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Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single‐arm, open‐label, phase 3 trial

BACKGROUND & AIM: An affordable, pangenotypic regimen remains as an unmet medical need for chronic hepatitis C patients in China. This single‐arm, open‐label, multicenter, phase 3 trial evaluated the efficacy and safety of coblopasvir, a pangenotypic non‐structural protein 5A (NS5A) inhibitor, c...

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Autores principales: Gao, Yanhang, Kong, Fei, Li, Guangming, Li, Cheng, Zheng, Sujun, Lin, Jianmei, Wen, Xiaofeng, Hu, Jinghua, Wang, Xiaozhong, Wu, Xiaofeng, Xing, Huichun, Jia, Jidong, Jia, Zhansheng, Guan, Yujuan, Li, Chenghao, Wu, Guicheng, Gao, Zhiliang, Mou, Zhuangbo, Ning, Qin, Mao, Qing, Yang, Yongfeng, Ning, Jing, Li, Li, Pan, Hai, Zhou, Desheng, Ding, Yanhua, Qin, Hong, Niu, Junqi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7702130/
https://www.ncbi.nlm.nih.gov/pubmed/33047868
http://dx.doi.org/10.1111/liv.14633
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author Gao, Yanhang
Kong, Fei
Li, Guangming
Li, Cheng
Zheng, Sujun
Lin, Jianmei
Wen, Xiaofeng
Hu, Jinghua
Wang, Xiaozhong
Wu, Xiaofeng
Xing, Huichun
Jia, Jidong
Jia, Zhansheng
Guan, Yujuan
Li, Chenghao
Wu, Guicheng
Gao, Zhiliang
Mou, Zhuangbo
Ning, Qin
Mao, Qing
Yang, Yongfeng
Ning, Jing
Li, Li
Pan, Hai
Zhou, Desheng
Ding, Yanhua
Qin, Hong
Niu, Junqi
author_facet Gao, Yanhang
Kong, Fei
Li, Guangming
Li, Cheng
Zheng, Sujun
Lin, Jianmei
Wen, Xiaofeng
Hu, Jinghua
Wang, Xiaozhong
Wu, Xiaofeng
Xing, Huichun
Jia, Jidong
Jia, Zhansheng
Guan, Yujuan
Li, Chenghao
Wu, Guicheng
Gao, Zhiliang
Mou, Zhuangbo
Ning, Qin
Mao, Qing
Yang, Yongfeng
Ning, Jing
Li, Li
Pan, Hai
Zhou, Desheng
Ding, Yanhua
Qin, Hong
Niu, Junqi
author_sort Gao, Yanhang
collection PubMed
description BACKGROUND & AIM: An affordable, pangenotypic regimen remains as an unmet medical need for chronic hepatitis C patients in China. This single‐arm, open‐label, multicenter, phase 3 trial evaluated the efficacy and safety of coblopasvir, a pangenotypic non‐structural protein 5A (NS5A) inhibitor, combined with sofosbuvir for treating Chinese patients with chronic hepatitis C virus (HCV) infection. METHODS: Treatment‐naïve and interferon‐experienced adult patients, including those with advanced fibrosis (F3) or compensated cirrhosis (F4), were treated with a universal, combinational regimen of coblopasvir 60 mg and sofosbuvir 400 mg, once daily, for 12 weeks. The primary efficacy endpoint was sustained virological response at post‐treatment week 12 (SVR12). RESULTS: Overall, 371 patients (men, 51%; age, 47 ± 11 years; genotype 1a < 1%, 1b 48%, 2a 26%, 3a 6%, 3b 7% and 6 12%) were enrolled from 19 sites. Fifty‐one patients (14%) had F3, 39 patients (11%) had F4 and 39 patients (11%) were interferon experienced. The overall SVR12 was 97% (95% CI, [94%, 98%]) for the full analysis set and was equal to or above 90% for all predefined subsets. Ten patients (3%) experienced virological relapse and two patients did not complete follow‐up. No adverse events (AEs) occurred at a frequency ≥5%, and the most often reported AEs (≥1%) were neutropenia and fatigue. The majority of AEs were mild to moderate and transient without specific medical intervention. CONCLUSIONS: The universal, pangenotypic combo of coblopasvir plus sofosbuvir is an efficacious and safe treatment for Chinese patients monoinfected with HCV of genotype 1, 2, 3 and 6, including those with compensated cirrhosis. LAY SUMMARY: The regimen of coblopasvir and sofosbuvir is a safe and effective treatment for Chinese patients with genotype 1, 2, 3 and 6 HCV infection, including those with compensated cirrhosis. Therefore, this regimen would be a novel choice of treatment for this patient population.
