Infectious Diseases and Therapy (Apr 2024)

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 Wu,
  • Chih-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

DOI
https://doi.org/10.1007/s40121-024-00968-5
Journal volume & issue
Vol. 13, no. 6
pp. 1199 – 1213

Abstract

Read online

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.

Keywords