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Hepatitis web study Hepatitis web study Telaprevir in Treatment Experienced GT-1 REALIZE (Study 216) Phase 3 Treatment Experienced Zeuzem S, et al. N Engl.

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Presentation on theme: "Hepatitis web study Hepatitis web study Telaprevir in Treatment Experienced GT-1 REALIZE (Study 216) Phase 3 Treatment Experienced Zeuzem S, et al. N Engl."— Presentation transcript:

1 Hepatitis web study Hepatitis web study Telaprevir in Treatment Experienced GT-1 REALIZE (Study 216) Phase 3 Treatment Experienced Zeuzem S, et al. N Engl J Med. 2011;364:2417-28.

2 Hepatitis web study Source: Zeuzem S, et al. N Engl J Med. 2011;364:2417-28. Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE Study: Study Design Drug Dosing Telaprevir = 750 mg q8h Peginterferon alfa-2a = 180 µg weekly Ribavirin = 1000 mg/day for wt 75 kg

3 Hepatitis web study Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE Study: Definitions for Prior Response No Response: Reduction of less than 2 log 10 in HCV RNA after 12 weeks of therapy Partial Response: Reduction of 2 log 10 or more in HCV RNA after 12 weeks of therapy, but with detectable HCV RNA Relapse: undetectable HCV RNA at the end of a previous course of therapy but HCV RNA positivity thereafter Source: Zeuzem S, et al. N Engl J Med. 2011;364:2417-28.

4 Hepatitis web study Placebo Telaprevir Source: Zeuzem S, et al. N Engl J Med. 2011;364:2417-28. Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE: Treatment Regimens Peginterferon + Ribavirin Telaprevir T12 PR48 Lead-In T12 PR48 PR48 N=266 N=264 N=132 1224480 Week 36416 Placebo Peginterferon + Ribavirin Placebo Peginterferon + Ribavirin

5 Hepatitis web study Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE Study: Results REALIZE: SVR24 by Regimen Source: Zeuzem S, et al. N Engl J Med. 2011;364:2417-28. SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin 171/266175/26422/132

6 Hepatitis web study Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE: Results Based on Prior History REALIZE: SVR24 by Prior Response Source: Zeuzem S, et al. N Engl J Med. 2011;364:2417-28. SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin 29/4926/484/27121/145124/14116/6821/7225/75 2/37

7 Hepatitis web study Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE: Adverse Effects REALIZE: Anemia Source: Zeuzem S, et al. N Engl J Med. 2011;364:2417-28. T = Telaprevir; P = Peginterferon + Ribavirin 71/26673/26420/13228/26636/2647/132

8 Hepatitis web study Source: Zeuzem S, et al. N Engl J Med. 2011;364:2417-28. Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE Study: Conclusions Conclusions: “Telaprevir combined with peginterferon plus ribavirin significantly improved rates of sustained virologic response in patients with previously treated HCV infection, regardless of whether there was a lead-in phase.”


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