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Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin

Phase 3. Treatment Naïve, Chronic HCV. Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin . Manns MP, et. al. Lancet. 2001;358:958-65. Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Study Design.

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Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin

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  1. Phase 3 TreatmentNaïve, Chronic HCV Peginterferon alfa-2b + Ribavirin versusInterferon alfa-2b + Ribavirin MannsMP, et. al. Lancet. 2001;358:958-65

  2. Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Study Design • Study- Open-label, randomized controlled trial - 62 sites in Europe, North America, & Argentina • Subjects- N = 1530 with chronic hepatitis C- Treatment naïve- Genotype 1: 68%; Genotype 2 or 3: 29%; Genotype 4,5, or 6: 3% - Serum ALT >34 IU/L for women, >43 IU/L for men • Regimens- Higher Dose Peginterferon alfa-2b: 1.5 µg/kg 1x/week + ribavirin 800 mg/day- Lower Dose Peginterferon alfa-2b: 1.5 µg/kg 1x/week x 4 weeks then 0.5 µg/kg 1x/week + ribavirin 1000-1200 mg/day*- Standard interferon alfa-2b: 3 million U 3x/week + ribavirin 1000-1200 mg/day* • Primary Endpoint (Sustained Virologic Response [SVR])- SVR = Undetectable serum HCV RNA 24 weeks after 48-week treatments *Ribavirin dosing: <75 kg: 1000 mg/day; >75 kg: 1200 mg/day Source: Manns MP, et. al. Lancet. 2001;358:958-65.

  3. Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Study Design Week 0 48 72 Higher-Dose Peginterferon + Ribavirin --------------------------------------------------------------------Peginterferon alfa-2b: 1.5µg/kg 1x/week + Ribavirin: 800 mg/day SVR24 N = 511 Lower-Dose Peginterferon + Ribavirin --------------------------------------------------------------------Peginterferon alfa-2b: 1.5 µg/kg 1x/week x 4 weeks, then 0.5 mcg/kg 1x/week + Ribavirin: 1000-1200 mg/day SVR24 N = 514 Interferon + Ribavirin -------------------------------------------------------------------- Standard Interferon alfa-2b: 3 million U 3x/week +Ribavirin: 1000-1200 mg/day SVR24 N = 505 From: Manns MP, et. al. Lancet. 2001;358:958-65.

  4. Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Results Response after 48 Weeks of Treatment 333/511 289/514 271/505 274/511 244/514 235/505 Source: Manns MP, et. al. Lancet. 2001;358:958-65.

  5. Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Results SVR24, Based on Genotype Source: Manns MP, et. al. Lancet. 2001;358:958-65.

  6. Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + RibavirinIDEAL Study: Conclusions Source: Manns MP, et. al. Lancet. 2001;358:958-65.

  7. 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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