Cited 2 times in
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 | 한광협 | - |
dc.date.accessioned | 2023-02-10T00:49:47Z | - |
dc.date.available | 2023-02-10T00:49:47Z | - |
dc.date.issued | 2021-11 | - |
dc.identifier.issn | 1976-2283 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/192404 | - |
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-naïve 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-naïve, 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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Editorial Office of Gut and Liver | - |
dc.relation.isPartOf | GUT AND LIVER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Aminoisobutyric Acids | - |
dc.subject.MESH | Antiviral Agents / adverse effects | - |
dc.subject.MESH | Benzimidazoles | - |
dc.subject.MESH | Clinical Trials, Phase III as Topic | - |
dc.subject.MESH | Cyclopropanes | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Genotype | - |
dc.subject.MESH | Hepacivirus / genetics | - |
dc.subject.MESH | Hepatitis C, Chronic* / drug therapy | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lactams, Macrocyclic | - |
dc.subject.MESH | Leucine / analogs & derivatives | - |
dc.subject.MESH | Proline / analogs & derivatives | - |
dc.subject.MESH | Pyrrolidines | - |
dc.subject.MESH | Quinoxalines | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Sulfonamides | - |
dc.subject.MESH | Sustained Virologic Response | - |
dc.subject.MESH | Treatment Outcome | - |
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.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Jeong Heo | - |
dc.contributor.googleauthor | Yoon Jun Kim | - |
dc.contributor.googleauthor | Jin-Woo Lee | - |
dc.contributor.googleauthor | Ji Hoon Kim | - |
dc.contributor.googleauthor | Young-Suk Lim | - |
dc.contributor.googleauthor | Kwang-Hyub Han | - |
dc.contributor.googleauthor | Sook-Hyang Jeong | - |
dc.contributor.googleauthor | Mong Cho | - |
dc.contributor.googleauthor | Ki Tae Yoon | - |
dc.contributor.googleauthor | Si Hyun Bae | - |
dc.contributor.googleauthor | Eric D Crown | - |
dc.contributor.googleauthor | Linda M Fredrick | - |
dc.contributor.googleauthor | Negar Niki Alami | - |
dc.contributor.googleauthor | Armen Asatryan | - |
dc.contributor.googleauthor | Do Hyun Kim | - |
dc.contributor.googleauthor | Seung Woon Paik | - |
dc.contributor.googleauthor | Youn-Jae Lee | - |
dc.identifier.doi | 10.5009/gnl20321 | - |
dc.contributor.localId | A04268 | - |
dc.relation.journalcode | J00954 | - |
dc.identifier.eissn | 2005-1212 | - |
dc.identifier.pmid | 34053916 | - |
dc.subject.keyword | Glecaprevir and pibrentasvir | - |
dc.subject.keyword | Hepatitis C virus | - |
dc.subject.keyword | Korea | - |
dc.subject.keyword | Pan-genotypic antivirals | - |
dc.contributor.alternativeName | Han, Kwang Hyup | - |
dc.contributor.affiliatedAuthor | 한광협 | - |
dc.citation.volume | 15 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 895 | - |
dc.citation.endPage | 903 | - |
dc.identifier.bibliographicCitation | GUT AND LIVER, Vol.15(6) : 895-903, 2021-11 | - |
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