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.
|Number of pages||9|
|Journal||Gut and liver|
|Publication status||Published - 2021|
Bibliographical noteFunding Information:
The design, study conduct, analysis, and financial support of the trials (ENDURANCE 1, ENDURANCE 2, SURVEYOR II part 4, VOYAGE I and VOYAGE II) was provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication. All authors had access to all relevant data.
The authors would like to express their gratitude to the trial participants, investigators, and coordinators who made this study possible. Medical writing assistance was provided by Syed Abdul Haseeb and Julia Ventura from MediTech Media (Singapore), which was funded by Ab-bVie in accordance with Good Publication Practice guidelines.
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