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Peginterferon alfa-2b + RBV versus Interferon alfa - 2b RIBAVIC STUDY

Phase 3. Treatment Naïve, Chronic HCV and HIV. Peginterferon alfa-2b + RBV versus Interferon alfa - 2b RIBAVIC STUDY. Carrat F, et. al. JAMA. 2004;292:2839-48. Peginterferon + RBV versus Interferon + RBV in HCV & HIV RIBAVIC Study: Design.

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Peginterferon alfa-2b + RBV versus Interferon alfa - 2b RIBAVIC STUDY

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  1. Phase 3 TreatmentNaïve, Chronic HCV and HIV Peginterferon alfa-2b + RBV versus Interferon alfa-2bRIBAVIC STUDY Carrat F, et. al. JAMA. 2004;292:2839-48.

  2. Peginterferon + RBV versus Interferon + RBV in HCV & HIVRIBAVIC Study: Design • Study- Randomized, phase 3, open-label, parallel group trial- Conducted at 71 French centers • Subjects- N = 412 chronically infected with both HCV and HIV - Treatment naïve; 48% genotype 1- CD4 >200 cells/mm3 • Regimens (48 Week Treatment)- Peginterferon alfa-2b 1.5 µg 1x/week + Ribavirin 800 mg/day - Interferon alfa-2b: 3 million IU 3x/week + Ribavirin 800 mg/day • Primary Endpoint- Undetectable serum HCV RNA 24 weeks after stopping treatment Source: Carrat F, et. al. JAMA. 2004;292:2839-48.

  3. Peginterferon + RBV versusInterferon + RBV in HCV & HIVRIBAVIC Study: Design 0 48 72 Week Peginterferon alfa-2b +Ribavirin N = 205 SVR24 Interferon alfa-2b +Ribavirin N = 207 SVR24 Drug DosingPeginterferon alfa-2b: 1.5 µg/kg 1x/weekStandard Interferon alfa-2b 3 million units 3x/weekRibavirin (divided bid): 800 mg/day Source: Carrat F, et. al. JAMA. 2004;292:2839-48.

  4. Peginterferon + RBV versus Interferon + RBV in HCV & HIVRIBAVIC Study: Design RIBAVIC Study: SVR24 by Treatment Regimen and Genotype P = .88 P = .047 P = .006 56/205 41/207 21/125 8/129 35/80 33/76 Source: Carrat F, et. al. JAMA. 2004;292:2839-48.

  5. Peginterferon + RBV versus Interferon + RBV in HCV & HIVRIBAVIC Study: Conclusions Source: Carrat F, et. al. JAMA. 2004;292:2839-48.

  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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