Schering-Plough Canada Reports Top-Line Results of First Head-to-Head Study in Hepatitis C

~First Large Study Comparing Leading Hepatitis C Therapies Shows Similar Sustained Response Rates; Fewer Patients Relapsed Following PEGETRON(R) Therapy~     

KIRKLAND, QC, Jan. 18 /CNW/ - Schering-Plough, a leader in hepatitis research, reported top-line results of the IDEAL (Individualized Dosing Efficacy vs. Flat Dosing to Assess optimaL pegylated interferon therapy) study, the first large, randomized, clinical study comparing the leading therapies for chronic hepatitis C: PEGETRON(R) (pegylated interferon alfa-2b plus ribavirin) therapy vs. PEGASYS RBV* (pegylated interferon alfa-2a plus ribavirin),(1) as well as a lower dose of PEGETRON in an investigational regimen. The results showed that sustained virologic response (SVR),(2) the primary endpoint of the study, was similar for the two leading combination therapies for hepatitis C. The study also showed that fewer patients treated with both PEGETRON regimens relapsed after the end of treatment compared to those receiving PEGASYS RBV.
    
"The IDEAL study results provide Canadian physicians with, for the first time, a large body of well-controlled clinical data comparing the two leading combination therapies for hepatitis C," said Dr. Stephen Shafran, Professor and Director of Infectious Diseases at, Walter Mackenzie Health Sciences Centre in Edmonton. "In my clinical experience, a low rate of relapse can also play an important role in the patient's overall 48-week treatment."

In the IDEAL study, both PEGETRON regimens utilized investigational weight-based ribavirin dosing. The three treatment regimens studied were:     

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(1)   pegylated interferon alfa-2b 1.5 mcg/kg/week and ribavirin 800-1,400 mg/day;
        
(2)   pegylated interferon alfa-2b 1.0 mcg/kg/week and ribavirin 800-1,400 mg/day; and
        
(3)   pegylated interferon alfa-2a 180 mcg/week and ribavirin 1,000-1,200 mg/day.
    
>>     
In the study, 3,070 previously untreated U.S. patients with hepatitis C virus (HCV) genotype 1, the most common form of the virus worldwide and the most difficult to treat, were randomized to one of the three treatment regimens and received up to 48 weeks of combination therapy with 24 weeks of follow-up. SVR, the primary endpoint of the study, was similar for the three treatment regimens (40 vs. 38 vs. 41 per cent, respectively). IDEAL results also showed that, while end of treatment response was higher in the PEGASYS RBV arm, fewer patients receiving PEGETRON therapy relapsed after the end of treatment (24 vs. 20 vs. 32 percent, respectively).     

About IDEAL     

The IDEAL study was undertaken by Schering-Plough as an important step in meeting the needs of the hepatitis C medical and patient communities to identify improved treatment strategies to optimize outcomes for patients. IDEAL, a Phase IIIb, randomized, parallel-group study, was conducted at 118 academic and community centres across the United States. The study treated 3,070 naive adult patients with chronic HCV genotype 1. Of these, 82 per cent of patients had high viral load (greater than or equal to 600,000 IU/mL),(3) 11 per cent had grade F3/4 fibrosis/cirrhosis, and 19 per cent were African Americans. Patient demographics and disease characteristics were similar across the three treatment arms.

The comparison of the two combination therapy doses (peginterferon alfa-2b and ribavirin) (1.5 vs. 1.0 mcg/kg/week) was conducted as a
post-approval commitment to the U.S. Food and Drug Administration (FDA). The comparison of the PEGETRON and PEGASYS combination therapy regimens was added to the study because no randomized, controlled head-to-head study of the two
available peginterferon regimens had been conducted to date. Cross-study comparisons and retrospective analyses of previous data are difficult to interpret because of differences in study designs, patient populations and assay limits.     

About Hepatitis C in Canada     

Hepatitis C is a serious and potentially life-threatening disease. The virus spreads primarily through exposure to infected blood, with intravenous (IV) drug use being the most common source of infection in Canada.(4) Hepatitis C is the most common blood-borne infection in Canada, and the most common form of liver disease, affecting approximately 240,000 people in Canada.(5) It is the leading cause of cirrhosis and liver cancer, and the number one reason for liver transplants in Canada.(6)     

About PEGETRON(R)(7)     

PEGETRON was approved by Health Canada on May 31, 2002 for the treatment of adult patients histologically proven chronic hepatitis C who have elevated transaminases without liver decompensation and who are positive for HCV-RNA or anti-HCV. This indication is based upon the results from a controlled clinical study in 1530 patients with confirmed chronic hepatitis C treated with ribavirin plus pegylated interferon alfa-2b or ribavirin plus interferon alfa-2b for 48 weeks.
    
The most frequently reported adverse events were fatigue (64%), headache (62%), myalgia (56%), rigors (48%), fever (46%), and insomnia (40%), which were also the most frequently reported adverse events with the combination of ribavirin plus interferon alfa-2b.
    
Hemolytic anemia (hemoglobin levels to (less than)10 g/dL) was observed in up to 14% of patients treated with ribavirin in combination with
peginterferon alfa-2b in clinical trials.     

PEGETRON therapy should be used with extreme caution in patients with a history of pre-existing psychiatric disorders who report a history of severe depression.
    
PEGETRON must not be used by women who are pregnant or by men whose female partners are pregnant.     

About Schering-Plough     

Schering-Plough Canada Inc. is a country operation of Schering-Plough Corporation that employs over 950 people across Canada. Schering-Plough Canada Inc.'s web site is www.schering-plough.ca.
    
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal
health products. In November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in the company's ongoing transformation. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world. The company is based in Kenilworth, N.J., U.S.A. and its Web site is www.schering-plough.com.     

PEGETRON(R) is a registered trademark of Schering-Plough Ltd., used under license by Schering-Plough Canada Inc.
     (C) Schering-Plough Canada Inc. 2008. All rights reserved.     

NOTE:  Medical experts are available for interviews in English and French.     

References:      -------------------------------

(1) * Pegasys and Pegasys RBV are registered trademarks of F. Hoffmann-La Roche AG Please see the Pegasys and Copegus product inserts for information on these products.
    
(2) SVR, the protocol specified primary efficacy endpoint, is defined as achievement of undetectable HCV-RNA at 24 weeks after the end of treatment. Per protocol, if a patient did not have a 24-week post-treatment assessment, the patient's 12-week post-treatment assessment was utilized.

(3) Roche Cobas Taqman 1.0 assay; lower limit of detection is 15 IU/mL.
    
(4) Public Health Agency Canada. Hepatitis C Prevention, Support and Research Program.
http://www.phac-aspc.gc.ca/hepc/pubs/psrpmideval-ppsrevalinter/i_problem_e.htm
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(5) Public Health Agency Canada. Hepatitis C Prevention, Support and Research Program.
http://www.phac-aspc.gc.ca/hepc/pubs/psrpmideval-ppsrevalinter/i_problem_e.htm
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(6) Public Health Agency Canada. Hepatitis C Prevention, Support and Research Program.
http://www.phac-aspc.gc.ca/hepc/pubs/psrpmideval-ppsrevalinter/i_problem_e.htm
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(7) Pegetron(R) Product Monograph, May 31, 2002   -30- /For further information: Julie Wu, Schering-Plough Canada Inc., (514) 426-7300, julie.wu@spcorp.com; Rosalind O'Connell, Manning Selvage & Lee, (416) 847-1321, rosalind.oconnell@mslpr.ca/
 

Posted: January 2008

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