BASEL, Switzerland, March 14 /PRNewswire/ --

- New International Trial Called PROGRESS Starts in 15 Countries

Roche today announces the start of a large multinational trial in patients with difficult-to-cure genotype 1 hepatitis C. This international study will evaluate the effect of PEGASYS (peginterferon alfa-2a (40KD)) and COPEGUS (ribavirin) in hepatitis C patients who have a high level of virus in the blood (high viral load) and who are heavier than average bodyweight. The trial, known as PROGRESS (PEGASYS and Ribavirin Optimized in Genotype 1 high viRal load patiEntS to improve SVR), will examine the benefits of using a fixed dose induction (360 microg) of peginterferon alfa-2a (40KD) for the first 12 weeks of therapy.

"We have seen huge advances in cure rates for hepatitis C in recent years," said Dr Rajender Reddy, from the University of Pennsylvania, Philadelphia, US and Dr Stephen Harrison, from the Brooke Army Medical Center, San Antonio, US who are the lead investigators of the study. "However, patients with high levels of genotype 1 virus in their blood and who are also overweight tend to respond less well to current antiviral therapy regimens. PROGRESS will reveal whether induction dosing with PEGASYS in combination with a higher dose of COPEGUS offers these patients an improved chance of a cure."

About the PROGRESS trial

Over 1,000 patients will be enrolled into PROGRESS and these patients will be randomized to receive one of four dosing regimens of peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks, followed by a 24-week treatment-free follow-up period.

The four dosing regimens are:

    
    Arm 1 - A fixed-dose induction (360 mg) of peginterferon alfa-2a
          (40KD) given once every week for the first 12 weeks, then the
          standard licensed 180 microg dose of peginterferon alfa-2a (40KD)
          for the following 36 weeks. Patients will also receive a
          1,400-1,600 mg daily ribavirin dose for the full 48 week
          treatment period.
    Arm 2 - A fixed-dose induction (360 microg) of peginterferon alfa-2a
          (40KD) given once every week for the first 12 weeks then the
          standard licensed 180 microg dose of peginterferon alfa-2a (40KD)
          for the following 36 weeks. Patients will also receive the
          standard dose of ribavirin (1,000-1,200 mg daily) for the full
          48 week treatment period.
    Arm 3 - The standard licensed 180 microg dose of peginterferon alfa-2a
          (40KD) for 48 weeks plus a 1,400-1,600 mg daily ribavirin dose
          for the full 48 week treatment period.
    Arm 4 - Control group who will receive the licensed standard of care
          with weekly 180 microg peginterferon alfa-2a (40KD) dose plus
          ribavirin (1,000-1,200 mg daily) for the full 48 week treatment
          period.

Large multinational clinical trial

Fifteen countries will participate in the trial with a total of 200 trial sites. Enrolment is ongoing in Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, Poland, Romania, Russia, Sweden, Switzerland, the Netherlands, the UK and the US. The trial is expected to conclude in 2008.

"Roche recognize that there is an urgent need to improve the chances of genotype 1 patients achieving a cure, which is why we are launching PROGRESS," said Claire Steers, PEGASYS Lifecycle Leader at Roche in Basel, Switzerland. "This ongoing research underscores our long-term commitment to achieve a cure for as many patients as possible with hepatitis C."

Previous studies have shown that induction doses of peginterferon alfa-2a (40KD), together with higher doses of ribavirin, may be of value in improving outcomes in patients with heavier than average bodyweight, genotype 1 hepatitis C and a high viral load.(1) PROGRESS will also assess the critical and evolving role of ribavirin in optimizing treatment for patients with 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, with an additional three to four million people newly infected each year.(2),(3) It is a leading cause of cirrhosis, liver cancer and liver failure.

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 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.

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References:

1. Diago M et al. Peginterferon alfa 2 a (40KD) (PEGASYS) and ribavirin (COPEGUS) in patients infected with genotype 1 who failed to respond to interferon and ribavirin: final results of the Spanish high dose induction pilot trial. Poster presented at AASLD, 2004

2. Initiative for Vaccine Research, Viral Cancers, Hepatitis C. World Health Organization, 2006. (Accessed July 24, 2006, at www.who.int/vaccine_research/diseases/viral_cancers/en/index2.ht ...)

3. 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.

Source: Roche Pharmaceuticals