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紧急!吉利德丙肝药Sovaldi和Harvoni禁与心脏病药物胺碘酮联用

来源:生物谷 2015-03-23 12:56

2015年3月23日讯 /生物谷BIOON/ --彭博社上周六报道,丙肝领导者吉利德(Gilead)上周五紧急向医疗提供商发布电子邮件,告知有关丙肝药物Sovaldi和Harvoni的一些安全信息。在信中,吉利德表示,有9例丙肝患者在进行Sovaldi或Harvoni治疗的同时接受心脏病药物胺碘酮(amiodarone)治疗后出现了异常缓慢的心跳,其中1例患者死于心脏骤停,3例患者需要植入心脏起搏器。

这9例患者中,6例症状性心动过缓(symptomatic bradycardia)病例发生在治疗的24小时内,3例发生在2-12天。所有患者均接受了心脏药物胺碘酮治疗,其中3例患者还服用了Harvoni,5例患者服用了Sovaldi和百时美施贵宝的daclatasvir,1例服用了Sovaldi和强生的Olysio。吉利德表示,不推荐服用Sovaldi和Harvoni的同时接受胺碘酮治疗,相关信息将在其产品标签中更新。

有分析师表示,这一警告信息可能会限制Sovaldi和Harvoni的使用。Sovaldi是吉利德研发的一款突破性、革命性丙肝药物,变革了丙肝的临床治疗。Harvoni则是新一代全口服丙肝鸡尾酒,完全消除了利巴韦林和注射药物干扰素。

胺碘酮(amiodarone)目前最常用的抗心律失常药物之一,属Ⅲ类抗心律失常药。(生物谷Bioon.com)

英文原文:Gilead Warns After Hepatitis Patient on Heart Drug Dies

(Bloomberg) -- Gilead Sciences Inc. said nine patients taking its hepatitis C drugs Harvoni or Sovaldi along with the heart treatment amiodarone developed abnormally slow heartbeats and one died of cardiac arrest. Three required a pacemaker to be inserted.

Gilead said in an e-mailed drug warning to health-care providers on Friday that six cases of symptomatic bradycardia occurred within the first 24 hours of treatment and the remaining three within the first two to 12 days. The patients were all taking amiodarone, with three also using Harvoni, five receiving Sovaldi with Bristol-Myers Squibb Co.’s daclatasvir and one on Sovaldi with Johnson & Johnson’s Olysio. Gilead said the combinations aren’t recommended and it will update its product labeling.

The warning might limit the use of Sovaldi and Harvoni, which have transformed how the liver infection hepatitis C is treated, with most patients being cured after 12 weeks. The drugs also have drawn criticism for their cost of more than $1,000 a day before discounts, or as much as $94,500 for a full course of treatment.

Harvoni generated $2.11 billion in sales in the fourth quarter of last year, and Sovaldi brought in $1.73 billion, together contributing more than half of the Foster City, California-based company’s total revenue of $7.31 billion. The drugs’ hefty profit margins helped boost fourth-quarter net income more than fourfold to $3.49 billion.

A competing treatment introduced late last year by AbbVie Inc. has put pressure on Gilead’s prices.

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