Clinical Trials with Previously Untreated Patients
The safety and efficacy of REBETRON
Combination Therapy were evaluated in two multicenter, double–blind clinical trials
involving 1,711 patients with compensated chronic hepatitis C and detectable HCV
RNA who were previously untreated with alpha interferon therapy.
Patients were randomized to receive subcutaneous injections of INTRON® A 3 million
international units (MIU) three times per week and either oral REBETOL® 1,000–1,200 mg
or matched placebo daily for 24 or 48 weeks followed by 24 weeks to off–therapy follow
up.
Results of these studies showed that patients receiving REBETRON Combination Therapy
had a significantly improved virologic and histologic response compared to patients
receiving INTRON®A alone. Six months after therapy was completed, 40 percent (198/496
patients) who were treated with 48 weeks of REBETRON Combination Therapy had undetectable
virus levels* as compared to 15 percent (73/491 patients) who were treated with
48 weeks of INTRON® A alone.
Clinical Trials with Relapsed Patients
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
alfa interferon and relapsed after having an initial response. Relapse patients were
defined as patients who had a normal serum ALT (alanine aminotransferase) level at
the end of alfa interferon therapy, with abnormal ALT values within
1 year following the end of the most recent course of therapy.
Patients in the clinical trials were randomized to receive subcutaneous injections
of INTRON® A
at 3 million international units (MIU) three times weekly and either oral REBETOL® 1,000–1,200 mg daily or a matched placebo for 24 weeks of treatment. At 6 months posttreatment, 80 of 173 patients
(46 percent) who received the combination therapy had undetectable virus levels*
compared to 9 of 172 patients (5 percent) who received INTRON® A plus placebo.
To review clinical trial data, administration guidelines, and safety information,
see "REBETRON™ Combination Therapy"
and "Important Safety Information."
*Defined as HCV RNA below limits of detection using a research-based RT-PCR
assay at 24 weeks posttreatment.