VALEANT BEGINS STUDY OF HEPATITIS C ANTIVIRAL

Valeant Pharmaceuticals announced it has begun enrolling patients in a Phase IIb study of its antiviral compound, taribavirin, an oral nucleoside (guanosine) analog, for the treatment of chronic hepatitis C in conjunction with a pegylated interferon.

The trial is a multicenter, randomized, parallel, open-label study in 260 treatment-naïve, genotype 1 patients. The study will evaluate taribavirin doses of 20, 25 and 30 mg/kg per day in combination with pegylated interferon alfa-2b. There also will be a control group taking ribavirin and pegylated interferon alfa-2b.

Valeant will perform analyses of the study data after all patients have reached the week-12 time point, which is the primary endpoint of the study. The results at week 12 are typically predictive of a full 48-week treatment course. Based on the 12-week data, the company will decide whether to begin another Phase III study at a more appropriate dose than used in the previous VISER studies.

Additionally, if the week-12 data are encouraging, the company intends to continue the current study for a full 48-week treatment course with a posttreatment follow-up at week 72. The 12-week results are expected to be available by the end of the year.