ST LOUIS (MD Consult) - On February 23, 2010, the US Food and Drug Administration (FDA) issued an alert about a potentially serious adverse cardiac effect that may be associated with the use of Invirase (saquinavir) in combination with Norvir (ritonavir). Invirase and Norvir are antiviral medications given together to treat infection with human immunodeficiency virus (HIV).

The study data under investigation were submitted by Roche, the manufacturer of Invirase. The preliminary data show that when Invirase boosted with Norvir (1000 mg/100 mg) was given to healthy persons aged 18 to 55 years, a dose-dependent prolongation of the QT and PR intervals occurred. The magnitude of the effect and clinical implications of QT- and PR-interval prolongation are still being reviewed by the FDA. A prolonged QT interval can increase the risk for development of cardiac arrhythmias, including torsades de pointes. A prolonged PR interval can lead to heart block.

Invirase and Norvir should not be prescribed for patients already taking medications known to cause QT-interval prolongation such as class IA (eg, quinidine) or class III (eg, amiodarone) antiarrhythmic drugs, nor should the combination be given to patients with a history of QT-interval prolongation. In addition, Invirase should not be prescribed for patients with preexisting cardiac conduction system disease, ischemic heart disease, cardiomyopathy, or underlying structural heart disease.

The FDA's analysis of these data is ongoing.

 

圣路易斯(MD Consult)——2010年2月23日，美国食品药品管理局（FDA）发布警告，提醒联用因服雷(沙奎那韦)和Norvir(利托那韦)可能会对心脏产生严重不良影响。因服雷和Norvir是联合用于治疗人类免疫缺陷病毒(HIV)感染的抗病毒药。

 

处于审查中的该研究数据由因服雷生产商罗氏公司递交。这些初步数据显示，联用因服雷和Norvir(1000 mg/100 mg)治疗年龄为18岁~55岁的健康个体，可导致QT和PR间期呈剂量依赖性延长。目前，FDA仍在对影响的程度及QT和PR间期延长的临床意义进行评价。QT间期延长可增加发生心律失常(包括尖端扭转性室性心动过速)的风险。PR间期延长可引起心脏传导阻滞。

 

因服雷和Norvir不应联用于治疗已经服用已知可导致QT间期延长的IA类(如奎尼丁)或III类(如胺碘酮)抗心律失常药的患者或具有QT间期延长病史的患者。此外，因服雷不应用于治疗既有心传导系统疾病、缺血性心脏病、心肌病或基础器质性心脏病的患者。

FDA对这些数据的分析还在进行当中。