Boceprevir in Treatment Naive SPRINT-2

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Boceprevir in Treatment Naive SPRINT-2 Phase 3 Treatment Naïve Boceprevir in Treatment Naive SPRINT-2 Poordad F, et al. N Engl J Med. 2011;364:1195-206.

Boceprevir for Treatment-Naïve HCV Genotype 1 SPRINT-2 Trial: Study Design SPRINT-2: Study Features N = 1097 HCV-monoinfected patients (159 black) Randomized, double-blind, placebo-controlled, phase 3 study All with chronic HCV and genotype 1 and treatment naïve Setting: multiple sites in United States and Europe HCV RNA > 10,000 IU/ml Mean age 50; 14.5% black Randomized to 3 arms (1:1:1) Drug Dosing Boceprevir = 800 mg three times daily Peginterferon alfa-2b = 1.5 µg/kg once weekly Ribavirin = 600-1400 mg/day (based on weight) Source: Poordad F, et al. N Engl J Med. 2011;364:1195-206.

Boceprevir for Treatment-Naïve HCV Genotype 1 SPRINT-2 Trial: Treatment Regimens Week 4 12 24 28 48 Lead In ✔ HCV RNA PR48 Placebo Peginterferon + Ribavirin Undetectable HCV RNA at week 8-24 Stop Therapy B24 PR28-48 Boceprevir Peginterferon + Ribavirin Detectable HCV RNA at week 8-24 Peginterferon + Ribavirin B44 PR48 Boceprevir Peginterferon + Ribavirin Source: Poordad F, et al. N Engl J Med. 2011;364:1195-206.

SPRINT-2: SVR 24 by Regimen Boceprevir for Treatment-Naïve HCV Genotype 1 SPRINT-2 Trial: Treatment Regimens SPRINT-2: SVR 24 by Regimen 137/163 233/368 242/366 B = Boceprevir; PR = Peginterferon + Ribavirin Source: Poordad F, et al. N Engl J Med. 2011;364:1195-206.

Boceprevir for Treatment-Naïve HCV Genotype 1 SPRINT-2 Trial: Results SPRINT-2: SVR 24 by Regimen 137/163 233/368 242/366 12/52 22/52 29/55 125/311 211/316 213/311 SVR = Sustained Virologic Response; B = Boceprevir; PR = Peginterferon + Ribavirin Source: Poordad F, et al. N Engl J Med. 2011;364:1195-206.

SPRINT-2: SVR 24 by Degree of Fibrosis Boceprevir for Treatment-Naïve HCV Genotype 1 SPRINT-2 Trial: SVR by Liver Histology SPRINT-2: SVR 24 by Degree of Fibrosis 123/138 213/319 211/313 9/24 14/34 22/42 PR48 = Peginteron/Ribavirin x 48 weeks PR/T12 = Peginteron/Ribavirin + Telaprevir x 12 weeks SVR = Sustained Virologic Response; B = Boceprevir; PR = Peginterferon + Ribavirin Source: Poordad F, et al. N Engl J Med. 2011;364:1195-206.

Boceprevir for Treatment-Naïve HCV Genotype 1 SPRINT-2 Trial: Conclusions Conclusions: “The addition of boceprevir to standard therapy with peginterferon–ribavirin, as compared with standard therapy alone, significantly increased the rates of sustained virologic response in previously untreated adults with chronic HCV genotype 1 infection. The rates were similar with 24 weeks and 44 weeks of boceprevir.” Source: Poordad F, et al. N Engl J Med. 2011;364:1195-206.