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PEG-Intron, Rebetol Study looks at doses in HCV. (Postmarketing Study in Hepatitis C).(hepatitis C virus)
Publication: Internal Medicine News Publication Date: 15-FEB-02 Author: Mechcatie, Elizabeth
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COPYRIGHT 2002 International Medical News Group
Guidance on optimal dosing of ribavirin and treatment response in African Americans may emerge from a large postmarketing trial of pegylated interferon and ribavirin.
These trials are among the postmarketing commitments for Schering-Plough's pegylated formulation of interferon alfa-2b (PEC-Intron). The drug was approved last year for use as a monotherapy and for use in combination with oral ribavirin (Rebetol) in adults who have chronic hepatitis C infections and compensated liver disease and have not been previously treated with alpha inrerferon. To resolve outstanding issues, the Food and Drug Administration often requires postmarketing studies when it approves a drug or biologic.
Roche, the manufacturer of another pegylated interferon formulation, Pegasys, has not yet filed for approval with the FDA. Studies of Pegasys with Rebetol, and Pegasys monotherapy have...
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