An algorithm for simplified hepatitis C virus treatment with non-specialist care based on nation-wide data from Taiwan

Ming Lung Yu; Chi‐Ming ‐M Tai; Lein Ray Mo; Hsing Tao Kuo; Chung Feng Huang; Kuo Chih Tseng; Ching Chu Lo; Ming Jong Bair; Szu Jen Wang; Jee Fu Huang; Ming Lun Yeh; Chun Ting Chen; Ming Chang Tsai; Chien Wei Huang; Pei Lun Lee; Tzeng Hue Yang; Yi Hsiang Huang; Lee Won Chong; Chien Lin Chen; Chi Chieh Yang; Chao Hung Hung; Sheng‐Shun ‐S Yang; Pin Nan Cheng; Tsai Yuan Hsieh; Jui Ting Hu; Wen Chih Wu; Chien Yu Cheng; Guei Ying Chen; Guo Xiong Zhou; Wei Lun Tsai; Chien Neng Kao; Chih Lang Lin; Chia Chi Wang; Ta Ya Lin; Chih‐Lin ‐L Lin; Wei Wen Su; Tzong Hsi Lee; Te Sheng Chang; Chun Jen Liu; Chia Yen Dai; Chi Yi Chen; Jia Horng Kao; Han Chieh Lin; Wan Long Chuang; Cheng Yuan Peng

doi:10.1007/s12072-023-10609-7

An algorithm for simplified hepatitis C virus treatment with non-specialist care based on nation-wide data from Taiwan

Ming Lung Yu, Chi‐Ming ‐M Tai, Lein Ray Mo, Hsing Tao Kuo, Chung Feng Huang, Kuo Chih Tseng, Ching Chu Lo, Ming Jong Bair, Szu Jen Wang, Jee Fu Huang, Ming Lun Yeh, Chun Ting Chen, Ming Chang Tsai, Chien Wei Huang, Pei Lun Lee, Tzeng Hue Yang, Yi Hsiang Huang, Lee Won Chong, Chien Lin Chen, Chi Chieh YangChao Hung Hung, Sheng‐Shun ‐S Yang, Pin Nan Cheng, Tsai Yuan Hsieh, Jui Ting Hu, Wen Chih Wu, Chien Yu Cheng, Guei Ying Chen, Guo Xiong Zhou, Wei Lun Tsai, Chien Neng Kao, Chih Lang Lin, Chia Chi Wang, Ta Ya Lin, Chih‐Lin ‐L Lin, Wei Wen Su, Tzong Hsi Lee, Te Sheng Chang, Chun Jen Liu, Chia Yen Dai, Chi Yi Chen, Jia Horng Kao, Han Chieh Lin, Wan Long Chuang^*, Cheng Yuan Peng^*

^*Corresponding author for this work

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

4 Scopus citations

Abstract

BACKGROUND: Both European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD-IDSA) guidelines recommend simplified hepatitis C virus (HCV) treatment with pan-genotypic sofosbuvir/velpatasvir or glecaprevir/pibrentasvir for eligible patients. This observational study used real-world data to assess these regimens' safety in eligible patients and develop an algorithm to identify patients suitable for simplified treatment by non-specialists.

METHODS: 7,677 HCV-infected patients from Taiwan Hepatitis C Registry (TACR) who received at least one dose of sofosbuvir/velpatasvir or glecaprevir/pibrentasvir, and fulfilled the EASL/AASLD-IDSA criteria for simplified treatment were analyzed. Multivariate analysis was conducted on patient characteristics and safety data.

RESULTS: Overall, 92.8% (7,128/7,677) of patients achieved sustained virological response and only 1.9% (146/7,677) experienced Grades 2-4 laboratory abnormalities in key liver function parameters (alanine aminotransferase, aspartate aminotransferase, and total bilirubin), with only 18 patients (0.23%) experiencing Grades 3-4 abnormalities. Age > 70 years old, presence of hepatocellular carcinoma, total bilirubin > 1.2 mg/dL, estimated glomerular filtration rate < 60 mL/min/1.73 m 2, and Fibrosis-4 > 3.25 were associated with higher risks of Grades 2-4 abnormalities. Patients with any of these had an odds of 4.53 times than that of those without in developing Grades 2-4 abnormalities (p < 0.01).

CONCLUSIONS: Real-world data from Taiwan confirmed that simplified HCV treatment for eligible patients with pan-genotypic regimens is effective and well tolerated. The TACR algorithm, developed based on this study's results, can further identify patients who can be safely managed by non-specialist care.

