Results from the ACCELERATE study, a new trial presented at the 41^st EASL (April 26-29, 2006, Vienna, Austria) demonstrate that 24 weeks of therapy with peginterferon alfa-2a (Pegasys) plus ribavirin is more effective than 16 weeks for patients infected with hepatitis C virus (HCV) genotypes 2 and 3.

The additional 8 weeks of therapy gives patients an increased chance of achieving a sustained virologic response (SVR) and it also decreases the rate of relapse following the end of treatment. The ACCELERATE trial is the only randomized controlled study designed specifically to examine a shorter treatment duration versus standard duration in patients with HCV genotypes 2 and 3.

“There has been a trend toward treating patients for shorter durations, but this study shows that genotypes 2 and 3 patients really do need 24 weeks of treatment for optimal results,” said Dr. Mitchell Shiffman, Chief of the Hepatology Section and Medical Director of the Liver Transplant Program at the Medical College of Virginia, Commonwealth University and MCV Hospitals and lead investigator of the study. “With these results, doctors can be confident that they are treating their patients for the correct period of time to give them the best chance for success.”

A total of 1,469 patients from eight countries took part in the trial. Patients were randomized to receive Pegasys 180 mcg once weekly plus Copegus (ribavirin) 800 mg daily for either 16 or 24 weeks, followed by 24 weeks of treatment-free follow-up.

The trial included patients from the United States, Australia, Canada, France, Germany, Italy, New Zealand and Spain, acceding to a Roche announcement of the study results.

The key findings of the trial were as follows:

More patients achieved a sustained virological response (SVR) after 24 weeks (n=679) of therapy compared with 16 weeks (n=630) of therapy (76 percent vs. 65 Percent). Ninety percent of rapid viral responders (a drop in the amount of virus in their blood to below the limits of detection after just four weeks of therapy) achieved a SVR after 24 weeks of therapy. The incidence of adverse events was similar in the two groups. However, more patients in the 24-week group had their dose of Pegasys and ribavirin modified or discontinued. “This trial underscores Roche’s continuing scientific commitment to optimizing treatment in people with hepatitis C,” said James A. Thommes, M.D., Senior Medical Director, Roche. “ACCELERATE joins a large number of other Pegasys trials that provide physicians with the most current scientific information to guide treatment decisions.

About the REPEAT Trial

In addition to the findings from the ACCELERATE trial, results of the REPEAT (Retreatment with Pegasys in Patients Not Responding to Peg-Intron Therapy) trial were presented at the 41^st EASL. Following are excerpts from Roche’s announcement of the study results:

The REPEAT trial focuses on patients who did not respond to previous therapy with peginterferon alfa-2b (PegIntron). Data presented from this study include a 12-week interim efficacy and safety analysis of standard-dose (180 mcg) and fixed-dose induction (360 mcg) therapy as well as similar outcomes for patients with cirrhosis and/or advanced fibrosis.

After the initial 12-week treatment period, all patients are being treated with the standard dose of Pegasys and Copegus for total treatment duration of either 48 or 72 weeks.

Interim results demonstrated the following outcomes:

Forty-five percent of patients treated with the standard dose of Pegasys with Copegus had an early viral response (EVR), defined as having a >2 log drop in viral load or having no detectable virus after 12 weeks of treatment (n = 469). An early virologic response (EVR) rate of 62 percent was achieved in the group of patients who were treated with the higher fixed-dose induction of Pegasys with standard Copegus for the first 12 weeks of therapy (n = 473). The adverse event profiles were similar for patients taking the higher fixed-dose induction of Pegasys with Copegus for 12 weeks compared to those taking the standard dose. More patients in the higher fixed-dose induction group had their dose of Pegasys and ribavirin modified or were discontinued.

05/02/06

Sources

Roche Pharmaceuticals. Pegasys® ACCELERATE Trial Shows Six Months of Treatment Is Optimal for Achieving Success in Category of Hepatitis C Patients--- Interim Analyses Results from a Second Study, REPEAT, for Hepatitis C Patients Who Have Failed on Peg-Intron®. Press Release. April 29, 2006.