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

研究成果: Article

19 引文 斯高帕斯(Scopus)

摘要

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.

原文English
頁(從 - 到)1101-1107
頁數7
期刊Liver International
36
發行號8
DOIs
出版狀態Published - 2016 八月 1

All Science Journal Classification (ASJC) codes

  • Hepatology

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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