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Valopicitabine Combined with Standard of Care Cleared Hepatitis C,Virus in 72% of Patients Who Completed 12 Weeks of Treatment in a,Phase II Trial

~ Valopicitabine achieved both primary and secondary endpoints of study; no negative drug-drug interaction was observed between valopicitabine and ribavirin ~

CAMBRIDGE, Mass., June 12, 2007 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. today announced results from a phase II study designed to evaluate triple combination therapy, consisting of valopicitabine (NM283), Idenix's lead drug candidate for the treatment of hepatitis C, pegylated interferon and ribavirin compared to pegylated interferon and ribavirin, the current standard of care, in patients infected with the genotype-1 strain of the hepatitis C virus (HCV). This study demonstrated no pharmacokinetic or pharmacodynamic drug-drug interaction between valopicitabine and ribavirin. The triple combination showed consistently higher rates of HCV PCR-negativity, defined as serum HCV RNA levels below 20 copies/mL, compared to the standard of care at every point analyzed in this study. Additionally, the tolerability of the triple combination was satisfactory, with only three discontinuations from the study.

"I am very encouraged to observe this degree of viral clearance coupled with a very low rate of discontinuations in patients treated with the triple combination of valopicitabine, pegylated-interferon and ribavirin in this study," said Dr. Fred Poordad, Chief of Hepatology and Liver Transplantation, Cedars Sinai Medical Center, and an investigator in this study. "These data represent an important achievement in the development of novel HCV combination therapy."

Study Design and Results

The three-arm, partially blinded, randomized study enrolled 117 treatment- naive, HCV genotype-1 infected patients at approximately 20 centers in the United States. Patients in arm A (n=39) received 200 mg/day of valopicitabine and pegylated interferon alpha 2a; patients in arm B (n=39) received 200 mg/day of valopicitabine, weight-based dosing o
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