REBETRON™ Combination Therapy containing REBETOL® (Ribavirin, USP) Capsules and INTRON®A (Interferon alfa–2b,
recombinant) Injection, was approved
by the Food and Drug Administration for marketing in June 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 alfa
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 percent (198/496) of patients who were treated
with 48 weeks of REBETRON Combination Therapy had undetectable virus levels* as
compared to 15 percent (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 percent of relapsed patients demonstrated a sustained virologic response, compared with 5 percent of INTRON A patients, at 24 weeks posttreatment. 63 percent of biopsied patients (88/139) showed histologic
improvement vs. 41 percent of patients (57/138) receiving INTRON®
A plus placebo.
See "REBETRON™ Combination Therapy Clinical
Studies/Outcomes."
*Defined as HCV RNA below limits of detection using a research-based RT-PCR assay
at 24 weeks posttreatment.