United States of America - The Food and Drug Administration has approved a supplemental indication for peginterferon alfa-2b (PEG-Intron®) an injectable approved to treat patients with chronic hepatitis C infections to be used in combination with ribavirin. (See following summary). Peginterferon alfa-2b is a longer acting form of interferon and requires only one injection per week for one year. In January 2001, FDA approved PEG-intron® alone to treat chronic hepatitis C in patients with liver disease who had not been treated before with interferon alfa and who are at least 18 years old.
Adverse events reported in clinical trials included flu-like symptoms, psychiatric disorders (including depression), and decreases in red blood cells, white blood cells, and platelets. Patients taking combination treatments must be carefully monitored and get regular blood tests to check for side effects and to determine treatment effectiveness.
Reference: FDA Talk Paper, T01 - 35 (2001).