Cargando…
Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan
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...
Autores principales: | , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group UK
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8241842/ https://www.ncbi.nlm.nih.gov/pubmed/34188161 http://dx.doi.org/10.1038/s41598-021-93095-x |
_version_ | 1783715500960776192 |
---|---|
author | Chang, Kao-Chi Tung, Shui-Yi Wei, Kuo-Liang Shen, Chen-Heng Hsieh, Yung-Yu Chen, Wei-Ming Chen, Yi-Hsing Chen, Chun-Hsien Yen, Chi-Wei Xu, Huang-Wei Tung, Wei-Lin Hung, Chao-Hung Lu, Sheng-Nan Chang, Te-Sheng |
author_facet | Chang, Kao-Chi Tung, Shui-Yi Wei, Kuo-Liang Shen, Chen-Heng Hsieh, Yung-Yu Chen, Wei-Ming Chen, Yi-Hsing Chen, Chun-Hsien Yen, Chi-Wei Xu, Huang-Wei Tung, Wei-Lin Hung, Chao-Hung Lu, Sheng-Nan Chang, Te-Sheng |
author_sort | Chang, Kao-Chi |
collection | PubMed |
description | 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 | Online Article Text |
id | pubmed-8241842 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Nature Publishing Group UK |
record_format | MEDLINE/PubMed |
spelling | pubmed-82418422021-07-06 Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan Chang, Kao-Chi Tung, Shui-Yi Wei, Kuo-Liang Shen, Chen-Heng Hsieh, Yung-Yu Chen, Wei-Ming Chen, Yi-Hsing Chen, Chun-Hsien Yen, Chi-Wei Xu, Huang-Wei Tung, Wei-Lin Hung, Chao-Hung Lu, Sheng-Nan Chang, Te-Sheng Sci Rep Article 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. Nature Publishing Group UK 2021-06-29 /pmc/articles/PMC8241842/ /pubmed/34188161 http://dx.doi.org/10.1038/s41598-021-93095-x Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Article Chang, Kao-Chi Tung, Shui-Yi Wei, Kuo-Liang Shen, Chen-Heng Hsieh, Yung-Yu Chen, Wei-Ming Chen, Yi-Hsing Chen, Chun-Hsien Yen, Chi-Wei Xu, Huang-Wei Tung, Wei-Lin Hung, Chao-Hung Lu, Sheng-Nan Chang, Te-Sheng Real-world efficacy and safety of pangenotypic direct-acting antivirals against hepatitis C virus infection in Taiwan |
title | 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_short | 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 |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8241842/ https://www.ncbi.nlm.nih.gov/pubmed/34188161 http://dx.doi.org/10.1038/s41598-021-93095-x |
work_keys_str_mv | AT changkaochi realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT tungshuiyi realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT weikuoliang realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT shenchenheng realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT hsiehyungyu realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT chenweiming realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT chenyihsing realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT chenchunhsien realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT yenchiwei realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT xuhuangwei realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT tungweilin realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT hungchaohung realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT lushengnan realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan AT changtesheng realworldefficacyandsafetyofpangenotypicdirectactingantiviralsagainsthepatitiscvirusinfectionintaiwan |