New Trial Examines Fixed Dose Induction of PEGASYS® in Patients With Difficult-to-Treat Characteristics

NUTLEY, N.J. -- Roche announced the start of a large, multinational trial to examine a new treatment strategy in hepatitis C patients with difficult-to-treat characteristics. This study will evaluate the effect of PEGASYS® (peginterferon alfa-2a) and ribavirin in patients who have a high level of genotype 1 virus in their blood (high viral load) and who are heavier than average in weight. The trial, known as PROGRESS (PEGASYS and Ribavirin Optimized in Genotype 1 high virRal load patiEntS to improve SVR), will examine the potential benefits of using a fixed dose induction (360 mcg) of PEGASYS for the first 12 weeks of therapy.

“We have seen major advances in treatment success rates for hepatitis C in recent years," said Rajender Reddy, of University of Pennsylvania, one of the lead study investigators. “However, patients with high levels of genotype 1 virus in their blood and who also are overweight tend not to respond as well to current antiviral therapy regimens. PROGRESS will reveal whether induction dosing with PEGASYS in combination with either a higher dose or a standard dose of ribavirin offers these patients an improved chance of treatment success."

More than 1,000 patients will be enrolled in PROGRESS and will be randomized to receive one of four dosing regimens of PEGASYS plus ribavirin for 48 weeks, followed by a 24-week treatment-free follow-up period. The four dosing regimens are:

A fixed-dose induction (360 mcg) of PEGASYS given once every week for the first 12 weeks, then the standard 180 mcg dose of PEGASYS 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.

A fixed-dose induction (360 mcg) of PEGASYS given once every week for the first 12 weeks, then the standard 180 mcg dose of PEGASYS 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.

The standard 180 mcg dose of PEGASYS for 48 weeks, plus a 1,400-1,600 mg daily ribavirin dose for the full 48-week treatment period.

The control group will receive the standard of care with weekly 180 mcg PEGASYS dose, plus ribavirin (1,000-1,200 mg daily) for the full 48-week treatment period.

Fifteen countries will participate in the trial, with a total of 150 trial sites. Enrollment is ongoing in the U.S., and well as Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Hungary, Norway, Poland, Romania, Russia, Sweden and the United Kingdom. The trial is expected to conclude in 2008.

“Roche recognizes that there is an urgent need to improve the chances of patients with difficult-to-treat characteristics to achieve treatment success, which is why we are launching PROGRESS," said Tom Klein, vice president, hepatology, Roche.

Previous studies have suggested that induction doses of PEGASYS, 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. PROGRESS also will assess the critical and evolving role of ribavirin in optimizing treatment for patients with hepatitis C.

Those interested in the trial can find more information at www.roche-trials.com.

Source: Business Wire

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