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I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks

Phase 3. Treatment Naïve, Chronic HCV. I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks. McHutchison JG, et al. N Engl J Med. 1998;339:1485-92. I nterferon alfa- 2b +/- Ribavirin for Chronic HCV Study Outline.

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I nterferon alfa-2b +/- Ribavirin for 24 or 48 weeks

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  1. Phase 3 TreatmentNaïve, Chronic HCV Interferon alfa-2b +/- Ribavirin for 24 or 48 weeks McHutchisonJG, et al. N Engl J Med. 1998;339:1485-92.

  2. Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Outline • Study-Randomized, double-blinded, placebo controlled, phase 3 trial- Conducted in 44 centers in United States • Subjects- N = 912 with chronic hepatitis C - Treatment naïve; 72% genotype 1 • Regimens -Interferon alfa-2b + Placebo x 24 or 48 weeks -Interferon alfa-2b + Ribavirin (weight based) x 24 or 48 weeks • Primary Endpoint- Undetectable serum HCV RNA 24 weeks after stopping treatment *Ribavirin weight based dosing: <75 kg = 1000 mg/day; >75 kg= 1200 mg/day Source: McHutchisonJG, et al. N Engl J Med. 1998;339:1485-92.

  3. Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Design Week 0 24 48 72 Interferon (n = 231) SVR24 Interferon(n = 225) SVR24 Interferon + Ribavirin(n = 228) SVR24 Interferon + Ribavirin(n = 228) SVR24 Drug DosingInterferon alfa-2b 3 million U 3x/weekWeight-based Ribavirin (divided bid): 1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg Source: McHutchisonJG, et al. N Engl J Med. 1998;339:1485-92.

  4. Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Results SVR 24, by Treatment Regimen 13/231 29/225 70/228 87/228 Source: McHutchisonJG, et al. N Engl J Med. 1998;339:1485-92.

  5. Interferon alfa-2b +/- Ribavirin for Chronic HCVStudy Conclusions Source: McHutchisonJG, et al. N Engl J Med. 1998;339:1485-92.

  6. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.

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