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RISS 인기검색어
- 검색키워드
- 저자 : ( Eric D. Crown ) (검색결과 1 건)
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( Jeong Heo ),( Yoon Jun Kim ),( Jin-woo Lee ),( Ji Hoon Kim ),( Young-suk Lim ),( Kwang-hyub Han ),( Sook-hyang Jeong ),( Mong Cho ),( Ki Tae Yoon ),( Si Hyun Bae ),( Eric D. Crown ),( Linda M. Fredr 대한간학회 2021 Gut and Liver Vol.15 No.6
Background/Aims: Glecaprevir/pibrentasvir (G/P) is the first pan-genotypic direct-acting antivi ral 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%) expe rienced 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 ob served in a pooled analysis of a global pan-genotypic population of patients with HCV infection who received G/P. (Gut Liver 2021;15:895-903)
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