Idenix Pharmaceuticals has announced partial 24-week data from an ongoing Phase IIb clinical trial evaluating valopicitabine combined with pegylated interferon in treatment-refractory patients with chronic hepatitis C. These 24-week data demonstrate continued increased viral suppression in patients treated with the combination of valopicitabine plus pegylated interferon compared to patients retreated with ribavirin plus pegylated interferon. All patients enrolled in the trial are chronically infected with the Genotype 1 strain of hepatitis C and have previously failed to respond to treatment with pegylated interferon plus ribavirin.
The 48-week trial is evaluating three dosing regimens of valopicitabine, administered once-daily, in combination with pegylated interferon compared to retreatment with combination therapy of pegylated interferon plus ribavirin. Valopicitabine combination dosing regimens include: valopicitabine 400 mg; valopicitabine ramping from 400 mg to 800 mg during Week 1 and continuing thereafter with 800 mg; and valopicitabine 800 mg. In all three arms, valopicitabine is given in combination with pegylated interferon alfa-2a (Pegasys) 180 5g with the initial dose of pegylated interferon administered on Day 8.