A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection

Jia Horng Kao; Rong Nan Chien; Ting Tsung Chang; Cheng Yuan Peng; Tsung Hui Hu; Gin Ho Lo; Horng Yuan Wang; Jyh Jou Chen; Jenny C. Yang; Steven J. Knox; Lingling Han; Hongmei Mo; Anita Mathias; Diana M. Brainard; I. Shyan Sheen; Yu Chun Hsu; Chi Jen Chu; Wan Long Chuang

doi:10.1111/liv.13082

A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection

Jia Horng Kao, Rong Nan Chien, Ting Tsung Chang, Cheng Yuan Peng, Tsung Hui Hu, Gin Ho Lo, Horng Yuan Wang, Jyh Jou Chen, Jenny C. Yang, Steven J. Knox, Lingling Han, Hongmei Mo, Anita Mathias, Diana M. Brainard, I. Shyan Sheen, Yu Chun Hsu, Chi Jen Chu, Wan Long Chuang

Department of Internal Medicine

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

25 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	1101-1107
Number of pages	7
Journal	Liver International
Volume	36
Issue number	8
DOIs	https://doi.org/10.1111/liv.13082
Publication status	Published - 2016 Aug 1

All Science Journal Classification (ASJC) codes

Hepatology

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10.1111/liv.13082

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Kao, J. H., Chien, R. N., Chang, T. T., Peng, C. Y., Hu, T. H., Lo, G. H., Wang, H. Y., Chen, J. J., Yang, J. C., Knox, S. J., Han, L., Mo, H., Mathias, A., Brainard, D. M., Sheen, I. S., Hsu, Y. C., Chu, C. J., & Chuang, W. L. (2016). A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection. Liver International, 36(8), 1101-1107. https://doi.org/10.1111/liv.13082

@article{64265b9aecb74209abcc56a012cf1e52,

title = "A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection",

abstract = "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.",

author = "Kao, {Jia Horng} and Chien, {Rong Nan} and Chang, {Ting Tsung} and Peng, {Cheng Yuan} and Hu, {Tsung Hui} and Lo, {Gin Ho} and Wang, {Horng Yuan} and Chen, {Jyh Jou} and Yang, {Jenny C.} and Knox, {Steven J.} and Lingling Han and Hongmei Mo and Anita Mathias and Brainard, {Diana M.} and Sheen, {I. Shyan} and Hsu, {Yu Chun} and Chu, {Chi Jen} and Chuang, {Wan Long}",

note = "Funding Information: Third-party writing assistance was provided by Tiffany DeSimone, PhD, of BlueMomentum, an Ashfield Company, part of UDG Healthcare plc, and was supported and paid for by Gilead Sciences, Inc. Financial support: This study was funded by Gilead Sciences, Inc. Conflict of interest: J-HK has served as a consultant for Abbott, AbbVie, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, Merck Sharp & Dohme, Novartis, and Roche. He has also served on speaker's bureaus for Abbott, Roche, Bayer, Bristol-Myers Squibb, GlaxoSmithKline, and Novartis. R-NC has served as an advisory committee member for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Johnson & Johnson, Merck Sharpe & Dohme, Novartis, and F. Hoffmann-La Roche. He has also served on speaker's bureaus for Bristol-Myers Squibb, Gilead Sciences, Merck Sharpe & Dohme, Roche and Novartis. T-TC, T-HH, G-HL, H-YW, J-JC, I-SS, Y-CH and C-JC have nothing to disclose. C-YP has served as an advisory committee member for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Merck Sharpe & Dohme, and F. Hoffmann-La Roche. JCY, SJK, LH, HM, AM and DMB are employees of Gilead Sciences, Inc. W-LC has served as an advisory board member for Gilead Sciences, AbbVie, and F. Hoffmann La-Roche. He has also served on speaker's bureaus for Gilead Sciences, Bristol-Myers Squibb, Merck Sharpe & Dohme, F. Hoffmann-La Roche, and Novartis. Publisher Copyright: {\textcopyright} 2016 The Authors. Liver International Published by John Wiley & Sons Ltd.",

year = "2016",

month = aug,

day = "1",

doi = "10.1111/liv.13082",

language = "English",

volume = "36",

pages = "1101--1107",

journal = "Liver International",

issn = "1478-3223",

publisher = "Wiley-Blackwell",

number = "8",

}

Kao, JH, Chien, RN, Chang, TT, Peng, CY, Hu, TH, Lo, GH, Wang, HY, Chen, JJ, Yang, JC, Knox, SJ, Han, L, Mo, H, Mathias, A, Brainard, DM, Sheen, IS, Hsu, YC, Chu, CJ & Chuang, WL 2016, 'A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection', Liver International, vol. 36, no. 8, pp. 1101-1107. https://doi.org/10.1111/liv.13082

TY - JOUR

T1 - A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection

AU - Kao, Jia Horng

AU - Chien, Rong Nan

AU - Chang, Ting Tsung

AU - Peng, Cheng Yuan

AU - Hu, Tsung Hui

AU - Lo, Gin Ho

AU - Wang, Horng Yuan

AU - Chen, Jyh Jou

AU - Yang, Jenny C.

AU - Knox, Steven J.

AU - Han, Lingling

AU - Mo, Hongmei

AU - Mathias, Anita

AU - Brainard, Diana M.

AU - Sheen, I. Shyan

AU - Hsu, Yu Chun

AU - Chu, Chi Jen

AU - Chuang, Wan Long

N1 - Funding Information: Third-party writing assistance was provided by Tiffany DeSimone, PhD, of BlueMomentum, an Ashfield Company, part of UDG Healthcare plc, and was supported and paid for by Gilead Sciences, Inc. Financial support: This study was funded by Gilead Sciences, Inc. Conflict of interest: J-HK has served as a consultant for Abbott, AbbVie, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, Merck Sharp & Dohme, Novartis, and Roche. He has also served on speaker's bureaus for Abbott, Roche, Bayer, Bristol-Myers Squibb, GlaxoSmithKline, and Novartis. R-NC has served as an advisory committee member for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Johnson & Johnson, Merck Sharpe & Dohme, Novartis, and F. Hoffmann-La Roche. He has also served on speaker's bureaus for Bristol-Myers Squibb, Gilead Sciences, Merck Sharpe & Dohme, Roche and Novartis. T-TC, T-HH, G-HL, H-YW, J-JC, I-SS, Y-CH and C-JC have nothing to disclose. C-YP has served as an advisory committee member for AbbVie, Bristol-Myers Squibb, Gilead Sciences, Merck Sharpe & Dohme, and F. Hoffmann-La Roche. JCY, SJK, LH, HM, AM and DMB are employees of Gilead Sciences, Inc. W-LC has served as an advisory board member for Gilead Sciences, AbbVie, and F. Hoffmann La-Roche. He has also served on speaker's bureaus for Gilead Sciences, Bristol-Myers Squibb, Merck Sharpe & Dohme, F. Hoffmann-La Roche, and Novartis. Publisher Copyright: © 2016 The Authors. Liver International Published by John Wiley & Sons Ltd.

PY - 2016/8/1

Y1 - 2016/8/1

N2 - 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.

AB - 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.

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DO - 10.1111/liv.13082

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JO - Liver International

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ER -

A phase 3b study of sofosbuvir plus ribavirin in Taiwanese patients with chronic genotype 2 hepatitis C virus infection

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