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3.1.1d Consensus Interferon (Infergen)

Consensus interferon, or CIFN, is a synthetic form of one type of interferon. Created by Amgen scientists, the drug has undergone extensive clinical testing for treating hepatitis C, cirrhosis and a form of cancer.

A Phase IV trial showed that the combination of consensus interferon plus ribavirin is more effective than Rebetron, with a 41% SVR in genotype 1 patients (InterMune Announces Phase IV Study Shows Infergen Combination Therapy More Effective Than Rebetron for Hepatitis C WebMD 11/5/2002).

A daily rather than three-times-weekly regimen of high-dose consensus interferon followed by interferon and ribavirin reduced HCV viral loads to undetectable in 72% of previous non-responders (Medscape Nov. 5, 2002).

Amgen has recently found that a combination of Infergen and interferon gamma-1b produced a more powerful antiviral effect in HCV cells in the laboratory ( PRNewswire-FirstCall, Mar 31, 2003).

InterMune’s Infergen trials show 52% of nonresponders clearing the virus. The induction part of the trial has patients taking 27 mcg of IFN alone for 4 weeks, and then adding on a daily combo therapy with 18 mcg of Infergen plus ribavirin for 12 weeks. Then the patients take 9 mcg. of IFN and ribavirin for another 8 weeks, continuing on, depending on the trial arm to which they were assigned, for 24 to 64 weeks more. Most of the patients on the trial have genotype 1 and a high viral load. At week 24, viral clearance was seen in 40% and 52% of patients with the daily dosing and induction dosing, respectively ( http://www.intermune.com ).

In January 2003, Intermune announced its Phase I trial with its pegylated version of Infergen, PEG-Alfacon ( www.hepatitisresources-calif.org/news/012302%20Intermune.htm). InterMune is involved in phase II study of interferon alfacon-1 (Infergen) plus interferon gamma-1b (Actimune) in non-responders who failed to show any significant reduction in viral load during previous treatment. At 12 weeks. 38% of the patients had undetectable levels of HCV. Ribavirin was not used (Dec. 16, 2003 /PRNewswire-FirstCall).



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