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A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection
BACKGROUND & AIMS: In Taiwan, patients with chronic hepatitis C virus (HCV) infection are currently treated with pegylated interferon‐alpha plus ribavirin, but interferon‐based regimens can be poorly tolerated, especially by those with advanced liver disease and the elderly. Sofosbuvir, an oral...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5071670/ https://www.ncbi.nlm.nih.gov/pubmed/26835876 http://dx.doi.org/10.1111/liv.13082 |
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author | Kao, Jia‐Horng Chien, Rong‐Nan Chang, Ting‐Tsung Peng, Cheng‐Yuan Hu, Tsung‐Hui Lo, Gin‐Ho Wang, Horng‐Yuan Chen, Jyh‐Jou Yang, Jenny C. Knox, Steven J. Han, Lingling Mo, Hongmei Mathias, Anita Brainard, Diana M. Sheen, I‐Shyan Hsu, Yu‐Chun Chu, Chi‐Jen Chuang, Wan‐Long |
author_facet | Kao, Jia‐Horng Chien, Rong‐Nan Chang, Ting‐Tsung Peng, Cheng‐Yuan Hu, Tsung‐Hui Lo, Gin‐Ho Wang, Horng‐Yuan Chen, Jyh‐Jou Yang, Jenny C. Knox, Steven J. Han, Lingling Mo, Hongmei Mathias, Anita Brainard, Diana M. Sheen, I‐Shyan Hsu, Yu‐Chun Chu, Chi‐Jen Chuang, Wan‐Long |
author_sort | Kao, Jia‐Horng |
collection | PubMed |
description | BACKGROUND & AIMS: In Taiwan, patients with chronic hepatitis C virus (HCV) infection are currently treated with pegylated interferon‐alpha plus ribavirin, but interferon‐based regimens can be poorly tolerated, especially by those with advanced liver disease and the elderly. Sofosbuvir, an oral nucleotide analogue inhibitor of HCV NS5B polymerase, is approved in Europe, the USA and Japan for treating chronic HCV infection. This phase 3b study examined the efficacy and safety of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 HCV infection ± compensated cirrhosis. METHODS: In this multicentre, open‐label, phase 3b (NCT02021643) study, 87 patients (n = 43, treatment‐naive; n = 44, treatment‐experienced) received 12 weeks of treatment with sofosbuvir plus weight‐based ribavirin. The primary efficacy endpoint was the proportion of patients with sustained virological response 12 weeks after treatment discontinuation (SVR12). Safety and pharmacokinetic data were also collected. RESULTS: All 87 patients (100%; 95% confidence interval, 92–100%) achieved SVR12, including the 13 patients with compensated cirrhosis. The most common treatment‐emergent adverse events (AEs) were insomnia (16%, 14/87) and upper respiratory tract infection (16%, 14/87). No grade 3 or grade 4 AE was reported. There was one serious AE (biliary colic), which was deemed unrelated to study treatment. Laboratory abnormalities other than ribavirin‐related reductions in haemoglobin were uncommon. CONCLUSIONS: The results from this phase 3b study demonstrate that 12 weeks of treatment with the interferon‐free regimen sofosbuvir plus ribavirin is effective and well tolerated in both treatment‐naive and treatment‐experienced Taiwanese patients with chronic genotype 2 HCV infection. |
format | Online Article Text |
id | pubmed-5071670 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-50716702016-11-02 A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection Kao, Jia‐Horng Chien, Rong‐Nan Chang, Ting‐Tsung Peng, Cheng‐Yuan Hu, Tsung‐Hui Lo, Gin‐Ho Wang, Horng‐Yuan Chen, Jyh‐Jou Yang, Jenny C. Knox, Steven J. Han, Lingling Mo, Hongmei Mathias, Anita Brainard, Diana M. Sheen, I‐Shyan Hsu, Yu‐Chun Chu, Chi‐Jen Chuang, Wan‐Long Liver Int Viral Hepatitis BACKGROUND & AIMS: In Taiwan, patients with chronic hepatitis C virus (HCV) infection are currently treated with pegylated interferon‐alpha plus ribavirin, but interferon‐based regimens can be poorly tolerated, especially by those with advanced liver disease and the elderly. Sofosbuvir, an oral nucleotide analogue inhibitor of HCV NS5B polymerase, is approved in Europe, the USA and Japan for treating chronic HCV infection. This phase 3b study examined the efficacy and safety of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 HCV infection ± compensated cirrhosis. METHODS: In this multicentre, open‐label, phase 3b (NCT02021643) study, 87 patients (n = 43, treatment‐naive; n = 44, treatment‐experienced) received 12 weeks of treatment with sofosbuvir plus weight‐based ribavirin. The primary efficacy endpoint was the proportion of patients with sustained virological response 12 weeks after treatment discontinuation (SVR12). Safety and pharmacokinetic data were also collected. RESULTS: All 87 patients (100%; 95% confidence interval, 92–100%) achieved SVR12, including the 13 patients with compensated cirrhosis. The most common treatment‐emergent adverse events (AEs) were insomnia (16%, 14/87) and upper respiratory tract infection (16%, 14/87). No grade 3 or grade 4 AE was reported. There was one serious AE (biliary colic), which was deemed unrelated to study treatment. Laboratory abnormalities other than ribavirin‐related reductions in haemoglobin were uncommon. CONCLUSIONS: The results from this phase 3b study demonstrate that 12 weeks of treatment with the interferon‐free regimen sofosbuvir plus ribavirin is effective and well tolerated in both treatment‐naive and treatment‐experienced Taiwanese patients with chronic genotype 2 HCV infection. John Wiley and Sons Inc. 2016-03-23 2016-08 /pmc/articles/PMC5071670/ /pubmed/26835876 http://dx.doi.org/10.1111/liv.13082 Text en © 2016 The Authors. Liver International Published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Viral Hepatitis Kao, Jia‐Horng Chien, Rong‐Nan Chang, Ting‐Tsung Peng, Cheng‐Yuan Hu, Tsung‐Hui Lo, Gin‐Ho Wang, Horng‐Yuan Chen, Jyh‐Jou Yang, Jenny C. Knox, Steven J. Han, Lingling Mo, Hongmei Mathias, Anita Brainard, Diana M. Sheen, I‐Shyan Hsu, Yu‐Chun Chu, Chi‐Jen Chuang, Wan‐Long A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection |
title | A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection |
title_full | A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection |
title_fullStr | A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection |
title_full_unstemmed | A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection |
title_short | A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection |
title_sort | phase 3b study of sofosbuvir plus ribavirin in taiwanese patients with chronic genotype 2 hepatitis c virus infection |
topic | Viral Hepatitis |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5071670/ https://www.ncbi.nlm.nih.gov/pubmed/26835876 http://dx.doi.org/10.1111/liv.13082 |
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