title: A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection.
abstract: In Taiwan, patients with chronic hepatitis C virus (HCV) infection are currently treated with pegylated interferon-alpha plus ribavirin, but interferon-based regimens can be poorly tolerated, especially by those with advanced liver disease and the elderly. Sofosbuvir, an oral nucleotide analogue inhibitor of HCV NS5B polymerase, is approved in Europe, the USA and Japan for treating chronic HCV infection. This phase 3b study examined the efficacy and safety of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 HCV infection ± compensated cirrhosis.
  
  
  
  In this multicentre, open-label, phase 3b (NCT02021643) study, 87 patients (n = 43, treatment-naive; n = 44, treatment-experienced) received 12 weeks of treatment with sofosbuvir plus weight-based ribavirin. The primary efficacy endpoint was the proportion of patients with sustained virological response 12 weeks after treatment discontinuation (SVR12). Safety and pharmacokinetic data were also collected.
  
  
  
  All 87 patients (100%; 95% confidence interval, 92-100%) achieved SVR12, including the 13 patients with compensated cirrhosis. The most common treatment-emergent adverse events (AEs) were insomnia (16%, 14/87) and upper respiratory tract infection (16%, 14/87). No grade 3 or grade 4 AE was reported. There was one serious AE (biliary colic), which was deemed unrelated to study treatment. Laboratory abnormalities other than ribavirin-related reductions in haemoglobin were uncommon.
  
  
  
  The results from this phase 3b study demonstrate that 12 weeks of treatment with the interferon-free regimen sofosbuvir plus ribavirin is effective and well tolerated in both treatment-naive and treatment-experienced Taiwanese patients with chronic genotype 2 HCV infection.
authors.affiliation: National Taiwan University College of Medicine and Hospital, Taipei, Taiwan.
authors.forename: Jia-Horng
authors.initials: JH
authors.lastname: Kao
authors.affiliation: Liver Research Unit, Chang Gung Memorial Hospital-Keelung, Keelung, Taiwan.
authors.forename: Rong-Nan
authors.initials: RN
authors.lastname: Chien
authors.affiliation: Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.
authors.forename: Ting-Tsung
authors.initials: TT
authors.lastname: Chang
authors.affiliation: Department of Internal Medicine, School of Medicine, China Medical University, Taichung, Taiwan.
authors.forename: Cheng-Yuan
authors.initials: CY
authors.lastname: Peng
authors.affiliation: Chang Gung Medical Foundation, Kaohsiung, Taiwan.
authors.forename: Tsung-Hui
authors.initials: TH
authors.lastname: Hu
authors.affiliation: Department of Medicine, E-Da Hospital, Kaohsiung, Taiwan.
authors.forename: Gin-Ho
authors.initials: GH
authors.lastname: Lo
authors.affiliation: Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan.
authors.forename: Horng-Yuan
authors.initials: HY
authors.lastname: Wang
authors.affiliation: Department of Internal Medicine, Chi Mei Hospital, Liouying, Tainan, Taiwan.
authors.forename: Jyh-Jou
authors.initials: JJ
authors.lastname: Chen
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Jenny C
authors.initials: JC
authors.lastname: Yang
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Steven J
authors.initials: SJ
authors.lastname: Knox
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Lingling
authors.initials: L
authors.lastname: Han
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Hongmei
authors.initials: H
authors.lastname: Mo
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Anita
authors.initials: A
authors.lastname: Mathias
authors.affiliation: Gilead Sciences, Inc., Foster City, CA, USA.
authors.forename: Diana M
authors.initials: DM
authors.lastname: Brainard
authors.affiliation: Chang Gung Memorial Hospital and Medical College, Chang Gung University, Taoyuan, Taiwan.
authors.forename: I-Shyan
authors.initials: IS
authors.lastname: Sheen
authors.affiliation: Department of Gastroenterology, Changhua Christian Hospital, Changhua, Taiwan.
authors.forename: Yu-Chun
authors.initials: YC
authors.lastname: Hsu
authors.affiliation: Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.|School of Medicine, National Yang-Ming University, Taipei, Taiwan.
authors.forename: Chi-Jen
authors.initials: CJ
authors.lastname: Chu
authors.affiliation: Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
authors.forename: Wan-Long
authors.initials: WL
authors.lastname: Chuang
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000821:virology; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D000069474:Sofosbuvir / Q000008:administration & dosage* / Q000009:adverse effects; D013624:Taiwan; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D000069474:Sofosbuvir
keywords: Taiwan; genotype 2; hepatitis C virus (HCV); ribavirin; sofosbuvir
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