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Hepatitis web study Hepatitis web study Telaprevir in Treatment Naïve GT-1 ADVANCE (Study 108) Phase 3 Treatment Naïve Jacobson IM, et. al. N Engl J Med.

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Presentation on theme: "Hepatitis web study Hepatitis web study Telaprevir in Treatment Naïve GT-1 ADVANCE (Study 108) Phase 3 Treatment Naïve Jacobson IM, et. al. N Engl J Med."— Presentation transcript:

1 Hepatitis web study Hepatitis web study Telaprevir in Treatment Naïve GT-1 ADVANCE (Study 108) Phase 3 Treatment Naïve Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16.

2 Hepatitis web study Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE: Study Design Drug Dosing Telaprevir = 750 mg every 8 hours Peginterferon alfa-2a = 180 µg weekly Ribavirin = 1000 mg/day for wt 75 kg

3 Hepatitis web study Telaprevir + PEG + RBV eRVR: PEG + RBV No eRVR: PEG + RBV Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: Treatment Regimens 82448 Week 0 Telaprevir + PEG + RBV Placebo + PEG + RBV PEG + RBV 12 T8 PR 24 or 48 T12 PR 24 or 48 PR48 N =364 N =363 N =361 PEG + RBV eRVR: PEG + RBV No eRVR: PEG + RBV

4 Hepatitis web study Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: Results ADVANCE: SVR24 by Regimen Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin 250/364271/363158/361

5 Hepatitis web study Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: RVR and eRVR Rates ADVANCE: Patients with RVR and eRVR Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. T = Telaprevir; PR = Peginterferon + Ribavirin; RVR = rapid virologic response; eRVR = extended rapid virologic response 242/364246/36334/361207/364212/36329/361

6 Hepatitis web study Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: Results According to eRVR ADVANCE: SVR24 by eRVR Status Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. T = Telaprevir; PR= Peginterferon + Ribavirin; SVR = Sustained Virologic Response eRVR = extended rapid virologic response (undetectable HCV RNA at weeks 4 and 12) 171/207189/21228/2979/15782/151130/342

7 Hepatitis web study Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: Results According to eRVR ADVANCE: SVR24 by eRVR Status Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin; eRVR = extended rapid virologic response (undetectable HCV RNA at weeks 4 and 12) 171/207189/21228/2979/15782/151130/342

8 Hepatitis web study Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: Results According to Race ADVANCE: SVR24 by Race Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin 221/315147/31816/26244/3257/2826/3515/3829/4423/40

9 Hepatitis web study Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: Results by Baseline HCV RNA ADVANCE: SVR24 by Baseline HCV RNA Level Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin 184/279207/28164/8257/8267/85101/279

10 Hepatitis web study Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: Results by Fibrosis Stage ADVANCE: SVR24 by Fibrosis Stage Source: Jacobson IM, et. al. Hepatology. 2010;52 (Supplement 1):427A. Abstract 211. SVR = Sustained Virologic Response; T = Telaprevir; PR = Peginterferon + Ribavirin 101/128109/13467/147104/151117/15667/14117/527/2132/5213/2134/5911/26

11 Hepatitis web study Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: Adverse Effects ADVANCE: Percentage of Patients with Anemia Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. T = Telaprevir; PR = Peginterferon + Ribavirin 146/36433/36433/363131/363 7/361 51/361

12 Hepatitis web study Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: Adverse Effects ADVANCE: Percentage of Patients with Rash Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. T = Telaprevir; PR = Peginterferon + Ribavirin 15/364 22/363 4/361129/364133/36388/361

13 Hepatitis web study Telaprevir for Treatment-Naïve HCV Genotype 1 SVR Rates by IL28B rs12979860 Genotype ADVANCE: SVR24 by rs12979860 Genotype Source: Telaprevir (Incivek) Prescribing Information. Vertex Pharmaceuticals. PR48 = Peginteron/Ribavirin x 48 weeks PR/T12 = Peginteron/Ribavirin + Telaprevir x 12 weeks 45/5035/556/2616/2220/8048/68

14 Hepatitis web study Source: Jacobson IM, et. al. N Engl J Med. 2011;364:2405-16. Telaprevir for Treatment-Naïve HCV Genotype 1 ADVANCE Study: Conclusions Conclusions: “Telaprevir with peginterferon–ribavirin, as compared with peginterferon–ribavirin alone, was associated with significantly improved rates of sustained virologic response in patients with HCV genotype 1 infection who had not received previous treatment, with only 24 weeks of therapy administered in the majority of patients.”


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