Source: DGNews  |  Posted 6 years ago

Study Results May Offer New Hope for Patients Who Had Not Responded to Treatment

SAN FRANCISCO, CA -- November 11, 2005 -- Roche announced today plans to present interim results from a study showing that re-treatment with Pegasys(R) (peginterferon alpha-2a) plus Copegus(R) (ribavirin, USP) reduced viral levels in hepatitis C patients for whom treatment with Peg-Intron(R) (peginterferon alpha-2b) plus Rebetol(R) (ribavirin, USP) had failed.

Interim study results from the REPEAT (REtreatment with PEgasys in pATients Not Responding to Peg-Intron Therapy) study will be presented here on Nov. 14, 2005, at the 56th annual meeting of the American Association for the Study of Liver Diseases (AASLD), which begins today.

The National Institutes of Health Consensus Development Conference Statement on the Management of Hepatitis C Investigators noted that failure to respond to optimal therapy with the combination of pegylated interferon and ribavirin presents a significant problem to hepatitis C patients.

REPEAT was designed to help find a solution for this growing problem: to provide patients who had previously failed treatment with another treatment option.

Interim results from the REPEAT study look at early markers of the efficacy and safety of different regimens of Pegasys and Copegus combination therapy in 950 patients with hepatitis C in whom previous treatment with Peg-Intron and Rebetol failed to generate a sustained virologic response (SVR).

Patients received either a standard (180 mcg/wk) or high fixed-dose induction (360 mcg/week) of Pegasys with Copegus for the first 12 weeks. After the initial 12-week treatment period, all patients are being treated with the standard dose of Pegasys and Copegus.

Forty-five percent of patients treated with the standard dose of Pegasys with Copegus had an early viral response (EVR), defined as having a greater than or equal to 2 log drop in viral load or having no detectable virus (n = 469). An EVR rate of 62 percent was achieved in the group of patients who were treated with the induction dose of Pegasys with Copegus for the first 12 weeks of therapy (n = 473).

"The interim results from this study suggest that previous non-responders to treatment can still be re-treated with some success, particularly in those treated with the higher dose of Pegasys with ribavirin," said Donald Jensen, MD, professor of medicine and director of the Center for Liver Diseases at the University of Chicago. "In addition, the interim data show that the high dose of Pegasys is generally well tolerated by patients."

Additional key findings from the 12-week REPEAT results presented at AASLD:

? Fifty percent of the patients in this trial with advanced fibrosis or cirrhosis who received the induction dose of Pegasys plus Copegus achieved an early viral response (n = 119).

? There was no difference in adverse events for patients taking the high fixed-dose induction of Pegasys with Copegus for 12 weeks compared to those taking the standard dose. Fatigue, headache and nausea were the most common individual adverse events reported, occurring in a similar proportion of patients in both groups analyzed. Serious adverse events were uncommon, occurring in 2 percent of patients in the high-dose induction group and 4 percent of those treated with standard-dose peginterferon alpha-2a.

? During the first 12 weeks of the study, a slightly higher proportion of patients receiving high-dose compared with standard-dose peginterferon alpha-2a discontinued treatment prematurely. Overall, a similar proportion of patients in the high-dose induction group and the standard-dose groups discontinued because of adverse events.

"Preliminary results from this study may be promising for the many patients who had believed that treatment would not work for them," said James A. Thommes, M.D. Roche Sr. Medical Director. "Not only are all patients in REPEAT non-responders to Peg-Intron plus Rebetol, many also have other baseline characteristics of difficult to treat virus. We believe this data may show potential for patients to safely and effectively have significant early viral responses when treated with the investigational dosing strategies of Pegasys plus Copegus therapy. We are looking forward to final results in the future."

As the REPEAT trial continues, Pegasys and Copegus will be given for either a total of 48-weeks or for a longer 72-week period.

"Many patients undergo treatment for hepatitis C only to find out that they did not respond," said Jules Levin, Executive Director of National AIDS Treatment Advocacy Project (NATAP). "Treatment options like those being evaluated in the REPEAT study lend hope to patients who might previously have thought their disease was not treatable."

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver, is transmitted through body fluids, primarily blood or blood products, and by sharing needles. Hepatitis C chronically infects an estimated 2.7 million Americans and 170 million people worldwide and is the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S.

About Pegasys
Pegasys, a pegylated alpha interferon, and Copegus were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha.

Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis.

Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week. Copegus is available as a 200mg tablet, and is administered orally two times a day as a split dose. Roche has backed Pegasys with the most extensive clinical research program ever undertaken in hepatitis C, with major studies initiated to advance treatment for hepatitis C patients with unmet needs, including patients co-infected with HIV and HCV, African Americans, patients with cirrhosis, and patients who have failed to respond to previous therapy.

Please see attached additional information about Pegasys indication and safety.

SOURCE: Roche