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Three Rivers Announces Positive Results from Phase 3 DIRECT Trial of Once-Daily INFERGEN(R) with Ribavirin in Hepatitis C Virus Treatment Failures
Date:6/16/2009

WARRENDALE, Pa., June 16 /PRNewswire/ -- Three Rivers Pharmaceuticals announced today positive results of the U.S.-based, randomized Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy (DIRECT) clinical trial authored by Bruce R. Bacon, M.D., of Saint Louis University, and colleagues at 44 centers in the United States. The primary endpoint of increased sustained virological response (SVR), was achieved demonstrating that INFERGEN provides a second chance to those HCV patients failing to respond to standard, first-line therapy of pegylated interferon (PEG-IFN) plus ribavirin (RBV). "The retreatment of PEG-IFN/RBV nonresponders with INFERGEN and RBV is safe and efficacious and can be considered a retreatment strategy for patients failing previous therapy with PEG-IFN/RBV, especially in interferon-sensitive patients with lower baseline fibrosis scores," stated Dr. Bruce Bacon the lead Investigator for the study.

Among participants who failed initial treatment with PEG-IFN/RBV, retreatment with INFERGEN in combination with RBV yielded SVR rates as high as 31.6 % in interferon-sensitive patients with low baseline liver fibrosis scores, the researchers reported in the June 2009 issue of Hepatology. Overall intent to treat analysis was 6.9% among the 9 mcg/day group and 10.7% in the 15 mcg/day group.

Defining viral response at Weeks 12 and 24 with INFERGEN and RBV in patients who were prior non-responders to PEG-IFN/RBV therapy can help predict SVR rates in this difficult-to-treat group of patients. All patients attaining SVR demonstrated > 2-log drop at Week 12 of INFERGEN/RBV therapy. Of significant note for these patients was the analysis regarding viral response at 12 weeks. In the DIRECT trial, 81.3% and 63.6% of patients achieving viral negativity at Week 12 went on to have an SVR in the 9 mcg and 15 mcg arms, respectively. In addition, slow responders achieved SVR rates of 11.
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SOURCE Three Rivers Pharmaceuticals, LLC
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