Two forms of peginterferon for hepatitis C are making their way through regulatory processes, and a low-cost hepatitis screening program has been launched.
*Schering-Plough announced on May 30 that the European Union's Commission of the European Communities has granted marketing authorization to Pegintron (peginterferon alfa-2b) as once-weekly monotherapy for the treatment of adults with chronic hepatitis C. The authorization becomes immediately valid in all 15 member states of the European Union. The drug is expected to be introduced upon the receipt of pricing approvals, where necessary, from individual countries. (See www.sch-plough.com/news/business/2000/053000.html.)
* Hoffmann-La Roche has asked the Food and Drug Administration for approval to market Pegasys (peginterferon alfa-2a) for the treatment of chronic hepatitis C in noncirrhotic and cirrhotic patients with compensated liver disease. Pegasys is a ready-to-use solution that is expected to be administered in once-weekly subcutaneous injections for one year. Pegasys also has been selected by the National Institutes of Health for study in the Hepatitis C Antiviral Long-Term Treatment to Prevent Cirrhosis (HALT-C) Trial. The study will examine 900 patients treated with interferon to determine if long-term interferon therapy with Pegasys can reduce the risk of histologic progression to cirrhosis, decompensated liver disease, or hepatocellular carcinoma in patients with chronic hepatitis C and advanced fibrosis or cirrhosis who failed to respond to previous interferon therapy. Screening for the trial is scheduled to begin in June. (See www.roche.com/roche/news/mrel00/e000523a.htm and www.roche.com/roche/news/mrel00/e000502a.htm.
* Hep-C Alert, Inc. is offering hepatitis C antibody blood tests to the public for $25 each, anywhere in the United States at Quest Diagnostic Laboratory patient service sites. People concerned about their risk for hepatitis C can call Hep-C Alert's toll-free hotline at 1-877-HELP-4-HEP (1-877-435-7443) for a health risk assessment and referral for a blood test.
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