Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan

Chun Chi Yang, Chung Feng Huang, Te Sheng Chang, Ching Chu Lo, Chao Hung Hung, 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 WuChih Lin Lin, Wei 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, Hsing Tao Kuo, Pei Chien Tsai, Chia Yen Dai, Jia Horng Kao, Han Chieh Lin, Wang Long Chuang, Kuo Chih Tseng, Chi Yi Chen, Ming Lung Yu

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-naïve (TN) patients with chronic hepatitis C (CHC), with or without compensated cirrhosis. Given that the Taiwanese government is committed to eliminating hepatitis C virus (HCV) by 2025, this study aimed to measure real-world evidence for TN patients using 8-week GLE/PIB in the Taiwan HCV Registry (TACR). Methods: The data of patients with CHC treated with 8-week GLE/PIB were retrieved from TACR, a nationwide registry program organized by the Taiwan Association for the Study of the Liver (TASL). Treatment efficacy, defined as a sustained virologic response at posttreatment week 12 (SVR12), was assessed in the modified intention-to-treat (mITT) population, which excluded patients who were lost to follow-up or lacked SVR12 data. The safety profile of the ITT population was assessed. Results: A total of 7246 (6897 without cirrhosis; 349 with cirrhosis) patients received at least one dose of GLE/PIB (ITT), 7204 of whom had SVR12 data available (mITT). The overall SVR12 rate was 98.9% (7122/7204) among all patients, 98.9% (6780/6856) and 98.3% (342/348) among patients without and with cirrhosis, respectively. For the selected subgroups, which included patients with genotype 3 infection, diabetes, chronic kidney disease, people who injected drugs, and those with human immunodeficiency virus coinfection, the SVR12 rates were 95.1% (272/286), 98.9% (1084/1096), 99.0% (1171/1183), 97.4% (566/581), and 96.1% (248/258), respectively. Overall, 14.1% (1021/7246) of the patients experienced adverse events (AEs). Twenty-two patients (0.3%) experienced serious AEs, and 15 events (0.2%) resulted in permanent drug discontinuation. Only one event was considered treatment drug related. Conclusion: Eight-week GLE/PIB therapy was effective and well tolerated in all TN patients, regardless of cirrhosis status.

Original languageEnglish
Pages (from-to)1199-1213
Number of pages15
JournalInfectious Diseases and Therapy
Volume13
Issue number6
DOIs
Publication statusAccepted/In press - 2024

Keywords

  • Direct-acting antivirals
  • Glecaprevir
  • Hepatitis C
  • Pibrentasvir
  • Real world
  • Taiwan

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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