Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan

Szu Jen Wang; 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; Hsing Tao Kuo; 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; Kuo Chih Tseng; Chi Yi Chen; Shu Chi Wang; Ming Lung Yu

doi:10.1002/kjm2.12929

Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan

Szu Jen Wang, 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, Hsing Tao Kuo, 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, Pei Chien Tsai, Chia Yen Dai, Jia Horng Kao, Han Chieh Lin, Wang Long Chuang, Kuo Chih Tseng, Chi Yi Chen, Shu Chi Wang, Ming Lung Yu^*

^*Corresponding author for this work

School of Traditional Chinese Medicine

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

Abstract

An 8-week regimen of glecaprevir/pibrentasvir is recommended for treatment-naïve patients with chronic hepatitis C (CHC). In alignment with the Taiwanese government's objective to eliminate hepatitis C by 2025, this study aimed to provide real-world evidence on the use of this regimen in treatment-naïve patients with chronic kidney disease (CKD) by using data from the Taiwan Association for the Study of the Liver HCV Registry (TACR). CKD was defined by an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m 2 or higher with proteinuria persisting for over 3 months. Patients were categorized as having early CKD (eGFR ≥45 mL/min/1.73 m 2) or pre-end-stage renal disease (pre-ESRD) (eGFR <45 mL/min/1.73 m 2). Among 1072 patients who received at least one dose of the regimen, 1054 had available data for assessing sustained virologic response at 12 weeks posttreatment (SVR12). The overall SVR12 rate was 99.6%, with rates of 99.7% for pre-ESRD patients and 99.6% for early CKD patients. Subgroup analysis showed 100% efficacy for genotype 3 and dyslipidemia, 99.5% for diabetes, 99.4% for cardiovascular disease, 96.9% for a history of cerebral vascular accident, and 95.5% for patients with a history of drug injection or HIV co-infection. Adverse events were reported in 16.8% of patients, with 0.8% experiencing serious events, and only two cases were treatment-related. Renal function significantly improved, with overall eGFR increasing from 39.2 to 41.9 mL/min/1.73 m 2. Early CKD patients showed an eGFR rise from 53.5 to 57.1, while pre-ESRD patients improved from 27.1 to 29.2 at SVR12. The study concluded that the 8-week regimen is highly effective, well-tolerated, and associated with significant renal function improvement in treatment-naïve CHC patients with both early CKD and pre-ESRD.

Original language	English
Article number	e12929
Pages (from-to)	e12929
Journal	Kaohsiung Journal of Medical Sciences
Volume	41
Issue number	2
DOIs	https://doi.org/10.1002/kjm2.12929
State	Published - 02 2025

Bibliographical note

Keywords

chronic hepatitis C (CHC)
chronic kidney disease (CKD)
direct-acting antivirals (DAA)
end-stage renal disease (ESRD)
real-world
Humans
Middle Aged
Renal Insufficiency, Chronic/drug therapy
Male
Quinoxalines/therapeutic use
Lactams, Macrocyclic
Sulfonamides/therapeutic use
Female
Hepatitis C, Chronic/drug therapy
Registries
Adult
Proline/analogs & derivatives
Leucine/analogs & derivatives
Kidney Failure, Chronic/drug therapy
Glomerular Filtration Rate
Benzimidazoles/therapeutic use
Cyclopropanes
Treatment Outcome
Aminoisobutyric Acids
Antiviral Agents/therapeutic use
Taiwan
Aged
Hepacivirus/drug effects
Sustained Virologic Response
Pyrrolidines/therapeutic use

UN SDGs

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

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Wang, S. J., 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., Kuo, H. T., Hsieh, T. Y., Lee, T. H., Lee, P. L., ... Yu, M. L. (2025). Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan. Kaohsiung Journal of Medical Sciences, 41(2), e12929. Article e12929. https://doi.org/10.1002/kjm2.12929

Wang, Szu Jen ; Huang, Chung Feng ; Chang, Te Sheng et al. / Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease : Insights from a nationwide hepatisis C virus registry in Taiwan. In: Kaohsiung Journal of Medical Sciences. 2025 ; Vol. 41, No. 2. pp. e12929.

