Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan

Abstract Clinical trials showed pangenotypic direct-acting antivirals’ (DAAs) excellent efficacy and safety when treating hepatitis C virus (HCV). Two pangenotypic regimens were examined, glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL), in a real-world Taiwanese setting, incl...

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Autores principales:	Kao-Chi Chang, Shui-Yi Tung, Kuo-Liang Wei, Chen-Heng Shen, Yung-Yu Hsieh, Wei-Ming Chen, Yi-Hsing Chen, Chun-Hsien Chen, Chi-Wei Yen, Huang-Wei Xu, Wei-Lin Tung, Chao-Hung Hung, Sheng-Nan Lu, Te-Sheng Chang
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/c3f883780e4f498eae4652d3f293f1fe
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spelling	oai:doaj.org-article:c3f883780e4f498eae4652d3f293f1fe2021-12-02T16:31:58ZReal-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan10.1038/s41598-021-93095-x2045-2322https://doaj.org/article/c3f883780e4f498eae4652d3f293f1fe2021-06-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-93095-xhttps://doaj.org/toc/2045-2322Abstract Clinical trials showed pangenotypic direct-acting antivirals’ (DAAs) excellent efficacy and safety when treating hepatitis C virus (HCV). Two pangenotypic regimens were examined, glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL), in a real-world Taiwanese setting, including all HCV patients treated with GLE/PIB or SOF/VEL from August 2018 to April 2020. The primary endpoint was sustained virologic response 12 weeks after treatment cessation (SVR12), including adverse events (AEs). A total of 1,356 HCV patients received pangenotypic DAA treatment during the study: 742 and 614 received GLE/PIB and SOF/VEL, respectively. The rates of SVR12 for GLE/PIB and SOF/VEL were 710/718 (98.9%) and 581/584 (99.5%), respectively, by per-protocol analysis, and 710/742 (95.7%) and 581/614 (94.6%), respectively, by evaluable population analysis. Eleven (GLE/PIB: 8, SOF/VEL: 3) did not achieve SVR12. The most common AEs for GLE/PIB and SOF/VEL were pruritus (17.4% vs. 2.9%), abdominal discomfort (5.8% vs. 4.4%), dizziness (4.2% vs. 2%), and malaise (3.1% vs. 2.9%). Laboratory abnormalities were uncommon; only < 1% exhibited elevated total bilirubin or aminotransferase levels with both regimens. Five drug discontinuations occurred due to AEs (bilirubin elevation: 3; dermatological issues: 2). Pangenotypic DAAs GLE/PIB and SOF/VEL are effective and well tolerated, achieving high SVR12 rates for patients with all HCV genotypes.Kao-Chi ChangShui-Yi TungKuo-Liang WeiChen-Heng ShenYung-Yu HsiehWei-Ming ChenYi-Hsing ChenChun-Hsien ChenChi-Wei YenHuang-Wei XuWei-Lin TungChao-Hung HungSheng-Nan LuTe-Sheng ChangNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Kao-Chi Chang Shui-Yi Tung Kuo-Liang Wei Chen-Heng Shen Yung-Yu Hsieh Wei-Ming Chen Yi-Hsing Chen Chun-Hsien Chen Chi-Wei Yen Huang-Wei Xu Wei-Lin Tung Chao-Hung Hung Sheng-Nan Lu Te-Sheng Chang Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan
description	Abstract Clinical trials showed pangenotypic direct-acting antivirals’ (DAAs) excellent efficacy and safety when treating hepatitis C virus (HCV). Two pangenotypic regimens were examined, glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL), in a real-world Taiwanese setting, including all HCV patients treated with GLE/PIB or SOF/VEL from August 2018 to April 2020. The primary endpoint was sustained virologic response 12 weeks after treatment cessation (SVR12), including adverse events (AEs). A total of 1,356 HCV patients received pangenotypic DAA treatment during the study: 742 and 614 received GLE/PIB and SOF/VEL, respectively. The rates of SVR12 for GLE/PIB and SOF/VEL were 710/718 (98.9%) and 581/584 (99.5%), respectively, by per-protocol analysis, and 710/742 (95.7%) and 581/614 (94.6%), respectively, by evaluable population analysis. Eleven (GLE/PIB: 8, SOF/VEL: 3) did not achieve SVR12. The most common AEs for GLE/PIB and SOF/VEL were pruritus (17.4% vs. 2.9%), abdominal discomfort (5.8% vs. 4.4%), dizziness (4.2% vs. 2%), and malaise (3.1% vs. 2.9%). Laboratory abnormalities were uncommon; only < 1% exhibited elevated total bilirubin or aminotransferase levels with both regimens. Five drug discontinuations occurred due to AEs (bilirubin elevation: 3; dermatological issues: 2). Pangenotypic DAAs GLE/PIB and SOF/VEL are effective and well tolerated, achieving high SVR12 rates for patients with all HCV genotypes.
format	article
author	Kao-Chi Chang Shui-Yi Tung Kuo-Liang Wei Chen-Heng Shen Yung-Yu Hsieh Wei-Ming Chen Yi-Hsing Chen Chun-Hsien Chen Chi-Wei Yen Huang-Wei Xu Wei-Lin Tung Chao-Hung Hung Sheng-Nan Lu Te-Sheng Chang
author_facet	Kao-Chi Chang Shui-Yi Tung Kuo-Liang Wei Chen-Heng Shen Yung-Yu Hsieh Wei-Ming Chen Yi-Hsing Chen Chun-Hsien Chen Chi-Wei Yen Huang-Wei Xu Wei-Lin Tung Chao-Hung Hung Sheng-Nan Lu Te-Sheng Chang
author_sort	Kao-Chi Chang
title	Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan
title_short	Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan
title_full	Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan
title_fullStr	Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan
title_full_unstemmed	Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan
title_sort	real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis c virus infection in taiwan
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/c3f883780e4f498eae4652d3f293f1fe
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Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan

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