Focus on Investigational HCV Agents.ppt
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Focus on Investigational
HCV Agents
CCO Independent Conference Coverage
of the 2008 Annual Meeting of the European Association for the Study of the Liver*
April 23-27, 2008
Milan, Italy
About These Slides
* Users are encouraged to include these slides in their own presentations, but we ask that content and attribution not be changed. Users are asked to honor this intent.
* These slides may not be published or posted online or used for any other commercial purpose without written permission from Clinical Care Options.
* We are grateful to Ira M. Jacobson, MD, with the Weill Medical College of Cornell University in New York, New York, for aiding in the content development of these slides.
Treatment-Naive Patients
PROVE 1: Telaprevir + PegIFN/RBV in Treatment-Naive HCV GT 1 Patients
* Randomized, placebo-controlled, phase II trial
PROVE 1: Response Rates (ITT)
PROVE 1: AEs Associated
With TVR
PROVE 2: TVR + PegIFN ± RBV in Treatment-Naive HCV GT 1 Patients
PROVE 2: HCV RNA Undetectable* Rates at Weeks 4 and 12 (ITT)
PROVE 2: SVR and Relapse Rates (ITT)
PROVE 2: AEs Reported in >25% of Patients Through 48 Weeks
SPRINT-1: Boceprevir + PegIFN/RBV in Treatment-Naive HCV GT 1 Patients
SPRINT-1: Undetectable HCV RNA* at Weeks 4 or 12 of Boceprevir Therapy
SPRINT-1:SVR 12* and Relapse Rates (ITT)
SPRINT-1: Highest WHO Grade Anemia During 28 Weeks of Treatment
HCV Protease Inhibitor TMC435350: Safety and Activity
4 Weeks of R1626 + PegIFN/RBV -->
44 Weeks of PegIFN/RBV: Efficacy
4 Weeks of R1626 + PegIFN/RBV -->
44 Weeks of PegIFN/RBV: Efficacy
4 Weeks of R1626 + PegIFN/RBV -->
44 Weeks of PegIFN/RBV: AEs
Polymerase Inhibitor R7128 + PegIFN/RBV: Efficacy
Debio 025 + PegIFN alfa-2a in Treatment-Naive Patients
PegIFN + Weight-Based Taribavirin or RBV in Treatment-Naive HCV GT 1
* No significant differences in Week 12 viral response (EVR)*
PegIFN + Weight-Based Taribavirin or RBV in Treatment-Naive HCV GT 1
STEALTH C-1: Nitazoxanide + PegIFN ± RBV in G4 HCV Patients
STEALTH C-1: NTZ + PegIFN ± RBV in G4 HCV Patients (cont'd)
Previous Nonresponders
TVR + PegIFN alfa-2a/RBV in PegIFN alfa-2a/RBV Nonresponders/Relapsers
TVR + PegIFN alfa-2a/RBV in Nonresponders or Relapsers
Boceprevir + PegIFN/RBV: Phase II Study in GT1 Nonresponders
Boceprevir + PegIFN/RBV in Null Responders
Silibinin ± PegIFN/RBV in PegIFN/RBV Nonresponders
Silibinin ± PegIFN/RBV in PegIFN/RBV Non responders
Focus on Investigational
HCV Agents
CCO Independent Conference Coverage
of the 2008 Annual Meeting of the European Association for the Study of the Liver*
April 23-27, 2008
Milan, Italy
About These Slides
* Users are encouraged to include these slides in their own presentations, but we ask that content and attribution not be changed. Users are asked to honor this intent.
* These slides may not be published or posted online or used for any other commercial purpose without written permission from Clinical Care Options.
* We are grateful to Ira M. Jacobson, MD, with the Weill Medical College of Cornell University in New York, New York, for aiding in the content development of these slides.
Treatment-Naive Patients
PROVE 1: Telaprevir + PegIFN/RBV in Treatment-Naive HCV GT 1 Patients
* Randomized, placebo-controlled, phase II trial
PROVE 1: Response Rates (ITT)
PROVE 1: AEs Associated
With TVR
PROVE 2: TVR + PegIFN ± RBV in Treatment-Naive HCV GT 1 Patients
PROVE 2: HCV RNA Undetectable* Rates at Weeks 4 and 12 (ITT)
PROVE 2: SVR and Relapse Rates (ITT)
PROVE 2: AEs Reported in >25% of Patients Through 48 Weeks
SPRINT-1: Boceprevir + PegIFN/RBV in Treatment-Naive HCV GT 1 Patients
SPRINT-1: Undetectable HCV RNA* at Weeks 4 or 12 of Boceprevir Therapy
SPRINT-1:SVR 12* and Relapse Rates (ITT)
SPRINT-1: Highest WHO Grade Anemia During 28 Weeks of Treatment
HCV Protease Inhibitor TMC435350: Safety and Activity
4 Weeks of R1626 + PegIFN/RBV -->
44 Weeks of PegIFN/RBV: Efficacy
4 Weeks of R1626 + PegIFN/RBV -->
44 Weeks of PegIFN/RBV: Efficacy
4 Weeks of R1626 + PegIFN/RBV -->
44 Weeks of PegIFN/RBV: AEs
Polymerase Inhibitor R7128 + PegIFN/RBV: Efficacy
Debio 025 + PegIFN alfa-2a in Treatment-Naive Patients
PegIFN + Weight-Based Taribavirin or RBV in Treatment-Naive HCV GT 1
* No significant differences in Week 12 viral response (EVR)*
PegIFN + Weight-Based Taribavirin or RBV in Treatment-Naive HCV GT 1
STEALTH C-1: Nitazoxanide + PegIFN ± RBV in G4 HCV Patients
STEALTH C-1: NTZ + PegIFN ± RBV in G4 HCV Patients (cont'd)
Previous Nonresponders
TVR + PegIFN alfa-2a/RBV in PegIFN alfa-2a/RBV Nonresponders/Relapsers
TVR + PegIFN alfa-2a/RBV in Nonresponders or Relapsers
Boceprevir + PegIFN/RBV: Phase II Study in GT1 Nonresponders
Boceprevir + PegIFN/RBV in Null Responders
Silibinin ± PegIFN/RBV in PegIFN/RBV Nonresponders
Silibinin ± PegIFN/RBV in PegIFN/RBV Non responders