Pennsylvania-based Three Rivers Pharmaceuticals has announced positive results from phase-III direct trial of once-daily Infergen with Ribavirin in Hepatitis C virus treatment failures.
Among participants who failed initial treatment with PEG-IFN/RBV, retreatment with Infergen in combination with RBV, yielded sustained virological response rates (as high as 31.6%) in interferon-sensitive patients with low baseline liver fibrosis scores. Overall intent to treat analysis was 6.9% among the 9 mcg/day group and 10.7% in the 15 mcg/day group.
Direct trial, a phase III, randomized, open-label, multicenter, US-based trial was 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.
Patients with cirrhosis were less likely to benefit from retreatment with Infergen and RBV, unless they displayed previous interferon sensitivity of at least 1-log drop in viral levels on prior therapy.
Donald Kerrish, President and CEO of Three Rivers Pharmaceuticals, said: “These results represent a significant step forward for HCV patients who deserve a second chance at a potential cure for this chronic viral infection.”