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November, 2001 -- The first study evaluating the
long-term effectiveness of PEGASYSâ, peginterferon
alfa-2a (40KD), a promising new hepatitis C treatment,
has found that 99% of patients remain viral free when
examined two to three years later.
This study with PEGASYS demonstrates the only
permanent and long-lasting results that have been
reported for pegylated interferons after monitoring
patients for several years following completion of
therapy. Results of this study were presented today at
the 52nd Annual Meeting of American Association for
the Study of Liver Diseases.
“Our study findings should give hepatitis C patients
treated with PEGASYS confidence that if they are virus
free six months after completing therapy, they are
very likely ‘cured’ of their disease,” said Dr.
Mark Swain, the principal investigator from the
University of Calgary, Alberta, Canada.
Importantly, two-thirds of the Hepatitis C Virus patients
participating in this study were originally infected
with genotype 1 Hepatitis C Virus, which is associated with a lower
overall response to therapy. Genotype 1 also
represents the majority of those infected with
hepatitis C in North America and Europe. Furthermore,
25 per cent of patients were cirrhotics, another
difficult-to-treat population.
To date, more than 300 patients have enrolled in the
study, which includes patients that had previously
participated in one of the three Phase III studies
with PEGASYS. Patients were included if they had
completed the 24 week follow-up period in the original
study and patients could not be on any anti-Hepatitis C Virus
therapy subsequent to their original treatment. All
patients were off original therapy for two to three
years.
PEGASYS: A Unique Treatment
PEGASYS is the next-generation [large 40 kilodalton (KD)
and branched] pegylated interferon for the treatment
of Hepatitis C Virus that provides consistent and sustained viral
suppression, resulting in a superior clinical profile.
With more than 13,000 PEGASYS-treated patients
involved in clinical trials worldwide, PEGASYS has
demonstrated the highest sustained virological
response seen to date with pegylated interferons in
both monotherapy trials and combination (with
ribavirin) trials. Conveniently injected once weekly
in a standard dose for all body weights, it has been
developed as a true once weekly antiviral to overcome
the limited effectiveness and multiple side effects
seen with the current standard of care.
PEGASYS recently received its first worldwide approval
in Switzerland and has since been approved in Mexico,
the Dominican Republic, Kuwait, and Peru with
approvals currently pending in several other Latin
American countries. PEGASYS has been filed with
regulatory authorities in the European Union and the
United States, where it is expected to be approved
next year, as well as being filed in Canada and many
other countries.
About Hepatitis C
Hepatitis C is a potentially life threatening viral
infection that can lead to liver inflammation, liver
disease, cirrhosis or liver cancer. Transmitted
primarily through infected blood, more than 170
million people worldwide are infected, making it more
common than the HIV virus.
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