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Peginterferon alfa-2a versus Interferon alfa-2a

Phase 3. Treatment Naïve, Chronic HCV. Peginterferon alfa-2a versus Interferon alfa-2a. Zeuzem S, et al. N Engl J Med. 2000;343:1666-72. Peginterferon alfa-2a versus Interferon alfa- 2a Study Features.

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Peginterferon alfa-2a versus Interferon alfa-2a

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  1. Phase 3 TreatmentNaïve, Chronic HCV Peginterferon alfa-2a versusInterferon alfa-2a Zeuzem S, et al. N Engl J Med. 2000;343:1666-72.

  2. Peginterferon alfa-2a versus Interferon alfa-2aStudy Features • Study- Randomized, open label, parallel dose, phase 3 trial- 36 international centers • Subjects- N = 531 with chronic hepatitis C-Treatment naïve - Any genotype (62% with genotype 1)- 18 years of age or older • Regimens- Peginterferon alfa-2a: 180 µg 1x/week x 48 weeks- Interferon alfa-2a: 6 million units 3x/week x 12 weeks, then 6 million units 3x/week x 36 weeks • Primary Endpoint: Sustained Virologic Response (SVR24)- SVR = undetectable serum HCV RNA 24 weeks after 48-week treatment- Undetectable serum HCV RNA = less than 100 copies/ml Source: Zeuzem S, et al. N Engl J Med. 2000;343:1666-72.

  3. Peginterferon alfa-2a versus Interferon alfa-2aStudy Design Week 0 24 48 72 Peginterferon alfa-2a N =267 SVR24 Interferon alfa-2a N =264 SVR24 Drug DosingPeginterferon alfa-2a: 180 µg once weeklyInterferon alfa-2a: 6 million units 3x/week x 12 weeks, then 6 million units 3x/week x 36 weeks Source: Zeuzem S, et al. N Engl J Med. 2000;343:1666-72.

  4. Peginterferon alfa-2a versus Interferon alfa-2aStudy Results Virologic Responses by Treatment Regimen (ITT Analysis) P = 0.001 P = 0.001 185/267 73/264 103/267 50/264 Source: Zeuzem S, et al. N Engl J Med. 2000;343:1666-72.

  5. Peginterferon alfa-2a versus Interferon alfa-2aStudy Results Independent Factors Associated with SVR, Multiple Regression Analysis 185/267 73/264 103/267 50/264 Source: Zeuzem S, et al. N Engl J Med. 2000;343:1666-72.

  6. Peginterferon alfa-2a versus Interferon alfa-2aStudy Conclusions Source: Zeuzem S, et al. N Engl J Med. 2000;343:1666-72.

  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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