Roche initiates PROGRESS trial

Swiss drug major Roche has initiated a large multinational trial in patients with difficult-to-cure genotype 1 hepatitis C to evaluate the effect of Pegasys (peginterferon alfa-2a (40KD)) and Copegus (ribavirin) in HCV patients who have a high viral load and who are heavier than average bodyweight.

The PROGRESS trial will examine the benefits of using a fixed dose induction (360mg) of peginterferon alfa-2a (40KD) for the first 12 weeks of therapy. According to Roche, over 1,000 patients will be enrolled into the PROGRESS study and they 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.

"We have seen huge advances in cure rates for hepatitis C in recent years," said Rajender Reddy, from the University of Pennsylvania, USA, lead study investigator. "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," he said.