Rebetol Recommended For European Approval For Relapse, Naive Hepatitis C Patients


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MADISON, NJ -- Feb. 26, 1999 -- The European Agency for the Evaluation of Medicinal Products’ committee for proprietary medicinal products has issued a positive opinion recommending the approval of Schering-Plough Corp.’s Rebetol® (ribavirin) Capsules for use in combination with for the treatment of both relapse and naive hepatitis C patients.

Rebetol is indicated in combination with interferon alfa-2b injection for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to alpha interferon therapy but who have subsequently relapsed, and for the treatment of adult patients with histologically proven chronic hepatitis C, not previously treated, without liver decompensation, with elevated ALT, who are positive for serum HCV-RNA and who have fibrosis or high inflammatory activity. Patients with only portal fibrosis (minimal fibrosis) should have a high inflammatory score.

Chronic hepatitis C is estimated to affect some 10 million people in major world markets. As many as five million Europeans (one to two percent of the general population) are chronically infected with the hepatitis C virus, according to a study conducted by the World Health Organization (WHO). In Europe, chronic hepatitis C is the leading cause of chronic liver disease and the most common reason for liver transplant. In the United States, Schering-Plough markets Rebetron™ Combination Therapy containing Rebetol® (ribavirin, USP) Capsules and Intron® A (interferon alfa-2b, recombinant) Injection for the treatment of chronic hepatitis C in patients with compensated liver disease previously untreated with alpha interferon or who have relapsed following alpha interferon therapy.

Some four million Americans are chronically infected with the hepatitis C virus, according to the Centers for Disease Control and Prevention.

Rebetol is an oral formulation of the antiviral agent ribavirin, a synthetic nucleoside analog. Intron A (interferon alfa-2b) is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects.

SOURCE: Doctor's Guide to Medical News -

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