Efficacy and Safety of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C: A Pooled Analysis of Five Phase II/III Trials
DC Field | Value | Language |
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dc.contributor.author | Heo, Jeong | - |
dc.contributor.author | Kim, Yoon Jun | - |
dc.contributor.author | Lee, Jin-Woo | - |
dc.contributor.author | Kim, Ji Hoon | - |
dc.contributor.author | Lim, Young-Suk | - |
dc.contributor.author | Han, Kwang-Hyub | - |
dc.contributor.author | Jeong, Sook-Hyang | - |
dc.contributor.author | Cho, Mong | - |
dc.contributor.author | Yoon, Ki Tae | - |
dc.contributor.author | Bae, Si Hyun | - |
dc.contributor.author | Crown, Eric D. | - |
dc.contributor.author | Fredrick, Linda M. | - |
dc.contributor.author | Alami, Negar Niki | - |
dc.contributor.author | Asatryan, Armen | - |
dc.contributor.author | Kim, Do Hyun | - |
dc.contributor.author | Paik, Seung Woon | - |
dc.contributor.author | Lee, Youn-Jae | - |
dc.date.accessioned | 2021-10-18T00:40:06Z | - |
dc.date.available | 2021-10-18T00:40:06Z | - |
dc.date.issued | 2021-11 | - |
dc.identifier.issn | 1976-2283 | - |
dc.identifier.issn | 2005-1212 | - |
dc.identifier.uri | https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/54517 | - |
dc.description.abstract | Background/Aims: Glecaprevir/pibrentasvir (G/P) is the first pan-genotypic direct-acting antiviral combination therapy approved in Korea. An integrated analysis of five phase II and III trials was conducted to evaluate the efficacy and safety of G/P in Korean patients with chronic hepatitis C virus (HCV) infection. Methods: The study analyzed pooled data on Korean patients with HCV infection enrolled in the ENDURANCE 1 and 2, SURVEYOR II part 4 and VOYAGE I and II trials, which evaluated the efficacy and safety of 8 or 12 weeks of G/P treatment. The patients were either treatment-naive or had received sofosbuvir or interferon-based treatment. Efficacy was evaluated by assessing the rate of sustained virologic response at 12 weeks posttreatment (SVR12). Safety was evaluated by monitoring adverse events (AEs) and laboratory assessments. Results: The analysis included 265 patients; 179 (67.5%) were HCV treatment-naive, and most patients were either subgenotype 1B (48.7%) or 2A (44.5%). In the intention-to-treat population, 262 patients (98.9%) achieved SVR12. Three patients did not achieve SVR12: one had virologic failure and two had non-virologic failures. Most AEs were grade 1/2; eight patients (3.0%) experienced at least one grade >_3 AE. No serious AEs related to G/P treatment were reported, and grade >_3 hepatic laboratory abnormalities were rare (0.8%). Conclusions: G/P therapy was highly efficacious and well tolerated in Korean patients with HCV infection, with most patients achieving SVR12. The safety profile was comparable to that observed in a pooled analysis of a global pan-genotypic population of patients with HCV infection who received G/P. (Gut Liver, Published online June 2, 2021) | - |
dc.format.extent | 9 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | 거트앤리버 발행위원회 | - |
dc.title | Efficacy and Safety of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C: A Pooled Analysis of Five Phase II/III Trials | - |
dc.type | Article | - |
dc.publisher.location | 대한민국 | - |
dc.identifier.doi | 10.5009/gnl20321 | - |
dc.identifier.scopusid | 2-s2.0-85119350635 | - |
dc.identifier.wosid | 000702910600001 | - |
dc.identifier.bibliographicCitation | Gut and Liver, v.15, no.6, pp 895 - 903 | - |
dc.citation.title | Gut and Liver | - |
dc.citation.volume | 15 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 895 | - |
dc.citation.endPage | 903 | - |
dc.type.docType | Article | - |
dc.identifier.kciid | ART002776218 | - |
dc.description.isOpenAccess | N | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.description.journalRegisteredClass | kci | - |
dc.relation.journalResearchArea | Gastroenterology & Hepatology | - |
dc.relation.journalWebOfScienceCategory | Gastroenterology & Hepatology | - |
dc.subject.keywordPlus | SUSTAINED VIROLOGICAL RESPONSE | - |
dc.subject.keywordPlus | GLECAPREVIR-PIBRENTASVIR | - |
dc.subject.keywordPlus | VIRUS-INFECTION | - |
dc.subject.keywordPlus | SINGLE-ARM | - |
dc.subject.keywordPlus | GENOTYPE 1 | - |
dc.subject.keywordPlus | OPEN-LABEL | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | PROGRESSION | - |
dc.subject.keywordPlus | MANAGEMENT | - |
dc.subject.keywordAuthor | Glecaprevir and pibrentasvir | - |
dc.subject.keywordAuthor | Pan-genotypic antivirals | - |
dc.subject.keywordAuthor | Hepatitis C virus | - |
dc.subject.keywordAuthor | Korea | - |
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