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.
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Cite this: Pancreatitis Events Halt Development of Alisporivir for HCV - Medscape - Apr 19, 2012.
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