https://scholars.lib.ntu.edu.tw/handle/123456789/581911
DC Field | Value | Language |
---|---|---|
dc.contributor.author | JIA-HORNG KAO | en_US |
dc.contributor.author | Jensen D.M. | en_US |
dc.contributor.author | Manns M.P. | en_US |
dc.contributor.author | Jacobson I. | en_US |
dc.contributor.author | Kumada H. | en_US |
dc.contributor.author | Toyota J. | en_US |
dc.contributor.author | Heo J. | en_US |
dc.contributor.author | Yoffe B. | en_US |
dc.contributor.author | Sievert W. | en_US |
dc.contributor.author | Bessone F. | en_US |
dc.contributor.author | Peng C.-Y. | en_US |
dc.contributor.author | Roberts S.K. | en_US |
dc.contributor.author | Lee Y.-J. | en_US |
dc.contributor.author | Bhore R. | en_US |
dc.contributor.author | Mendez P. | en_US |
dc.contributor.author | Hughes E. | en_US |
dc.contributor.author | Noviello S. | en_US |
dc.date.accessioned | 2021-09-04T06:11:15Z | - |
dc.date.available | 2021-09-04T06:11:15Z | - |
dc.date.issued | 2016 | - |
dc.identifier.issn | 1478-3223 | - |
dc.identifier.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84979502248&doi=10.1111%2fliv.13049&partnerID=40&md5=78c7cc817f497a024d979c2bfbbb28f6 | - |
dc.identifier.uri | https://scholars.lib.ntu.edu.tw/handle/123456789/581911 | - |
dc.description.abstract | Background & Aims: We compared outcomes by cirrhosis status across studies of the all-oral combination of daclatasvir (DCV) plus asunaprevir (ASV). Methods: Outcomes from global and Japanese phase 2 and 3 clinical studies of DCV+ASV in patients with genotype (GT) 1b infection were assessed by cirrhosis status. Sustained virological response (SVR) was assessed in individual phase 3 studies; a pooled analysis was carried out for safety outcomes. Results: In the Japanese phase 3 study, SVR12 was achieved by 91% of patients with cirrhosis (n = 22) and 84% of patients without cirrhosis (n = 200); in the global phase 3 study, SVR12 was achieved by 84% of patients with cirrhosis (n = 206) and by 85% of patients without cirrhosis (n = 437). The frequency of serious adverse events, adverse events leading to treatment discontinuation and treatment-emergent grade 3/4 laboratory abnormalities was low (<10%) and similar among patients with (n = 229) or without (n = 689) compensated cirrhosis receiving DCV+ASV. Grade 3/4 reductions in platelets and neutrophils were more common among patients with cirrhosis (1.3 and 2.2%, respectively) compared with those without cirrhosis (both 0.6%). Grade 3/4 liver function test abnormalities were less common among patients with cirrhosis (1.8%) compared with those without cirrhosis (3.5–4.7%). Alanine aminotransferase elevations were not associated with hepatic decompensation. Conclusions: The safety and efficacy of DCV+ASV were similar in patients with or without compensated cirrhosis. This all-oral, interferon- and ribavirin-free combination is an effective and well-tolerated treatment option for patients with HCV GT1b infection and cirrhosis. Trial registrations numbers: Clinicaltrials.gov identifiers: NCT01012895; NCT01051414; NCT01581203; NCT01497834. ? 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd | - |
dc.publisher | Blackwell Publishing Ltd | - |
dc.relation.ispartof | Liver International | - |
dc.subject | cirrhosis; direct acting antiviral; hepatitis C; safety | - |
dc.subject.other | alanine aminotransferase; aspartate aminotransferase; asunaprevir; bilirubin; creatinine; daclatasvir; triacylglycerol lipase; abnormal laboratory result; adult; alanine aminotransferase blood level; antiviral therapy; Article; ascites; aspartate aminotransferase blood level; bilirubin blood level; clinical effectiveness; compensated liver cirrhosis; creatinine blood level; diarrhea; esophagus varices bleeding; fatigue; female; headache; hepatitis C; hepatitis C virus genotype 1b infection; hepatitis C virus genotype 1b infection; Hepatitis C virus subtype 1b; human; liver cell carcinoma; lymphocyte count; major clinical study; male; nausea; neutrophil count; outcome assessment; patient safety; phase 3 clinical trial; rhinopharyngitis; side effect; thrombocyte count; triacylglycerol lipase blood level | - |
dc.subject.other | [SDGs]SDG3 | - |
dc.title | Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis | en_US |
dc.type | Journal Article | - |
dc.identifier.doi | 10.1111/liv.13049 | - |
dc.identifier.pmid | 26683763 | - |
dc.identifier.scopus | 2-s2.0-84979502248 | - |
dc.relation.pages | 954-962 | - |
dc.relation.journalvolume | 36 | - |
dc.relation.journalissue | 7 | - |
item.grantfulltext | none | - |
item.fulltext | no fulltext | - |
item.cerifentitytype | Publications | - |
item.openairetype | Journal Article | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
crisitem.author.dept | Clinical Medicine | - |
crisitem.author.dept | Internal Medicine-NTUH | - |
crisitem.author.orcid | 0000-0002-2442-7952 | - |
crisitem.author.parentorg | College of Medicine | - |
crisitem.author.parentorg | National Taiwan University Hospital | - |
Appears in Collections: | 臨床醫學研究所 |
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