PPT-Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir

Prepared by Sophie Woolston MD and David H Spach MD Last Updated November 18 2014 3D Background and Dosing 3D Paritaprevir Ritonavir Ombitasvir Dasabuvir 3D Paritaprevir. Paritaprevir. -. Ritonavir (. Technivie. ). Prepared by: . David H. Spach, MD. Last . Updated: . July 27, 2015. Background and Dosing. Ombitasvir-Paritaprevir. -. Ritonavir (. Technivie. ) . Ombitasvir-Paritaprevir. -Ritonavir. -Ombitasvir . + Dasabuvir) . + RBV in . GT1. SAPPHIRE-II. Phase . 3. Treatment. . Experienced. Zeuzem. S, . et al. N . Engl. J Med. . 2014;370:1604-14.. Source: . Zeuzem. S, et al. N . OBV/PTV/r + . DSV . + RBV. OBV/PTV/r + . DSV . + RBV. Randomisation*. 1 : . 1. Open-label. 18-70 years. HCV genotype 1. HCV RNA ≥ 10,000 IU/ml. Naïve or pre-treated with PEG-IFN + RBV. HIV infection, on ATV/. OBV/PTV/r . + . DSV . + RBV. OBV/PTV/r + . DSV . + RBV. Randomisation**. 1 : 1. Open-label. 18-70 years. HCV genotype 1. Naïve or pre-treated. Cirrhosis*. Child-Pugh A < 7. HCV RNA ≥ 10,000 IU/ml. SAPPHIRE-I. Phase 3. . Treatment. . Naïve. Feld JJ, et al. N . Engl. J Med. 2014;370:1594-1603.. Source: Feld JJ, et al. N . Engl. J Med. 2014;370:1594-1603.. 3D . (Paritaprevir-Ritonavir-. Ombitasvir + Dasabuvir) + Ribavirin in GT1. Co-formulated . ombitasvir. (OBV)/. paritaprevir. (PTV)/. rironavir. (r) :. 25/150/100 mg QD = 2 tablets. Dasabuvir. (DSV) : 250 mg bid. Objective. SVR. 12. (HCV RNA < 25 IU/ml). TURQUOISE-III . OBV/PTV/r . + . DSV . + RBV. OBV/PTV/r + . DSV . + RBV. Randomisation**. 1 : 1. Open-label. 18-70 years. HCV genotype 1. Naïve or pre-treated. Cirrhosis*. Child-Pugh A < 7. HCV RNA ≥ 10,000 IU/ml. . and Dasabuvir +/- . RBV in . GT1b. PEARL-II. Phase . 3. Treatment. . Experienced. Andreone. P, . et al. . Gastroenterology. 2014;147:359-65.. Source: . Andreone. P, et al. Gastroenterology. 2014;147:359-65.. Paritaprevir. -. Ritonavir. . and . Dasabuvir. +/- RBV in GT1. PEARL-III and PEARL-IV. Phase 3. . Treatment. . Naïve. Ferenci. P, et al. N . Engl. J Med. 2014;370:1983-92.. Source: . Ferenci. . -. Ritonavir . and Dasabuvir . + RBV in . GT1. SAPPHIRE-II. Phase . 3. Treatment. . Experienced. Zeuzem. S, . et al. N . Engl. J Med. . 2014;370:1604-14.. Source: . Zeuzem. S, et al. N . Engl. . and Dasabuvir + RBV in GT1. SAPPHIRE-I. Phase 3. . Treatment. . Naïve. Feld JJ, et al. N . Engl. J Med. 2014;370:1594-1603.. Source: Feld JJ, et al. N . Engl. J Med. 2014;370:1594-1603.. Ombitasvir-Paritaprevir-Ritonavir . Feld JJ. NEJM . 2014;370:1594-1603. SAPPHIRE-I . Study. : . o. mbitasvir/paritaprevir/ritonavir. . + . d. asabuvir. . + . ribavirin. . for genotype 1. Treatment regimens. Co-formulated . ombitasvir. DSV . placebo. Randomisation*. Partial blind. 18-70 years. Chronic HCV infection. Genotype 1 . Treatment-naïve. HCV RNA > 10,000 IU/ml. No cirrhosis. No HBV or HIV co-infection. * Randomisation 1:2 if genotype 1a (PEARL-IV) ; . Ombitasvir + . Dasabuvir) +/- . RBV in . GT1b. PEARL-II. Phase . 3. Treatment. . Experienced. Andreone. P, . et al. . Gastroenterology. 2014;147:359-65.. Source: . Andreone. P, et al. Gastroenterology. 2014;147:359-65..