Three Rivers Pharmaceuticals receives FDA expanded labeling for INFERGEN

Three Rivers Pharmaceuticals, LLC, today received expanded labeling from the U.S. Food and Drug Administration (FDA) to include daily use of INFERGEN (Consensus Interferon) in combination with ribavirin (RBV) for retreatment of chronic hepatitis C patients. The expanded labeling targets hepatitis C patients who need retreatment. In the clinical trial leading to the expanded labeling, the primary endpoint of increased sustained virological response (SVR) was achieved demonstrating that INFERGEN provides a second chance for patients to clear their hepatitis C virus.

“Our hope is that INFERGEN will become the standard of care for the retreatment of chronic hepatitis C patients.”

"Approximately 50 percent of patients with chronic hepatitis C do not respond to their initial course of therapy," stated Dr. Bruce Bacon, the lead investigator for the registration trial. "The FDA's recognition of this expanded label allows patients failing therapy a safe and efficacious retreatment strategy. The results from this study legitimize how we properly treat these patients helping them to achieve SVR."

The data reported and published in Hepatology (2009) from the U.S.-based, randomized, DIRECT clinical trial (Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy) led to the approval of the expanded label. Results from the DIRECT trial had shown that the use of INFERGEN and RBV is a safe and effective retreatment strategy for patients failing initial therapy with PEG-IFN/RBV. This was especially apparent with interferon-sensitive patients with lower baseline fibrosis scores. In fact, up to 38 percent of non-cirrhotic patients (in the 15mcg arm) who were sensitive to Peg-IFN/RBV and who did not modify their INFERGEN and RBV dosages achieved an SVR. Additionally, patients with cirrhosis were less likely to benefit from retreatment with INFERGEN and RBV unless they displayed previous interferon sensitivity or at least 1-log₁₀ drop in viral levels on prior therapy.

"The expanded labeling for INFERGEN is a significant step forward for retreatment of hepatitis C patients who deserve a second chance to overcome their HCV," stated Patrick Kerrish, R.Ph, M.B.A., President of Three Rivers Pharmaceuticals, LLC. "Our hope is that INFERGEN will become the standard of care for the retreatment of chronic hepatitis C patients."

Three Rivers Pharmaceuticals, LLC is expanding its INFERGEN and hepatitis C education efforts via physician outreach and online patient support programs. An instructional video and guide about proper at-home injections of INFERGEN, tips for patient compliance, access to reimbursement specialists and a hotline staffed by nurse counselors are available at www.infergen.com.