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"These results are particularly encouraging given that this is a" real life "community study with similar patient distribution by genotype within each weight group," said Paul Marotta, MD, Principal Investigator, London (Ontario) Health Sciences Centre. "These results are consistent with data from Canadian registration of PEG-INTRON and REBETOL for patients and underscore the value of seeking treatment for hepatitis C because the virus can be eliminated a significant percentage of patients. "
In the United States, PEG-INTRON (1.5 mcg / kg weekly) is approved in combination with REBETOL (800 mg daily) for a treatment duration of 48 weeks. In the U.S. label, the SVR rate of this scheme is 52 percent. apportioning by weight REBETOL is currently under investigation in U.S. studies.
Canadian Study on observation and results
In the study, known as PEGETRON Prospective Optimal Weight-Based Dosing Response Program (POWER) (2), 2194 treatment-naive patients with chronic hepatitis C virus (HCV) were prospectively enrolled between December 2002 and December 2004 in an open trial conducted at 160 academic and community clinics across Canada. Patients were grouped by weight into one of five categories: less than 50 kg, 50 kg to less than 64 kg, 64 kg to less than 75 kg, 75 kg to less than 85 kg and 85 kg or more, with the highest percentage of patients (for 33.8 percent) weighing 85 kg or more.
All patients were eligible for treatment with PEG-INTRON and Rebetol based on the criteria listed in the Canadian Product Monograph. Patients were treated for 24 weeks (genotype non-1) or 48 weeks (genotype 1).
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SVR results were collected on 952 patients to date. SVR by body weight did not differ significantly among the weight groups: less than 50 kg (67 percent), 50 kg to less than 64 kg (67 percent), 64 kg to less than 75 kg (63 percent) , 75 kg to less than 85 kg (65 percent) and 85 kg or more (69 percent). Patient distribution by genotype within each weight group was similar, from 48 percent to 52 percent of patients with genotype 1 and 46 percent to 52 percent with genotype 2 or 3.
Among the patients in the study for which data fibrosis have been reported, over a third (37 percent) had severe fibrosis or cirrhosis (F3 or F4 Metavir) and 63 percent had mild to moderate (F0-F2) levels of fibrosis. Especially, the weight increased, an increasing number of patients had severe fibrosis or cirrhosis (64 kg to less than 75 kg: F3/F4 = 33 percent, 75 kg or more: F3/F4 = 38 percent). More patients with baseline level of fibrosis F0, F1 or F2 achieved an SVR (76 percent or 68 percent, respectively) than patients with a level of F3 or F4 fibrosis (42 percent or 41 percent, respectively).
Combination Therapy PEG-INTRON and REBETOL
PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a treatment administered once a week depending on the patient's body weight that is designed to achieve an effective balance between antiviral activity and half-life of elimination. Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog with broad spectrum antiviral activity.
Chronic hepatitis C is estimated to affect more than 10 million people in major world markets, including Canada, Europe and the United States. It is a major cause of chronic liver disease.
Posted on February 10, 2010.
