PPT-3D (Paritaprevir-Ritonavir-Ombitasvir + Dasabuvir) + RBV in

SAPPHIREI Phase 3 Treatment Naïve Feld JJ et al N Engl J Med 201437015941603 Source Feld JJ et al N Engl J Med 201437015941603 3D ParitaprevirRitonavir Ombitasvir Dasabuvir Ribavirin in GT1. 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 . Paritaprevir. -. Ritonavir (. Technivie. ). Prepared by: . David H. Spach, MD. Last . Updated: . July 27, 2015. Background and Dosing. Ombitasvir-Paritaprevir. -. Ritonavir (. Technivie. ) . Ombitasvir-Paritaprevir. 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. HCV RNA ≥ 10,000 IU/ml. Naïve or pre-treated with PEG-IFN + RBV. HIV infection, on ATV/. 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. Randomisation. Open-label. W8. * Liver biopsy or . Fibroscan. . > 12.5 . kPa. or . Fibrotest. . . >. 0.75 + APRI . > 2. Objective. Primary endpoint: SVR. 12 . (HCV RNA < 15 IU/mL), full analysis set . Updated: . July . 6. , . 2015. Treatment of Hepatitis C in Patients with Renal Insufficiency. Robert G. Gish MD. Professor Consultant, Stanford University Medical Center. Senior Medical Director, St Josephs Hospital and Medical Center, Liver Program, Phoenix, Arizona. ≥ 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). 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. C-WORTHY/D. GZR + EBR + RBV. GZR + EBR + RBV. N = 21. N = 20. Design. W12. W18. SVR. 12. >. 18 years. HCV genotype . 3. HCV RNA ≥ 10 000 IU/mL. Treatment naïve . No cirrhosis. No HBV or HIV co-infection. AI424-043 . Study. Atazanavir vs. Lopinavir-ritonavir in Previous PI Failure . AI424-043. : Study Design. Source: . Cohen C, et al. . Curr Med Res Opin. . 2005;21:. 1683-92.. Atazanavir 400 mg once daily + 2 NRTIs. 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,. Study 105. Atazanavir + [Cobicistat or Ritonavir] + TDF-FTC (Phase 2). Study 105: Study Design. Source: . Elion. R, et al. AIDS. 2011;25:1881-6. . Background. : Randomized, partially placebo-controlled, double-blind phase 2 trial to compare the safety and efficacy of cobicistat and ritonavir as pharmacokinetic enhancers administered with atazanavir and fixed-dose tenofovir DF-emtricitabine in treatment-naïve adults with HIV infection.