@article{e275cd2031cf4494958873938afff2e5,

title = "Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan",

abstract = "An 8-week regimen of glecaprevir/pibrentasvir is recommended for treatment-na{\"i}ve patients with chronic hepatitis C (CHC). In alignment with the Taiwanese government's objective to eliminate hepatitis C by 2025, this study aimed to provide real-world evidence on the use of this regimen in treatment-na{\"i}ve patients with chronic kidney disease (CKD) by using data from the Taiwan Association for the Study of the Liver HCV Registry (TACR). CKD was defined by an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m 2 or higher with proteinuria persisting for over 3 months. Patients were categorized as having early CKD (eGFR ≥45 mL/min/1.73 m 2) or pre-end-stage renal disease (pre-ESRD) (eGFR <45 mL/min/1.73 m 2). Among 1072 patients who received at least one dose of the regimen, 1054 had available data for assessing sustained virologic response at 12 weeks posttreatment (SVR12). The overall SVR12 rate was 99.6%, with rates of 99.7% for pre-ESRD patients and 99.6% for early CKD patients. Subgroup analysis showed 100% efficacy for genotype 3 and dyslipidemia, 99.5% for diabetes, 99.4% for cardiovascular disease, 96.9% for a history of cerebral vascular accident, and 95.5% for patients with a history of drug injection or HIV co-infection. Adverse events were reported in 16.8% of patients, with 0.8% experiencing serious events, and only two cases were treatment-related. Renal function significantly improved, with overall eGFR increasing from 39.2 to 41.9 mL/min/1.73 m 2. Early CKD patients showed an eGFR rise from 53.5 to 57.1, while pre-ESRD patients improved from 27.1 to 29.2 at SVR12. The study concluded that the 8-week regimen is highly effective, well-tolerated, and associated with significant renal function improvement in treatment-na{\"i}ve CHC patients with both early CKD and pre-ESRD. ",

keywords = "chronic hepatitis C (CHC), chronic kidney disease (CKD), direct-acting antivirals (DAA), end-stage renal disease (ESRD), real-world, Humans, Middle Aged, Renal Insufficiency, Chronic/drug therapy, Male, Quinoxalines/therapeutic use, Lactams, Macrocyclic, Sulfonamides/therapeutic use, Female, Hepatitis C, Chronic/drug therapy, Registries, Adult, Proline/analogs & derivatives, Leucine/analogs & derivatives, Kidney Failure, Chronic/drug therapy, Glomerular Filtration Rate, Benzimidazoles/therapeutic use, Cyclopropanes, Treatment Outcome, Aminoisobutyric Acids, Antiviral Agents/therapeutic use, Taiwan, Aged, Hepacivirus/drug effects, Sustained Virologic Response, Pyrrolidines/therapeutic use",

author = "Wang, {Szu Jen} 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 Kuo, {Hsing Tao} 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 Tseng, {Kuo Chih} and Chen, {Chi Yi} and Wang, {Shu Chi} and Yu, {Ming Lung}",

note = "{\textcopyright} 2025 The Author(s). The Kaohsiung Journal of Medical Sciences published by John Wiley & Sons Australia, Ltd on behalf of Kaohsiung Medical University.",

year = "2025",

month = feb,

doi = "10.1002/kjm2.12929",

language = "英语",

volume = "41",

pages = "e12929",

journal = "Kaohsiung Journal of Medical Sciences",

issn = "1607-551X",

publisher = "John Wiley and Sons Inc",

number = "2",

}

Wang, SJ, 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, Kuo, HT, 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, Tseng, KC, Chen, CY, Wang, SC & Yu, ML 2025, 'Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan', Kaohsiung Journal of Medical Sciences, vol. 41, no. 2, e12929, pp. e12929. https://doi.org/10.1002/kjm2.12929

Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan. / Wang, Szu Jen; Huang, Chung Feng; Chang, Te Sheng et al.
In: Kaohsiung Journal of Medical Sciences, Vol. 41, No. 2, e12929, 02.2025, p. e12929.

