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PEGASYS(R) Gets European Approval for a Shorter Treatment Duration for Some Genotype 1 and 4 Hepatitis C Patients who Show a Rapid Response to Therapy
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BASEL, Switzerland, March 6 /PRNewswire/ --
- Shorter, Simplified Treatment Option May Encourage More Patients to Seek Treatment
Some hepatitis C patients with difficult-to-treat HCV genotype 1 who respond quickly to treatment with a combination of PEGASYS(R) (pegylated interferon alfa-2a (40KD)) plus COPEGUS(R) (ribavirin) can benefit from a shorter and simplified course of therapy, following Thursday's Commission decision. With the new approval, a subset of patients with genotypes 1 and 4 HCV who achieve rapid viral response can now receive a shortened, 24-week duration of treatment with Roche's PEGASYS plus COPEGUS. This is half the normal treatment duration.
Shorter, Simplified Treatment Shows Excellent Chance for a Cure
The EU approval is based on data from two pivotal clinical trials for PEGASYS plus COPEGUS.(1,2) Results from these trials show that among patients who achieved a rapid viral response (undetectable viral load at week 4) in the first month of treatment up to 93 per cent of patients with genotype 1 HCV with a low pre-treatment viral load and 83 per cent of patients with genotype 4 were cured following only 24 weeks of therapy - a similar cure rate to that seen following 48 weeks of therapy.(3)
"This is excellent news for patients with hepatitis C," said Dr Peter Ferenci, Professor of the Department of Internal Medicine IV, Gastroenterology and Hepatology, at the University of Vienna, Austria. "This means that patients can find out within one month of starting therapy if they have an excellent chance of being cured and can benefit from a shortened treatment duration. This is likely to encourage patients to seek treatment and motivate them to stay on therapy."
New Recommendations for Treatment
A shorter, 24-week course with PEGASYS plus COPEGUS is now an option for the following patients:(4)
- Genotype 1 HCV with a low pre-treatment viral load (defined as <800,000 IU/mL) and an undetectable viral load at weeks 4 and 24;
- Genotype 4 HCV regardless of pre-treatment viral load and an undetectable viral load at weeks 4 and 24.
"This licence change reflects Roche's commitment to finding better treatment solutions for patients with HCV by improving treatment with existing therapies and developing new medicines to treat hepatitis C," said Claire Steers, PEGASYS Lifecycle Leader at Roche in Basel, Switzerland. "Roche is committed to finding solutions for a broad range of hepatitis C patients by continuing to simplify treatment with PEGASYS."
About Hepatitis C
Hepatitis C, the most common chronic blood-borne infection, is transmitted primarily through blood or blood products. Hepatitis C chronically infects 180 million people worldwide, with an additional three to four million people newly infected each year.(5,6) It is a leading cause of cirrhosis, liver cancer and liver failure.
About PEGASYS
PEGASYS, the market leader worldwide in hepatitis C therapy, provides significant benefit over conventional interferon therapy in HCV patients of all genotypes. The benefits of PEGASYS are derived from its large 40 kilodalton (KD) branched-chain polyethylene glycol (PEG) construction, which allows for sustained drug levels over the course of a full week. PEGASYS also distributes more readily to the liver (the primary site of infection) than conventional interferon. PEGASYS is the only pegylated interferon available as a ready-to-administer solution. Each weekly subcutaneous injection contains 180 microg of pegylated interferon alfa-2a (40KD), which is the approved dose for all patients, regardless of body weight.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation, and a market leader in virology. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
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References
1. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347(13):975-82.
2. Hadziyannis SJ, Sette H, Jr., Morgan TR, et al. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004;140(5):346-55.
3. Data on file, Roche 2006.
4. PEGASYS(R) EMEA Summary of Product Characteristics. www.emea.eu.int.
5. Initiative for Vaccine Research, Viral Cancers, Hepatitis C. World Health Organization, 2006. (Accessed July 24, 2006, at http://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.)
6. Global surveillance and control of hepatitis C. Report of a WHO Consultation organized in collaboration with the Viral Hepatitis Prevention Board, Antwerp, Belgium. J Viral Hepat 1999;6(1):35-47.
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