Cited 37 times in
Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 박준용 | - |
dc.date.accessioned | 2020-12-01T17:08:35Z | - |
dc.date.available | 2020-12-01T17:08:35Z | - |
dc.date.issued | 2020-05 | - |
dc.identifier.issn | 1478-3223 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/180141 | - |
dc.description.abstract | Background and aims: Chronic hepatitis C virus (HCV) infection increases the risk of incident chronic kidney disease (CKD) and progression to end-stage renal disease (ESRD). Previously available direct-acting antiviral regimens are not approved for patients with advanced CKD across all HCV genotypes. Methods: EXPEDITION-5 is a phase 3 study to evaluate efficacy and safety of the fixed-dose combination of glecaprevir and pibrentasvir (G/P) for chronic HCV infection (genotype 1 through 6) in adults without cirrhosis or with compensated cirrhosis and with stage 3b, 4 or 5 CKD. Patients received approved duration of G/P according to HCV genotype, cirrhosis status and prior HCV treatment experience. The primary efficacy endpoint was percentage of patients with sustained virologic response at 12 weeks post-treatment (SVR12). Results: Among the 101 patients enrolled in the study, 24% had predialysis CKD and 76% were on dialysis. Eighty-four patients were treated with G/P for 8 weeks, 13 patients for 12 weeks and four patients for 16 weeks. Fifty-five per cent of patients had genotype 1, 27% had genotype 2, 15% had genotype 3 and 4% had genotype 4, and none had genotype 5 or 6 infection. The SVR12 rate was 97% (98/101, 95% confidence interval, 91.6-99.0). No patients experienced virologic failure. Adverse events (AEs) reported in at least 5% of the patients were pruritus, bronchitis, hypertension and generalized pruritus. Serious AEs were reported in 12% of patients; none related to study drug. Conclusions: G/P treatment yielded high SVR12 rates irrespective of the presence of stage 3b, 4 or 5 CKD. No safety signals were detected. CLINICALTRIALS. Gov identifier: This Phase 3 clinical trial was funded by AbbVie and registered with clinicaltrials.gov as NCT03069365 (EXPEDITION-5). | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Wiley-Blackwell | - |
dc.relation.isPartOf | LIVER INTERNATIONAL | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Eric Lawitz | - |
dc.contributor.googleauthor | Robert Flisiak | - |
dc.contributor.googleauthor | Manal Abunimeh | - |
dc.contributor.googleauthor | Meghan E Sise | - |
dc.contributor.googleauthor | Jun Y Park | - |
dc.contributor.googleauthor | Marwan Kaskas | - |
dc.contributor.googleauthor | Annette Bruchfeld | - |
dc.contributor.googleauthor | Marcus-Alexander Wörns | - |
dc.contributor.googleauthor | Andrea Aglitti | - |
dc.contributor.googleauthor | Philippe J Zamor | - |
dc.contributor.googleauthor | Zhenyi Xue | - |
dc.contributor.googleauthor | Gretja Schnell | - |
dc.contributor.googleauthor | Yash J Jalundhwala | - |
dc.contributor.googleauthor | Ariel Porcalla | - |
dc.contributor.googleauthor | Federico J Mensa | - |
dc.contributor.googleauthor | Marcello Persico | - |
dc.identifier.doi | 10.1111/liv.14320 | - |
dc.contributor.localId | A01675 | - |
dc.relation.journalcode | J02171 | - |
dc.identifier.eissn | 1478-3231 | - |
dc.identifier.pmid | 31821716 | - |
dc.identifier.url | https://onlinelibrary.wiley.com/doi/full/10.1111/liv.14320 | - |
dc.subject.keyword | chronic kidney disease | - |
dc.subject.keyword | cirrhosis | - |
dc.subject.keyword | direct-acting antiviral | - |
dc.subject.keyword | hepatitis C virus | - |
dc.subject.keyword | pangenotypic | - |
dc.contributor.alternativeName | Park, Jun Yong | - |
dc.contributor.affiliatedAuthor | 박준용 | - |
dc.citation.volume | 40 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 1032 | - |
dc.citation.endPage | 1041 | - |
dc.identifier.bibliographicCitation | LIVER INTERNATIONAL, Vol.40(5) : 1032-1041, 2020-05 | - |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.