Nov. 3, 2009 (PR Newswire) --
ALISO VIEJO, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals (NYSE: VRX) today announced that results from the week-72 analysis for its Phase IIb dose-finding clinical trial for taribavirin, a prodrug of ribavirin which is in development for the treatment of chronic hepatitis C in conjunction with a pegylated interferon, were presented at the American Association for the Study of Liver Disease (AASLD) 60th Annual Meeting in Boston. It is believed that taribavirin (TBV) may present an alternative therapy to ribavirin (RBV) for the treatment of hepatitis C by delivering similar efficacy to ribavirin but with significantly less anemia, which is the main treatment-limiting toxicity associated with ribavirin.
The results were presented in an abstract entitled "Sustained Virologic Response Results for Weight-Based Taribavirin Versus Weight-Based Ribavirin, in Naïve Chronic Hepatitis C, Genotype 1 Patients", with an oral presentation given by Fred Poordad, M.D., Chief of Hepatology at the Center for Liver Disease and Transplant, Cedars-Sinai Medical Center, Los Angeles, CA and principal investigator in this study.
"The final results of this Phase IIb study are promising, and imply that comparable efficacy can be achieved when compared to ribavirin," said Dr. Poordad. "As is known for ribavirin, low doses are associated with a high relapse rate and, except for the lowest dose with taribavirin, relapse rates are also comparable to ribavirin. The safety of this ribavirin analog is of particular relevance in that its use is associated with significantly less anemia in an evolving era of small molecule therapies, where anemia appears to be more problematic."
The company has previously reported results from this Phase IIb trial exploring weight- based dosing of taribavirin at 20, 25 and 30mg/kg vs. weight-base dosed ribavirin 800-1400mg. The study consisted of 48 weeks of treatment with a 24-week post-treatment follow-up period. Consistent with previous reports, the viral response data continued to show comparable reductions in viral load for weight-based doses of taribavirin and ribavirin in a difficult-to-treat population of subjects infected with hepatitis C genotype 1 and end-of-study sustained virologic response rates were again comparable across the treatment groups. Relapse rates were identical for taribavirin 25mg/kg and weight-based doses of ribavirin. Importantly, the statistically significantly lower anemia rate for patients receiving taribavirin in the 20mg/kg and 25mg/kg arms versus the ribavirin control arm has been maintained at a rate similar to the end-of- treatment (week 48) throughout.
