Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry

Te Sheng Chang, Chung Feng Huang, Hsing Tao Kuo, Ching Chu Lo, Chien Wei Huang, Lee Won Chong, Pin Nan Cheng, Ming Lun Yeh, Cheng Yuan Peng, Chien Yu Cheng, Jee Fu Huang, Ming Jong Bair, Chih Lang Lin, Chi Chieh Yang, Szu Jen Wang, Tsai Yuan Hsieh, Tzong Hsi Lee, Pei Lun Lee, Wen Chih Wu, Chih Lin LinWei Wen Su, Sheng Shun Yang, Chia Chi Wang, Jui Ting Hu, Lein Ray Mo, Chun Ting Chen, Yi Hsiang Huang, Chun Chao Chang, Chia Sheng Huang, Guei Ying Chen, Chien Neng Kao, Chi Ming Tai, Chun Jen Liu, Mei Hsuan Lee, Pei Chien Tsai, Chia Yen Dai, Jia Horng Kao, Han Chieh Lin, Wang Long Chuang, Chi Yi Chen, Kuo Chih Tseng, Chao Hung Hung, Ming Lung Yu

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)

Abstract

Background: Large-scale real-world data of the 8-week glecaprevir/pibrentasvir (GLE/PIB) therapy for treatment-naïve patients of chronic hepatitis C virus (HCV) infection with compensated cirrhosis is scarce. Methods: The TASL HCV Registry (TACR) is an ongoing nationwide registry program that aims to set up a database and biobank of patients with chronic HCV infection in Taiwan. In this study, data were analyzed as of 31 October 2021 for treatment-naïve HCV patients with compensated cirrhosis receiving 8-week GLE/PIB therapy. Effectiveness reported as sustained virologic response at off-therapy week 12 (SVR12) and safety profiles were assessed. Patient characteristics potentially related to SVR12 were also evaluated. Results: Of the 301 patients enrolled, 275 had available SVR12 data. The SVR12 rate was 98.2% (270/275) in the modified intention-to-treat (mITT) population and 89.7% (270/301) in the ITT population. For those mITT patients with genotype 3, FibroScan > 20 kPa, platelet < 150,000/µl, and FibroScan > 20 kPa and platelet < 150,000/µl, the SVR12 rates were 100% (6/6), 100% (12/12), 98.0% (144/147), 100% (7/7), respectively. Overall, 24.9% (75/301) patients experienced adverse events (AEs). The most frequent AEs (> 5%) included fatigue (9.0%) and pruritus (7.0%). Seven (2.3%) patients experienced serious AEs and two (0.7%) resulted in permanent drug discontinuation. None of them were considered as GLE/PIB-related. Conclusions: In this large-scale real-world Taiwanese cohort, 8-week GLE/PIB therapy was efficacious and well tolerated for treatment-naïve compensated cirrhosis patients. SVR12 rates were similarly high as in the clinical trials, including those with characteristics of advanced liver disease.

Original languageEnglish
Pages (from-to)550-561
Number of pages12
JournalHepatology International
Volume17
Issue number3
DOIs
Publication statusPublished - Jun 2023

Keywords

  • Compensated cirrhosis
  • GLE/PIB
  • HCV
  • Sustained virologic response

ASJC Scopus subject areas

  • Hepatology

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