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 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; 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

doi:10.1007/s12072-023-10506-z

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^*

^*Corresponding author for this work

School of Traditional Chinese Medicine

Research output: Contribution to journal › Journal Article › peer-review

9 Scopus citations

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 language	English
Pages (from-to)	550-561
Number of pages	12
Journal	Hepatology International
Volume	17
Issue number	3
DOIs	https://doi.org/10.1007/s12072-023-10506-z
State	Published - 06 2023

Bibliographical note

Keywords

Compensated cirrhosis
GLE/PIB
HCV
Sustained virologic response
Hepacivirus/genetics
Humans
Proline
Quinoxalines/adverse effects
Genotype
Taiwan/epidemiology
Liver Cirrhosis/epidemiology
Antiviral Agents/adverse effects
Hepatitis C, Chronic/complications
Registries
Sustained Virologic Response

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s12072-023-10506-z

Cite this

Chang, T. S., Huang, C. F., Kuo, H. T., Lo, C. C., 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., Wu, W. C., ... Yu, M. L. (2023). Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry. Hepatology International, 17(3), 550-561. https://doi.org/10.1007/s12072-023-10506-z

@article{7008f1e1922f46b186bbba3761ac9383,

title = "Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-na{\"i}ve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry",

abstract = "Background: Large-scale real-world data of the 8-week glecaprevir/pibrentasvir (GLE/PIB) therapy for treatment-na{\"i}ve 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-na{\"i}ve 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-na{\"i}ve compensated cirrhosis patients. SVR12 rates were similarly high as in the clinical trials, including those with characteristics of advanced liver disease.",

keywords = "Compensated cirrhosis, GLE/PIB, HCV, Sustained virologic response, Hepacivirus/genetics, Humans, Proline, Quinoxalines/adverse effects, Genotype, Taiwan/epidemiology, Liver Cirrhosis/epidemiology, Antiviral Agents/adverse effects, Hepatitis C, Chronic/complications, Registries, Sustained Virologic Response",

author = "Chang, {Te Sheng} and Huang, {Chung Feng} and Kuo, {Hsing Tao} and Lo, {Ching Chu} 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 Tsai, {Pei Chien} and Dai, {Chia Yen} and Kao, {Jia Horng} and Lin, {Han Chieh} and Chuang, {Wang Long} and Chen, {Chi Yi} and Tseng, {Kuo Chih} and Hung, {Chao Hung} and Yu, {Ming Lung}",

note = "{\textcopyright} 2023. Asian Pacific Association for the Study of the Liver.",

year = "2023",

month = jun,

doi = "10.1007/s12072-023-10506-z",

language = "英语",

volume = "17",

pages = "550--561",

journal = "Hepatology International",

issn = "1936-0533",

publisher = "Springer",

number = "3",

}

Chang, TS, Huang, CF, Kuo, HT, Lo, CC, 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, Tsai, PC, Dai, CY, Kao, JH, Lin, HC, Chuang, WL, Chen, CY, Tseng, KC, Hung, CH & Yu, ML 2023, 'Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry', Hepatology International, vol. 17, no. 3, pp. 550-561. https://doi.org/10.1007/s12072-023-10506-z

Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis: real-world experience from Taiwan nationwide HCV registry. / Chang, Te Sheng; Huang, Chung Feng; Kuo, Hsing Tao et al.
In: Hepatology International, Vol. 17, No. 3, 06.2023, p. 550-561.

Research output: Contribution to journal › Journal Article › peer-review

TY - JOUR

T1 - Effectiveness and safety of 8-week glecaprevir/pibrentasvir in HCV treatment-naïve patients with compensated cirrhosis

T2 - real-world experience from Taiwan nationwide HCV registry

AU - Chang, Te Sheng

AU - Huang, Chung Feng

AU - Kuo, Hsing Tao

AU - Lo, Ching Chu

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 - Tsai, Pei Chien

AU - Dai, Chia Yen

AU - Kao, Jia Horng

AU - Lin, Han Chieh

AU - Chuang, Wang Long

AU - Chen, Chi Yi

AU - Tseng, Kuo Chih

AU - Hung, Chao Hung

AU - Yu, Ming Lung

PY - 2023/6

Y1 - 2023/6

N2 - 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.

AB - 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.

KW - Compensated cirrhosis

KW - GLE/PIB

KW - HCV

KW - Sustained virologic response

KW - Hepacivirus/genetics

KW - Humans

KW - Proline

KW - Quinoxalines/adverse effects

KW - Genotype

KW - Taiwan/epidemiology

KW - Liver Cirrhosis/epidemiology

KW - Antiviral Agents/adverse effects

KW - Hepatitis C, Chronic/complications

KW - Registries

KW - Sustained Virologic Response

UR - http://www.scopus.com/inward/record.url?scp=85150983333&partnerID=8YFLogxK

U2 - 10.1007/s12072-023-10506-z

DO - 10.1007/s12072-023-10506-z

M3 - 文章

C2 - 36973633

AN - SCOPUS:85150983333

SN - 1936-0533

VL - 17

SP - 550

EP - 561

JO - Hepatology International

JF - Hepatology International

IS - 3

ER -

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

Abstract

Bibliographical note

Keywords

UN SDGs

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