Original language	English
Pages (from-to)	461-475
Number of pages	15
Journal	Hepatology International
Volume	18
Issue number	2
DOIs	https://doi.org/10.1007/s12072-023-10609-7
State	Published - 04 2024
Externally published	Yes

Bibliographical note

Keywords

American Association for the Study of Liver Diseases and the Infectious Diseases Society of America
Direct-acting antivirals
European Association for the Study of the Liver
Laboratory abnormalities
Liver function
Safety
Simplified treatment
Taiwan hepatitis C registry
glecaprevir/pibrentasvir
sofosbuvir/velpatasvir
Benzimidazoles
Humans
Bilirubin
Quinoxalines/therapeutic use
Heterocyclic Compounds, 4 or More Rings
Lactams, Macrocyclic
Liver Neoplasms/drug therapy
Hepatitis C, Chronic/complications
Proline/analogs & derivatives
Leucine/analogs & derivatives
Hepacivirus/genetics
Cyclopropanes
Genotype
Antiviral Agents
Benzopyrans
Taiwan/epidemiology
Aminoisobutyric Acids
Hepatitis C/drug therapy
Sulfonamides
Sofosbuvir/therapeutic use
Carbamates
Aged

UN SDGs

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

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10.1007/s12072-023-10609-7

Cite this

Yu, M. L., Tai, CM. M., Mo, L. R., Kuo, H. T., Huang, C. F., Tseng, K. C., Lo, C. C., Bair, M. J., Wang, S. J., Huang, J. F., Yeh, M. L., Chen, C. T., Tsai, M. C., Huang, C. W., Lee, P. L., Yang, T. H., Huang, Y. H., Chong, L. W., Chen, C. L., ... Peng, C. Y. (2024). An algorithm for simplified hepatitis C virus treatment with non-specialist care based on nation-wide data from Taiwan. Hepatology International, 18(2), 461-475. https://doi.org/10.1007/s12072-023-10609-7

@article{f066819a3d7a4263900d2b337021416a,

title = "An algorithm for simplified hepatitis C virus treatment with non-specialist care based on nation-wide data from Taiwan",

abstract = "BACKGROUND: Both European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD-IDSA) guidelines recommend simplified hepatitis C virus (HCV) treatment with pan-genotypic sofosbuvir/velpatasvir or glecaprevir/pibrentasvir for eligible patients. This observational study used real-world data to assess these regimens' safety in eligible patients and develop an algorithm to identify patients suitable for simplified treatment by non-specialists.METHODS: 7,677 HCV-infected patients from Taiwan Hepatitis C Registry (TACR) who received at least one dose of sofosbuvir/velpatasvir or glecaprevir/pibrentasvir, and fulfilled the EASL/AASLD-IDSA criteria for simplified treatment were analyzed. Multivariate analysis was conducted on patient characteristics and safety data.RESULTS: Overall, 92.8% (7,128/7,677) of patients achieved sustained virological response and only 1.9% (146/7,677) experienced Grades 2-4 laboratory abnormalities in key liver function parameters (alanine aminotransferase, aspartate aminotransferase, and total bilirubin), with only 18 patients (0.23%) experiencing Grades 3-4 abnormalities. Age > 70 years old, presence of hepatocellular carcinoma, total bilirubin > 1.2 mg/dL, estimated glomerular filtration rate < 60 mL/min/1.73 m 2, and Fibrosis-4 > 3.25 were associated with higher risks of Grades 2-4 abnormalities. Patients with any of these had an odds of 4.53 times than that of those without in developing Grades 2-4 abnormalities (p < 0.01). CONCLUSIONS: Real-world data from Taiwan confirmed that simplified HCV treatment for eligible patients with pan-genotypic regimens is effective and well tolerated. The TACR algorithm, developed based on this study's results, can further identify patients who can be safely managed by non-specialist care.",

keywords = "American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, Direct-acting antivirals, European Association for the Study of the Liver, Laboratory abnormalities, Liver function, Safety, Simplified treatment, Taiwan hepatitis C registry, glecaprevir/pibrentasvir, sofosbuvir/velpatasvir, Benzimidazoles, Humans, Bilirubin, Quinoxalines/therapeutic use, Heterocyclic Compounds, 4 or More Rings, Lactams, Macrocyclic, Liver Neoplasms/drug therapy, Hepatitis C, Chronic/complications, Proline/analogs & derivatives, Leucine/analogs & derivatives, Hepacivirus/genetics, Cyclopropanes, Genotype, Antiviral Agents, Benzopyrans, Taiwan/epidemiology, Aminoisobutyric Acids, Hepatitis C/drug therapy, Sulfonamides, Sofosbuvir/therapeutic use, Carbamates, Aged",

