Cited 16 times in
Daclatasvir/asunaprevir/beclabuvir, all-oral, fixed-dose combination for patients with chronic hepatitis C virus genotype 1
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 안상훈 | - |
dc.date.accessioned | 2018-07-20T12:03:28Z | - |
dc.date.available | 2018-07-20T12:03:28Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 0815-9319 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/161709 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Blackwell Scientific Publications | - |
dc.relation.isPartOf | JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Benzazepines/administration & dosage* | - |
dc.subject.MESH | Cohort Studies | - |
dc.subject.MESH | Drug Combinations | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Follow-Up Studies | - |
dc.subject.MESH | Genotype* | - |
dc.subject.MESH | Hepacivirus/genetics* | - |
dc.subject.MESH | Hepatitis C, Chronic/drug therapy* | - |
dc.subject.MESH | Hepatitis C, Chronic/virology* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Imidazoles/administration & dosage* | - |
dc.subject.MESH | Indoles/administration & dosage* | - |
dc.subject.MESH | Isoquinolines/administration & dosage* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Russia | - |
dc.subject.MESH | Sulfonamides/administration & dosage* | - |
dc.subject.MESH | Taiwan | - |
dc.subject.MESH | Treatment Outcome | - |
dc.subject.MESH | Young Adult | - |
dc.title | Daclatasvir/asunaprevir/beclabuvir, all-oral, fixed-dose combination for patients with chronic hepatitis C virus genotype 1 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Jia‐Horng Kao | - |
dc.contributor.googleauthor | Ming‐Lung Yu | - |
dc.contributor.googleauthor | Cheng‐Yuan Peng | - |
dc.contributor.googleauthor | Jeong Heo | - |
dc.contributor.googleauthor | Chi‐Jen Chu | - |
dc.contributor.googleauthor | Ting‐Tsung Chang | - |
dc.contributor.googleauthor | Youn‐Jae Lee | - |
dc.contributor.googleauthor | Tsung‐Hui Hu | - |
dc.contributor.googleauthor | Ki Tae Yoon | - |
dc.contributor.googleauthor | Seung Woon Paik | - |
dc.contributor.googleauthor | Young Suk Lim | - |
dc.contributor.googleauthor | Sang Hoon Ahn | - |
dc.contributor.googleauthor | Vasily Isakov | - |
dc.contributor.googleauthor | Fiona McPhee | - |
dc.contributor.googleauthor | Wenhua Hu | - |
dc.contributor.googleauthor | Eugene Scott Swenson | - |
dc.contributor.googleauthor | Philip D Yin | - |
dc.contributor.googleauthor | Michelle Treitel | - |
dc.identifier.doi | 10.1111/jgh.13796 | - |
dc.contributor.localId | A02226 | - |
dc.relation.journalcode | J01417 | - |
dc.identifier.eissn | 1440-1746 | - |
dc.identifier.pmid | 28370350 | - |
dc.identifier.url | https://onlinelibrary.wiley.com/doi/abs/10.1111/jgh.13796 | - |
dc.subject.keyword | Asia | - |
dc.subject.keyword | NS5A | - |
dc.subject.keyword | hepatitis | - |
dc.subject.keyword | treatment | - |
dc.contributor.alternativeName | Ahn, Sang Hoon | - |
dc.contributor.affiliatedAuthor | Ahn, Sang Hoon | - |
dc.citation.volume | 32 | - |
dc.citation.number | 12 | - |
dc.citation.startPage | 1998 | - |
dc.citation.endPage | 2005 | - |
dc.identifier.bibliographicCitation | JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Vol.32(12) : 1998-2005, 2017 | - |
dc.identifier.rimsid | 61730 | - |
dc.type.rims | ART | - |
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