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PEG-INTERFERON alpha-2B + RIBAVIRIN FOR TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C WHO HAVE PREVIOUSLY FAILED TO ACHIEVE A SUSTAINED VIROLOGIC RESPONSE FOLLOWING INTERFERON ALFA OR INTERFERON A-2B + RIBAVIRIN THERAPY



PEG-INTERFERON alpha-2B + RIBAVIRIN FOR TREATMENT OF PATIENTS WITH CHRONIC HEPATITIS C WHO HAVE PREVIOUSLY FAILED TO ACHIEVE A SUSTAINED VIROLOGIC RESPONSE FOLLOWING INTERFERON ALFA OR INTERFERON A-2B + RIBAVIRIN THERAPY



Digestive Disease Week Abstracts & Itinerary Planner : Abstract No T1292



Background: The role of Pegylated interferfon(IFN) alpha-2b (PEG) and ribavirin (RBV) therapy for patients (pts) with chronic Hepatitis C (HCV) who have previously failed IFN-based therapies is not fully known. Objective: To compare the safety and efficacy of continuous weight-based (CONT) vs. Categorical weight-based (CAT) PEG-IFN alfa-2b/RBV in pts who have failed to achieve sustained virologic response after previous IFN/RBV treatment. Methods: This is an open-label, multi-center, randomized clinical trial of CONT vs. CAT PEG/RBV. Pts were randomized to receive 800mg RBV QD with either Continuous weight adjusted PEG-IFN aldfa-2b (1.5 mcg/kg) QW (n=259) or Categorical weight adjusted PEG-IFN alfa-2b (100 mcg if < 80kg, 150 mcg if > 80kg) for 48 weeks. HCV RNA was evaluated at baseline (BL), week 12 (EVR), and end of treatment (EOT). Intent-to-treat response rates were compared using Fischer's Exact Test and logistic regression. Results: 517 pts were enrolled and took at least one dose of drug. The median age was 47 years, and the pts were 64.8% male, 76.8% Caucasian, 13.5% Black and 8.3% Asian. HCV Genotype 1, 90.5% and 2 or 3, 9.5%. 207 pts completed 48 weeks of treatment. 278 pts withdrew before EOT; the primary reason for withdraw was viral non-response. No differences were observed in AEs between treatment groups, including neutropenia (p=0.7). EVR/EOT for CONT and CAT were 40.0%/24.3% and 31.0%/25.6%, respectively (p=0.47 and 0.64)). EVR/EOT for relapsers and non-responders were 50.6%/34.9% and 23.9%/20.3%, respectively (p < .0003). EOT response was 23.8% in genotype 1 and 36.7% in genotype 2/3(p=0.046). Conclusions: Continuous and Categorical weight-based dosing of PEG-IFN alfa-2b/RBV had similar safety and efficacy in the re-treatment of PTS who failed or relapsed after original IFN-based therapy for HCV. Among non-responders to prior therapy, the EOT response was more than 20%; as expected the EOT was higher among relapsers. These data suggest that PEG-IFN alfa-2b/RBV may be effective in persons who initially failed to respond to or relapsed after previous IFN/RBV treatment.

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