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| |  FDA Approves Rebetron Combination Therapy For Chronic Hepatitis C MADISON, NJ -- June 3, 1998 -- The United States Food and Drug Administration has approved Schering-Plough Corp.’s Rebetron™, a combination therapy for chronic hepatitis C in patients with compensated liver disease who have relapsed following alpha interferon therapy Rebetron is a combination of Rebetol(R) (ribavirin, USP) Capsules and Intron(R) A (interferon alfa-2b, recombinant) Injection. Prior to Rebetron combination therapy, the only drugs approved in the U.S. for treating hepatitis C had been alpha interferons. The FDA decision was based in part on clinical data from two pivotal multicentre Phase III studies involving patients with hepatitis C who had relapsed following alpha interferon therapy. Results of these studies showed that Rebetron combination therapy resulted in a 10-fold increase in the number of patients showing eradication of detectable [HCV-RNA (qPCR)-negative] hepatitis C virus as compared to patients receiving Intron A alone. "Rebetron combination therapy is an exciting treatment breakthrough," said Willis Maddrey, M.D., professor of medicine at the University of Texas-Southwestern Medical Center in Dallas. "We've learned from research in viral diseases such as AIDS that combination therapies rather than monotherapy offer the best potential for effective treatment." Some four million Americans are chronically infected with the hepatitis C virus, according to the Centers for Disease Control and Prevention (CDCP). The CDCP has estimated that 20 to 50 percent of chronically infected hepatitis C patients will develop liver cirrhosis and 20-30 percent of those will go on to develop liver cancer or liver failure requiring liver transplant. Hepatitis C infection contributes to the deaths of 8,000 to 10,000 Americans each year. This toll is expected to triple by the year 2010 and exceed the number of annual deaths due to AIDS, according to the CDCP. The American Liver Foundation has reported that liver failure due to hepatitis C infection is the leading cause of liver transplants in the U.S. The safety and efficacy of Rebetron combination therapy were evaluated in two identical controlled double-blind clinical trials involving 345 chronic hepatitis C patients who had received previous treatment with alpha interferon and relapsed after having an initial response. Relapse patients were defined as patients who had a normal serum alanine aminotransferase (ALT) level at the end of up to 18 months of alpha interferon therapy with abnormal ALT values within one year following the end of the most recent course of therapy. Patients in the clinical trials were randomised to receive subcutaneous injections of Intron A three million international units (MIU) three times a week and either oral Rebetol 1,000-1,200 mg daily or a matched placebo for 24 weeks of treatment. At six months post-treatment, 79 of 173 patients (45.7 percent) who received the combination therapy had undetectable virus levels compared to eight of 172 patients (4.7 percent) who received Intron A and placebo. Patient tolerance of the combination therapy was good, with six percent of patients treated with Rebetron discontinuing therapy due to adverse events versus three percent of patients treated with Intron A and placebo. The most common adverse experiences associated with Rebetron combination therapy are flu-like symptoms, such as headache, fatigue, myalgia and fever, which appear to decrease in severity as treatment continues. Psychiatric disorders have been reported during Rebetron combination therapy, both in patients with a previous psychiatric history and in patients with no history. These adverse events include depression, which may be severe, and rare cases of suicide ideation and suicidal attempt. Rebetron combination therapy is associated with a significant risk of abnormal fetal development. Women of childbearing potential should not begin therapy until a report of a negative pregnancy test has been obtained.
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