Until recently, the only treatment approved by the Food and Drug Administration for patients with chronic hepatitis was interferon monotherapy. A major step forward in the treatment of patients with chronic hepatitis C is REBETRON™ Combination Therapy containing REBETOL® (Ribavirin, USP) Capsules and INTRON® A (Interferon alfa-2b, recombinant) for Injection. This combination therapy consists of interferon and an antiviral agent, ribavirin.
Treatment for Chronic Hepatitis B
INTRON® A (Interferon alfa-2b) for Injection is indicated for the initial therapy of appropriate chronic hepatitis B patients.
To be eligible for interferon alfa-2b treatment, chronic hepatitis B patients must be at least 1 year old and have been HBsAg-positive for at least 6 months, with elevated serum ALT levels, and HBV replication as determined by the presence of HBeAg in serum. Other selection criteria include the presence of compensated liver disease and a liver biopsy consistent with chronic hepatitis B.
See also INTRON® A.
Important Safety Information
| WARNING Alpha interferons, including INTRON® A, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping INTRON A therapy. |
All patients receiving INTRON A therapy experienced mild-to-moderate side effects. Some patients experienced more severe side effects, including neutropenia, fatigue, myalgia, headache, fever, chills, and increased SGOT. Other frequently occurring side effects were nausea, vomiting, depression, alopecia, diarrhea, and thrombocytopenia. DEPRESSION AND SUICIDAL BEHAVIOR, INCLUDING SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES, HAVE BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALFA INTERFERONS, INCLUDING INTRON A THERAPY.
Treatment for Chronic Hepatitis C
REBETRON Combination Therapy containing REBETOL® (Ribavirin, USP) Capsules and INTRON® A (Interferon alfa-2b, recombinant) for Injection
REBETRON Combination Therapy is indicated for the initial treatment of chronic hepatitis C in patients with compensated liver disease or in patients who have not maintained a response following alpha interferon monotherapy.
Prior to the availability of REBETRON Combination Therapy, the only drugs approved in the United States for treating hepatitis C had been alfa interferons.
Suitable chronic hepatitis C patients are 18 years or older with compensated liver disease.
See also REBETRON™ Combination Therapy.
Important Safety Information
WARNINGS AND CONTRAINDICATIONS
Anemia associated with therapy may exacerbate symptoms of coronary disease or deteriorate cardiac function. It is advised that complete blood counts (CBC) 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 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. |
| WARNING Alpha interferons, including INTRON® A, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping INTRON A therapy. |
INTRON® A (Interferon alfa-2b, recombinant) for Injection
INTRON® A is indicated for the initial treatment of chronic hepatitis C patients. The best treatment results with INTRON® A were obtained in circumstances that included the following patient factors:
- HCV genotype other than type I
- Low pretreatment HCV RNA levels
- Absence of cirrhosis
- Low hepatic iron concentration
- Younger age
- Short disease duration
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