ALISO VIEJO, Calif., Nov. 3 /PRNewswire-FirstCall/ -- Valeant Pharmaceuticals 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 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.”
Table: Efficacy/Safety (intent-to-treat)
The Phase IIb trial was a U.S. multi-center, randomized, parallel, open-label study in 278 treatment-naive, genotype 1 patients evaluating taribavirin at weight-based doses of 20 mg/kg, 25 mg/kg, and 30 mg/kg per day in combination with pegylated interferon alfa-2b. The control group was administered weight-based dose ribavirin (800/1000/1200/1400mg daily) and pegylated interferon alfa-2b. Overall treatment duration was 48 weeks with a post-treatment follow-up period of 24 weeks.
About Study 204
In the Phase IIb study (previously disclosed as Study 204), 278 treatment naive, genotype 1 patients were randomized with the following patient demographics: mean age 48.8 yr, 61.1% male, 30% African-American or Latino, 80.7% viral load >=400,000 IU/mL and 82.1 kg mean weight. Week 72 efficacy and safety results for the intention-to-treat (ITT) population are shown in the table above.
FORWARD-LOOKING STATEMENTS
This press release may contain forward-looking statements, including, but not limited to, statements regarding the potential for taribavirin in the treatment of hepatitis C, and the continuing role of ribavirin or taribavirin in the treatment of hepatitis C, Forward-looking statements may be identified by the use of the words “anticipates,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” or “continue” and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the company’s most recent annual or quarterly report filed with the U.S. Securities and Exchange Commission, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
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