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HCV Advocate Video Update Top Line Phase III Data: Telaprevir – REALIZE

HCV Advocate Video Update Top Line Phase III Data: Telaprevir – REALIZE. Alan Franciscus Executive Director, Hepatitis C Support Project Editor-in-Chief, HCV Advocate Website Join me on Twitter & Facebook – HCVAdvocate BLOG: hcvadvocate.blogspot.com/. Telaprevir.

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HCV Advocate Video Update Top Line Phase III Data: Telaprevir – REALIZE

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  1. HCV Advocate Video UpdateTop Line Phase III Data:Telaprevir – REALIZE Alan Franciscus Executive Director, Hepatitis C Support Project Editor-in-Chief, HCV Advocate Website Join me on Twitter & Facebook – HCVAdvocate BLOG: hcvadvocate.blogspot.com/ www.hcvadvocate.org

  2. Telaprevir • Telaprevir is an HCV protease inhibitor that works to block the replication of the hepatitis C virus • Phase III Studies: • ADVANCE and ILLUMINATE: HCV genotype 1 people who have never been treated • REALIZE: HCV genotype 1 people who had a previous course of pegylated interferon plus ribavirin therapy, but did not achieve an SVR www.hcvadvocate.org

  3. Top Line Results* – Telaprevir Vertex - Phase III Study: REALIZE HCV Genotype 1 – Patients who did not achieve a sustained virological response (SVR**) with a previous course of pegylated interferon and ribavirin **SVR = HCV RNA (viral load) undetectable 24 weeks after the last dose of medicine is taken *Source: Company press release www.hcvadvocate.org

  4. Patient Population 89% - had high viral load (greater than or equal to 800,000 IU/mL) 26% - with cirrhosis 50% - genotype 1 a; 50% genotype 1b www.hcvadvocate.org

  5. Types of Response 3 response Groups: Relapser Partial responder Null responder www.hcvadvocate.org

  6. Prior Treatment Response Terms Relapser: A person who was given a previous course of therapy for at least 42 weeks–became viral load undetectable during the treatment period, but became viral load detectable during the 24 week follow-up period www.hcvadvocate.org

  7. Prior Treatment Response Terms Partial responder: A person who had achieved a 2 log10 drop by week 12 but never became viral load undetectable by week 24 of a previous course of treatment Example: 2 log10 drop = 15,000,000 IU/mL to 150,000 IU/mL www.hcvadvocate.org

  8. Prior Treatment Response Terms Null Responder: A person who has less than a 2 log10 drop in viral load at the 12th week of treatment. Example: 2 log10 drop = 15,000,000 IU/mL to 150,000 IU/mL Null responder = A viral load that starts at 15,000,000 and does not decrease below 150,000 www.hcvadvocate.org

  9. Compared to Standard of Care Standard of Care Groups: Pegylated interferon plus ribavirin www.hcvadvocate.org

  10. Note: Lead-in Phase In this trial two different groups: Patients given pegylated interferon and ribavirin for 4 weeks prior to adding telaprevir Patients were started on triple therapy immediately The SVR rates were similar between the two groups—for simplicity I am combining the SVR rates between the two groups and the SVR rates by type of prior non-response www.hcvadvocate.org

  11. HCV Medications & Treatment Duration Groups that received telaprevir: 12 weeks of telaprevir (750 mg, every 8 hours), pegylated interferon (once a week) and weight-based ribavirin (twice a day) for 12 weeks only Followed by pegylated interferon (once a week) and weight-based ribavirin (twice a day) for 32 or 36 weeks www.hcvadvocate.org

  12. HCV Medications & Treatment Duration Standard of Care (SOC) – pegylated interferon (once a week) plus weight-based ribavirin (twice a day) for 48 weeks (placebo included for 12 weeks) www.hcvadvocate.org

  13. Results: Overall SVR Rates All arms that contained telaprevir: SVR = 65% All arms standard of care (SOC): SVR = 17% www.hcvadvocate.org

  14. Results: Relapsers Telaprevir arms: SVR = 86% (245 out of 286 patients) SOC arms: SVR = 24% (16 out of 68 patients) www.hcvadvocate.org

  15. Results: Partial Responders Telaprevir arms; SVR = 57% (55 out of 97 patients) SOC arms: SVR = 15% (4 out of 27 patients) www.hcvadvocate.org

  16. Results: Null Responders Telaprevir arms: SVR = 31% (46 of 147 patients) SOC arms: SVR = 5% (2 out of 37 patients) www.hcvadvocate.org

  17. Side Effects Side effects reported were mild to moderate Discontinuation rates were similar between groups including the group that did not receive telaprevir www.hcvadvocate.org

  18. Summary Overall SVR = 65% Relapsers –SVR = 86% Partial Responders – SVR = 57% Null Responders –SVR = 31% Treatment duration: 44 or 48 weeks Telaprevir is only given for 12 weeks www.hcvadvocate.org

  19. Marketing Approval Vertex states that they will complete filing for marketing approval with the fda towards the end of 2010 FDA approval is expected 2011-2012 www.hcvadvocate.org

  20. More Information Check back at www.hcvadvocate.org for new fact sheets: Boceprevir – phase III Top-line results Telaprevir –phase III Top-line results 2010 ASSLD Conference – more results will be released and reported www.hcvadvocate.org

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