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10/17/2002

New Hepatitis C Treatment Approved by FDA

Cheryl A. Thompson

The Food and Drug Administration has approved the biologics license for Pegasys (PDF), or peginterferon alfa-2a, according to an announcement yesterday by Hoffmann–La Roche Inc.

Peginterferon alfa-2a is an interferon-based product in which polyethylene glycol is covalently bound to the recombinant protein, resulting in a substance that retains its activity longer than interferon alfa-2a. The pegylated interferon is used once weekly for 48 weeks in the treatment of adults with chronic hepatitis C who have not previously received interferon alfa therapy and who have compensated liver disease.

A similar product, peginterferon alfa-2b, has been available from Schering Corp. since 2001.

Roche said it will give physicians, at their request, samples of peginterferon alfa-2a for the first 12 weeks of a patient's treatment as long as the patient is among the first 15,000 to start therapy by Dec. 31. According to the company, clinicians can determine at week 12 whether a patient will likely have a detectable serum level of hepatitis C RNA one year later and, thus, not attain a sustained response to the treatment.

Peginterferon alfa-2a is contraindicated in patients with autoimmune hepatitis or decompensated liver disease or in whom decompensated liver disease later develops. Pegasys, which contains benzyl alcohol, is also contraindicated in neonates and infants.

During the clinical studies, the most common adverse events reported were psychiatric reactions, such as depression and irritability, and flu-like symptoms.

The recommended dosage of peginterferon alfa-2a is 180 mcg once a week administered by subcutaneous injection into the abdomen or thigh. Pegasys will be available in single-dose vials containing 180 mcg of the drug in 1 mL of solution. The vials must be stored in the refrigerator.

Roche said that pharmacies will have the new product within two weeks.

Update 18 September 2002—Patients who obtain their supply of Pegasys from a pharmacy are to receive an FDA-approved medication guide (PDF).