1 / 8

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.

msandy
Download Presentation

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

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 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.

More Related