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Phase 2 Treatment Naïve Study: Peginterferon Alfa-2a + RBV vs Interferon Alfa-2a + RBV in HCV & HIV

This study compares the efficacy of Peginterferon Alfa-2a + RBV and Interferon Alfa-2a + RBV in treatment-naïve patients with chronic HCV and HIV. The primary endpoint is undetectable HCV RNA 24 weeks after treatment.

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Phase 2 Treatment Naïve Study: Peginterferon Alfa-2a + RBV vs Interferon Alfa-2a + RBV in HCV & HIV

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  1. Phase 2 TreatmentNaïve, Chronic HCV and HIV Peginterferon alfa-2a + RBV versus Interferon alfa-2a + RBV ACTG 5071 Chung RT, et. al. N Engl J Med. 2004;351:451-9.

  2. PEG alfa-2a + RBV versusIFN alfa-2a + RBV in HCV & HIV ACTG 5071 Study: Features • Study- Randomized, placebo-controlled, phase 2 trial- Conducted at 21 ATG sites in United States • Subjects- N = 133 chronically infected with both HCV and HIV - Treatment naïve- 78% genotype 1 • Regimens (48 Week Treatment)- Peginterferon alfa-2a 180 µg 1x/week + Ribavirin (dose escalation)- Interferon alfa-2a: 6million IU 3x/week, then 3 million IU 3x/week + Ribavirin (dose escalation) • Primary Endpoint- Undetectable HCV RNA (< 50 IU/ml) 24 weeks after stopping Rx Source: Chung RT, et. al. N Engl J Med. 2004;351:451-9.

  3. PEG alfa-2a + RBV versus IFN alfa-2a + RBV in HCV & HIV ACTG 5071 Study: Design 0 48 72 Week Peginterferon alfa-2a +Ribavirin N = 66 SVR24 Interferon alfa-2a +Ribavirin N = 67 SVR24 Drug DosingPeginterferon alfa-2a 180 µg 1x/weekx 48 weeksInterferon alfa-2a 6 million IU 3x/week x 12 weeks, then 6 million IU 3x/week x 36 weeks Ribavirin (divided bid): 600 mg/day x 4 weeks, then 800 mg/day x 4 weeks, then 1000 mg/day x 40 weeks Source: Chung RT, et. al. N Engl J Med. 2004;351:451-9.

  4. PEG alfa-2a + RBV versus IFN alfa-2a + RBV in HCV & HIV ACTG 5071 Study: Results ACTG 5071 Study: Virologic Responses by Treatment Regimen 27/66 8/67 18/66 8/67 Source: Chung RT, et. al. N Engl J Med. 2004;351:451-9.

  5. PEG alfa-2a + RBV versus IFN alfa-2a + RBV in HCV & HIV ACTG 5071 Study: Results ACTG 5071 Study: SVR24 by Treatment Regimen and Genotype 18/66 8/67 7/51 3/52 11/15 5/15 Source: Chung RT, et. al. N Engl J Med. 2004;351:451-9.

  6. PEG alfa-2a + RBV versus IFN alfa-2a + RBV in HCV & HIV ACTG 5071: Predictive Value of Early Virologic Response SVR N = 22 (51%) Yes N = 43(42%) No SVR N = 21 (49%) Week 12 HCV RNA (N =106) 2-log drop or undetectable HCV RNA SVR N = 0 (0%) N = 63(59%) No No SVR N = 63 (100%) Source: Chung RT, et. al. N Engl J Med. 2004;351:451-9.

  7. PEG alfa-2a + RBV versus IFN alfa-2a + RBV in HCV & HIV ACTG 5071 Study: Conclusions Source: Chung RT, et. al. N Engl J Med. 2004;351:451-9.

  8. 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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