REBETRON™ Combination Therapy containing REBETOL® (Ribavirin, USP) Capsules and INTRON® A (Interferon alfa-2b, recombinant) Injection REBETRON™ Combination Therapy was approved by the Food and Drug Administration for marketing in mid-1998. REBETRON Combination Therapy is indicated for the initial treatment of chronic hepatitis C patients with compensated liver disease and in those who have relapsed following alpha interferon treatment. INTRON® A is a recombinant version of naturally occurring alfa interferon, which has been shown to exert both antiviral and immunomodulatory effects. REBETOL® is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity. Prior to the approval of REBETRON Combination Therapy, the only drugs for treating hepatitis C had been alfa interferons. The ribavirin component of REBETRON Combination Therapy is associated with a significant risk of abnormal fetal development. See "Important Safety Information." In previously untreated patients... With REBETRON Combination Therapy, 40% (198/496) of patients who were treated with 48 weeks of REBETRON Combination Therapy had undetectable virus levels as compared to 15% (73/491) of patients who were treated with 48 weeks of INTRON A alone. Patients treated with REBETRON Combination Therapy had a significantly improved histologic response compared to patients treated with INTRON® A and placebo. In patients treated with interferon who have relapsed... With REBETRON Combination Therapy, 46% of relapsed patients demonstrated a sustained virologic response, compared with 5% of INTRON A patients, at 24 weeks posttreatment. Sixty-three percent of biopsied patients (87/139) showed histologic improvement vs 41% of patients (57/138) receiving INTRON® A plus placebo.* See Clinical Efficacy of REBETRON Combination Therapy *Data on file Side Effects and Safety Information REBETRON™ Combination Therapy containing REBETOL® (Ribavirin, USP) Capsules and INTRON® A (Interferon alfa-2b, recombinant) Injection Anemia associated with therapy may exacerbate symptoms of coronary disease or deteriorate cardiac function. It is advised that complete blood counts (CBC) should be obtained at baseline and at weeks 2 and 4 of therapy or more frequently if clinically indicated. 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. Severe psychiatric adverse events, including depression, psychoses, aggressive behavior, hallucinations, violent behavior (suicidal ideation, suicidal attempts, suicides), and rare instances of homicidal ideation have occurred during combination REBETOL/INTRON A therapy, both in patients with and without a previous psychiatric disorder. 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 during the 6 months after stopping therapy. Combination REBETOL/INTRON A therapy should not be initiated until a report of a negative pregnancy test 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 6-month posttreatment follow-up period. Significant teratogenic and/or embryocidal 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 twentieth of the recommended human dose of REBETOL®. If pregnancy occurs in a patient or partner of a patient during treatment or during the 6 months after treatment stops, physicians are encouraged to report such cases by calling (800) 727-7064. 5 of 11 Terms and Conditions | Privacy Policy | Important Safety Information