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Hepatitis
C Virus (HCV)
Information, Education, Advocacy, Support & Resources |
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Health
Canada Approves Pegasys RBV Canadian
Hepatitis C Community Applauds Approval of May
12, 2004
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 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/
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- 2006 by Barbara Anello