By John Gever, Senior Editor, MedPage Today
Published: April 19, 2012
Three cases of acute pancreatitis, one fatal, have led the FDA to put a clinical hold on a trial of an investigational oral drug for hepatitis C called alisporivir, according to the product's manufacturer.
An official at Novartis broke the news at a press conference held Thursday at the European Association for the Study of the Liver meeting in Barcelona.
Responding to a reporter's question, Nikolai Naoumov, MD, confirmed that the FDA had ordered a halt to a trial involving alisporivir.
"The FDA has notified Novartis to put the program on clinical hold," Naoumov said. "The reason is that in the last few months we had a cluster of three patients who developed acute pancreatitis and one last week who died, unfortunately. So, as a result, this is to assess the risk. All these patients had been treated with alisporivir plus PR [pegylated interferon and ribavirin]. We know pancreatitis is on the label of interferon, and we are working to see if adding alisporivir potentiated a known side effect."
Alisporivir is an orally active inhibitor of cyclophilin, a protein found in most vertebrates that appears to be necessary for hepatitis C virus (HCV) replication. It was initially developed under the name DEB-025 by the Swiss firm Debiopharm, which has licensed rights in most of the world to Novartis.
The HCV community has been hopeful that cyclophilin inhibitors such as alisporivir would not need to be given with interferon drugs, but could instead replace them.
Interferon therapy causes debilitating flu-like symptoms that continue throughout the months-long course of treatment. Results in clinical studies of alisporivir have suggested a more favorable side effect profile and efficacy that has prompted speculation about interferon-free treatment regimens for HCV.
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