PPT-Atazanavir + [Cobicistat or Ritonavir] + TDF-FTC (Phase 2)

Study 105 Atazanavir Cobicistat or Ritonavir TDFFTC Phase 2 Study 105 Study Design Source Elion R et al AIDS 20112518816 Background Randomized partially placebocontrolled doubleblind phase 2 trial to compare the safety and efficacy of cobicistat and ritonavir as pharmacokinetic enhancers administered with atazanavir and fixeddose tenofovir DFemtricitabine in treatmentnaïve adults with HIV infection. 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. . 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. . . 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 . in pregnancy: . . preterm delivery rates, . infant outcomes and . virological efficacy.. Dr Melissa Perry. Guy’s & St Thomas’ NHS Foundation Trust. London. United Kingdom. Low rates of mother-to-child transmission of HIV . TARV. JHÓSEP ANDRÉS BLANCO MEJÍA. Interno Junior Farmacología Clínica. Universidad de La Sabana. CONTENIDO. Presentación de caso clínico. Consideraciones . farmacoterapéuticas. Recomendaciones. 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. GS-US-216-0114. . Gallant JE. JID 2013;208:32-9. GS-US-216-0114. Design. Objective. Non inferiority of COBI compared with RTV at W48: % HIV RNA < 50 c/mL . by intention to treat, snapshot analysis (lower limit for the 95% CI for the difference = -12%, 95% power). Selected Adverse Eventstransporters of creatinine This increases serum creatinine and reduces estimated glomerular filtration rate with no change in glomerular functionSpecial Instructionsis not inter G-143Last updated December 29 2020 last reviewed December 29 2020Animal StudiesCarcinogenicityNo increases in tumor incidence were seen in male and female mice at cobicistat COBI exposures that were 7 Study 1249. Elvitegravir-Cobicistat-TAF-FTC in HIV/HBV Coinfection . Study 1249: . Design. Source: Gallant J, et al. . J. . Acquir. Immune . Defic. . Syndr. . 2016;73:294-8.. Baseline ART. (n = 72). 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. 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.. Study 112. Elvitegravir-Cobicistat-TAF-FTC in Renal Impairment. Study 112: . Design. Source: . Pozniak. A, et al. J . Acquir. Immune . Defic. . Syndr. . 2016;71:530-7.. Baseline ART*. (n = 242). Study Design: Study 112.