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Phase 3. Treatment Naïve. 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + RBV in GT1 SAPPHIRE-I. Feld JJ, et al. N Engl J Med. 2014;370:1594-1603. 3D (Paritaprevir-Ritonavir- Ombitasvir + Dasabuvir) + Ribavirin in GT1 SAPPHIRE-I Study : Design.
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Phase 3 TreatmentNaïve 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + RBV in GT1SAPPHIRE-I Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.
3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + Ribavirin in GT1SAPPHIRE-I Study: Design Source: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.
3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + Ribavirin in GT1SAPPHIRE-I Study: Study Regimens 0 12 24 36 Week Double blind 3D + Ribavirin Group AN = 473 SVR12 Open label (data pending) Placebo 3D + Ribavirin Group BN = 158 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: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.
3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + Ribavirin in GT1SAPPHIRE-I Study: Baseline Characteristics Source: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.
3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + Ribavirin in GT1SAPPHIRE-I Study: Results SAPPHIRE-I: SVR12 in Group A (3D + Ribavirin) 455/473 307/322 148/151 Source: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.
NUTRINO: SVR 12 by Liver Disease 3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + Ribavirin in GT1SAPPHIRE-I Study: Adverse Events During Double-Blind Phase Source: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.
3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + Ribavirin in GT1SAPPHIRE-I Study: Conclusions Note: ABT-450/r = Paritaprevir-Ritonavir Source: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.
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.