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Health Canada Approves Pegasys RBV
for Treatment of Canada's "Silent Epidemic"

Canadian Hepatitis C Community Applauds Approval of
Long-Awaited Therapy and Calls for Quick Patient Access

May 12, 2004


Mississauga, 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.

Hepatitis 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.

"We 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 disease."

Approval 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 March 2004.2

Further, 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 and Europe.

Pivotal 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 of care.

"Different 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."

"What 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 effects."

Another 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.

Patients 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 any longer."

John 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.

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.

"The 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."

About 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.

PEGASYS 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.

"Each 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.

About 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.

For more information about Hepatitis C, visit www.hepquest.com

1 ... Hepatitis C in Canada - Get the facts. Health Canada Web Site. http://www.hc-sc.gc.ca/hppb/hepatitis_c/
2 ... 2nd Canadian Conference on Hepatitis C, Vancouver, March 27-30, 2004 3 IMS weekly data for the week ending December 26, 2003.


 

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HCV - FAQs

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Hepatitis C Virus (HCV) Resources

   
 

This section provides immediate access to all of HCV resources in both HTML and PDF formats (PDF requires Adobe Acrabot Reader)

FAQs PDF

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Multilingual Hepatitis C Information (March 2004)

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Hepatitis C Get the Facts (101 KB) or HTML

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Frequency Asked Questions about Compensation (273 KB) or HTML

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Quick Facts PDF

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Hepatitis C Information for Health Professionals (101 KB) or HTML

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Hepatitis C & Injection Drug Use (220 KB) or HTML

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Hepatitis C & Injection Drug Use - A Focus On Youth (221 KB) or HTML

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Regional Project Funding PDF

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Roll-Up Report of Prevention & Community-Based Support Regional Projects Funded/In-Progress 1999-2000 (660 KB) or HTML

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Regional Project Funding - Guidelines (516 KB) or HTML

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Regional Project Funding - Application Form (438 KB) or HTML

Publications PDF

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Hepatitis C Prevention: An Examination of Current International Evidence (1,113 KB) or HTML  (February 2002)

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Responding to an Emergency: Education, Advocacy and Community Care by a Peer-driven Organization of Drug Users (1,751 KB) or HTML (December 2001)

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Harm reduction and injection drug use: An international comparative study of contextual factors influencing the development and implementation of relevant policies and programs (September 2001) (860 KB) or HTML (September 2001)

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Estimating the number of persons co-infected with Hepatitis C virus and Human Immunodeficiency virus in Canada (694 KB) or HTML (March 2001)

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Special Report on Youth, Piercing, Tattooing and Hepatitis C (583KB) or HTML (March 2001)

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Mediums to Reach Injection Drug Users - A Discussion Paper
(64 KB) or HTML  (September 2000)

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Profile of Hepatitis C & Injection Drug Use in Canada (99 KB) or HTML (September 2000)

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Resources for Hepatitis C & Injection Drug Use - A Needs Assessment (99 KB) or HTML (July 2000)

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Angus Reid Survey (93 KB) or HTML (January 2000)

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Estimating the number of blood transfusion recipients infected by hepatitis C virus in Canada, 1960-85 and 1990-92. Report to Health Canada (240 KB) (June 1998)

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Medical and Treatment Guidelines PDF

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Management of Viral Hepatitis: A Canadian Consensus Conference 2003/2004
- Evaluation Questionnaire - PDF only

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Hepatitis C: Nutrition Care - Canadian Guidelines for Health Care Providers (1,229 KB) or HTML
September 2003

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Nutrition Tips for People with Hepatitis C:
   Helping You Feel Your Best! (370 KB) or HTML
   Dealing With Discomforts (365 KB) or HTML
   September 2003

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Hepatitis C: A Nursing Guide (185 KB) or HTML

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Management of Viral Hepatitis: Recommended Guidelines for Physicians (306 KB) or HTML

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Management Guidelines for the HCV-HIV Co-infected Adult (130 KB) or HTML

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Executive Summary (16 KB) or HTML

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Reproductive Care of Women Living with Hep C Infection (156 KB) or HTML

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The Management of Viral Hepatitis. Proceedings of a consensus conference held in Montreal, Quebec in March 1999

Programs and Services PDF

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Hepatitis C (2002) (60 KB) or HTML

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Get the Facts: Mid-term Evaluation Report (2003) (758 KB) or HTML
November 2003 

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Get the Facts: Collection of Project Case Studies (2003) (880 KB) or HTML 
November 2003

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Wendy's Wellness Website
This site is devoted to providing updated reliable information for people infected with or affected by Hepatitis C. Wendy has been living & coping with this illness for 35 years now and has learned many
ways to improve daily quality of life issues. To read Wendy's Hep C story and share collective knowledge please check www.wendyswellness.ca


 

DISCLAIMER:
Information & advice is not intended to be used in place
of professional medical advice.
Ask your doctor before acting
on any advice to be sure it's right for your particular health situation.

 

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1999 - 2006 by Barbara Anello