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Peginterferon alfa-2b + Ribavirin for 12 or 24 Weeks in GT 2,3

Phase 3. Treatment Naïve, Chronic HCV. Peginterferon alfa-2b + Ribavirin for 12 or 24 Weeks in GT 2,3 . Mangia A, et al. N Engl J Med. 2005;352:1609-17. . Peginterferon alfa-2b + RBV for 12 or 24 Weeks in GT 2 or 3 Study Design.

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Peginterferon alfa-2b + Ribavirin for 12 or 24 Weeks in GT 2,3

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  1. Phase 3 TreatmentNaïve, Chronic HCV Peginterferon alfa-2b + Ribavirin for 12 or 24 Weeks in GT 2,3 Mangia A, etal. N Engl J Med. 2005;352:1609-17.

  2. Peginterferon alfa-2b + RBV for 12 or 24 Weeks in GT 2 or 3Study Design • Study- Randomized, open-label trial- Conducted in 12 centers in Italy • Subjects- N = 283 with chronic hepatitis C- Treatment naïve adult patients- Genotype 2 or 3 • Regimens - Peginterferon alfa-2b: 1.0 µg/kg/wk+ Ribavirin: 1000-1200 mg/d x 24 wks -Peginterferon alfa-2b: 1.0 µg/kg/wk + Ribavirin: 1000-1200 mg/d x 12 or 24 wks* • Primary Endpoint- Undetectable serum HCV RNA at end of treatment (ETR) - Undetectable serum HCV RNA 24 wks after cessation of treatment (SVR) *Duration based on whether week 4 HCV RNA negative (12 weeks) or positive (24 weeks) Source: Mangia A, et al. N Engl J Med. 2005;352:1609-17.

  3. Peginterferon alfa-2b + RBV for 12 or 24 Weeks in GT 2 or 3Treatment Duration and Ribavirin Dose Week 0 12 24 36 48 Standard: All received 24 week of treatment Peginterferon alfa-2b + Ribavirin N = 70 SVR24 Variable: Duration based on Week 4 HCV RNA (negative = 12 week Rx; positive = 24 week Rx) Peginterferon alfa-2b +Ribavirin N = 76 SVR24 Peginterferon alfa-2b + Ribavirin SVR24 N = 132 Drug DosingPeginterferon alfa-2b: 1.5 µg/kg 1x/weekRibavirin (divided bid): <75 kg (1000 mg/day); ≥75 kg (1200 mg/day) Source: Mangia A, et al. N Engl J Med. 2005;352:1609-17.

  4. Peginterferon alfa-2b + RBV for 12 or 24 Weeks in GT 2 or 3Treatment Duration and Ribavirin Dose SVR24 Rates, by Regimen 53/70 113/133 51/80 40/53 89/102 51/80 13/17 24/31 9/22 Source: Mangia A, et al. N Engl J Med. 2005;352:1609-17.

  5. Peginterferon alfa-2b + RBV for 12 or 24 Weeks in GT 2 or 3Conclusions Source: Mangia A, et al. N Engl J Med. 2005;352:1609-17.

  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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