SPRINT-1 Study Design

1
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
N104
Control
Peg-IFN?2b RBV 800-1400 mg
44 wks Follow-up
Peg-IFN?2b 1.5 µg/kg RBV 800-1400mg
Boceprevir 800 mg TID for 28 wks
N103
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
N103
Peg-IFN?2b 1.5 µg/kg RBV 800-1400 mg
Boceprevir 800 mg TID for 28 wks
44 wks Follow-up
N107
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
N103
Peg-IFN?2b 1.5 µg/kg RBV 800-1400 mg
Boceprevir 800 mg TID for 48 wks
24 wks Follow-up
N16
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
N59
aPart two consisted of 75 patients at 10 US
sites, 14 randomization.