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T. Poynard , MD

Interim Results from HCV SPRINT-1 Phase 2 Study of Boceprevir Plus Peginterferon alfa-2b/ Ribavirin in Treatment-Naïve Subjects with Genotype-1 CHC. T. Poynard , MD. Luis Balart Thomas Boyer Robert Brown William Cassidy Raymond Chung Gary Davis Mitchell Davis Steven Flamm

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T. Poynard , MD

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  1. Interim Results from HCV SPRINT-1Phase 2 Study of Boceprevir Plus Peginterferonalfa-2b/Ribavirin in Treatment-Naïve Subjects with Genotype-1 CHC T. Poynard, MD

  2. Luis Balart Thomas Boyer Robert Brown William Cassidy Raymond Chung Gary Davis Mitchell Davis Steven Flamm Bradley Freilich Joseph Galati Greg Galler Reem Ghalib Alexandra Gibas Eliot Godofsky Jorge Herrera Ira Jacobson Shobha Joshi John King Paul Kwo Eric Lawitz William Lee James Levin Jonathan McCone Timothy Morgan Frederick Nunes Lisa Marie Nyberg Mary Pat Pauly Craig Peine Gary Poleynard Fred Poordad David Pound Natarajan Ravendhran Lorenzo Rossaro Raymond Rubin Michael Ryan Eugene Schiff Kenneth Sherman Mitchell Shiffman Coleman Smith Robert Strauss Mark Sulkowski John Vierling Ziad Younes HCV SPRINT-1 Investigators Canada US EU Frank Anderson Jenny Heathcote Paul Marotta Stephen Shafran Michael Adler Rafael Barcena Thomas Berg Marc Bourliere Jean-Pierre Bronowicki Giampiero Carosi Antonio Craxi Rafael Esteban-Mur Xavier Forns Christophe Hezode Michael Manns Patrick Marcellin Fredrik Nevens Claus Niederau Thierry Poynard Jurg Reichen Henk Reesink Mario Rizzetto Christian Trepo Stefan Zeuzem

  3. Aims of the Study • To evaluate the most effective treatment strategy in HCV-1 treatment naïve patients • Duration of therapy • 28 weeks vs. 48 weeks • Lead-in strategy with Peginterferon alfa-2b + ribavirin followed by boceprevir 800 mg TID vs. Triple therapy from Day 1 • Standard vs low dose ribavirin • 800-1400 mg/day vs 400-1000 mg/day • To evaluate the predictability of Week 4 and 12 HCV-RNA undetectability on SVR

  4. Study Design PEG-INTRON + REBETOL 800-1400 mg x 4 weeks PEG 1.5 µg/kg + REBETOL 800-1400 mg + boceprevir 800 mg TID for 24 weeks Follow-up x 44 weeks Lead-in Dosing Strategy PEG-INTRON + REBETOL 800-1400 mg x 4 weeks PEG 1.5 µg/kg + REBETOL 800-1400 mg + boceprevir 800 mg TID for 44 weeks Follow-up x 24 weeks PEG 1.5 µg/kg + REBETOL 800-1400 mg + boceprevir 800 mg TID for 28 weeks Follow-up x 44 weeks No Lead-in Dosing Strategy PEG 1.5 µg/kg + REBETOL 800-1400 mg + boceprevir 800 mg TID for 48 weeks Follow-up x 24 weeks Low dose REBETOL Dosing Strategy PEG 1.5 µg/kg + REBETOL 400-1000 mg + boceprevir 800 mg TID for 48 weeks Follow-up x 24 weeks PEG 1.5 µg/kg + REBETOL 800-1400 mg for 48 weeks Follow-up x 24 weeks Control

  5. SVR Data Available for Interim Analysis PEG-INTRON + REBETOL 800-1400 mg x 4 weeks PEG 1.5 µg/kg + REBETOL 800-1400 mg + boceprevir 800 mg TID for 24 weeks Follow-up x 44 weeks Lead-in Dosing Strategy PEG 1.5 µg/kg + REBETOL 800-1400 mg + boceprevir 800 mg TID for 28 weeks Follow-up x 44 weeks No Lead-in Dosing Strategy SVR 12

  6. Baseline Characteristics ‡ Boceprevir added to treatment regimen after 4 week lead-in of PEG-IFN α-2b + ribavirin.

  7. HCV-1 Patients with Undetectable HCV-RNA* at Weeks 4 and 12 of Boceprevir Therapy (ITT) P/R lead-in → P/R/boceprevir, N=103‡ P/R/boceprevir, N=107 P/R control, N=104 * Roche TaqMan 1.0 (LLD 15 IU/mL) ‡ Boceprevir added to treatment regimen after 4 week lead-in of PEG-IFN α-2b + ribavirin.

  8. Just Available Data SVR for 28/48 Weeks and Peg/riba Control

  9. Sustained Virologic Response*for 28/48 Weeks and P/R Control 28 Wks n=103 48 Wks n=103 28 Wks n=107 48 Wks n=103 48 Wks n=103 *SVR 12 or later timepoint ‡ Boceprevir added to treatment regimen after 4 week lead-in of PEG-IFN α-2b + ribavirin.

  10. Safety for 28 Weeks of Treatment

  11. Treatment Discontinuations x 28 Weeks * Lost to Follow Up, Subject Did Not Wish to Continue, Non-compliance with Protocol ‡ Boceprevir added to treatment regimen after 4 week lead-in of PEG-IFN α-2b + ribavirin.

  12. Most Common Adverse Events x 28 Weeks(≥15% in any Arm) ‡ Boceprevir added to treatment regimen after 4 week lead-in of PEG-IFN α-2b + ribavirin.

  13. Skin and Subcutaneous Disorders* x 28 Weeks P/R lead-in → P/R/boceprevir, N=103‡ P/R/boceprevir, N=107 P/R control, N=104 *Includes rash (all types), eczema, erythema, photosensitivity reaction, dermatitis, skin irritation and skin exfoliation. § Severe Erythema. Patient was in PEG-IFN α-2b + ribavirin lead in; never received boceprevir ‡ Boceprevir added to treatment regimen after 4 week lead-in of PEG-IFN α-2b + ribavirin.

  14. Hemoglobin: Worst WHO Grade Category Observed During Treatment x 28 Weeks† P/R lead-in → P/R/boceprevir, N=206‡ P/R/boceprevir, N=226 P/R control, N=104 † Epoetin-alfa use allowed; 48% in P/R lead-in, 45% in P/R/boceprevir, 25% in P/R control ‡ Boceprevir added to treatment regimen after 4 week lead-in of PEG-IFN α-2b + ribavirin.

  15. Summary of Interim Results Boceprevir with P/R X 28 and 48 weeks Greater SVR than P/R alone X 48 weeks in HCV-1 naïve patients.1-4 Safety Boceprevir containing regimens appear to be well-tolerated. Incidence of rash and pruritis comparable to Control. No boceprevir-defining toxicity responsible for treatment discontinuation. 16 1 Fried M, et al. N Engl J Med 2002;347:975-82. 2 Manns M, et al. Lancet 2001; 358: 958–65.3 Sulkowski M, et al. Abstract #LB 2, EASL 2008. 4 Jacobson I, et al. Hepatology 2007;46:982-990.

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