Factors associated with treatment failure of direct-acting antivirals for chronic hepatitis C: A real-world nationwide hepatitis C virus registry programme in Taiwan

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

doi:10.1111/liv.14849

Factors associated with treatment failure of direct-acting antivirals for chronic hepatitis C: A real-world nationwide hepatitis C virus registry programme in Taiwan

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

Department of Internal Medicine(NCKUH)

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

13 Citations (Scopus)

Abstract

Background/aims: Direct-acting antivirals (DAAs) are highly effective in treating chronic hepatitis C virus (HCV)-infected patients. The real-world treatment outcome in Taiwanese patients on a nationwide basis is elusive. Methods: The Taiwan HCV Registry (TACR) programme is a nationwide registry platform including 48 study sites, which is organized and supervised by the Taiwan Association for the Study of the Liver. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA 12 weeks after end-of-treatment). Results: A total of 13 951 registered patients with SVR12 data available were analysed (mean age, 63.0 years; female, 55.9%; HCV genotype-1 [GT1], 57.9%; cirrhosis, 38.4%; preexisting hepatocellular carcinoma [HCC], 10.6%; and hepatitis B virus coinfection, 7.7%). The overall SVR12 rate was 98.3%, with 98.7%, 98.0%, 98.4% and 97.4% in treatment-naïve noncirrhotic, treatment-naïve cirrhotic, treatment-experienced noncirrhotic and treatment-experienced cirrhotic patients, respectively. The SVR12 rate was > 95% across all subgroups except treatment-experienced cirrhotic patients who received sofosbuvir/ribavirin (88.7%), treatment-naïve noncirrhotic patients (94.8%) and treatment-experienced cirrhotic (94.8%) patients who received daclatasvir/asunaprevir. The most important factor associated with treatment failure was DAA adherence < 60% (adjusted odds ratio [aOR]/95% confidence interval [CI]: 117.1/52.4-261.3, P <.001), followed by GT3/GT2 (aOR/CI: 5.78/2.25-14.9, P =.0003 and aOR/CI: 1.55/1.05-2.29, P =.03, compared with GT1), active hepatocellular carcinoma (aOR/CI: 4.29/2.57-7.16, P <.001), the use of sofosbuvir/ribavirin (aOR/CI: 2.51/1.67-3.77, P <.001) and daclatasvir/asunaprevir (aOR/CI: 3.29/1.94-5.58, P <.001), decompensated liver cirrhosis (aOR/CI: 2.50/1.20-5.22, P =.02) and high HCV viral loads (aOR/CI: 2.16/1.57-2.97, P <.001). Conclusions: DAAs are highly effective in treating Taiwanese HCV patients in the real-world setting. Maintaining DAA adherence and selecting highly efficacious regimens are keys to ensure treatment success.

Original language	English
Pages (from-to)	1265-1277
Number of pages	13
Journal	Liver International
Volume	41
Issue number	6
DOIs	https://doi.org/10.1111/liv.14849
Publication status	Published - 2021 Jun

All Science Journal Classification (ASJC) codes

Hepatology

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10.1111/liv.14849

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Chen, C. Y., Huang, C. F., Cheng, P. N., Tseng, K. C., Lo, C. C., Kuo, H. T., Huang, Y. H., Tai, C. M., Peng, C. Y., Bair, M. J., Chen, C. H., Yeh, M. L., Lin, C. L., Lin, C. Y., Lee, P. L., Chong, L. W., Hung, C. H., Huang, J. F., Yang, C. C., ... Yu, M. L. (2021). Factors associated with treatment failure of direct-acting antivirals for chronic hepatitis C: A real-world nationwide hepatitis C virus registry programme in Taiwan. Liver International, 41(6), 1265-1277. https://doi.org/10.1111/liv.14849

