BASEL, Switzerland, March 6 /PRNewswire/ --
- Shorter, Simplified Treatment Option May Encourage More Patients toSeek Treatment
Some hepatitis C patients with difficult-to-treat HCV genotype 1who respond quickly to treatment with a combination of PEGASYS(R) (pegylatedinterferon alfa-2a (40KD)) plus COPEGUS(R) (ribavirin) can benefit from ashorter and simplified course of therapy, following Thursday's Commissiondecision. With the new approval, a subset of patients with genotypes 1 and 4HCV who achieve rapid viral response can now receive a shortened, 24-weekduration of treatment with Roche's PEGASYS plus COPEGUS. This is half thenormal treatment duration.
Shorter, Simplified Treatment Shows Excellent Chance for a Cure
The EU approval is based on data from two pivotal clinical trialsfor PEGASYS plus COPEGUS.(1,2) Results from these trials show that amongpatients who achieved a rapid viral response (undetectable viral load at week4) in the first month of treatment up to 93 per cent of patients withgenotype 1 HCV with a low pre-treatment viral load and 83 per cent ofpatients with genotype 4 were cured following only 24 weeks of therapy - asimilar cure rate to that seen following 48 weeks of therapy.(3)
"This is excellent news for patients with hepatitis C," said DrPeter Ferenci, Professor of the Department of Internal Medicine IV,Gastroenterology and Hepatology, at the University of Vienna, Austria. "Thismeans that patients can find out within one month of starting therapy if theyhave an excellent chance of being cured and can benefit from a shortenedtreatment duration. This is likely to encourage patients to seek treatmentand motivate them to stay on therapy."
New Recommendations for Treatment
A shorter, 24-week course with PEGASYS plus COPEGUS is now anoption for the following patients:(4)
- Genotype 1 HCV with a low pre-treatment viral load (definedas <800,000 IU/mL) and an undetectable viral load at weeks 4 and 24;
- Genotype 4 HCV regardless of pre-treatment viral load and anundetectable viral load at weeks 4 and 24.
"This licence change reflects Roche's commitment to findingbetter treatment solutions for patients with HCV by improving treatment withexisting therapies and developing new medicines to treat hepatitis C," saidClaire Steers, PEGASYS Lifecycle Leader at Roche in Basel, Switzerland."Roche is committed to finding solutions for a broad range of hepatitis Cpatients by continuing to simplify treatment with PEGASYS."
About Hepatitis C
Hepatitis C, the most common chronic blood-borne infection, istransmitted primarily through blood or blood products. Hepatitis Cchronically infects 180 million people worldwide, with an additional three tofour million people newly infected each year.(5,6) It is a leading cause ofcirrhosis, liver cancer and liver failure.
About PEGASYS
PEGASYS, the market leader worldwide in hepatitis C therapy,provides significant benefit over conventional interferon therapy in HCVpatients of all genotypes. The benefits of PEGASYS are derived from its large40 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 ofinfection) than conventional interferon. PEGASYS is the only pegylatedinterferon available as a ready-to-administer solution. Each weeklysubcutaneous injection contains 180 microg of pegylated interferon alfa-2a(40KD), which is the approved dose for all patients, regardless of bodyweight.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leadingresearch-focused healthcare groups in the fields of pharmaceuticals anddiagnostics. As a supplier of innovative products and services for the earlydetection, prevention, diagnosis and treatment of disease, the Groupcontributes on a broad range of fronts to improving people's health andquality of life. Roche is a world leader in diagnostics, the leading supplierof medicines for cancer and transplantation, and a market leader in virology.Roche employs roughly 70,000 people in 150 countries and has R&D agreementsand strategic alliances with numerous partners, including majority ownershipinterests in Genentech and Chugai. Additional information about the RocheGroup 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 plusribavirin for chronic hepatitis C virus infection. N Engl J Med2002;347(13):975-82.
2. Hadziyannis SJ, Sette H, Jr., Morgan TR, et al. Peginterferon-alpha2aand ribavirin combination therapy in chronic hepatitis C: a randomized studyof 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. WorldHealth Organization, 2006. (Accessed July 24, 2006, athttp://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.)
6. Global surveillance and control of hepatitis C. Report of a WHOConsultation organized in collaboration with the Viral Hepatitis PreventionBoard, Antwerp, Belgium. J Viral Hepat 1999;6(1):35-47.
Roche Pharmaceuticals
Contact: Janet Kettels, Roche, +1-862-596-9084, Natalie Henson, Axon Communications, +44-(0)20-843-99-406
