1 / 8

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.

remy
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related