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| |  DDW: Pegasys Dosing Comparable For Cirrhotic And Non-Cirrhotic Patients With Chronic Hep C ORLANDO, FL -- May 17, 1999 -- Data presented today at Digestive Disease Week demonstrate that that Hoffmann-La Roche Inc.’s Pegasys(TM) (peginterferon alfa-2a), an investigational, longer-lasting form of interferon, when administered once-weekly in cirrhotic patients reaches the same blood levels as non-cirrhotic patients. Twenty percent of people with hepatitis C develop cirrhosis of the liver -- a complication that makes those the most difficult hepatitis C patients to treat. Cirrhosis causes the filtering process of the liver to slow down, affecting its ability to process medication. Sustained response rates for cirrhotic patients treated with currently marketed interferon are substantially lower than in patients without cirrhosis. The pharmacokinetic data were collected from patients participating in a controlled, randomised, multicentre Phase II study evaluating the activity of Pegasys. Forty patients received either 90 or 180 mcg. of Pegasys once-weekly for 48 weeks and were followed by a 24-week observation period. Blood samples were collected after the first dose of Pegasys and after the dose at 48 weeks of treatment. Blood levels of Pegasys in the cirrhotic patients were similar to those reported by healthy volunteers. "Hepatitis C patients with end stage liver disease are in need of better treatments that can clear the virus from the liver and slow their possible progression to hepatocellular carcinoma," said Jenny Heathcote, MD, division head, division of gastroenterology, The Toronto Hospital. "Pegasys kinetics in chronic hepatitis C patients with cirrhosis are similar to those reported in healthy volunteers." In Phase II clinical trials adverse events with Pegasys appear to be similar to those seen with traditional interferon regimens, such as fatigue, headache, myalgia/arthralgia, flu-like symptoms, nausea/vomiting, injection site reactions, fever, chills, diarrhea, partial alopecia, abdominal pain, depression, irritability, insomnia, dizziness and anorexia. Although dose-dependent reduction of white blood cells is more frequent with Pegasys than currently marketed interferon, this does not appear to be related to an increased risk of infection. Other data from a Phase II study of non-cirrhotic patients were presented during the opening plenary of Digestive Disease Week. The data from a controlled, randomised, multicentre trial found that 36 percent 45 of patients treated with 180 mcg. of Pegasys experienced a sustained response of undetectable levels of hepatitis C virus (HCV) compared to three percent of 33 patients treated with currently marketed interferon. Sustained response is measured at 24 weeks following a treatment period of 48 weeks. The presence of HCV was measured by the Roche Diagnostics Amplicor(R) HCV Test for which the company has initiated filing with the U.S. Food and Drug Administration. Pegylation is the process of attaching one or more hair-like strands of an inert, synthetic polymer called polyethylene glycol (PEG) to another molecule. The PEG attachment encircles the protein and disguises it from the human metabolic system. Pegylation provides a rapid and sustained delivery of this optimised interferon, changing its absorption characteristics and delaying its metabolism. Research shows the length of the PEG strands attached to a molecule is directly related to the increase in a compound's half-life, therefore, the larger the PEG, the longer the half-life. Pegasys has a 40-kilodalton (40k) molecular weight. The 40K refers to the size of the PEG strand attached to interferon alfa. Using 40K PEG increases the half-life of interferon alfa from 7-10 hours to approximately 100 hours. Hepatitis C, a blood-borne infectious disease of the liver, is a leading cause of cirrhosis and liver cancer and the number-one reason for liver transplants in the U.S. An estimated four million Americans are infected with the virus, with 35,000 to 180,000 new infections occurring each year. In the U.S., the Centers for Disease Control and Prevention estimate that hepatitis C is responsible for 8,000 to 10,000 deaths per year and could increase to 38,000 by the year 2010, surpassing annual HIV/AIDS deaths. Hepatitis C is a blood-borne virus transmitted through body fluids, primarily blood or blood products, and sharing needles. In many patients, the mode of transmission is unknown. Unfortunately, most people who are infected with hepatitis C are unaware of it because, like HIV, it may take years for symptoms to develop. In addition, it is estimated that as many as 40 percent of people with HIV may be co-infected with hepatitis C.
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