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Idenix Reports Results from Two Phase IIb Studies of the,Combination of Valopicitabine and Pegylated Interferon in Hepatitis,C Genotype-1 Patients at the 42nd Annual Meeting of the European,Association for the Study of the Liver

development."

48-Week End-of-Treatment Results in Study of Treatment-Naive Patients

The first study, which was conducted at 23 sites in the United States, evaluated the safety and efficacy of various doses of valopicitabine plus pegylated interferon in 173 HCV genotype-1 infected, treatment-naive patients over 48 weeks. The primary endpoint of the study is sustained virologic response (SVR), defined as maintained viral clearance six months after treatment is stopped. At the end of the treatment period, which was 48 weeks, 53 percent (n=18/34) of patients treated with 200 mg/day valopicitabine plus pegylated interferon achieved undetectable HCV levels by the TaqMan(R) assay (<20 IU/mL).

"These data are encouraging," said Eric Lawitz, M.D., medical director, Alamo Medical Research. "It is important to remember that ribavirin was not used in this study. The addition of ribavirin to the combination of valopicitabine and pegylated interferon may increase on-treatment response and may help to prevent post-treatment relapse. I look forward to the results from the company's ongoing study exploring the triple combination."

Through 48 weeks of treatment, 38 out of a total of 173 patients discontinued from the trial for adverse events (AEs), mostly gastrointestinal (GI)-related; of these, 3 patients were receiving the 200 mg/day dose of valopicitabine. Seven serious adverse events (SAEs) were assessed as attributable to either valopicitabine or valopicitabine and pegylated interferon during the first 48 weeks of treatment, most of which were GI- related. In this study, no valopicitabine-related GI SAEs have occurred since March 2006, when this study was amended to reduce the dose of valopicitabine administered to 200 mg/day or 400 mg/day.

Final Results in Study of Treatment-Experienced Patients

The second phase IIb clinical trial, which was conducted at 22 sites in the United States, evaluated various doses of valopicitabine in combin
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