Canada Approves Pegasys RBV
for Treatment of Canada's "Silent Epidemic"
Hepatitis C Community Applauds Approval of
Long-Awaited Therapy and Calls for Quick Patient Access
ON - May 12, 2004 - For the estimated 250,000 Canadians living
with hepatitis C a condition only about two-thirds of infected
patients know they have a long-awaited new combination treatment
option is now available.1 Hoffmann-La Roche Limited today
announced that Health Canada has approved Pegasys RBV (PEGASYS
[peginterferon alfa-2a] in combination with COPEGUS [ribavirin])
for the treatment of adults with chronic hepatitis C including
those with compensated cirrhosis.
C virus (HCV) is known as the "silent epidemic" because
most people with HCV have no symptoms and can be infected for
10 to 20 years before serious health concerns make them aware
they have the disease. Consequently, they can unknowingly infect
others. In Canada, HCV is a leading cause of cirrhosis (liver
scarring), liver failure and liver transplants.
applaud Health Canada for approving Pegasys RBV," said
Durhane Wong-Rieger, Secretariat, Canadian Hepatitis C Network.
"Prior to this approval, Canadians with hepatitis C only
had one combination treatment option available to them. Many
hepatitis C patients have waited many years for this new therapy.
In fact, some have even delayed treatment in anticipation of
its approval, because they felt Pegasys RBV was their best chance
to clear the virus. News of its availability will be welcomed
by the thousands of Canadians living with this debilitating
of Pegasys RBV was based on the results of two pivotal Phase
III clinical trials. Both studies demonstrated that virus genotype
was the strongest predictor of whether or not a patient would
achieve a sustained virological response (SVR) - the primary
goal of treatment. These study results have had a profound influence
on the way physicians in Canada and around the world treat hepatitis
C. Viral genotype as the strongest predictor of treatment response
was also validated during a presentation of soon-to-be published
Canadian consensus guidelines on the management of viral hepatitis
at the 2nd Canadian Conference on Hepatitis C in Vancouver in
the results showed that Pegasys RBV successfully treats the
disease with fewer side effects than standard interferon therapy
plus ribavirin, even amongst the most difficult to treat patients
- those with genotype 1 and cirrhosis. Genotype 1 represents
70 per cent of those infected with hepatitis C in North America
Studies Have Profound Influence on the Way Physicians Treat
Hepatitis C A pivotal study published in the March 2, 2004 Annals
of Internal Medicine found that patients infected with the 'easier-to-treat'
hepatitis C genotypes 2 and 3 could reduce the length of treatment
with Pegasys RBV from one year to six months and lower the dose
of COPEGUS from the standard dose of 1000 or 1200mg to 800mg
and still achieve an SVR of 84 per cent. This landmark study
provided the evidence of the importance of tailoring PEGASYS
and COPEGUS combination therapy according to genotype. Today,
this approach is considered by many physicians to be the standard
genotypes of the hepatitis C virus need to be approached differently.
Some are easier to treat while others are stubborn and more
challenging to treat," said Dr. Sam Lee, a hepatologist
at the University of Calgary. "With Pegasys RBV, we can
now effectively tailor the dosage and duration of a patient's
therapy to the genotype of the virus, without compromise."
is also gratifying is that this comes with an improved tolerance,"
said Dr. Morris Sherman, a hepatologist at Toronto General Hospital.
"The side effects that are often the most troubling, namely
flu-like symptoms and depression, occur less frequently with
Pegasys RBV than with interferon alfa-2b plus ribavirin. This
means fewer patients will have to stop therapy because of side
pivotal study, published in the September 26, 2002 issue of
The New England Journal of Medicine, showed that Pegasys RBV
is a more effective treatment for chronic hepatitis C than interferon
alfa-2b plus ribavirin. Specifically, the SVR rate in the Pegasys
RBV treated patients was 56 per cent compared to 44 per cent
in the interferon alfa-2b and ribavirin group. Only Pegasys
RBV has shown increased efficacy versus interferon alfa-2b plus
ribavirin in all patient sub-types in a large, randomized, prospective
trial. Patient sub-types include genotype 1 patients with both
high and low viral loads; patients with cirrhosis; and genotype
2 and 3 patients with both high and low viral loads.
Demand Quick Access "We know from the many patient stories
that it is critical for Canadians living with hepatitis C to
have more than one treatment option available to them, as what
works for some, does not work for all," said Wong-Rieger.
"But beyond the approval of new medications, we also need
to consider quick provincial formulary approval across Canada
so that patients who need this treatment do not have to wait
Bartzis has just completed a full course of Pegasys RBV treatment
through a worldwide expanded access protocol (clinical trial).
"I feel fortunate to have had the chance to go through
this therapy and am pleased to report that it has been successful.
I feel healthier, I have more energy, and I think it's important
for other Canadians who suffer with hepatitis C to have hope,
and to know that if it can work for me it could work for them
too," said John.
also says that what helped him to stay on therapy was the fact
that Pegasys RBV is available as an easy-to-use, fixed dose,
pre-filled syringe and only needed to be injected once a week.
fact that I only had to inject this medication once a week made
a huge difference when faced with the prospect of completing
almost one full year of therapy it made it easy," he explained.
"And the pre-filled syringe helped remove the guesswork."
Pegasys RBV PEGASYS (peginterferon alfa-2a) in combination with
COPEGUS (ribavirin) provides superior efficacy compared to standard
interferon combination therapy in hepatitis C patients of all
genotypes. The benefits of PEGASYS are derived from its new
generation large 40 kilodalton (KD) branched-chain polyethylene
glycol (PEG) design, which allows for constant viral suppression
over the course of a full week. PEGASYS is the only pegylated
interferon available as a ready-to-administer solution in a
pre-filled syringe. Each weekly subcutaneous injection contains
180mcg of pegylated interferon alfa-2a (40KD) which is the approved
standard dose for all patients, regardless of body weight. PEGASYS
also distributes more readily to the liver (the primary site
of infection) than standard interferon.
in combination with COPEGUS has been approved for use in more
than 80 countries, including the US and the majority of European
Union countries, and is now the most prescribed interferon therapy
in the United States for the treatment of chronic hepatitis
C. 3 Pegasys RBV was submitted for priority review to Health
Canada in August 2002 and received approval on May 10, 2004.
Product will be available in approximately one month.
year, an estimated 5,000 more Canadians are infected with this
potentially fatal disease.1 Any drug or combination of drugs
that can improve quality of life and health represents a major
step forward for Canadian patients," said Tim McClemont,
Executive Director of the Hepatitis C Society of Canada.
Hoffmann-La Roche Limited
Hoffmann-La Roche Limited is a healthcare company committed
to the discovery and development of new and innovative medicines
to help treat human illnesses. The company is active in a broad
range of therapeutic categories that include AIDS, cardiology,
dermatology, hepatitis C, infectious disease, metabolism, transplant,
oncology and virology.
... Hepatitis C in Canada - Get the facts. Health Canada Web
2 ... 2nd Canadian Conference on Hepatitis C, Vancouver, March
27-30, 2004 3 IMS weekly data for the week ending December 26,