Hepatitis web study Hepatitis web study Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Phase 3 Treatment Naïve, Chronic HCV Manns.

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Presentation transcript:

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

Hepatitis web study 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 mg/day* - Standard interferon alfa-2b: 3 million U 3x/week + ribavirin mg/day* Primary Endpoint (Sustained Virologic Response [SVR]) - SVR = Undetectable serum HCV RNA 24 weeks after 48-week treatments Source: Manns MP, et. al. Lancet. 2001;358: *Ribavirin dosing: 75 kg: 1200 mg/day

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

Hepatitis web study Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin Results Response after 48 Weeks of Treatment Source: Manns MP, et. al. Lancet. 2001;358: /511244/514235/505333/511289/514271/505

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

Hepatitis web study Source: Manns MP, et. al. Lancet. 2001;358: Peginterferon alfa-2b + Ribavirin versus Interferon alfa-2b + Ribavirin IDEAL Study: Conclusions Interpretation: “In patients with chronic hepatitis C, the most effective therapy is the combination of peginterferon alfa-2b 1.5 µg/kg per week plus ribavirin. The benefit is mostly achieved in patients with HCV genotype 1 infections.”

Hepatitis web study Hepatitis web study This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Online Hepatitis Web Study Funded by a grant from the Centers for Disease Control and Prevention.