Roche Welcomes the Initiative and Comments Upon New European Guidelines
The Final Statement from the 1st European Consensus Conference on the Treatment of Chronic Hepatitis B and C in HIV Co-infected Patients, released today, includes a definitive recommendation that HIV patients co-infected with the hepatitis C virus (HCV) should be treated with pegylated interferon combination therapy. Following the recent approval from the European Commission in February, PEGASYS� (pegylated interferon alpha 2a (40KD)) in combination with ribavirin, is now the only pegylated interferon which can be used in accordance with these new guidelines to treat HIV-HCV co-infected patients.
�While the Jury made many important recommendations today, we are particularly pleased that they have recognized pegylated interferon combination therapy as the gold standard of treatment for patients who are co-infected with hepatitis C and HIV,� said Ciro Caravaggio, Head of the Hepatitis Franchise at Roche. �Because PEGASYS is the only pegylated interferon combination therapy approved by both the EU and US authorities for treatment of these patients, we recognise that we have a responsibility to help physicians implement the guidelines outlined by the Jury. We welcome this opportunity to work with physicians across Europe to ensure patients receive a medication with trusted safety and efficacy.�
The Consensus Conference, which was endorsed by the European Association for the Study of the Liver and the European AIDS Clinical Society, was convened to review current knowledge on the treatment of hepatitis B and HCV in HIV co-infected patients. In addition to their recommendations regarding optimal treatments for those with HIV-HCV co-infection, the Jury also addressed other critical matters including the compelling reasons to treat viral hepatitis C in HIV co-infected patients, effective screening and diagnosis strategies, and areas for future research.
Innovative Research from Roche Guides Jury Deliberations
Over the two-day conference, a wealth of data was presented, including the results of Roche�s AIDS PEGASYS� Ribavirin International Co-infection Trial (APRICOT). This study was critical to the Jury�s analysis of options for HIV-HCV co-infection as this is the largest study in co-infected patients.
�The results from APRICOT have truly had enormous implications for millions of people worldwide infected with hepatitis C and HIV,� said Professor Vincent Soriano, from Hospital Carlos III in Madrid and an investigator in the study. �Today�s recommendations by the Consensus Conference Jury emphasize the importance of this data in changing our approach to treating these patients.�
APRICOT was the first and remains the only large international multicentre prospective study to evaluate the proven efficacy and trusted safety of pegylated interferon combination therapy in HIV-HCV co-infected patients. It established that PEGASYS combination therapy produced an overall sustained virological response (SVR, indicative of a cure) rate of 40% in HIV-HCV co-infected patients. This is the highest cure rate ever seen in a trial of this size and scope.
APRICOT formed the basis for the very recent US and EU approvals of PEGASYS combination therapy for HCV in HIV co-infected patients. This is the sixth PEGASYS trial to have been published in the New England Journal of Medicine.[i]
PEGASYS Receives Five Regulatory Nods in Four Months
Over the past four months, PEGASYS has received a steady stream of approvals from health authorities around the world. Last week, the US Food and Drug Administration approved PEGASYS in combination with ribavirin for the treatment of chronic hepatitis C in patients co-infected with hepatitis C and HIV. On the same day, the European Commission approved PEGASYS for use amongst patients with hepatitis B. In previous weeks, PEGASYS was approved for use by co-infected patients in the EU, as well as those with �normal� levels of alanine aminotransferases (ALT). Swiss authorities also approved the use of PEGASYS for those infected with hepatitis B.
PEGASYS � The Right Solution for More Patients
PEGASYS is the newest and most frequently prescribed pegylated interferon for patients infected with hepatitis C. An extensive clinical study programme has demonstrated its safety and efficacy, particularly for those with difficult-to-treat disease. The benefits of PEGASYS are derived from its unique molecule construction, which provides sustained viral control for patients during the once weekly dosing interval.
In addition to becoming the first and only treatment approved for hepatitis C patients who are co-infected with HIV, PEGASYS is also the only EU approved medication for hepatitis C patients with �normal� levels of alanine aminotransferases (ALT) - a patient population previously thought not to benefit from treatment. PEGASYS is currently under the consideration of health authorities around the world for use amongst those infected with chronic hepatitis B, with approvals already granted in Switzerland and very recently in Europe.
Roche
Headquartered in Basel, Switzerland, Roche is one of the world�s leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the 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. In 2004, the Pharmaceuticals Division generated 21.7 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
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Notes for the editor:
Roche announced US approval for PEGASYS in co-infected patients on February 25, 2005
Roche announced EU approval for PEGASYS in co-infected patients on January 21, 2005
Roche announced EU approval for HBV on February 25, 2005
Roche announced Swiss approval for HBV on December 22, 2004
Roche announced EU approval for HCV patients with �normal� ALT on November 11, 2004
Further information:
About hepatitis C: http://www.health-kiosk.ch/start_hepa
About Roche in virology: http://www.roche-hiv.com
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[1] Torriani FJ et al. Peginterferon Alfa-2a plus Ribavirin for Chronic Hepatitis c Virus Infection in HIV-Infected Patients. N Engl. J Med. 2204;351(5): 438-450.