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

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

year = "2024",

month = apr,

doi = "10.1007/s12072-023-10609-7",

language = "英语",

volume = "18",

pages = "461--475",

journal = "Hepatology International",

issn = "1936-0533",

publisher = "Springer",

number = "2",

}

Yu, ML, Tai, CMM, Mo, LR, Kuo, HT, Huang, CF, Tseng, KC, Lo, CC, Bair, MJ, Wang, SJ, Huang, JF, Yeh, ML, Chen, CT, Tsai, MC, Huang, CW, Lee, PL, Yang, TH, Huang, YH, Chong, LW, Chen, CL, Yang, CC, Hung, CH, Yang, SSS, Cheng, PN, Hsieh, TY, Hu, JT, Wu, WC, Cheng, CY, Chen, GY, Zhou, GX, Tsai, WL, Kao, CN, Lin, CL, Wang, CC, Lin, TY, Lin, CLL, Su, WW, Lee, TH, Chang, TS, Liu, CJ, Dai, CY, Chen, CY, Kao, JH, Lin, HC, Chuang, WL & Peng, CY 2024, 'An algorithm for simplified hepatitis C virus treatment with non-specialist care based on nation-wide data from Taiwan', Hepatology International, vol. 18, no. 2, pp. 461-475. https://doi.org/10.1007/s12072-023-10609-7

TY - JOUR

T1 - An algorithm for simplified hepatitis C virus treatment with non-specialist care based on nation-wide data from Taiwan

