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SPRINT-1 Study Design

PART 1. PART 2 a. SPRINT-1 Study Design. Week 28. Week 4. Week 48. Peg-IFN  2b 1.5 μ g/kg + RBV 800-1400 mg for 48 wks . 24 wks Follow-up. N=104. Control. 44 wks Follow-up. Peg-IFN  2b + RBV 800-1400 mg. Peg-IFN  2b 1.5 μ g/kg + RBV 800-1400mg +

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SPRINT-1 Study Design

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  1. PART 1 PART 2a SPRINT-1 Study Design Week 28 Week 4 Week 48 Peg-IFN2b 1.5 μg/kg + RBV 800-1400 mg for 48 wks 24 wks Follow-up N=104 Control 44 wks Follow-up Peg-IFN2b + RBV 800-1400 mg Peg-IFN2b 1.5 μg/kg + RBV 800-1400mg + Boceprevir 800 mg TID for 28 wks N=103 Lead-in Strategy Peg-IFN2b + RBV 800-1400 mg Peg-IFN2b 1.5 μg/kg + RBV 800-1400 mg + Boceprevir 800 mg TID for 44 wks 24 wks Follow-up N=103 Peg-IFN2b 1.5 μg/kg + RBV 800-1400 mg + Boceprevir 800 mg TID for 28 wks 44 wks Follow-up N=107 No Lead-in Strategy Peg-IFN2b 1.5 μg/kg + RBV 800-1400 mg + Boceprevir 800 mg TID for 48 wks 24 wks Follow-up N=103 Peg-IFN2b 1.5 μg/kg + RBV 800-1400 mg + Boceprevir 800 mg TID for 48 wks 24 wks Follow-up N=16 Low Dose RBV Strategy Peg-IFN2b 1.5 μg/kg + RBV 400-1000 mg + Boceprevir 800 mg TID for 48 wks 24 wks Follow-up N=59 aPart two consisted of 75 patients at 10 US sites, 1:4 randomization.

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