胰臟炎事件影響了發展Alisporivir用於HCV的情況


  【24drs.com】美國食品藥物管理局(FDA)要求諾華擱置研究成分alisporivir的臨床發展,因為有胰臟炎顧慮。在藥物試驗中,一種原本用於治療C型肝炎病毒(HCV)感染之口服製劑的使用者,發生3例胰臟炎,其中1例死亡。發展該藥的諾華藥廠在「International Liver Congress 2012: 47th Annual Meeting of the European Association for the Study of the Liver (EASL)」這項會議中提出報告。
  
  瑞士諾華藥廠全球頭部、肝炎、臨床發展與醫療事務負責人Nikolai Naoumov醫師在記者會中向聽眾表示,FDA已經通知諾華藥廠暫停alisporivir臨床試驗,原因是,在幾個月前共發生了3例急性胰臟炎案例,其中1人在上週過世。很遺憾有1人死亡,胰臟炎是使用干擾素的已知風險,干擾素是該試驗併用alisporivir的藥物之一。
  
  EASL秘書長General Mark Thursz醫師主持記者會時表示,我們暸解問題發生在併用干擾素治療的病患中。
  
  Naoumov醫師表示,該公司目前正評估併用alisporivir和干擾素是否是胰臟炎的潛在風險因素。
  
  所有發生胰臟炎的病患都接受過pegylated干擾素和ribavirin這種C型肝炎標準照護,再加上alisporivir。
  
  Alisporivir是一種口服製劑,可抑制cyclophilin,這是HCV複製所需的宿主蛋白質。
  
  目前有許多新的、有不同作用機制的小分子口服製劑研發用於治療HCV,希望這些藥物有一些可以不需要加入干擾素,干擾素會引起類流感症狀,會導致憂鬱,且療程需使用好幾個月。
  
  資料來源:http://www.24drs.com/professional/list/content.asp?x_idno=6796&x_classno=0&x_chkdelpoint=Y
  

Pancreatitis Events Halt Development of Alisporivir for HCV

By Daniel M. Keller, PhD
Medscape Medical News

April 19, 2012 (Barcelona, Spain) — The US Food and Drug Administration (FDA) has asked Novartis to put clinical development of the investigational compound alisporivir on hold because of concerns about pancreatitis. In trials of the drug, an oral agent intended for the treatment of patients infected with the hepatitis C virus (HCV), 3 cases of pancreatitis, including 1 death, have been reported, an official with Novartis, the developer of the drug, reported here today at the International Liver Congress 2012: 47th Annual Meeting of the European Association for the Study of the Liver (EASL).

Nikolai Naoumov, MD, global head, hepatitis, clinical development and medical affairs, at Novartis Pharma in Basel, Switzerland, told attendees at a news conference here, "The FDA has notified Novartis to put the alisporivir program on clinical hold. And the reason is that in the last few months we had a cluster of 3 patients who developed acute pancreatitis, and 1 which was last week. A patient has died, unfortunately." He said pancreatitis is a known risk with the use of interferon, 1 of the drugs used in combination with alisporivir in the trial.

Moderating the news conference, EASL Secretary General Mark Thursz, MD, said, "I understand that the problems have been in the group of patients who are on combination therapy with the interferon as well."

Dr. Naoumov said that his company is "currently working to assess whether the combination of alisporivir plus interferon may have potentiated the known risk of [pancreatitis]."

All of the patients with pancreatitis had been treated with pegylated interferon and ribavirin, a standard of care for hepatitis C virus infection, to which alisporivir had been added.

Alisporivir is an oral agent that inhibits cyclophilin, a host protein that HCV appears to require for replication.

Several new, small-molecule oral agents with distinct mechanisms of action are in development for the treatment of HCV. The hope is that some of these drugs will work without requiring the addition of interferon, which causes flu-like symptoms, can lead to depression, and must be used for months.

Dr. Naoumov is an employee of Novartis. Disclosure information for Dr. Thursz was not available.

The International Liver Congress 2012: 47th Annual Meeting of the European Association for the Study of the Liver (EASL). Presented April 19, 2012.

    
相關報導
社工在C型肝炎治療中的角色
2014/3/26 上午 10:55:04
C型肝炎:有效的6種預防策略
2013/7/31 上午 10:19:22
異性伴侶之間的C型肝炎傳染很罕見
2013/3/27 上午 10:00:41

上一頁
   1   2   3   4   5   6   7   8   9   10  




回上一頁