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® -
Vienna, Austria – April 29, 2006 – Roche announced today
that results from a new trial have shown that 24 weeks of therapy with
PEGASYS® (peginterferon alfa-2a) combined with ribavirin is more effective
than 16 weeks for patients infected with hepatitis C genotypes 2 and 3. The
additional eight weeks gave patients a greater chance of being successfully
treated for chronic hepatitis C and also lowered the relapse rate after
treatment. The results of the ACCELERATE trial, the only randomized
controlled study specifically designed to examine a shorter treatment
duration versus standard duration in patients with genotypes 2 and 3, were
presented at the 41st Annual Meeting of the European Association for the
Study of the Liver (EASL).
“There has been a trend toward treating patients for shorter durations, but
thisstudy shows that genotypes 2 and 3 patients really do need 24 weeks of
treatment for optimal results,” said Mitchell Shiffman, M.D., Professor of
Medicine, 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 180mcg once weekly plus COPEGUS®
(ribavirin) 800mg 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.
The key findings of the trial were:
· 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 ACCELERATE, results were announced from the REPEAT (REtreatment
with PEgasys in PATients Not Responding to Peg-Intron Therapy) trial, which
focuses on patients who did not respond to previous therapy with Peg-Intron.
Data presented from this study include a 12-week interim efficacy and safety
analysis of standard-dose (180mcg) and fixed-dose induction (360mcg) 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 a total treatment
duration of either 48 or 72 weeks.
Interim results showed:
· 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 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. However, more patients in the higher fixed-dose
induction group had their dose of PEGASYS and ribavirin modified or were