PPT-Ombitasvir-

Paritaprevir Ritonavir Technivie Prepared by David H Spach MD Last Updated July 27 2015 Background and Dosing OmbitasvirParitaprevir Ritonavir Technivie OmbitasvirParitaprevir. PTV150/r + OBV + . DSV . + RBV. PTV150/r + . DSV . + RBV. 2-steps. Randomisation*. Open-label. W12. W8. W24. 18-70 years. Chronic HCV infection . Genotype 1. HCV RNA ≥ 50,000 IU/ml. Treatment-naïve . TURQUOISE-II. Phase 3. . Treatment. Naïve and Treatment . Experienced. Poordad. F, et al. N . Engl. J Med. 2014;370:1973-82.. Compensated Cirrhosis. Source: . Poordad. F, et al. N . Engl. J Med. 2014;370:1973-82.. Out With the Old, In With the New. Current Standard of Care. NEUTRINO and FISSION. . SOF + RBV ± pegIFN for Treatment-naive Patients. NEUTRINO and FISSION. . SOF + RBV ± pegIFN for Treatment-naive Patients. 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 . 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. 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. 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/. 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. . 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. . + Dasabuvir) + RBV in GT1 . TURQUOISE-I. Phase . 2 . Treatment. Naïve and Treatment . Experienced. Wyles. D, et al. 65. th. AASLD. 2014: Abstract . 1939. . . HIV Coinfection. Source: . Wyles. D, et al. 65. 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) ; . ≥ 18 years. Chronic HCV infection. Genotype 1. Treatment-. naïve or . PEG-IFN RBV-. experienced . HCV RNA > 1,000 IU/ml. Chronic kidney disease with. eGFR. (MDRD) < 30 ml/min/1.73m. 2. (dialysis permitted). 20. th. International AIDS Conference. • . Melbourne, Australia . • . 21 July . 2014. Mark S. Sulkowski. , Joseph J. Eron, David Wyles, Roger Trinh, Jay Lalezari, Jihad Slim, Joseph Gathe, Peter J. Ruane, Chia Wang, Richard Elion,. 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..