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Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan.
Yang, Chun-Chi; Huang, Chung-Feng; Chang, Te-Sheng; Lo, Ching-Chu; Hung, Chao-Hung; Huang, Chien-Wei; Chong, Lee-Won; Cheng, Pin-Nan; Yeh, Ming-Lun; Peng, Cheng-Yuan; Cheng, Chien-Yu; Huang, Jee-Fu; Bair, Ming-Jong; Lin, Chih-Lang; Yang, Chi-Chieh; Wang, Szu-Jen; Hsieh, Tsai-Yuan; Lee, Tzong-Hsi; Lee, Pei-Lun; Wu, Wen-Chih; Lin, Chih-Lin; Su, Wei-Wen; Yang, Sheng-Shun; Wang, Chia-Chi; Hu, Jui-Ting; Mo, Lein-Ray; Chen, Chun-Ting; Huang, Yi-Hsiang; Chang, Chun-Chao; Huang, Chia-Sheng; Chen, Guei-Ying; Kao, Chien-Neng; Tai, Chi-Ming; Liu, Chun-Jen; Lee, Mei-Hsuan; Kuo, Hsing-Tao; Tsai, Pei-Chien; Dai, Chia-Yen; Kao, Jia-Horng; Lin, Han-Chieh; Chuang, Wang-Long; Tseng, Kuo-Chih; Chen, Chi-Yi; Yu, Ming-Lung.
Afiliación
  • Yang CC; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chi Mei Medical Center, Yongkang District, Tainan, Taiwan.
  • Huang CF; Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, Taiwan.
  • Chang TS; Ph.D. Program in Translational Medicine, College of Medicine, Academia Sinica, Kaohsiung Medical University, Kaohsiung, Taiwan.
  • Lo CC; Division of Hepatogastroenterology, Department of Internal Medicine, ChiaYi Chang Gung Memorial Hospital, Chiayi, Taiwan.
  • Hung CH; College of Medicine, Chang Gung University, Taoyuan, Taiwan.
  • Huang CW; Division of Gastroenterology, Department of Internal Medicine, St. Martin De Porres Hospital, Chiayi, Taiwan.
  • Chong LW; Division of Hepatogastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan.
  • Cheng PN; Division of Gastroenterology, Kaohsiung Armed Forces General Hospital, Kaohsiung, Taiwan.
  • Yeh ML; Division of Hepatology and Gastroenterology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
  • Peng CY; School of Medicine, Fu-Jen Catholic University, New Taipei City, Taiwan.
  • Cheng CY; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.
  • Huang JF; College of Medicine, National Cheng Kung University, Tainan, Taiwan.
  • Bair MJ; Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, Taiwan.
  • Lin CL; Hepatitis Research Center, College of Medicine, Center for Liquid Biopsy and Cohort Research, Kaohsiung Medical University, Kaohsiung, Taiwan.
  • Yang CC; Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
  • Wang SJ; School of Medicine, China Medical University, Taichung, Taiwan.
  • Hsieh TY; Division of Infectious Diseases, Department of Internal Medicine, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.
  • Lee TH; Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100, Tzyou 1st Road, Kaohsiung, Taiwan.
  • Lee PL; Hepatitis Research Center, College of Medicine, Center for Liquid Biopsy and Cohort Research, Kaohsiung Medical University, Kaohsiung, Taiwan.
  • Wu WC; School of Medicine and Doctoral Program of Clinical and Experimental Medicine, College of Medicine and Center of Excellence for Metabolic Associated Fatty Liver Disease, National Sun Yat-Sen University, Kaohsiung, Taiwan.
  • Lin CL; Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung, Taiwan.
  • Su WW; Mackay Medical College, New Taipei City, Taiwan.
  • Yang SS; Liver Research Unit, Department of Hepato-Gastroenterology and Community Medicine Research Center, Chang Gung Memorial Hospital at Keelung, College of Medicine, Chang Gung University, Keelung, Taiwan.
  • Wang CC; Department of Gastroenterology, Division of Internal Medicine, Show Chwan Memorial Hospital, Changhua, Taiwan.
  • Hu JT; Division of Gastroenterology, Department of Internal Medicine, Yuan's General Hospital, Kaohsiung, Taiwan.
  • Mo LR; Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
  • Chen CT; Division of Gastroenterology and Hepatology, Far Eastern Memorial Hospital, New Taipei City, Taiwan.
  • Huang YH; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chi Mei Medical Center, Liouying, Tainan, Taiwan.
  • Chang CC; Wen-Chih Wu Clinic, Fengshan, Kaohsiung, Taiwan.
  • Huang CS; Department of Gastroenterology, Renai Branch, Taipei City Hospital, Taipei, Taiwan.
  • Chen GY; Department of Gastroenterology and Hepatology, Changhua Christian Hospital, Changhua, Taiwan.
  • Kao CN; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
  • Tai CM; Buddhist Tzu Chi Medical Foundation and School of Medicine, Taipei Tzu Chi Hospital, Tzu Chi University, Taipei, Taiwan.
  • Liu CJ; Liver Center, Cathay General Hospital, Taipei, Taiwan.
  • Lee MH; Division of Gastroenterology, Tainan Municipal Hospital (Managed by Show Chwan Medical Care Corporation), Tainan, Taiwan.
  • Kuo HT; Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
  • Tsai PC; Division of Gastroenterology, Department of Internal Medicine Tri-Service, General Hospital Penghu Branch, National Defense Medical Center, Taipei, Taiwan.
  • Dai CY; Division of Gastroenterology and Hepatology, Department of Medicine; and Healthcare and Service Center, Taipei Veterans General Hospital, Taipei, Taiwan.
  • Kao JH; Institute of Clinical Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
  • Lin HC; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan.
  • Chuang WL; Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
  • Tseng KC; Yang Ming Hospital, Chiayi, Taiwan.
  • Chen CY; Penghu Hospital, Ministry of Health and Welfare, Penghu, Taiwan.
  • Yu ML; National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan.
Infect Dis Ther ; 13(6): 1199-1213, 2024 Jun.
Article en En | MEDLINE | ID: mdl-38679663
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.
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Texto completo: 1 Bases de datos: MEDLINE Idioma: En Revista: Infect Dis Ther Año: 2024 Tipo del documento: Article País de afiliación: Taiwán
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Bases de datos: MEDLINE Idioma: En Revista: Infect Dis Ther Año: 2024 Tipo del documento: Article País de afiliación: Taiwán