@article{b5ffa0e3b51a403795771d7a2a97e10d,

title = "Factors associated with treatment failure of direct-acting antivirals for chronic hepatitis C: A real-world nationwide hepatitis C virus registry programme in Taiwan",

abstract = "Background/aims: Direct-acting antivirals (DAAs) are highly effective in treating chronic hepatitis C virus (HCV)-infected patients. The real-world treatment outcome in Taiwanese patients on a nationwide basis is elusive. Methods: The Taiwan HCV Registry (TACR) programme is a nationwide registry platform including 48 study sites, which is organized and supervised by the Taiwan Association for the Study of the Liver. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA 12 weeks after end-of-treatment). Results: A total of 13 951 registered patients with SVR12 data available were analysed (mean age, 63.0 years; female, 55.9%; HCV genotype-1 [GT1], 57.9%; cirrhosis, 38.4%; preexisting hepatocellular carcinoma [HCC], 10.6%; and hepatitis B virus coinfection, 7.7%). The overall SVR12 rate was 98.3%, with 98.7%, 98.0%, 98.4% and 97.4% in treatment-na{\"i}ve noncirrhotic, treatment-na{\"i}ve cirrhotic, treatment-experienced noncirrhotic and treatment-experienced cirrhotic patients, respectively. The SVR12 rate was > 95% across all subgroups except treatment-experienced cirrhotic patients who received sofosbuvir/ribavirin (88.7%), treatment-na{\"i}ve noncirrhotic patients (94.8%) and treatment-experienced cirrhotic (94.8%) patients who received daclatasvir/asunaprevir. The most important factor associated with treatment failure was DAA adherence < 60% (adjusted odds ratio [aOR]/95% confidence interval [CI]: 117.1/52.4-261.3, P <.001), followed by GT3/GT2 (aOR/CI: 5.78/2.25-14.9, P =.0003 and aOR/CI: 1.55/1.05-2.29, P =.03, compared with GT1), active hepatocellular carcinoma (aOR/CI: 4.29/2.57-7.16, P <.001), the use of sofosbuvir/ribavirin (aOR/CI: 2.51/1.67-3.77, P <.001) and daclatasvir/asunaprevir (aOR/CI: 3.29/1.94-5.58, P <.001), decompensated liver cirrhosis (aOR/CI: 2.50/1.20-5.22, P =.02) and high HCV viral loads (aOR/CI: 2.16/1.57-2.97, P <.001). Conclusions: DAAs are highly effective in treating Taiwanese HCV patients in the real-world setting. Maintaining DAA adherence and selecting highly efficacious regimens are keys to ensure treatment success.",

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

note = "Funding Information: The study was also supported by grants from Kaohsiung Medical University (MOST 109‐2314‐B‐037‐044) and Kaohsiung Medical University Hospital (KMUH‐DK(整)109005 ~ 1, KMUH‐DK(世)109002, KMUH108‐8R05, KMUH108‐8R09, MOHW109‐TDU‐B‐212‐114006 and MOST 109‐2314‐B‐037‐044). Funding Information: The study was also supported by grants from Kaohsiung Medical University (MOST 109-2314-B-037-044) and Kaohsiung Medical University Hospital (KMUH-DK(整)109005 ~ 1, KMUH-DK(世)109002, KMUH108-8R05, KMUH108-8R09, MOHW109-TDU-B-212-114006 and MOST 109-2314-B-037-044). The authors would like to thank the Taiwan Association for the Study of Liver (TASL), the TASL Foundation and Taiwan Liver Research Foundation for grant support and the TACR study group for data collection. We also thank the Center for Medical informatics and Statistics of Kaohsiung Medical University for providing administrative and funding support. Funding Information: The authors would like to thank the Taiwan Association for the Study of Liver (TASL), the TASL Foundation and Taiwan Liver Research Foundation for grant support and the TACR study group for data collection. We also thank the Center for Medical informatics and Statistics of Kaohsiung Medical University for providing administrative and funding support. Publisher Copyright: {\textcopyright} 2021 The Authors. Liver International published by John Wiley & Sons Ltd.",

year = "2021",

month = jun,

doi = "10.1111/liv.14849",

language = "English",

volume = "41",

pages = "1265--1277",

journal = "Liver International",

issn = "1478-3223",

publisher = "Wiley-Blackwell",

number = "6",

}

Chen, CY, Huang, CF, Cheng, PN, Tseng, KC, Lo, CC, Kuo, HT, Huang, YH, Tai, CM, Peng, CY, Bair, MJ, Chen, CH, Yeh, ML, Lin, CL, Lin, CY, Lee, PL, Chong, LW, Hung, CH, Huang, JF, Yang, CC, Hu, JT, Lin, CW, Chen, CT, Wang, CC, Su, WW, Hsieh, TY, Lin, CL, Tsai, WL, Lee, TH, Chen, GY, Wang, SJ, Chang, CC, Mo, LR, Yang, SS, Wu, WC, Huang, CS, Hsiung, CK, Kao, CN, Tsai, PC, Liu, CH, Lee, MH, Liu, CJ, Dai, CY, Kao, JH, Chuang, WL, Lin, HC & Yu, ML 2021, 'Factors associated with treatment failure of direct-acting antivirals for chronic hepatitis C: A real-world nationwide hepatitis C virus registry programme in Taiwan', Liver International, vol. 41, no. 6, pp. 1265-1277. https://doi.org/10.1111/liv.14849

