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 -
http://www.pslgroup.com/dg/e9226.htm
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