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PEG alfa-2a + RBV versus PEG alfa- 2a versus INF + RBV APRICOT STUDY

Phase 3. Treatment Naïve, Chronic HCV and HIV. PEG alfa-2a + RBV versus PEG alfa- 2a versus INF + RBV APRICOT STUDY. Torriani FJ, et. al. N Engl J Med. 2004;351:438-50. . PEG + RBV versus PEG versus INF + RBV in HCV & HIV APRICOT Study: Features.

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PEG alfa-2a + RBV versus PEG alfa- 2a versus INF + RBV APRICOT STUDY

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  1. Phase 3 TreatmentNaïve, Chronic HCV and HIV PEG alfa-2a + RBV versusPEG alfa-2a versus INF + RBV APRICOT STUDY Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.

  2. PEG + RBV versusPEG versusINF + RBV in HCV & HIV APRICOT Study: Features • Study- Randomized, placebo-controlled trial- Conducted at 95 centers in 19 countries in U.S., Canada, & Europe • Subjects- N = 868 chronically infected with both HCV and HIV - Treatment naïve; 61% genotype 1- CD4 >200 cells/mm3 or CD4 = 100-200 cells/mm3 +HIV RNA level <5,000 copies/ml • Regimens (48 Week Treatment)- Peginterferon alfa-2a 180 µg 1x/week + Ribavirin 800 mg/day - Peginterferon alfa-2a 180 µg 1x/week + Placebo- Interferon alfa-2a: 3 million IU 3x/week + Ribavirin 800 mg/day • Primary Endpoint- Undetectable HCV RNA (< 50 IU/ml) 24 weeks after stopping Rx Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.

  3. PEG + RBV versus PEG versus INF + RBV in HCV & HIVAPRICOT Study: Design 0 48 72 Week Peginterferon alfa-2a +Ribavirin N = 289 SVR24 Peginterferon alfa-2a+ Placebo SVR24 N = 286 Interferon alfa-2a +Ribavirin N = 285 SVR24 Drug DosingPeginterferon alfa-2a 180 µg 1x/weekRibavirin (divided bid): 800 mg/dayInterferon alfa-2a 3 million IU 3x/week Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.

  4. PEG + RBV versus PEG versus INF + RBV in HCV & HIV APRICOT Study: Results APRICOT Study: Virologic Responses by Treatment Regimen 136/289 90/286 40/285 116/289 58/286 33/285 Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.

  5. PEG + RBV versus PEG versus INF + RBV in HCV & HIVAPRICOT Study: Results APRICOT Study: SVR24 by Treatment Regimen and Genotype 116/289 58/286 33/285 51/176 24/175 12/171 59/95 32/90 18/89 Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.

  6. PEG + RBV versus PEG versus INF + RBV in HCV & HIV APRICOT: Predictive Value of Early Virologic Response Peginterferon alfa-2a + Ribavirin SVR N = 114 (56%) Yes N = 204(71%) No SVR N = 90 (44%) Week 12 HCV RNA (N =289) 2-log drop or undetectable HCV RNA SVR N = 2 (2%) N = 85(29%) No No SVR N = 83 (98%) Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.

  7. PEG + RBV versus PEG versus INF + RBV in HCV & HIV APRICOT Study: Conclusions Source: Torriani FJ, et. al. N Engl J Med. 2004;351:438-50.

  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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