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Phase 3. Treatment Experienced. 3 D (Paritaprevir -Ritonavir -Ombitasvir + Dasabuvir) + RBV in GT1 SAPPHIRE-II. Zeuzem S, et al. N Engl J Med. 2014;370:1604-14. 3D (Paritaprevir-Ritonavir-Ombitasvir) + Dasabuvir + RBV in GT1 SAPPHIRE -II: Study Design.
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Phase 3 TreatmentExperienced 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + RBV in GT1SAPPHIRE-II Zeuzem S, et al. N Engl J Med. 2014;370:1604-14.
3D (Paritaprevir-Ritonavir-Ombitasvir) + Dasabuvir + RBV in GT1SAPPHIRE-II: Study Design Source: Zeuzem S, et al. N Engl J Med. 2014;370:1604-14.
3D (Paritaprevir-Ritonavir-Ombitasvir) + Dasabuvir + RBV in GT1SAPPHIRE-II: Regimens 0 12 24 36 Week Double blind 3D + Ribavirin Active N = 297 SVR12 Open label (data pending) Placebo 3D + Ribavirin PlaceboN = 97 SVR12 3D = Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir Drug Dosing3D = Paritaprevir-Ritonavir-Ombitasvir (150/100/25 mg once daily)+ Dasabuvir: 250 mg twice dailyRibavirin (RBV): weight-based and divided bid (1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kg) Source: Zeuzem S, et al. N Engl J Med. 2014;370:1604-14.
3D (Paritaprevir-Ritonavir-Ombitasvir) + Dasabuvir + RBV in GT1SAPPHIRE-II Study: Baseline Characteristics Source: Zeuzem S, et al. N Engl J Med. 2014;370:1604-14.
3D (Paritaprevir-Ritonavir-Ombitasvir) + Dasabuvir + RBV in GT1SAPPHIRE-II: Results SAPPHIRE-II: Results by Genotype 1 Subtype 286/297 166/173 119/123 Source: Zeuzem S, et al. N Engl J Med. 2014;370:1604-14.
3D (Paritaprevir-Ritonavir-Ombitasvir) + Dasabuvir + RBV in GT1SAPPHIRE-II: Results SAPPHIRE-II: Results by Prior Treatment Response 286/297 82/86 65/65 139/146 Source: Zeuzem S, et al. N Engl J Med. 2014;370:1604-14.
3D (Paritaprevir-Ritonavir-Ombitasvir) + Dasabuvir + RBV in GT1SAPPHIRE-II Study: Key Adverse Events Source: Zeuzem S, et al. N Engl J Med. 2014;370:1604-14.
3D (Paritaprevir-Ritonavir-Ombitasvir) + Dasabuvir + RBV in GT1SAPPHIRE-II: Conclusions Source: Zeuzem S, et al. N Engl J Med. 2014;370:1604-14.
This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.