Infergen gains expanded indication

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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