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:10.1007/s40121-024-00968-5

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^*

^*Corresponding author for this work

School of Traditional Chinese Medicine

Research output: Contribution to journal › Journal Article › peer-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 language	English
Pages (from-to)	1199-1213
Number of pages	15
Journal	Infectious Diseases and Therapy
Volume	13
Issue number	6
DOIs	https://doi.org/10.1007/s40121-024-00968-5
State	Published - 06 2024

Bibliographical note

Keywords

Direct-acting antivirals
Glecaprevir
Hepatitis C
Pibrentasvir
Real world
Taiwan

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10.1007/s40121-024-00968-5

Cite this

Yang, C. C., Huang, C. F., Chang, T. S., Lo, C. C., Hung, C. H., Huang, C. W., Chong, L. W., Cheng, P. N., Yeh, M. L., Peng, C. Y., Cheng, C. Y., Huang, J. F., Bair, M. J., Lin, C. L., Yang, C. C., Wang, S. J., Hsieh, T. Y., Lee, T. H., Lee, P. L., ... Yu, M. L. (2024). Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan. Infectious Diseases and Therapy, 13(6), 1199-1213. https://doi.org/10.1007/s40121-024-00968-5

@article{62a142a57b234aeba4874a7a4ebb10e5,

title = "Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Na{\"i}ve Patients from a Nationwide HCV Registry in Taiwan",

abstract = "Introduction: Eight-week glecaprevir/pibrentasvir (GLE/PIB) is indicated for treatment-na{\"i}ve (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 = "Direct-acting antivirals, Glecaprevir, Hepatitis C, Pibrentasvir, Real world, Taiwan",

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

note = "{\textcopyright} 2024. The Author(s).",

year = "2024",

month = jun,

doi = "10.1007/s40121-024-00968-5",

language = "英语",

volume = "13",

pages = "1199--1213",

journal = "Infectious Diseases and Therapy",

issn = "2193-8229",

publisher = "Springer Healthcare",

number = "6",

}

Yang, CC, Huang, CF, Chang, TS, Lo, CC, Hung, CH, Huang, CW, Chong, LW, Cheng, PN, Yeh, ML, Peng, CY, Cheng, CY, Huang, JF, Bair, MJ, Lin, CL, Yang, CC, Wang, SJ, Hsieh, TY, Lee, TH, Lee, PL, Wu, WC, Lin, CL, Su, WW, Yang, SS, Wang, CC, Hu, JT, Mo, LR, Chen, CT, Huang, YH, Chang, CC, Huang, CS, Chen, GY, Kao, CN, Tai, CM, Liu, CJ, Lee, MH, Kuo, HT, Tsai, PC, Dai, CY, Kao, JH, Lin, HC, Chuang, WL, Tseng, KC, Chen, CY & Yu, ML 2024, 'Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan', Infectious Diseases and Therapy, vol. 13, no. 6, pp. 1199-1213. https://doi.org/10.1007/s40121-024-00968-5

TY - JOUR

T1 - Real-World Efficacy and Safety of Universal 8-Week Glecaprevir/Pibrentasvir for Treatment-Naïve Patients from a Nationwide HCV Registry in Taiwan

AU - Yang, Chun Chi

AU - Huang, Chung Feng

AU - Chang, Te Sheng

AU - Lo, Ching Chu

AU - Hung, Chao Hung

AU - Huang, Chien Wei

AU - Chong, Lee Won

AU - Cheng, Pin Nan

AU - Yeh, Ming Lun

AU - Peng, Cheng Yuan

AU - Cheng, Chien Yu

AU - Huang, Jee Fu

AU - Bair, Ming Jong

AU - Lin, Chih Lang

AU - Yang, Chi Chieh

AU - Wang, Szu Jen

AU - Hsieh, Tsai Yuan

AU - Lee, Tzong Hsi

AU - Lee, Pei Lun

AU - Wu, Wen Chih

AU - Lin, Chih Lin

AU - Su, Wei Wen

AU - Yang, Sheng Shun

AU - Wang, Chia Chi

AU - Hu, Jui Ting

AU - Mo, Lein Ray

AU - Chen, Chun Ting

AU - Huang, Yi Hsiang

AU - Chang, Chun Chao

AU - Huang, Chia Sheng

AU - Chen, Guei Ying

AU - Kao, Chien Neng

AU - Tai, Chi Ming

AU - Liu, Chun Jen

AU - Lee, Mei Hsuan

AU - Kuo, Hsing Tao

AU - Tsai, Pei Chien

AU - Dai, Chia Yen

AU - Kao, Jia Horng

AU - Lin, Han Chieh

AU - Chuang, Wang Long

AU - Tseng, Kuo Chih

AU - Chen, Chi Yi

AU - Yu, Ming Lung

PY - 2024/6

Y1 - 2024/6

N2 - 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.

AB - 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.

KW - Direct-acting antivirals

KW - Glecaprevir

KW - Hepatitis C

KW - Pibrentasvir

KW - Real world

KW - Taiwan

UR - http://www.scopus.com/inward/record.url?scp=85191756387&partnerID=8YFLogxK

U2 - 10.1007/s40121-024-00968-5

DO - 10.1007/s40121-024-00968-5

M3 - 文章

C2 - 38679663

AN - SCOPUS:85191756387

SN - 2193-8229

VL - 13

SP - 1199

EP - 1213

JO - Infectious Diseases and Therapy

JF - Infectious Diseases and Therapy

IS - 6

ER -

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

Abstract

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Keywords

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