Promising phase II data on novel treatments for chronic hepatitis C were presented at the European Association for the Study of the Liver Congress, Paris, France.
Better-tolerated and more effective therapies are needed as around 70% of the 7 million people with HCV in the US, EU and Japan are infected with the difficult-to-treat genotype strain 1. Currently, only 40%-50 % of these patients have a successful response to the standard treatment of pegylated interferon plus ribavirin.
Dr Nezam Afdhal, Chief of Hepatology at Beth Israel Deaconess Medical Center in Boston, presented preliminary Phase IIa clinical trial data for Idenix Pharmaceutical’s drug valopicitabine (NM283) in treatment-naive genotype 1 HCV patients. In this study, nine patients receiving the combination of valopicitabine and pegylated interferon achieved a mean reduction in serum HCV of more than 99.99% after 24 weeks’ treatment. ‘These preliminary data are promising. For the first time we are seeing rapid and marked anti-HCV activity from an antiviral drug that directly targets a specific enzyme of the hepatitis C virus,’ said Dr Afdhal, a principal investigator in the study.
Dose-limiting anaemia can often limit therapy with ribavirin plus pegylated interferon-2a. Now, data from a Phase II study on Valeant Pharmaceuticals’ viramidine, a pro-drug of ribavirin, show promising anti-HCV genotype 1 activity without the complications of severe anaemia. The study compared ribavirin plus pegylated interferon to viramidine (400mg, 600mg, 800mg) plus pegylated interferon in 180 HCV therapy-naïve patients. Announcing the results at EASL, Valeant Pharmaceuticals said that viramidine plus pegylated interferon had antiviral activity comparable to that of ribavirin plus pegylated interferon with no dose modification due to anaemia.
Finally, details of a Phase II study evaluating the effects of albuferon, a new form of interferon, in the treatment of HCV genotype 1 infected patients were also presented at EASL. In the randomised study, patients were enrolled to receive two subcutaneous injections with 200 mcg, 450 mcg, 670 mcg, 900 mcg, or 1,200 mcg of albuferon (given 14 days apart). Better responses were achieved with the highest doses and the authors concluded that albuferon was safe and showed robust antiviral activity after two doses in interferon-naïve HCV-1 infected patients.
By Vicki Madden at the European Association for the Study of the Liver Congress