TY - JOUR

T1 - Factors associated with treatment failure of direct-acting antivirals for chronic hepatitis C

T2 - A real-world nationwide hepatitis C virus registry programme in Taiwan

AU - Chen, Chi Yi

AU - Huang, Chung Feng

AU - Cheng, Pin Nan

AU - Tseng, Kuo Chih

AU - Lo, Ching Chu

AU - Kuo, Hsing Tao

AU - Huang, Yi Hsiang

AU - Tai, Chi Ming

AU - Peng, Cheng Yuan

AU - Bair, Ming Jong

AU - Chen, Chien Hung

AU - Yeh, Ming Lun

AU - Lin, Chih Lang

AU - Lin, Chun Yen

AU - Lee, Pei Lun

AU - Chong, Lee Won

AU - Hung, Chao Hung

AU - Huang, Jee Fu

AU - Yang, Chi Chieh

AU - Hu, Jui Ting

AU - Lin, Chih Wen

AU - Chen, Chun Ting

AU - Wang, Chia Chi

AU - Su, Wei Wen

AU - Hsieh, Tsai Yuan

AU - Lin, Chih Lin

AU - Tsai, Wei Lun

AU - Lee, Tzong Hsi

AU - Chen, Guei Ying

AU - Wang, Szu Jen

AU - Chang, Chun Chao

AU - Mo, Lein Ray

AU - Yang, Sheng Shun

AU - Wu, Wen Chih

AU - Huang, Chia Sheng

AU - Hsiung, Chou Kwok

AU - Kao, Chien Neng

AU - Tsai, Pei Chien

AU - Liu, Chen Hua

AU - Lee, Mei Hsuan

AU - Liu, Chun Jen

AU - Dai, Chia Yen

AU - Kao, Jia Horng

AU - Chuang, Wan Long

AU - Lin, Han Chieh

AU - Yu, Ming Lung

N1 - Funding Information: The study was also supported by grants from Kaohsiung Medical University (MOST 109‐2314‐B‐037‐044) and Kaohsiung Medical University Hospital (KMUH‐DK(整)109005 ~ 1, KMUH‐DK(世)109002, KMUH108‐8R05, KMUH108‐8R09, MOHW109‐TDU‐B‐212‐114006 and MOST 109‐2314‐B‐037‐044). Funding Information: The study was also supported by grants from Kaohsiung Medical University (MOST 109-2314-B-037-044) and Kaohsiung Medical University Hospital (KMUH-DK(整)109005 ~ 1, KMUH-DK(世)109002, KMUH108-8R05, KMUH108-8R09, MOHW109-TDU-B-212-114006 and MOST 109-2314-B-037-044). The authors would like to thank the Taiwan Association for the Study of Liver (TASL), the TASL Foundation and Taiwan Liver Research Foundation for grant support and the TACR study group for data collection. We also thank the Center for Medical informatics and Statistics of Kaohsiung Medical University for providing administrative and funding support. Funding Information: The authors would like to thank the Taiwan Association for the Study of Liver (TASL), the TASL Foundation and Taiwan Liver Research Foundation for grant support and the TACR study group for data collection. We also thank the Center for Medical informatics and Statistics of Kaohsiung Medical University for providing administrative and funding support. Publisher Copyright: © 2021 The Authors. Liver International published by John Wiley & Sons Ltd.

