title: Twelve-week ribavirin-free direct-acting antivirals for treatment-experienced Chinese with HCV genotype 1b infection including cirrhotic patients.
abstract: BACKGROUND
  Treatment-experienced chronic hepatitis C (CHC) genotype (GT) 1b represents a major medical burden in China. We evaluate the efficacy, safety and cost-effectiveness of ribavirin (RBV)-free pan-oral direct-acting antivirals (DAAs) in treatment-experienced Chinese with GT1b CHC, including patients with cirrhosis.
  
  
  METHODS
  One hundred forty treatment-experienced GT1b CHC Chinese with and without cirrhosis were included in this study. Ninety-four patients were treated with either daclatasvir (DCV, 60 mg)-sofosbuvir (SOF, 400 mg) (group 1, n = 46) or ledipasvir (LDV, 90 mg)-SOF (400 mg) (group 2, n = 48) for 12 weeks. Forty-six patients treated with pegylated interferon and RBV therapy for 72 weeks were enrolled as the control group (group 3). Patients were followed at 4-weekly intervals till 24 weeks after the end of treatment.
  
  
  RESULTS
  All patients in group 1 (46/46, 100 %) and 2 (48/48, 100 %) had achieved sustained virologic response at 24 weeks after the end of treatment (SVR 24), which was significantly higher than that of group 3 (13/46, 28.3 %) (p < 0.001). The SVR 24 rates of cirrhotic patients in group 1 (27/27, 100 %) and 2 (27/27, 100 %) were also significantly higher than that of group 3 (3/25, 12 %) (p < 0.001). Twelve weeks of RBV-free LDV-SOF and DCV-SOF was either cost-saving or cost-effective. Adverse events were significantly lower in group 1 and 2 compared with group 3 (p < 0.001).
  
  
  CONCLUSIONS
  Compared with standard therapies, 12 weeks of RBV-free DAA therapies is highly effective, well tolerated and cost-effective in treatment-experienced Chinese with GT1b CHC including patients with cirrhosis.
authors.affiliation: Second Liver Cirrhosis Diagnosis and Treatment Center, Beijing 302 Hospital, Beijing, China.|Liver Failure Treatment and Research Center, Beijing 302 Hospital, Beijing, China.
authors.forename: Dong
authors.initials: D
authors.lastname: Ji
authors.affiliation: Second Liver Cirrhosis Diagnosis and Treatment Center, Beijing 302 Hospital, Beijing, China.
authors.forename: Guo-Feng
authors.initials: GF
authors.lastname: Chen
authors.affiliation: Division of Gastroenterology and Hepatology, Humanity and Health Medical Centre, Hong Kong S.A.R., China.|State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.
authors.forename: Cheng
authors.initials: C
authors.lastname: Wang
authors.affiliation: Division of Gastroenterology and Hepatology, Humanity and Health Medical Centre, Hong Kong S.A.R., China.
authors.forename: Yu-Dong
authors.initials: YD
authors.lastname: Wang
authors.affiliation: Second Liver Cirrhosis Diagnosis and Treatment Center, Beijing 302 Hospital, Beijing, China.
authors.forename: Qing
authors.initials: Q
authors.lastname: Shao
authors.affiliation: Second Liver Cirrhosis Diagnosis and Treatment Center, Beijing 302 Hospital, Beijing, China.
authors.forename: Bing
authors.initials: B
authors.lastname: Li
authors.affiliation: Liver Failure Treatment and Research Center, Beijing 302 Hospital, Beijing, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Zhao
authors.affiliation: Liver Failure Treatment and Research Center, Beijing 302 Hospital, Beijing, China.
authors.forename: Shao-Li
authors.initials: SL
authors.lastname: You
authors.affiliation: Liver Failure Treatment and Research Center, Beijing 302 Hospital, Beijing, China.
authors.forename: Jin-Hua
authors.initials: JH
authors.lastname: Hu
authors.affiliation: Second Liver Cirrhosis Diagnosis and Treatment Center, Beijing 302 Hospital, Beijing, China.
authors.forename: Jia-Liang
authors.initials: JL
authors.lastname: Liu
authors.affiliation: Second Liver Cirrhosis Diagnosis and Treatment Center, Beijing 302 Hospital, Beijing, China.
authors.forename: Xiao-Xia
authors.initials: XX
authors.lastname: Niu
authors.affiliation: Division of Gastroenterology and Hepatology, Humanity and Health Medical Centre, Hong Kong S.A.R., China.
authors.forename: Jing
authors.initials: J
authors.lastname: Chen
authors.affiliation: Division of Gastroenterology and Hepatology, Humanity and Health Medical Centre, Hong Kong S.A.R., China.
authors.forename: Lei
authors.initials: L
authors.lastname: Lu
authors.affiliation: Division of Gastroenterology and Hepatology, Humanity and Health Medical Centre, Hong Kong S.A.R., China.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Wu
authors.affiliation: Second Liver Cirrhosis Diagnosis and Treatment Center, Beijing 302 Hospital, Beijing, China. gkklau@netvigator.com.|Division of Gastroenterology and Hepatology, Humanity and Health Medical Centre, Hong Kong S.A.R., China. gkklau@netvigator.com.|Institute of Translational Hepatology, Beijing 302 Hospital, Beijing, China. gkklau@netvigator.com.
authors.forename: George
authors.initials: G
authors.lastname: Lau
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000191:economics; D002681:China; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination / Q000191:economics*; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics / Q000821:virology; D006801:Humans; D008103:Liver Cirrhosis / Q000188:drug therapy* / Q000191:economics / Q000821:virology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012254:Ribavirin / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin
keywords: Chronic hepatitis C; Direct-acting antivirals; Genotype 1b; Ribavirin-free