PPT-Switch from Efavirenz + ZDV-3TC to Efavirenz + TDF-FTC

SWEET Trial Switch to Efavirenz TDFFTC SWEET Study Design Source Fisher M et al J Acquir Immune Defic Syndr 2009515628 Background Randomized controlled openlabel phase 3 trial evaluating a simplification strategy for patients suppressed . r. + 3TC. OLE . Study. LPV/. r. bid + 3TC or FTC . qd. + NRTI. N =. 127. N =. 123. LPV/. r. bid + 3TC/FTC . qd. Design. Randomisation*. 1: 1. Open-label. Objective. Primary Endpoint :. proportion without treatment failure at W48 . STRIIVING . Study. Design. Endpoints. Primary: proportion of patients maintaining HIV RNA < 50 c/mL at W48 . (ITT-E, snapshot) ; non-inferiority if lower margin of the two-sided 95% CI . for the difference = - 10%, 90% power . STRATEGY-PI . Study. STRATEGY-NNRTI . Study. Design. Endpoints. Primary: proportion of patients maintaining HIV RNA < 50 c/mL at W48 (mITT, snapshot) ; non-inferiority if lower margin of a two-sided 95% CI for the difference = -12%, 85% power. If non-inferiority and lower margin > 0, assessment for superiority. tenofovir. . disoproxil. . fumarate. (TDF) . use on HIV-exposed newborn bone mineral content. . Siberry GK, Tierney C, . Stranix-Chibanda L. , Marr C, Shepherd JA, Browning R, . Kalkwarf. H, George K and Fowler MG for the IMPAACT P1084s Study . 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. . Doravirine. /Lamivudine/TDF is Non-Inferior to . Efavirenz. /. Emtricitabine. /TDF in Treatment-Naïve Adults With HIV-1 Infection: Week 48 Results of the Phase 3 DRIVE-AHEAD Study. Kathleen E Squires. 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. . Endpoints. Primary: proportion of patients with HIV RNA ≥ 50 c/mL at W48 (ITT-E, snapshot) ; non-inferiority if upper margin of the two-sided 95% CI for the difference = 4%, 97.3% power . Secondary: proportion of patients with HIV RNA < 50 c/mL at W48 (ITT-E, snapshot) ; non-inferiority if lower margin of the two-sided 95% CI for the difference = - 8%. Study GS-366-1216. Switch from TDF to TAF, each with RPV and FTC. Study GS-366-1216: Design. Source: . Orkin. C et al. Lancet HIV. 2017;4:e195-e204.. *. NOTE. :. of 632 participants randomized, 2 were never treated (630 individuals treated). 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. ARV . strategies. DOR > DRV/r 1st line. (DRIVE-FORWARD W96). DTG. monotherapy. Switch PI/r-DTG (NEAT22). Switch RPV+DTG . (SWORD). Test and . Treat. D/C/F/TAF . (DIAMOND). −10% noninferiority margin for individual studies.. Dr. Kay Mahomed. Netcare. Garden City Clinic. Mayfair West. 083 294 7007. 011 495 5243. overall_1_132245246515670924 columns_1_132245246515670924 . Goals of . Treatment. ART is the cornerstone of HIV . 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 .