Novartis' alisporivir may become first interferon-free oral for hepatitis C G2/G3

The clear conclusion from a clinical trial of alisporivir (DEB025, from Swiss drug major Novartis [NOVN: VX]), an oral host-targeting cyclophilin inhibitor, is that treatment based on it may be an effective, interferon (IFN)-free alternative for individuals with genotype 2 or 3 (G2/G3) hepatitis C virus (HCV) infections. The finding was presented by Jean-Michel Pawlotsky, a professor at the Henri Mondor Hospital, University of Paris-Est, Creteil, France, at a late-breaking poster session on November 7, 2011 at the 62nd annual meeting of the American Association for the Study of Liver Diseases (AASLD) held last week in San Francisco.

Novartis in-licensed DEB025 from Debiopharm, an independent biopharmaceuticals company based in Switzerland, under an agreement which gives Novartis exclusive worldwide development, manufacturing and marketing rights (excluding Japan; The Pharma Letter February 9, 2010).

IFN therapy is associated with significant adverse events, including flu-like symptoms, fatigue and nausea, all of which can significantly impact treatment adherence, and therefore also response rates and disease control. HCV G2/G3 represents the second most prevalent variant of HCV infection. While an effective and well-tolerated oral IFN-free HCV treatment would likely be widely embraced, because registrations trials are not yet completed, investigators and Novartis representatives were unwilling to speculate on the impact of an ultimate alisporivir approval.