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spelling pubmed-77021302020-12-14 Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single‐arm, open‐label, phase 3 trial Gao, Yanhang Kong, Fei Li, Guangming Li, Cheng Zheng, Sujun Lin, Jianmei Wen, Xiaofeng Hu, Jinghua Wang, Xiaozhong Wu, Xiaofeng Xing, Huichun Jia, Jidong Jia, Zhansheng Guan, Yujuan Li, Chenghao Wu, Guicheng Gao, Zhiliang Mou, Zhuangbo Ning, Qin Mao, Qing Yang, Yongfeng Ning, Jing Li, Li Pan, Hai Zhou, Desheng Ding, Yanhua Qin, Hong Niu, Junqi Liver Int Viral Hepatitis BACKGROUND & AIM: An affordable, pangenotypic regimen remains as an unmet medical need for chronic hepatitis C patients in China. This single‐arm, open‐label, multicenter, phase 3 trial evaluated the efficacy and safety of coblopasvir, a pangenotypic non‐structural protein 5A (NS5A) inhibitor, combined with sofosbuvir for treating Chinese patients with chronic hepatitis C virus (HCV) infection. METHODS: Treatment‐naïve and interferon‐experienced adult patients, including those with advanced fibrosis (F3) or compensated cirrhosis (F4), were treated with a universal, combinational regimen of coblopasvir 60 mg and sofosbuvir 400 mg, once daily, for 12 weeks. The primary efficacy endpoint was sustained virological response at post‐treatment week 12 (SVR12). RESULTS: Overall, 371 patients (men, 51%; age, 47 ± 11 years; genotype 1a < 1%, 1b 48%, 2a 26%, 3a 6%, 3b 7% and 6 12%) were enrolled from 19 sites. Fifty‐one patients (14%) had F3, 39 patients (11%) had F4 and 39 patients (11%) were interferon experienced. The overall SVR12 was 97% (95% CI, [94%, 98%]) for the full analysis set and was equal to or above 90% for all predefined subsets. Ten patients (3%) experienced virological relapse and two patients did not complete follow‐up. No adverse events (AEs) occurred at a frequency ≥5%, and the most often reported AEs (≥1%) were neutropenia and fatigue. The majority of AEs were mild to moderate and transient without specific medical intervention. CONCLUSIONS: The universal, pangenotypic combo of coblopasvir plus sofosbuvir is an efficacious and safe treatment for Chinese patients monoinfected with HCV of genotype 1, 2, 3 and 6, including those with compensated cirrhosis. LAY SUMMARY: The regimen of coblopasvir and sofosbuvir is a safe and effective treatment for Chinese patients with genotype 1, 2, 3 and 6 HCV infection, including those with compensated cirrhosis. Therefore, this regimen would be a novel choice of treatment for this patient population. John Wiley and Sons Inc. 2020-10-13 2020-11 /pmc/articles/PMC7702130/ /pubmed/33047868 http://dx.doi.org/10.1111/liv.14633 Text en © 2020 The Authors. Liver International published by John Wiley & Sons Ltd This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Viral Hepatitis
Gao, Yanhang
Kong, Fei
Li, Guangming
Li, Cheng
Zheng, Sujun
Lin, Jianmei
Wen, Xiaofeng
Hu, Jinghua
Wang, Xiaozhong
Wu, Xiaofeng
Xing, Huichun
Jia, Jidong
Jia, Zhansheng
Guan, Yujuan
Li, Chenghao
Wu, Guicheng
Gao, Zhiliang
Mou, Zhuangbo
Ning, Qin
Mao, Qing
Yang, Yongfeng
Ning, Jing
Li, Li
Pan, Hai
Zhou, Desheng
Ding, Yanhua
Qin, Hong
Niu, Junqi
Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single‐arm, open‐label, phase 3 trial
title Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single‐arm, open‐label, phase 3 trial
title_full Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single‐arm, open‐label, phase 3 trial
title_fullStr Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single‐arm, open‐label, phase 3 trial
title_full_unstemmed Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single‐arm, open‐label, phase 3 trial
title_short Coblopasvir and sofosbuvir for treatment of chronic hepatitis C virus infection in China: A single‐arm, open‐label, phase 3 trial
title_sort coblopasvir and sofosbuvir for treatment of chronic hepatitis c virus infection in china: a single‐arm, open‐label, phase 3 trial
topic Viral Hepatitis
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7702130/
https://www.ncbi.nlm.nih.gov/pubmed/33047868
http://dx.doi.org/10.1111/liv.14633
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