BASEL, Switzerland, September 13 /PRNewswire/ --
-- PROPHESYS Will Identify Factors That Influence Early Response to Treatment
Roche announces the start of a large multinational observational study, called PROPHESYS, in patients with hepatitis C (HCV). This international cohort study will evaluate the important factors that give hepatitis C patients the best chance of treatment success with PEGASYS(R) (peginterferon alfa-2a (40 KD)) plus COPEGUS(R) (ribavirin). PROPHESYS (PROspective observational study on Predictors of early on-treatment response on sustained virological response in a coHort of trEatment naïve HCV patientS treated with pegYlated interferonS) is the largest study of its kind and will identify factors that influence a patient's response to treatment. It is well known that patients who respond early to treatment are more likely to achieve a sustained virological response (SVR or cure) and have less chance of relapse.
"For patients with hepatitis C, early response to treatment leads to the best chance of a cure. The PROPHESYS study will establish what factors help a patient to respond early and will give doctors a better understanding of treatment success," said Mario Rizzetto, Professor of Gastroenterology at the University of Torino, Italy, and lead investigator of the study. "Large studies, such as PROPHESYS, can define real-world clinical practice for hepatitis C."
PROPHESYS - Examining How Early Response to Treatment Influences Overall Success
Over 5,000 patients with HCV will be treated with PEGASYS plus COPEGUS in this large international observational study. Patients will be monitored during treatment and for a further 24 weeks after the end of treatment using Roche's highly sensitive COBAS(R) TaqMan(R) real-time PCR tests to measure the amount of virus in the patient's blood. Viral load levels will be recorded prior to treatment, during treatment and at the end of treatment, as well as at 12 and 24 weeks after treatment.
The study will examine whether it is possible to predict if a patient will achieve a cure based on his or her response to treatment at weeks 2, 4 or 12. The study will also examine how certain factors can influence a patient's chance for an early response, sustained virological response (SVR or cure) and relapse. Factors being evaluated include:
-- Age
-- Pre-treatment viral load
-- Alanine aminotransferase (ALT)
-- Liver fibrosis stage
-- Metabolic parameters
-- Race
-- Weight
-- Gender
Five hundred centres within 18 countries will participate in the study. Enrolment is ongoing and the study is expected to conclude in 2010.
"Roche recognises that there is a need to examine how on-treatment response can influence the overall success for people with HCV, which is why we are launching PROPHESYS," said Claire Steers, PEGASYS Lifecycle Leader at Roche in Basel, Switzerland. "This ongoing research underscores Roche's long-term commitment to curing more people of hepatitis C."
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, which makes it over four times more prevalent than HIV.(1),(2) It is a leading cause of cirrhosis, liver cancer and liver failure, despite the fact that many patients can be cured.
Efficacy of PEGASYS plus COPEGUS Combination Therapy
PEGASYS plus COPEGUS is the only pegylated interferon combination therapy to have demonstrated significantly superior benefits over conventional interferon combination therapy across all HCV genotypes, irrespective of viral load.(3),(4),(5) The combination of PEGASYS plus COPEGUS consistently shows high cure rates - up to 66% overall sustained virological response - across a number of large, randomised clinical studies including in patients with difficult-to-cure disease such as genotype 1 HCV, cirrhosis and HIV-HCV co-infection.(3),(4-8)
About Roche COBAS(R) TaqMan(R) Tests
For more than a decade, Roche Diagnostics has been the world leader in providing molecular diagnostic tests for Hepatitis C, Hepatitis B, HIV, cytomegalovirus (CMV), and other infectious diseases, and was the first to develop and commercialise real-time PCR, the new gold standard in molecular testing. Roche's broad portfolio of virology tests are designed to improve disease management through diagnosis of active infections, quantification of the amount of virus in the blood (viral-load monitoring) and identification of treatment failure and disease recurrence. With a focus on helping to improve answers for doctors and patients and efficiency for labs, in 2005 Roche introduced the fully automated COBAS(R) AmpliPrep/COBAS TaqMan(R) platform, the first system to fully automate real-time PCR testing. It provides labs with flexible configurations, true walk-away capabilities and improved test-result integrity.
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 the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. Additional information is available on the Internet at http://www.roche.com.
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References:
(1). Initiative for Vaccine Research, Viral Cancers, Hepatitis C. World Health Organization, 2006. (Accessed July 24, 2006, at http://www.who.int/vaccine_research/dise....)
(2). AIDS Epidemic Update. 2006. (Accessed February 27, 2007, at http://www.who.int/hiv/mediacentre/2006_....)
(3). 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.
(4). Torriani FJ, Rodriguez-Torres M, Rockstroh JK, et al. Peginterferon Alfa-2a plus ribavirin for chronic hepatitis C virus infection in HIV-infected patients. N Engl J Med 2004;351(5):438-50.
(5). 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.
(6). Marcellin P, Brillanti S, Cheinquer H. Peginterferon alfa-2a (40KD) (PEGASYS) plus ribavirin (COPEGUS) is an efficacious and safe treatment for chronic hepatitis C (CHC) in patients with compensated cirrhosis. In: 38th Annual Meeting of the European Association for the Study of the Liver (EASL) July 3-6; 2003; Geneva, Switzerland; 2003.
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