NEJM再发Sovaldi喜讯:革命性丙肝药物大获成功
生物通/叶予 · 2015/12/03
贝斯以色列女执事医疗中心(BIDMC)和Intermountain医学中心的研究人员最近发现,使用特定的抗病毒药物组合,能够在超过90%的晚期肝病患者中根除丙肝感染。这项名为ASTRAL-4的临床研究发表在顶级医学期刊《新英格兰医学》上。


人们首次认识到丙肝这种疾病是在上世纪七十年代,这是一种经血液传播的非甲非乙型肝炎病毒,是引起输血后肝炎的主要病因之一。1989年,人们首次鉴定到了丙肝病毒(HCV)。这种病毒善于躲避患者机体的免疫系统,能够建立长达数十年的感染。这种持续性的感染会损伤肝脏,甚至引发肝癌。绝大多数感染者起初并不表现出症状,直到病毒引起严重的肝脏损伤。

贝斯以色列女执事医疗中心(BIDMC)和Intermountain医学中心的研究人员最近发现,使用特定的抗病毒药物组合,能够在超过90%的晚期肝病患者中根除丙肝感染。这项名为ASTRAL-4的临床研究发表在顶级医学期刊《新英格兰医学》上。

“这项研究中有一大半是丙肝治疗失败的患者,”文章的共同第一作者,BIDMC的Michael Curry博士介绍道。“研究显示,每天使用抗病毒药物Sofosbuvir和Velpatasvir的组合,可以成功治疗83%-94%的丙肝患者。”Sofosbuvir被称为革命性的丙肝治疗药物,这种核苷酸类似物可作用于几乎所有丙肝病毒,不会引起严重的副作用,只需12 周就能实现治愈。

全世界有上亿人受到丙肝病毒的感染,这种感染会引起肝功能衰竭和肝硬化。当患者的健康肝脏组织被瘢痕组织取代,肝功能衰竭和肝硬化就会发生,最终使肝脏无法正常执行自己的功能。

据介绍,总共有267名肝功能衰竭的患者参与了这项临床研究。“对于已经出现肝硬化和肝功能衰竭的丙肝患者来说,可选择的治疗方式其实很少,”Curry说。“在我们这项研究中,大部分参与者的肝功能都出现了改善。这种改善体现在Child-Pugh评分和MELD评分上,Child-Pugh评分主要评估肝硬化的严重性,MELD评分用于确定患者在肝移植中的优先次序。”

肝脏是人体内最大的实体器官,起到了许多关键性的作用,包括生产血蛋白促进凝血和免疫系统功能、生成胆汁帮助机体消化食物、以及储存产能的葡萄糖。此外,肝脏还为机体排出酒精等有害物质。

“因为丙肝发生肝功能衰竭的患者,在未来十年将大大增加,”Curry说。“我们的研究表明,晚期肝病患者依然可以从丙肝治疗中获益,根除丙肝感染有助于肝功能的改善。”

这项研究也引起了我国传染病专家的广泛关注,有专家评论道:“最近丙型肝炎的抗病毒药物很多,开启了丙肝治疗的新纪元”。

所有文章仅代表作者观点,不代表本站立场。如若转载请联系原作者。
查看更多
  • Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis

    The number of patients with decompensated cirrhosis caused by chronic infection with the hepatitis C virus (HCV) is projected to rise in the coming decade.1 For many years, the only treatment option for such patients was liver transplantation. Recently, however, clinical trials of newly approved direct-acting antiviral agents have shown that it is possible to treat HCV infection safely and effectively in patients with decompensated cirrhosis and that successful treatment is associated with early improvement in liver function.2-11 The possible long-term benefits of treatment on existing liver disease remain unknown. The only regimen that is currently approved for the treatment of HCV infection in patients with decompensated cirrhosis is 24 weeks of ledipasvir–sofosbuvir plus ribavirin, which is approved in Europe for patients with HCV genotypes 1 and 4.12 A highly effective regimen to treat HCV infection of all genotypes in patients with decompensated liver disease that has acceptable side effects would address a significant unmet medical need. The NS5B nucleotide inhibitor sofosbuvir is approved for the treatment of HCV infection in combination with other agents.13,14 Velpatasvir (formerly known as GS-5816, Gilead Sciences) is an investigational inhibitor of the HCV NS5A protein with antiviral activity against all HCV genotypes.15-17 The combination of velpatasvir and sofosbuvir with or without ribavirin provided high rates of sustained virologic response in patients with all HCV genotypes in phase 2 clinical trials.18,19 In the phase 3 ASTRAL-1, ASTRAL-2, and ASTRAL-3 trials (now published in the Journal),20,21 treatment with sofosbuvir–velpatasvir in a fixed-dose combination tablet for 12 weeks resulted in high rates of sustained virologic response among patients with HCV genotypes 1 through 6 without cirrhosis or with compensated cirrhosis. We conducted a phase 3, open-label trial to assess the efficacy and safety of a fixed dose of sofosbuvir–velpatasvir with or without ribavirin for 12 weeks or sofosbuvir–velpatasvir for 24 weeks in patients infected with HCV genotypes 1 through 6 and with decompensated cirrhosis.

    展开 收起
发表评论 我在frontend\modules\comment\widgets\views\文件夹下面 test