PEG-Intron and Rebetol.

(peginterferon alfa-2b and ribavirin, Schering-Plough Corp.)

A long-acting formulation of Intron-A (interferon alfa-2b) with the antiviral Rebetol, for people aged 18 and over who have chronic hepatitis C infections with compensated liver disease, and who have not been treated previously with alfa-interferon. This combination of PEG-Intron and Rebetol is considered the standard of care for chronic hepatitis C infection.

Intron-A and other interferons were previously approved for treating hepatitis C. The combination of Intron-A and Rebetol was previously approved because of the improved patient response, compared with Intron-A alone. PEG-Intron, which was approved in January as monotherapy for this indication, is the only pegylated alfa-interferon formulation available.

* Recommended Dosage: One subcutaneous injection of PEG-Intron per week, with Rebetol capsules every morning and afternoon. Dosages are based on weight.

* Special Considerations: Rebetol monotherapy is not effective and is not indicated for chronic hepatitis C.

Patients receiving PEG-Intron will receive a medication guide describing possible risks. (Such guides, distributed by pharmacists, are mandated for certain products by the Food and Drug Administration.)

In clinical trials, the most common side effects of the combination treatment included flu-like symptoms, depression, and neutropenia.