Valeant Reports Encouraging Results of Phase IIb Hepatitis Trial
Posted on: Tuesday, 18 March 2008, 06:00 CDT
Valeant Pharmaceuticals has reported positive results at the treatment week 12 analysis point for the Phase IIb clinical trial for its antiviral compound, taribavirin, for the treatment of chronic hepatitis C in conjunction with a pegylated interferon.
The Phase IIb trial is a US multi-center, randomized, parallel, open-label study in 278 treatment-naive, genotype 1 patients evaluating taribavirin at 20mg/kg, 25mg/kg, and 30mg/kg per day in combination with pegylated interferon alfa-2b. The control group is being administered weight-based dose ribavirin (800/1000/1200/1400mg daily) and pegylated interferon alfa-2b.
The 12-week early viral response (EVR) data from the Phase IIb study showed comparable reductions in viral load for weight-based doses of taribavirin and ribavirin. The anemia rate was statistically significantly lower for patients receiving taribavirin in the 20mg/kg and 25mg/kg arms versus the ribavirin control arm.
Michael Pearson, Valeant's chairman and CEO, said: "We are encouraged that these data suggest that weight-based dosing with taribavirin at higher doses may have a role in the treatment of patients infected with hepatitis C while continuing to produce lower anemia than ribavirin. We will use these data to explore the best options for taribavirin's continued role in our portfolio, including consideration of partnering options."
Source: Datamonitor
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