PY - 2021/6

Y1 - 2021/6

N2 - Background/aims: Direct-acting antivirals (DAAs) are highly effective in treating chronic hepatitis C virus (HCV)-infected patients. The real-world treatment outcome in Taiwanese patients on a nationwide basis is elusive. Methods: The Taiwan HCV Registry (TACR) programme is a nationwide registry platform including 48 study sites, which is organized and supervised by the Taiwan Association for the Study of the Liver. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA 12 weeks after end-of-treatment). Results: A total of 13 951 registered patients with SVR12 data available were analysed (mean age, 63.0 years; female, 55.9%; HCV genotype-1 [GT1], 57.9%; cirrhosis, 38.4%; preexisting hepatocellular carcinoma [HCC], 10.6%; and hepatitis B virus coinfection, 7.7%). The overall SVR12 rate was 98.3%, with 98.7%, 98.0%, 98.4% and 97.4% in treatment-naïve noncirrhotic, treatment-naïve cirrhotic, treatment-experienced noncirrhotic and treatment-experienced cirrhotic patients, respectively. The SVR12 rate was > 95% across all subgroups except treatment-experienced cirrhotic patients who received sofosbuvir/ribavirin (88.7%), treatment-naïve noncirrhotic patients (94.8%) and treatment-experienced cirrhotic (94.8%) patients who received daclatasvir/asunaprevir. The most important factor associated with treatment failure was DAA adherence < 60% (adjusted odds ratio [aOR]/95% confidence interval [CI]: 117.1/52.4-261.3, P <.001), followed by GT3/GT2 (aOR/CI: 5.78/2.25-14.9, P =.0003 and aOR/CI: 1.55/1.05-2.29, P =.03, compared with GT1), active hepatocellular carcinoma (aOR/CI: 4.29/2.57-7.16, P <.001), the use of sofosbuvir/ribavirin (aOR/CI: 2.51/1.67-3.77, P <.001) and daclatasvir/asunaprevir (aOR/CI: 3.29/1.94-5.58, P <.001), decompensated liver cirrhosis (aOR/CI: 2.50/1.20-5.22, P =.02) and high HCV viral loads (aOR/CI: 2.16/1.57-2.97, P <.001). Conclusions: DAAs are highly effective in treating Taiwanese HCV patients in the real-world setting. Maintaining DAA adherence and selecting highly efficacious regimens are keys to ensure treatment success.

AB - Background/aims: Direct-acting antivirals (DAAs) are highly effective in treating chronic hepatitis C virus (HCV)-infected patients. The real-world treatment outcome in Taiwanese patients on a nationwide basis is elusive. Methods: The Taiwan HCV Registry (TACR) programme is a nationwide registry platform including 48 study sites, which is organized and supervised by the Taiwan Association for the Study of the Liver. The primary endpoint was sustained virological response (SVR12, undetectable HCV RNA 12 weeks after end-of-treatment). Results: A total of 13 951 registered patients with SVR12 data available were analysed (mean age, 63.0 years; female, 55.9%; HCV genotype-1 [GT1], 57.9%; cirrhosis, 38.4%; preexisting hepatocellular carcinoma [HCC], 10.6%; and hepatitis B virus coinfection, 7.7%). The overall SVR12 rate was 98.3%, with 98.7%, 98.0%, 98.4% and 97.4% in treatment-naïve noncirrhotic, treatment-naïve cirrhotic, treatment-experienced noncirrhotic and treatment-experienced cirrhotic patients, respectively. The SVR12 rate was > 95% across all subgroups except treatment-experienced cirrhotic patients who received sofosbuvir/ribavirin (88.7%), treatment-naïve noncirrhotic patients (94.8%) and treatment-experienced cirrhotic (94.8%) patients who received daclatasvir/asunaprevir. The most important factor associated with treatment failure was DAA adherence < 60% (adjusted odds ratio [aOR]/95% confidence interval [CI]: 117.1/52.4-261.3, P <.001), followed by GT3/GT2 (aOR/CI: 5.78/2.25-14.9, P =.0003 and aOR/CI: 1.55/1.05-2.29, P =.03, compared with GT1), active hepatocellular carcinoma (aOR/CI: 4.29/2.57-7.16, P <.001), the use of sofosbuvir/ribavirin (aOR/CI: 2.51/1.67-3.77, P <.001) and daclatasvir/asunaprevir (aOR/CI: 3.29/1.94-5.58, P <.001), decompensated liver cirrhosis (aOR/CI: 2.50/1.20-5.22, P =.02) and high HCV viral loads (aOR/CI: 2.16/1.57-2.97, P <.001). Conclusions: DAAs are highly effective in treating Taiwanese HCV patients in the real-world setting. Maintaining DAA adherence and selecting highly efficacious regimens are keys to ensure treatment success.

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DO - 10.1111/liv.14849

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JO - Liver International

JF - Liver International

SN - 1478-3223

IS - 6

ER -

Factors associated with treatment failure of direct-acting antivirals for chronic hepatitis C: A real-world nationwide hepatitis C virus registry programme in Taiwan

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