| Autor: |
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. Fredrick, Negar Niki Alami, Armen Asatryan, Do Hyun Kim, Seung Woon Paik, Youn-Jae Lee |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
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| Zdroj: |
Gut and Liver, Vol 15, Iss 6, Pp 895-903 (2021) |
| Druh dokumentu: |
article |
| ISSN: |
1976-2283 |
| DOI: |
10.5009/gnl20321 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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