] Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Pei-Jer
authors.initials: PJ
authors.lastname: Chen
authors.affiliation: 1] Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan [2] Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan [3] Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan [4] Genomics Research Center, Academia Sinica, Taiwan.
authors.forename: Ding-Shinn
authors.initials: DS
authors.lastname: Chen
authors.affiliation: 1] Institute of Clinical Medicine and Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan [2] Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan.
authors.forename: Wan-Long
authors.initials: WL
authors.lastname: Chuang
authors.affiliation: 1] Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan [2] Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan [3] Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Jia-Horng
authors.initials: JH
authors.lastname: Kao
authors.affiliation: 1] Institute of Clinical Medicine and Faculty of Internal Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan [2] Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan [3] Institute of Biomedical Sciences, National Sun Yat-Sen University, Kaohsiung, Taiwan.
authors.forename: Ming-Lung
authors.initials: ML
authors.lastname: Yu
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D007372:Interferons; D007378:Interleukins / Q000235:genetics / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D020641:Polymorphism, Single Nucleotide; D012367:RNA, Viral / Q000032:analysis / Q000235:genetics; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome; D000095022:Interferon Lambda
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D007372:Interferons; D007378:Interleukins; D011092:Polyethylene Glycols; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin; C000624353:interferon-lambda, human; D000095022:Interferon Lambda; C100416:peginterferon alfa-2a