The FDA has approved expanded labeling for Infergen (consensus interferon, from Three Rivers) to include its daily use in combination with ribavirin for retreatment of chronic hepatitis C patients. This approval was based on data from the DIRECT (Daily-Dose Consensus Interferon and Ribavirin: Efficacy of Combined Therapy) trial that demonstrated Infergen plus ribavirin to be a safe and effective retreatment strategy for patients failing initial therapy with PEG-interferon plus ribavirin.
This was especially apparent with interferon-sensitive patients with lower baseline fibrosis scores. Up to 38% of non-cirrhotic patients (in the 15mcg arm) who were sensitive to PEG-interferon plus ribavirin and who did not modify their Infergen plus ribavirin dosages achieved a sustained virological response. Additionally, patients with cirrhosis were less likely to benefit from retreatment with Infergen plus ribavirin unless they displayed previous interferon sensitivity or at least 1-log10 drop in viral levels on prior therapy.
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