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| |  Rebetol Approved In EU For Chronic Hepatitis C Treatment NEW YORK, NY -- May 10, 1999 -- The European Commission has approved Schering-Plough Corp.’s Rebetol(R) (ribavirin) for use in combination therapy for treatment of chronic hepatitis C patients in the European Union. The approval of the centralised application for Rebetol Capsules for use in combination with interferon alfa-2b injection for the treatment of both relapsed and previously untreated hepatitis C patients results in a single marketing authorisation with unified labelling that is immediately valid in all 15 EU-member states. Hepatitis C is the leading cause of liver disease in Western Europe and the most common reason for liver transplant. As many as five million people in Western Europe (one to two percent of the general population) are chronically infected with the hepatitis C virus, according to a study conducted by the World Health Organization. Rebetol is indicated in combination with interferon alfa-2b for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to alpha interferon therapy but who have subsequently relapsed and for the treatment of adult patients with histologically proven chronic hepatitis C, not previously treated, without liver decompensation, with elevated ALT, who are positive for serum HCV-RNA and who have fibrosis or high inflammatory activity. Patients with only portal fibrosis (minimal fibrosis) should have a high inflammatory score. The safety and efficacy of Rebetol Capsules have been established only in combination with interferon alfa-2b. In four well-controlled Phase III clinical trials, 2,089 hepatitis C patients were randomised to receive subcutaneous injections of interferon alfa-2b 3 million international units (MIU) three times per week and either oral Rebetol 1,000-1,200 mg or a matched placebo daily for 24 or 48 weeks followed by 24 weeks of off-therapy follow up. In these studies, efficacy was defined as sustained response (including both virologic and histologic improvement) at six months post-treatment. Eligible patients for these trials had chronic hepatitis C confirmed by a positive HCV-RNA polymerase chain reaction assay (PCR) (greater than 100 copies/ml); a liver biopsy consistent with a histologic diagnosis of chronic hepatitis, with no other cause for the chronic hepatitis; and abnormal serum ALT. A total of 345 relapse patients were treated for 24 weeks in these trials, with 173 patients receiving Rebetol in combination with interferon alfa-2b and 172 patients receiving interferon alfa-2b alone. A total of Results of these studies showed that patients receiving Rebetol in combination with interferon alfa-2b had a significantly improved sustained virologic and histologic response as compared to patients receiving interferon alfa-2b alone. In the studies involving relapse patients, 48.6 percent of patients receiving Rebetol in combination with interferon alfa-2b had undetectable HCV-RNA levels (HCV less than 100 copies/ml by PCR) at six months post-treatment as compared to 4.7 percent of patients receiving interferon alfa-2b alone. In the studies involving naive patients, 41 percent of patients receiving the combination therapy for 48 weeks had undetectable virus levels at six months post-treatment as compared to 16 percent of patients receiving 48 weeks of interferon alfa-2b alone. The increased sustained response achieved with the combination of Rebetol and interferon alfa-2b, as compared to interferon alfa-2b alone, was maintained across all HCV genotypes m these studies. Hemolytic anemia associated with the use of Rebetol in combination with interferon alfa-2b may exacerbate symptoms of coronary disease or deteriorate cardiac function. It is advised that complete blood counts (CBC) be obtained at baseline and at week two and week four of therapy or more frequently if clinically indicated. The most common adverse experiences associated with combination Rebetol/interferon alfa-2b therapy are flu-like symptoms, such as headache, fatigue, myalgia and fever, which appear to decrease in severity as treatment continues. Severe psychiatric adverse events may manifest in patients receiving therapy with interferons, including Intron A therapy. Depression and suicidal behaviour, including suicidal ideation, suicidal attempts and completed suicides, may occur. Combination Rebetol/Intron A therapy must not be used by women, or male partners of women, who are or may become pregnant during therapy and the six months after stopping therapy. Combination Rebetol/Intron A therapy should not be initiated until a report of a negative pregnancy has been obtained immediately prior to initiation of therapy. Women of childbearing potential and men must use effective contraception (two reliable forms) during treatment and during the six-month post-treatment follow-up period. Significant teratogenic and/or embriocidal effects have been demonstrated for ribavirin in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one-20th of the recommended human dose of Rebetol. Rebetol Capsules are administered orally at a dose of 1,000 mg or 1,200 mg daily in two divided (morning and evening) doses in combination with interferon alfa-2b solution for injection administered subcutaneously at a dose of 3 MIU three times a week. Patients weighing 75 kg (165 pounds) or less should receive 1,000 mg of Rebetol daily, while patients weighing more than 75 kg should receive 1,200 mg of Rebetol daily. The recommended duration of treatment with Rebetol in combination with interferon alfa-2b for naive patients is six to 12 months. The duration of treatment should be individualized to the patient depending on baseline disease characteristics, response to therapy and tolerability of the regimen. For relapse patients, the recommended duration of treatment with Rebetol in combination with interferon alfa-2b is six months. Rebetol is an oral formulation of the antiviral agent ribavirin. Interferon alfa-2b is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects.
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