AU - Yu, Ming Lung

AU - Tai, Chi‐Ming ‐M

AU - Mo, Lein Ray

AU - Kuo, Hsing Tao

AU - Huang, Chung Feng

AU - Tseng, Kuo Chih

AU - Lo, Ching Chu

AU - Bair, Ming Jong

AU - Wang, Szu Jen

AU - Huang, Jee Fu

AU - Yeh, Ming Lun

AU - Chen, Chun Ting

AU - Tsai, Ming Chang

AU - Huang, Chien Wei

AU - Lee, Pei Lun

AU - Yang, Tzeng Hue

AU - Huang, Yi Hsiang

AU - Chong, Lee Won

AU - Chen, Chien Lin

AU - Yang, Chi Chieh

AU - Hung, Chao Hung

AU - Yang, Sheng‐Shun ‐S

AU - Cheng, Pin Nan

AU - Hsieh, Tsai Yuan

AU - Hu, Jui Ting

AU - Wu, Wen Chih

AU - Cheng, Chien Yu

AU - Chen, Guei Ying

AU - Zhou, Guo Xiong

AU - Tsai, Wei Lun

AU - Kao, Chien Neng

AU - Lin, Chih Lang

AU - Wang, Chia Chi

AU - Lin, Ta Ya

AU - Lin, Chih‐Lin ‐L

AU - Su, Wei Wen

AU - Lee, Tzong Hsi

AU - Chang, Te Sheng

AU - Liu, Chun Jen

AU - Dai, Chia Yen

AU - Chen, Chi Yi

AU - Kao, Jia Horng

AU - Lin, Han Chieh

AU - Chuang, Wan Long

AU - Peng, Cheng Yuan

PY - 2024/4

Y1 - 2024/4

N2 - BACKGROUND: Both European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD-IDSA) guidelines recommend simplified hepatitis C virus (HCV) treatment with pan-genotypic sofosbuvir/velpatasvir or glecaprevir/pibrentasvir for eligible patients. This observational study used real-world data to assess these regimens' safety in eligible patients and develop an algorithm to identify patients suitable for simplified treatment by non-specialists.METHODS: 7,677 HCV-infected patients from Taiwan Hepatitis C Registry (TACR) who received at least one dose of sofosbuvir/velpatasvir or glecaprevir/pibrentasvir, and fulfilled the EASL/AASLD-IDSA criteria for simplified treatment were analyzed. Multivariate analysis was conducted on patient characteristics and safety data.RESULTS: Overall, 92.8% (7,128/7,677) of patients achieved sustained virological response and only 1.9% (146/7,677) experienced Grades 2-4 laboratory abnormalities in key liver function parameters (alanine aminotransferase, aspartate aminotransferase, and total bilirubin), with only 18 patients (0.23%) experiencing Grades 3-4 abnormalities. Age > 70 years old, presence of hepatocellular carcinoma, total bilirubin > 1.2 mg/dL, estimated glomerular filtration rate < 60 mL/min/1.73 m 2, and Fibrosis-4 > 3.25 were associated with higher risks of Grades 2-4 abnormalities. Patients with any of these had an odds of 4.53 times than that of those without in developing Grades 2-4 abnormalities (p < 0.01). CONCLUSIONS: Real-world data from Taiwan confirmed that simplified HCV treatment for eligible patients with pan-genotypic regimens is effective and well tolerated. The TACR algorithm, developed based on this study's results, can further identify patients who can be safely managed by non-specialist care.

AB - BACKGROUND: Both European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD-IDSA) guidelines recommend simplified hepatitis C virus (HCV) treatment with pan-genotypic sofosbuvir/velpatasvir or glecaprevir/pibrentasvir for eligible patients. This observational study used real-world data to assess these regimens' safety in eligible patients and develop an algorithm to identify patients suitable for simplified treatment by non-specialists.METHODS: 7,677 HCV-infected patients from Taiwan Hepatitis C Registry (TACR) who received at least one dose of sofosbuvir/velpatasvir or glecaprevir/pibrentasvir, and fulfilled the EASL/AASLD-IDSA criteria for simplified treatment were analyzed. Multivariate analysis was conducted on patient characteristics and safety data.RESULTS: Overall, 92.8% (7,128/7,677) of patients achieved sustained virological response and only 1.9% (146/7,677) experienced Grades 2-4 laboratory abnormalities in key liver function parameters (alanine aminotransferase, aspartate aminotransferase, and total bilirubin), with only 18 patients (0.23%) experiencing Grades 3-4 abnormalities. Age > 70 years old, presence of hepatocellular carcinoma, total bilirubin > 1.2 mg/dL, estimated glomerular filtration rate < 60 mL/min/1.73 m 2, and Fibrosis-4 > 3.25 were associated with higher risks of Grades 2-4 abnormalities. Patients with any of these had an odds of 4.53 times than that of those without in developing Grades 2-4 abnormalities (p < 0.01). CONCLUSIONS: Real-world data from Taiwan confirmed that simplified HCV treatment for eligible patients with pan-genotypic regimens is effective and well tolerated. The TACR algorithm, developed based on this study's results, can further identify patients who can be safely managed by non-specialist care.

KW - American Association for the Study of Liver Diseases and the Infectious Diseases Society of America

KW - Direct-acting antivirals

KW - European Association for the Study of the Liver

KW - Laboratory abnormalities

KW - Liver function

KW - Safety

KW - Simplified treatment

KW - Taiwan hepatitis C registry

KW - glecaprevir/pibrentasvir

KW - sofosbuvir/velpatasvir

KW - Benzimidazoles

KW - Humans

KW - Bilirubin

KW - Quinoxalines/therapeutic use

KW - Heterocyclic Compounds, 4 or More Rings

KW - Lactams, Macrocyclic

KW - Liver Neoplasms/drug therapy

KW - Hepatitis C, Chronic/complications

KW - Proline/analogs & derivatives

KW - Leucine/analogs & derivatives

KW - Hepacivirus/genetics

KW - Cyclopropanes

KW - Genotype

KW - Antiviral Agents

KW - Benzopyrans

KW - Taiwan/epidemiology

KW - Aminoisobutyric Acids

KW - Hepatitis C/drug therapy

KW - Sulfonamides

KW - Sofosbuvir/therapeutic use

KW - Carbamates

KW - Aged

UR - http://www.scopus.com/inward/record.url?scp=85182676235&partnerID=8YFLogxK

U2 - 10.1007/s12072-023-10609-7

DO - 10.1007/s12072-023-10609-7

M3 - 文章

C2 - 38246899

AN - SCOPUS:85182676235

SN - 1936-0533

VL - 18

SP - 461

EP - 475

JO - Hepatology International

JF - Hepatology International

IS - 2

ER -

An algorithm for simplified hepatitis C virus treatment with non-specialist care based on nation-wide data from Taiwan

Abstract

Bibliographical note

Keywords

UN SDGs

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