中国的NMPA批准新的肝炎药物Vosevi

StephenW

China’s NMPA approves new hepatitis drug Vosevi
The Chinese National Medical Products Administration (NMPA) has approved Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy, from US biotech major Gilead Sciences (Nasdaq: GILD), whose share moved 2.4% higher to $66.85 om Friday following the announcement.

The approval of Vosevi in China is supported by two global Phase III studies, POLARIS-1 and POLARIS-4, which evaluated 12 weeks of treatment with Vosevi among adults with HCV genotype 1-6 with or without compensated cirrhosis who had failed prior DAA treatment with or without an NS5A inhibitor. Across POLARIS-1 and POLARIS-4, 97% of patients treated with Vosevi (n=431/445) achieved SVR12, the primary endpoint to determine cure rate, defined as HCV RNA undetectable 12 weeks after completing therapy.

“People who have not achieved HCV cure with direct acting antiviral medicines are often faced with limited choices for re-treatment,” said Professor Lai Wei, director of the Hepatology and Pancreatic Center, Tsinghua University-affiliated Beijing Tsinghua Changgung Hospital. “With high cure rates across all genotypes, Vosevi is a promising option for people who require a new regimen to potentially achieve an HCV cure,” he added.
Option for with difficult-to-treat chronic HCV infection

“The approval of Vosevi in China means that many more patients with difficult-to-treat chronic HCV infection now have another chance at cure,” said Dr Merdad Parsey, chief medical officer, Gilead Sciences, noting that “it also represents another important step forward in achieving the public health goal of eliminating HCV in China and worldwide.”

Vosevi received marketing approval from the US Food and Drug Administration and the European Medicines Agency in 2017. In the USA, Vosevi has a Boxed Warning in its product label regarding the risk of hepatitis B virus (HBV) reactivation in HCV/HBV coinfected patients.

In China, approximately 10 million people are infected with HCV and it is the fourth most commonly reported infectious disease. HCV genotypes 1, 2, 3 and 6 account for more than 96% of all cases.

StephenW

中国的NMPA批准新的肝炎药物Vosevi
中国国家药品监督管理局（NMPA）已批准Vosevi（索非布韦400mg / velpatasvir 100mg / voxilaprevir 100mg），这是一种每日一次的单片治疗方案，用于治疗无肝硬化或经补偿的成人慢性丙型肝炎病毒（HCV）美国生物技术巨头吉利德科学公司（Nasdaq：GILD）的直接作用抗病毒（DAA）疗法在先前治疗中失败的肝硬化患者，其股价在上周五宣布后上涨了2.4％，至66.85美元。

Vosevi在中国的批准得到两项全球第三阶段研究POLARIS-1和POLARIS-4的支持，该研究评估了在有或没有代偿性肝硬化的HCV成人1-6成年人中，DAA之前治疗失败的Vosevi治疗12周有或没有NS5A抑制剂。在POLARIS-1和POLARIS-4中，接受Vosevi治疗的患者（n = 431/445）中有97％达到了SVR12，这是确定治愈率的主要终点，定义为完成治疗12周后无法检测到的HCV RNA。

清华大学附属北京清华长庚医院肝病和胰腺中心主任赖伟教授说：“用直接作用的抗病毒药物无法治愈HCV的人通常面临有限的再治疗选择。”他补充说：“由于所有基因型的治愈率很高，对于需要新疗法以潜在实现HCV治愈的人们来说，Vosevi是一个有前途的选择。”
难以治疗的慢性HCV感染的选择

Gilead Sciences首席医学官Merdad Parsey博士说：“ Vosevi在中国的批准意味着现在有更多的难以治疗的慢性HCV感染患者有了另一种治愈的机会，”他指出，“这也代表了又一个重要步骤朝着实现消除中国和全球HCV的公共卫生目标迈进。”

Vosevi于2017年获得了美国食品药品监督管理局和欧洲药品管理局的市场批准。在美国，Vosevi的产品标签上标有“盒装警告”，说明在HCV / HBV合并感染的患者中乙肝病毒（HBV）再次激活的风险。

在中国，大约有1000万人感染了HCV，它是第四大最常报告的传染病。 HCV基因型1、2、3和6占所有病例的96％以上