The standard combo treatment injections three time a week has been the main stay for all Hepatitis C patients. With variances in dose for those more sensitive to these powerful medications. These are patients who have blood counts and platelet numbers that reach critically low and unhealthy number during mono or combination therapy. Daily dose injections of a smaller amount of interferon are introduced in a number of these patients who's physicians feel that it is critical to lower the amount of medication in the blood stream to insure successful duration time for the standard treatment of 24 weeks or 48 weeks.
With the introduction of the Pegylation (PEG) product, it will be possible for the physician to have another option in the Hepatitis C treatment arsenal. Pegylation involves the attachment of polyethylene glycol to the interferon molecule. This is very much like the time-capsule on a Tylenol or allergy medication. Placing the PEG coating on the interferon allows for a slower dissolving of the medication, providing a steady stream of interferon into the bloodstream.
This should minimize the side effects brought on by the current heavy dosage 3 times a week, or every other day with a 2 day spread after the third dose. It also will provide a more convenient once-a-week schedule for patients. Although the results of the studies done in European countries show that greater numbers of patients are becoming RESPONDERS using the PEG-INTRON therapy, this is still an interferon based product. There will still be patients who will not be able to tolerate this medication.
Schering-Plough on Dec. 23, 1999, submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for PEG-INTRON for the treatment of chronic hepatitis C. On Feb. 17, 2000, the European Union's (EU) Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) issued a positive opinion recommending approval of PEG-INTRON for the treatment of hepatitis C. The CPMP opinion serves as the basis for European Commission approval, which would result in one single Marketing Authorization with unified labeling that would be valid in all 15 EU-Member States.
At this time, the clinical trials for PEG-INTRON in the US and Canada should begin this year. However, there are several differing opinions on exactly which dates this product will be available for use on Hepatitis C patients. There were reports released that Clinics around the North American region could expect product availability by September 2000, however that date has now been postponed, possibly to December 2000.
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