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Phase 3. Treatment Naïve. Ombitasvir- Paritaprevir - Ritonavir and Dasabuvir +/- RBV in GT1 PEARL-III and PEARL-IV. Ferenci P, et al. N Engl J Med. 2014;370:1983-92. Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1 PEARL -III and PEARL-IV: Study Design.
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Phase 3 TreatmentNaïve Ombitasvir-Paritaprevir-Ritonavirand Dasabuvir +/- RBV in GT1PEARL-III and PEARL-IV Ferenci P, et al. N Engl J Med. 2014;370:1983-92.
Ombitasvir-Paritaprevir-Ritonavirand Dasabuvir +/- RBV in GT1PEARL-III and PEARL-IV: Study Design Source: FerenciP, et al. N Engl J Med. 2014;370:1983-92.
Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1PEARL-III and PEARL-IV: Study Regimens 0 12 24 Week HCV Genotype 1a SVR12 n = 100 3D + Ribavirin SVR12 n = 205 3D + Placebo HCV Genotype 1b SVR12 n = 210 3D+ Ribavirin SVR12 n = 209 3D + Placebo 3D =Ombitasvir-Paritaprevir-Ritonavir + Dasabuvir Drug Dosing3D = Ombitasvir-Paritaprevir-Ritonavir (25/150/100 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: Ferenci P, et al. N Engl J Med. 2014;370:1983-92.
Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1PEARL-III and PEARL-IV: Baseline Characteristics Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92.
Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1PEARL-III and PEARL-IV: Results 97/100 185/205 209/210 207/209 Genotype 1a Genotype 1b 3D = Ombitasvir-Paritaprevir-Ritonavirand DasabuvirRBV = Ribavirin Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92.
Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1PEARL-III and PEARL-IV: Adverse Events Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92.
Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1PEARL-III and PEARL-IV: Adverse Events Source: Ferenci P, et al. N Engl J Med. 2014;370:1983-92.
Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir +/- RBV in GT1PEARL-III and PEARL-IV: Conclusions Note: ABT-450/r = Paritaprevir-Ritonavir Source: FerenciP, et al. N Engl J Med. 2014;370:1983-92.
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.