索非布韦加利巴韦林治疗慢性基因1型或6丙型肝炎病毒感染在

StephenW

Sofosbuvir plus ribavirin for the treatment of patients with chronic genotype 1 or 6 hepatitis C virus infection in Hong Kong

    C. L. Lai1, V. W.-S. Wong2, M. F. Yuen1, J. C. Yang3, S. J. Knox3, H. Mo3, L. L. Han3, D. M. Brainard3 andH. L. Y. Chan2,*

Article first published online: 26 OCT 2015

DOI: 10.1111/apt.13429

© 2015 John Wiley & Sons Ltd

Issue
Cover image for Vol. 42 Issue 11-12
Alimentary Pharmacology & Therapeutics

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    1    Queen Mary Hospital, Hong Kong, China
    2    Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, China
    3    Gilead Sciences Inc., Foster City, CA, USA

* Correspondence to:
Prof. H. L. Y. Chan, Department of Medicine and Therapeutics, 9/F Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Hong Kong.
E-mail: [email protected]

    This article was accepted for publication after full peer-review.


Summary
Background

In Hong Kong, most patients with hepatitis C virus (HCV) have either genotype 6a or 1b infection.
Aim

To evaluate the efficacy and safety of sofosbuvir with ribavirin in treatment-naïve patients in Hong Kong with HCV genotype 1 or 6.
Methods

In an open-label study, patients were randomised to sofosbuvir 400 mg once daily plus ribavirin 1000–1200 divided twice daily for 12 (n = 10), 16 (n = 11) or 24 (n = 10) weeks. The primary endpoint was the percentage of patients with HCV RNA < LLOQ (lower limit of quantification, 25 IU/mL) 12 weeks after cessation of therapy (SVR12).
Results

All 31 patients (20 HCV genotype 1 and 11 genotype 6) had HCV RNA < LLOQ by Week 4 of treatment and at their last on-treatment visit. SVR12 rates were high in all treatment groups: 100% (10/10) for 12 weeks, 100% (11/11) for 16 weeks and 90% (9/10) for 24 weeks of therapy. The only patient who did not reach SVR12 had genotype 1 HCV and relapsed at post-treatment Week 4. Sofosbuvir with ribavirin was generally well tolerated. The most common adverse events were malaise (13%) and upper respiratory tract infection (13%), followed by anaemia (10%). No patients experienced serious adverse events. One patient discontinued treatment at Week 16 because of an adverse event. The event, upper respiratory tract infection, was not considered treatment related by the investigator. This subject achieved SVR12.
Conclusions

The all-oral regimen sofosbuvir plus ribavirin is effective in treatment-naïve patients in Hong Kong with genotype 1 or 6 HCV. Trial registration number: NCT02021643.

StephenW

索非布韦加利巴韦林治疗慢性基因1型或6丙型肝炎病毒感染在香港治疗

    C. L. Lai1，五W.-S. Wong2，MF Yuen1，JC Yang3，SJ Knox3，H MO3，LL Han3，DM Brainard3 andH。 L. Y. CHAN2，*

文章首次在网上公布：2015年10月26日

DOI：10.1111 / apt.13429

©2015年约翰·威利父子有限公司

问题
封面图片卷。 42期11-12
消化系统药理学和治疗

早期的浏览（包含之前录制的网上版本发表在一期）
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    1玛丽医院，香港，中国
    消化疾病香港的中国大学2研究所，中国香港
    3吉利德科学公司，福斯特市，CA，USA

*通讯作者：
HLY教授陈，内科及药物治疗，9系/˚F吕志和临床科学大楼，威尔斯亲王医院，香港。
电子信箱：[email protected]

    这篇文章被接受后满同行评审的出版物。


摘要
底

在香港，大部分患者丙型肝炎病毒（HCV）要么6a型或1b感染。
目标

为了评估疗效和索非布韦与利巴韦林的安全治疗初治患者在香港HCV基因型1或6。
方法

在一个开放性研究中，患者被随机分配到每日一次索非布韦400毫克加利巴韦林1000-1200分，每天两次为12（N = 10），16（N = 11）或24（N = 10）周。主要终点是患者的HCV RNA <LLOQ（定量下限，25 IU / mL）的12个星期的治疗停止（SVR12）之后的百分比。
结果

所有31名患者（20 HCV基因型1和11基因型6）有HCV RNA <LLOQ通过治疗4周，并在他们的最后的处理访问。 SVR12率很高所有治疗组中：100％（10/10，）12周100％（一十一分之一十一）16周和90％（9/10）为24周的治疗。谁没有达到SVR12唯一的病人有基因1型丙型肝炎病毒，复发在治疗后第四周索非布韦利巴韦林一般耐受性良好。最常见的不良事件是身体不适（13％）和上呼吸道感染（13％），其次是贫血（10％）。没有患者出现严重不良事件。一个病人中断，因为不良事件的治疗在第16周。的情况下，上呼吸道感染，不被认为治疗由研究者相关。本课题取得SVR12。
结论

全口服方案索非布韦联合利巴韦林是有效的治疗初治患者在香港基因型1或6丙型肝炎病毒。试用注册号：NCT02021643。

盆垂草

大陆什么时候有啊？？？？？？？？？？？？？？？

hengyin

短时间内大陆不会有，在香港买也不便宜，在印度能买到，价格不算贵