Comments:

DEB025 (Alisporivir) is a once-a-day cyclophilin inhibitor that works by blocking a part of the replication process in the HCV NS5A region needed by the hepatitis C virus to replicate. It is not considered an HCV direct antiviral medication but may have a broad application because it works on the host rather than a specific virus. In early studies Alisporivir given alone or in combination with pegylated interferon and ribavirin was found to produce rapid reductions in HCV RNA and has a low drug resistance profile. DEB025 is being developed by Novartis.

EASL 2011: Results from a Phase II study of 300 HCV genotype 1 treatment-naïve patients who were treated with alisporivir plus pegylated interferon and ribavirin reported a 76% SVR rate in the group that was treated for 48 weeks compared to 55% in the group that received pegylated interferon plus ribavirin (without alisporivir).

Phase II
AASLD 2011: In a study that included an interferon-free arm (alisporivir monotherapy & alisporivir plus ribavirin), at week 6, 49% HCV genotype 2 and 3 treatment-naïve patients were HCV RNA undetectable (the highest rates were seen in the alisporivir plus ribavirin arms).

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On Nov 3 Two phase III studies were announced of Alisporivir (DEB025):

• The triple combination of alisporivir, pegylated interferon and ribavirin in people with HCV genotype 1 treatment- naive will be compared to pegylated interferon and ribavirin, and

• The triple combination of alisporivir pegylated interferon and ribavirin to treat HCV genotype 1 treatment- naive African American patients will be compared to the treatment of boceprevir, pegylated interferon plus ribavirin.