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Daclatasvir/asunaprevir/beclabuvir, all-oral, fixed-dose combination for patients with chronic hepatitis C virus genotype 1

Authors
 Jia‐Horng Kao  ;  Ming‐Lung Yu  ;  Cheng‐Yuan Peng  ;  Jeong Heo  ;  Chi‐Jen Chu  ;  Ting‐Tsung Chang  ;  Youn‐Jae Lee  ;  Tsung‐Hui Hu  ;  Ki Tae Yoon  ;  Seung Woon Paik  ;  Young Suk Lim  ;  Sang Hoon Ahn  ;  Vasily Isakov  ;  Fiona McPhee  ;  Wenhua Hu  ;  Eugene Scott Swenson  ;  Philip D Yin  ;  Michelle Treitel 
Citation
 JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Vol.32(12) : 1998-2005, 2017 
Journal Title
 JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY 
ISSN
 0815-9319 
Issue Date
2017
MeSH
Adult ; Aged ; Aged, 80 and over ; Benzazepines/administration & dosage* ; Cohort Studies ; Drug Combinations ; Female ; Follow-Up Studies ; Genotype* ; Hepacivirus/genetics* ; Hepatitis C, Chronic/drug therapy* ; Hepatitis C, Chronic/virology* ; Humans ; Imidazoles/administration & dosage* ; Indoles/administration & dosage* ; Isoquinolines/administration & dosage* ; Male ; Middle Aged ; Republic of Korea ; Russia ; Sulfonamides/administration & dosage* ; Taiwan ; Treatment Outcome ; Young Adult
Keywords
Asia ; NS5A ; hepatitis ; treatment
Abstract
BACKGROUND AND AIM: This multinational (Taiwan, South Korea, Russia) phase 3 study evaluated the all-oral, ribavirin-free, fixed-dose combination (DCV-TRIO) of daclatasvir (NS5A inhibitor) 30 mg, asunaprevir (NS3 inhibitor) 200 mg, and beclabuvir (NS5B inhibitor) 75 mg, in patients with chronic hepatitis C virus genotype-1 infection, with or without compensated cirrhosis. METHODS: UNITY-4 (NCT02170727) was an open-label, two-cohort study in which 169 patients, treatment-naive (n = 138) or treatment-experienced (n = 31), received twice-daily DCV-TRIO for 12 weeks with 24 weeks of post-treatment follow-up. The primary efficacy end point was sustained virologic response at post-treatment week 12 (SVR12) in treatment-naive patients. RESULTS: Eighty-eight (52%) patients were men, 81 (48%) Taiwanese, 78 (46%) Korean, and 10 (6%) Russian; 23 (14%) had compensated cirrhosis, and 52 (31%) were IL28B (rs1297860) non-CC genotype. Baseline resistance-associated NS5A polymorphisms (L31 and/or Y93) were detected in 25/165 (15%) patients with available genotype-1 sequencing data. SVR12 was achieved by 98.6% (136/138; 95% confidence interval: 94.9-99.8%) of treatment-naive and 100% (31/31; 95% confidence interval: 88.8-100%) of treatment-experienced patients. Both virologic failures were found to be infected with hepatitis C virus genotype-6g; 100% SVR12 was observed for genotype-1a (n = 8) and genotype-1b (n = 157). Two patients experienced serious adverse events. Eight (5%) patients experienced reversible grade 3/4 alanine aminotransferase or aspartate aminotransferase elevations, leading to discontinuation in four (2%); all achieved SVR12. There were no grade 3/4 total bilirubin increases and no deaths. CONCLUSIONS: Twelve weeks of DCV-TRIO was well tolerated and provided 100% SVR12 in treatment-naive and treatment-experienced patients with genotype-1 infection, with or without cirrhosis, including those with baseline NS5A-L31 or NS5A-Y93 resistance-associated substitutions.
Full Text
https://onlinelibrary.wiley.com/doi/abs/10.1111/jgh.13796
DOI
10.1111/jgh.13796
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/161709
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