在使用较新的丙型肝炎药物的患者中发现的急性肝衰竭的病

StephenW

                                      Medical News |   
   
                Physician's First Watch


  
   

  

  
   
                January 27, 2017


  
   
                Cases of Acute Liver Failure Found in Patients Taking Newer Hepatitis C Drugs


  
   
               

      By Kelly Young   

      Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS   

The Institute for Safe Medicine Practices reviewed 12 months of FDA data and identified hundreds of cases of acute liver failure in patients taking direct-acting antivirals for hepatitis C.

In October, the FDA announced that it was adding a boxed warning to the labels of direct-acting antivirals after identifying 24 cases of hepatitis B reactivation. Three of these patients experienced liver failure.

This prompted the Institute for Safe Medicine Practices to review additional FDA data, thereby identifying 524 cases of acute liver failure in patients taking direct-acting antivirals. Nearly a third of these patients died. Over 40% of cases included encephalopathy.

Paritaprevir combinations were most often implicated (35% of cases), followed by sofosbuvir (33%). Nine out of 10 cases were reported by clinicians as a drug-related adverse event and not the result of hepatitis C progression. The group also found over 1000 cases of severe liver damage that had not yet progressed to liver failure.

The maker of sofosbuvir told the institute that its drug was approved for patients with liver failure, so that could account for some of the cases.

Link(s):

Institute for Safe Medicine Practices report (Free PDF)

Background: Physician's First Watch coverage of FDA putting boxed warning on direct-acting antivirals (Free)

StephenW

医学新闻|
医生的第一眼
2017年1月27日
在使用较新的丙型肝炎药物的患者中发现的急性肝衰竭的病例

作者：Kelly Young

由AndréSofair，MD，MPH和William E. Chavey，MD，MS编辑

安全医学实践研究所审查了12个月的FDA数据，并确定了数百例急性肝衰竭的病人服用丙型肝炎的直接作用抗病毒药物。

10月，FDA宣布，在确定24例乙型肝炎再激活后，向直接作用抗病毒药物的标签添加了一个盒装警告。其中三例患者发生肝功能衰竭。

这促使安全医学实践研究所审查额外的FDA数据，从而确定524例直接作用抗病毒药物的急性肝衰竭病例。这些患者中有三分之一死亡。超过40％的病例包括脑病。

临床医生报告10例中有9例为药物相关的不良事件，而不是丙型肝炎进展的结果。该组还发现（35％的病例），其次是sofosbuvir（33％），Paritaprevir组合最常见的涉及超过1000例严重肝损伤尚未发展为肝衰竭。

索非布韦的制造商告诉该研究所，他们的药物被批准用于肝衰竭的患者，因此可以解释一些病例。
链接：

安全医学实践报告（免费PDF）

背景：医生首次观察FDA对直接作用抗病毒药物的警告（免费）