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Clinical Efficacy in
Previously Untreated Patients
REBETRON™ Combination Therapy containing REBETOL® (Ribavirin, USP) Capsules
and INTRON® A (Interferon alfa-2b, recombinant) Injection
Achieves 40%* sustained virologic response in previously untreated patients
Sustained Loss of Detectable HCV RNA...
- 40% of patients (198/496) remained
HCV-RNA negative† at 24 weeks posttreatment*
Comparative
Virologic Response Rates: REBETRON Combination Therapy vs INTRON® A
Monotherapy

*Combined
results from two multicenter, randomized, double-blind studies evaluating
1,711 chronic hepatitis C patients who were previously untreated.
Dosing regimen/duration: INTRON® A
3 MIU tiw plus either placebo or REBETOL®
1200 mg daily (1000 mg daily for patients weighing less than or equal to 165 lbs)
for either 48 weeks or 24 weeks with 24 weeks of off-therapy follow-up.
Results: Study 1 (n=912): Sustained virologic response in 85/228
REBETRON Combination Therapy patients vs. 27/225 INTRON A/placebo
patients. Study 2 (n=799): Sustained virologic response in 113/268
REBETRON Combination Therapy patients vs. 46/266 INTRON /placebo
patients.
† Defined as HCV RNA levels below limits of detection using a research-based
RT-PCR assay at end of treatment and during follow-up period.
...And Greater Improvements in Liver Histology
40% of biopsied patients (198/496) showed histologic improvement
vs. 27% (134/491). Combined results.
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