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U.S. Department of Health and Human Services

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Pegasys and Copegus Indications Expanded to Include Treatment of Hepatitis C and HIV Coinfection

FDA approved, on February 25, 2005, efficacy supplements for Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), making them the first approved therapies for treatment of Hepatitis C in patients coinfected with HIV. The approvals expand the therapeutic indications to include Peginteferon alone, or in combination with ribavirn, for the treatment of adult chronic hepatitis C in patients coinfected with HIV, who have clinically stable HIV disease (patients either on stable HIV antiretroviral therapy, or those who have not met the criteria to begin therapy).

Note that patients receiving Pegasys/Copegus and Nucleoside Reverse Transcriptase Inhibitors (NRTIs) should be closely monitored for treatment-associated toxicities.

Revised labeling for Pegasys and Copegus is attached in pdf format.

Descriptive information about the clinical trial to support the supplement are contained in respective product labeling. (See Study 6.)

Pegasys and Copegus are manufactured by Hoffmann-La Roche Inc., Nutley, NJ

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration