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ALAN FRANCISCUS EXECUTIVE DIRECTOR, HEPATITIS C SUPPORT PROJECT EDITOR-IN-CHIEF, HCV ADVOCATE WEBSITE JOIN ME ON TWITTER & FACEBOOK – HCVADVOCATE BLOG:

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Presentation on theme: "ALAN FRANCISCUS EXECUTIVE DIRECTOR, HEPATITIS C SUPPORT PROJECT EDITOR-IN-CHIEF, HCV ADVOCATE WEBSITE JOIN ME ON TWITTER & FACEBOOK – HCVADVOCATE BLOG:"— Presentation transcript:

1 ALAN FRANCISCUS EXECUTIVE DIRECTOR, HEPATITIS C SUPPORT PROJECT EDITOR-IN-CHIEF, HCV ADVOCATE WEBSITE JOIN ME ON TWITTER & FACEBOOK – HCVADVOCATE BLOG: HCVADVOCATE.BLOGSPOT.COM/ HCV Advocate Video Update Top Line Phase III Data: Telaprevir – REALIZE 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 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 Top Line Results* – Telaprevir www.hcvadvocate.org

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

5 3 RESPONSE GROUPS: Relapser Partial responder Null responder Types of Response www.hcvadvocate.org

6 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 Prior Treatment Response Terms www.hcvadvocate.org

7 Partial responder: A person who had achieved a 2 log 10 drop by week 12 but never became viral load undetectable by week 24 of a previous course of treatment Example: 2 log 10 drop = 15,000,000 IU/mL to 150,000 IU/mL Prior Treatment Response Terms www.hcvadvocate.org

8 Null Responder: A person who has less than a 2 log 10 drop in viral load at the 12 th week of treatment. Example: 2 log 10 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 Prior Treatment Response Terms www.hcvadvocate.org

9 STANDARD OF CARE GROUPS: Pegylated interferon plus ribavirin Compared to Standard of Care www.hcvadvocate.org

10 IN THIS TRIAL TWO DIFFERENT GROUPS: 1. Patients given pegylated interferon and ribavirin for 4 weeks prior to adding telaprevir 2. 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 Note: Lead-in Phase www.hcvadvocate.org

11 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 HCV Medications & Treatment Duration www.hcvadvocate.org

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

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

14 Telaprevir arms: SVR = 86% (245 OUT OF 286 PATIENTS) SOC arms: SVR = 24% (16 OUT OF 68 PATIENTS) Results: Relapsers www.hcvadvocate.org

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

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

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

18 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 Summary www.hcvadvocate.org

19 VERTEX STATES THAT THEY WILL COMPLETE FILING FOR MARKETING APPROVAL WITH THE FDA TOWARDS THE END OF 2010 FDA APPROVAL IS EXPECTED 2011-2012 Marketing Approval www.hcvadvocate.org

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


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