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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

7% and 35.4% in the 9 mcg and 15 mcg arms. Regardless of treatment dose used, attaining viral negativity at Week 12 or at Week 24 while on therapy with INFERGEN and RBV leads to a high sustained virological response rate.

"These results represent a significant step forward for HCV patients who deserve a second chance at a potential cure for this chronic viral infection" stated Donald Kerrish, President and CEO of Three Rivers Pharmaceuticals.

Approximately 50% of patients with chronic hepatitis C fail to respond to their initial course of PEG-IFN/RBV therapy. No standard has yet emerged for second-line therapy, since simply repeating the same treatment, in well controlled trials, has yielded low response rates around 2-6%.

The DIRECT trial was a phase 3, randomized, open-label, multicenter, U.S.-based trial conducted to investigate the efficacy, tolerability, and safety of daily INFERGEN at dosages of 9 and 15 mcg/day administered with daily weight-based RBV. The study tested 2 dosages of INFERGEN in 487 documented non-responders, of which 80% did not achieve a 2-log drop on prior pegylated-interferon plus ribavirin therapy. The best SVR rates were seen in:

  • Patients achieving the greatest reduction in baseline viral load with peg-IFN/RBV therapy, especially in patients demonstrating > 1-log drop with initial therapy
  • Patients with fibrosis scores of F0 to F3 at baseline demonstrated SVRs of 7.8% in the 9 mcg arm and 13.1% in the 15 mcg arm
  • Patients maintaining full dose of INFERGEN/RBV therapy had SVRs of 7% and 17% for the 9 mcg and 15 mcg arms respectively
  • Patients demonstrating partial response (>2-log drop) with previous treatment and low fibrosis scores F0-F3 had SVRs of 10.7% and 31.6% for the 9 mcg and 15 mcg arms

Patients with cirrhosis were less likely to bene
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SOURCE Three Rivers Pharmaceuticals, LLC
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