Phase 3 Treatment Experienced Telaprevir in Treatment Experienced

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Phase 3 Treatment Experienced Telaprevir in Treatment Experienced GT-1 REALIZE (Study 216) Zeuzem S,

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

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE Study: Study Design REALIZE: Study Features §

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE Study: Study Design REALIZE: Study Features § § § § Phase 3 trial Randomized, double-blind, placebo-controlled Eligible if 18 to 70 years of age All with genotype 1 chronic HCV infection Lack of SVR with prior peginterferon + ribavirin treatment N = 663 enrolled Setting: 100 international sites (most in Europe and US) Randomized to one of 3 arms (2: 2: 1 ratio) Drug Dosing Telaprevir = 750 mg q 8 h Peginterferon alfa-2 a = 180 µg weekly Ribavirin = 1000 mg/day for wt < 75 kg; 1200 mg/day for wt > 75 kg Source: Zeuzem S, et al. N Engl J Med. 2011; 364: 2417 -28. Hepatitis web study

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE Study: Definitions for Prior Response • No

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. Hepatitis web study

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE: Treatment Regimens Week 0 N=266 T 12

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE: Treatment Regimens Week 0 N=266 T 12 PR 48 Lead-In N=264 T 12 PR 48 4 12 Telaprevir 16 24 36 48 Placebo Peginterferon + Ribavirin Placebo Telaprevir Peginterferon + Ribavirin Placebo N=132 PR 48 Peginterferon + Ribavirin Source: Zeuzem S, et al. N Engl J Med. 2011; 364: 2417 -28. Hepatitis web study

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE Study: Results REALIZE: SVR 24 by Regimen

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE Study: Results REALIZE: SVR 24 by Regimen Patients with SVR (%) 100 80 64 66 60 40 17 20 0 171/266 175/264 22/132 T 12/PR 48(no lead in) T 12/PR 48 (with lead in) PR 48 SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin Source: Zeuzem S, et al. N Engl J Med. 2011; 364: 2417 -28. Hepatitis web study

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE: Results Based on Prior History REALIZE: SVR

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE: Results Based on Prior History REALIZE: SVR 24 by Prior Response T 12/PR 48 (no lead in) Patients with SVR (%) 100 T 12/PR 48 (with lead in) 83 PR 48 88 80 59 60 40 29 54 33 24 15 20 5 0 21/72 25/75 2/37 No Response 29/49 26/48 4/27 121/145 124/141 Partial Response 16/68 Relapse Previous Type of Response SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin Source: Zeuzem S, et al. N Engl J Med. 2011; 364: 2417 -28. Hepatitis web study

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE: Adverse Effects REALIZE: Anemia 50 T 12/PR

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE: Adverse Effects REALIZE: Anemia 50 T 12/PR 48 (no lead in) Patients (%) 40 30 T 12/PR 48 (with lead in) 27 PR 48 28 20 15 11 14 10 0 5 71/266 73/264 20/132 Hb 8. 5 to ≤ 10 g/d. L 28/266 36/264 7/132 Hb < 8. 5 g/d. L Hemoglobin (Hb) Nadir Through Week 12 T = Telaprevir; P = Peginterferon + Ribavirin Source: Zeuzem S, et al. N Engl J Med. 2011; 364: 2417 -28. Hepatitis web study

Telaprevir for Treatment-Experienced HCV Genotype 1 REALIZE Study: Conclusions: “Telaprevir combined with peginterferon plus

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