Roche Pharmaceuticals

Treatment Optimisation With PEGASYS Plus COPEGUS Offers Patients With Hepatitis C an Excellent Chance for a Cure

    Basel, Switzerland (ots/PRNewswire) -

    - High Response Rates Confirmed in 'Real-Life' Study and Clinical Trials

BASEL, Switzerland, April 13 /PRNewswire/ --

    Patients with hepatitis C who respond quickly to treatment have an excellent chance of being cured of the disease, according to data presented today at the 42nd Annual Meeting of the European Association for the Study of the Liver (EASL). Patients with genotype 1 hepatitis C (HCV) who clear the virus within a month of starting treatment with PEGASYS (peginterferon alfa-2a (40KD)) plus COPEGUS (ribavirin) have up to a 91% chance of achieving a sustained virological response (SVR), considered a cure by researchers.

    "Now we can tell earlier than ever - at just week 4 of treatment - whether a patient has a good chance to be cured." said Professor Patrick Marcellin, Hôpital Beaujon, Clichy, France. "Knowing their virus levels in the first and third months of treatment helps patients take ownership of beating the disease and helps motivate them to stay on treatment. This information should be made available for everyone starting therapy."

    Early Response to Treatment Means Patients Have an Excellent Chance for a Cure

    An analysis of six different clinical trials highlights the value of checking how well patients with genotype 1 HCV have responded to treatment at weeks 4 and 12 of therapy(1). The results of the analysis showed that of  those patients treated with PEGASYS 180 mcg weekly plus COPEGUS  1,000-1,200 mg daily:

    - Up to one in five cleared the virus by week 4 of therapy (called rapid viral response)

    - 83-91% of patients with a rapid viral response went on to be cured of their hepatitis C

    - About 40% of patients who did not achieve a rapid viral response managed to clear the virus by week 12 of therapy (called complete early virological response); 65-67% of these patients were cured

    Excellent Chance for a Cure for Rapid Viral Responders Confirmed in 'Real-Life' Study

    A large real-life study involving 4,377 patients conducted by the Association of German Independent Gastroenterologists confirms that these results can be replicated in clinical practice(2):

    - One quarter of patients with 'difficult-to-cure' genotype 1 or 4 HCV who had their viral levels tested at week 4 of treatment achieved a rapid viral response

    - While the study is not yet complete, over 70% of those who have finished their 6-month post-treatment follow-up period were cured

    "These are really important results," said Dr Elmar Zehnter, Gastroenterologist and Hepatologist, Dortmund, Germany, and researcher in the study. "This study confirms that the high cure rates reported for rapid viral responders in clinical trials translate into clinical practice and are relevant to the patients we see every day. At the moment, testing viral levels at 4 weeks of treatment is not standard practice. Based on these results, however, testing viral levels at 4 weeks of therapy should become a routine test."

    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 more than four times more prevalent than HIV(3,4). Alarmingly, many people infected  with hepatitis C don't even know they carry the virus. For example, it is estimated that 80-90% of people with hepatitis C in the UK are unaware that they are infected(5). Hepatitis C is a leading cause of cirrhosis, liver  cancer and liver failure, despite the fact that many patients can be cured  with treatments that are available today.

    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 mcg 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 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, metabolism and 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 employs roughly 75,000 worldwide 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 at www.roche.com.

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    References

    1. Marcellin P, Hadziyannis S, Berg T, et al. Virological response at 4 and 12 weeks predict high rates of sustained virological response in genotype 1 patients treated with peginterferon alfa-2a (40KD) plus ribavirin. In: 42nd Annual Meeting of the European Association for the Study of the Liver; 2007 April 11-15; Barcelona, Spain; 2007.

    2. Zehnter E, Mauss S, Boeker K, et al. Potential relevance of rapid viral response for SVR and optimisation of the treatment of hepatitis C (CHC) with peginterferon alfa-2a (PEG) and ribavirin (RBV). In: 42nd Annual Meeting of the European Association for the Study of the Liver; 2007 April 11-15; Barcelona, Spain; 2007.

    3. AIDS Epidemic Update. 2006. (Accessed February 27, 2007, at http://www.who.int/hiv/mediacentre/2006_EpiUpdate_en.pdf.)

    4. Initiative for Vaccine Research, Viral Cancers, Hepatitis C. World Health Organization, 2006. (Accessed July 24, 2006, at http://w ww.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.)

    5. The hepatitis C scandal. London: All-Party Parliamentary Group on Hepatology; 2004.

ots Originaltext: Roche Pharmaceuticals
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Contact: Janet Kettels, Roche, +1-862-596-9084; Natalie Henson, Axon
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