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

TY - JOUR

T1 - Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease

T2 - Insights from a nationwide hepatisis C virus registry in Taiwan

AU - Wang, Szu Jen

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 - Kuo, Hsing Tao

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 - Tseng, Kuo Chih

AU - Chen, Chi Yi

AU - Wang, Shu Chi

AU - Yu, Ming Lung

PY - 2025/2

Y1 - 2025/2

N2 - An 8-week regimen of glecaprevir/pibrentasvir is recommended for treatment-naïve patients with chronic hepatitis C (CHC). In alignment with the Taiwanese government's objective to eliminate hepatitis C by 2025, this study aimed to provide real-world evidence on the use of this regimen in treatment-naïve patients with chronic kidney disease (CKD) by using data from the Taiwan Association for the Study of the Liver HCV Registry (TACR). CKD was defined by an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m 2 or higher with proteinuria persisting for over 3 months. Patients were categorized as having early CKD (eGFR ≥45 mL/min/1.73 m 2) or pre-end-stage renal disease (pre-ESRD) (eGFR <45 mL/min/1.73 m 2). Among 1072 patients who received at least one dose of the regimen, 1054 had available data for assessing sustained virologic response at 12 weeks posttreatment (SVR12). The overall SVR12 rate was 99.6%, with rates of 99.7% for pre-ESRD patients and 99.6% for early CKD patients. Subgroup analysis showed 100% efficacy for genotype 3 and dyslipidemia, 99.5% for diabetes, 99.4% for cardiovascular disease, 96.9% for a history of cerebral vascular accident, and 95.5% for patients with a history of drug injection or HIV co-infection. Adverse events were reported in 16.8% of patients, with 0.8% experiencing serious events, and only two cases were treatment-related. Renal function significantly improved, with overall eGFR increasing from 39.2 to 41.9 mL/min/1.73 m 2. Early CKD patients showed an eGFR rise from 53.5 to 57.1, while pre-ESRD patients improved from 27.1 to 29.2 at SVR12. The study concluded that the 8-week regimen is highly effective, well-tolerated, and associated with significant renal function improvement in treatment-naïve CHC patients with both early CKD and pre-ESRD.

AB - An 8-week regimen of glecaprevir/pibrentasvir is recommended for treatment-naïve patients with chronic hepatitis C (CHC). In alignment with the Taiwanese government's objective to eliminate hepatitis C by 2025, this study aimed to provide real-world evidence on the use of this regimen in treatment-naïve patients with chronic kidney disease (CKD) by using data from the Taiwan Association for the Study of the Liver HCV Registry (TACR). CKD was defined by an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m 2 or higher with proteinuria persisting for over 3 months. Patients were categorized as having early CKD (eGFR ≥45 mL/min/1.73 m 2) or pre-end-stage renal disease (pre-ESRD) (eGFR <45 mL/min/1.73 m 2). Among 1072 patients who received at least one dose of the regimen, 1054 had available data for assessing sustained virologic response at 12 weeks posttreatment (SVR12). The overall SVR12 rate was 99.6%, with rates of 99.7% for pre-ESRD patients and 99.6% for early CKD patients. Subgroup analysis showed 100% efficacy for genotype 3 and dyslipidemia, 99.5% for diabetes, 99.4% for cardiovascular disease, 96.9% for a history of cerebral vascular accident, and 95.5% for patients with a history of drug injection or HIV co-infection. Adverse events were reported in 16.8% of patients, with 0.8% experiencing serious events, and only two cases were treatment-related. Renal function significantly improved, with overall eGFR increasing from 39.2 to 41.9 mL/min/1.73 m 2. Early CKD patients showed an eGFR rise from 53.5 to 57.1, while pre-ESRD patients improved from 27.1 to 29.2 at SVR12. The study concluded that the 8-week regimen is highly effective, well-tolerated, and associated with significant renal function improvement in treatment-naïve CHC patients with both early CKD and pre-ESRD.

KW - chronic hepatitis C (CHC)

KW - chronic kidney disease (CKD)

KW - direct-acting antivirals (DAA)

KW - end-stage renal disease (ESRD)

KW - real-world

KW - Humans

KW - Middle Aged

KW - Renal Insufficiency, Chronic/drug therapy

KW - Male

KW - Quinoxalines/therapeutic use

KW - Lactams, Macrocyclic

KW - Sulfonamides/therapeutic use

KW - Female

KW - Hepatitis C, Chronic/drug therapy

KW - Registries

KW - Adult

KW - Proline/analogs & derivatives

KW - Leucine/analogs & derivatives

KW - Kidney Failure, Chronic/drug therapy

KW - Glomerular Filtration Rate

KW - Benzimidazoles/therapeutic use

KW - Cyclopropanes

KW - Treatment Outcome

KW - Aminoisobutyric Acids

KW - Antiviral Agents/therapeutic use

KW - Taiwan

KW - Aged

KW - Hepacivirus/drug effects

KW - Sustained Virologic Response

KW - Pyrrolidines/therapeutic use

UR - http://www.scopus.com/inward/record.url?scp=85215534489&partnerID=8YFLogxK

U2 - 10.1002/kjm2.12929

DO - 10.1002/kjm2.12929

M3 - 文章

C2 - 39829106

AN - SCOPUS:85215534489

SN - 1607-551X

VL - 41

SP - e12929

JO - Kaohsiung Journal of Medical Sciences

JF - Kaohsiung Journal of Medical Sciences

IS - 2

M1 - e12929

ER -

Wang SJ, Huang CF, Chang TS, Lo CC, Hung CH, Huang CW et al. Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan. Kaohsiung Journal of Medical Sciences. 2025 Feb;41(2):e12929. e12929. doi: 10.1002/kjm2.12929

Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan

Abstract

Bibliographical note

Keywords

UN SDGs

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