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Roche Driving PROGRESS in Treatment of Difficult-to-Cure Hepatitis C Patients With New PEGASYS (R) (peginterferon alfa-2a (40KD)) and COPEGUS(R) (ribavirin) Trial
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Ress release from Roche
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.
All trademarks used or mentioned in this release are protected by law.
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 http://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.)
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.
Distributed by PR Newswire on behalf of Roche Pharmaceuticals
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