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Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in GT1 SAPPHIRE-I

Phase 3. Treatment Naïve. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in GT1 SAPPHIRE-I. Feld JJ, et al. N Engl J Med. 2014;370:1594-1603. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + Ribavirin in GT1 SAPPHIRE-I Study : Design.

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Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + RBV in GT1 SAPPHIRE-I

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  1. Phase 3 TreatmentNaïve Ombitasvir-Paritaprevir-Ritonavirand Dasabuvir + RBV in GT1SAPPHIRE-I Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.

  2. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + Ribavirin in GT1SAPPHIRE-I Study: Design Source: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.

  3. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + Ribavirin in GT1SAPPHIRE-I Study: Study Regimens 0 12 24 36 Week Double blind Ombitasvir-Paritaprevir-RTV + Dasabuvir + Ribavirin Group AN = 473 SVR12 Open label (data pending) Placebo Ombitasvir-Paritaprevir-RTV + Dasabuvir+ Ribavirin Group BN = 158 SVR12 RTV =Ritonavir Drug DosingOmbitasvir-Paritaprevir-Ritonavir (25/150/100 mg once daily)+ Dasabuvir: 250 mg twice dailyRibavirin (RBV): weight-based and divided bid (1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg) Source: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.

  4. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + Ribavirin in GT1SAPPHIRE-I Study: Baseline Characteristics Source: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.

  5. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + Ribavirin in GT1SAPPHIRE-I Study: Results SAPPHIRE-I: SVR12 in Group A, by Genotype 1 Subtype 455/473 307/322 148/151 Source: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.

  6. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir + Ribavirin in GT1SAPPHIRE-I Study: Results SAPPHIRE-I: SVR12 in Group A, Fibrosis Score 352/363 66/70 37/40 Source: Feld JJ, et al. N Engl J Med. 2014;370:1594-1603.

  7. NUTRINO: SVR 12 by Liver Disease Ombitasvir-Paritaprevir-Ritonavirand 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.

  8. Ombitasvir-Paritaprevir-Ritonavir and 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.

  9. 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.

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