PPT-Switch to EVG/c/FTC/TDF

STRATEGYPI Study STRATEGYNNRTI Study Design Endpoints Primary proportion of patients maintaining HIV RNA lt 50 cmL at W48 mITT snapshot noninferiority if lower margin of a twosided 95 CI for the difference 12 85 power If noninferiority and lower margin gt 0 assessment for superiority. Fostemsavir. , . prodrug. of . temsavir. . (. attachment . inhibitor. ). AI438011 . Study. TAF (TFV . prodrug. ). Study . 292-0102. Study . 299-0102. Doravirine (non nucleoside reverse transcriptase inhibitor). FLAMINGO. GS-236-0103. ACTG A5257. WAVES . ARIA . Squires K. Lancet HIV 2016; 3(9):e410-e420. Design. Objective. Non inferiority of EVG/C/FTC/TDF at W48: % HIV RNA < 50 c/. mL. by intention. to treat, snapshot analysis (lower margin of the 2-sided 95% CI for the difference = -12%). David Geffen School of Medicine. at University of California Los Angeles. Antiretrovirals. in the Management of HIV Infection: Case-Based, Panel Discussion. From ES . Daar. , MD, at Los Angeles, Ca: April 22, 2013, IAS-USA. . Massachusetts General Hospital. Boston, Massachusetts. State-of-the-ART in Antiretroviral Therapy: Optimal Initial Regimens in 2016. Washington, DC: August 23, 2016. Thanks to Alice Pau, Roger Bedimo and Marilyn Shi for assistance with slides. Estudio GS-US-311-1089 . Estudio GS-US-366-1216 . Estudio GS-US-366-1160 . . Diseño. Endpoints. Primario: proporción de pacientes . con C. V . < 50 c/mL a S48 (ITT, . snapshot. ) ; no inferioridad si el margen inferior de IC95% de dos colas para la diferencia = - 8%, poder 85%. Progressive rises in weight and clinical obesity for TAF/FTC+DTG and TDF/FTC+DTG versus TDF/FTC/EFV: ADVANCE and NAMSAL trials Andrew Hill, Francois Venter, Eric Delaporte , Simiso Sokhela, Charles amoe@mednet.ucla.edu. UCLA CARE clinic/NEVHC Van Nuys . 21 June 2014. I do not have any financial arrangements or affiliations with commercial sponsors which have direct interest in the subject matter. GEMINI 1 and GEMINI 2: Week 48 Data. DTG + 3TC . versus . DTG + TDF-FTC as Initial ART. GEMINI 1 and 2: Background. Source: Cahn P, et al. Lancet. 2019;393:143-55.. Study Design: GEMINI 1 and 2. Background. ADVANCE. . Design. Primary endpoint. Proportion of patients with HIV RNA < 50 c/mL at W48, ITT-E snapshot analysis ; non-inferiority of TFA/FTC if lower margin CI for . the difference = - 10%, 80% power. FTC. Study 311-1089. Switching from TDF/FTC to TAF/. FTC. Study 311: Design. Source. : Gallant JE, et al. Lancet HIV. 2016;3:e158-65.. Switch to TAF/FTC*. . (n = 333). Continue TDF/FTC. (n = 330). *Patients on a pharmacokinetic booster (ritonavir) received tenofovir alafenamide-emtricitabine 10/200 mg. iPrEx. Trial . Substudy. TDF-FTC versus Placebo as HIV . PrEP. for Transgender Women. iPrEx. . Substudy. : Study Design. Source: Deutsch MB, et al. Lancet HIV. 2015;2:e512-9.. Background. : . Subgroup analysis of the . Andrew Hill, Francois Venter, Eric . Delaporte. , . Simiso. Sokhela, Charles . Kouanfack. , . Michelle Moorhouse. , Kaitlyn McCann, Bryony Simmons. , . Alexandra . Calmy. Disclosures. Speaker fees and honoraria from Gilead Sciences, AbbVie, Cipla, Johnson and Johnson, Sanofi, Pfizer, ViiV Healthcare, Mylan and Southern African HIV Clinicians Society. ROCKET-1 Trial. Switch from EFV + ABC-3TC to EFV-TDF-FTC. ROCKET-1: Design. Source: Moyle GJ, et al. . PLoS. One. 2015;10:e0116297.. Immediate switch arm. EFV-TDF-FTC. . (n = 79). Delayed switch arm . RADAR Trial. Raltegravir. + Darunavir/r versus TDF-FTC + Darunavir/r. RADAR: Study Design. Source: . Bedimo. RJ, et al. . PLoS. One. 2014;9:e106221.. Darunavir QD + Ritonavir QD + Raltegravir BID .