SWEET Trial Switch to Efavirenz + TDF-FTC SWEET: Design Study - PowerPoint PPT Presentation

Switch from Efavirenz + ZDV-3TC to Efavirenz + TDF-FTC SWEET Trial

Switch to Efavirenz + TDF-FTC SWEET: Design Study Design: SWEET Study • Background : Randomized, controlled, open label phase 3 trial evaluating a simplification strategy for patients suppressed on efavirenz- Switch arm based ART by switching from twice-daily zidovudine-lamivudine to once-daily tenofovir Efavirenz + TDF-FTC QD DF-emtricitabine in adults with HIV (n = 117) • Inclusion Criteria (n = 234) - Age ≥18 years - On EFV + ZDV-3TC for >6 months Maintain arm - No resistance to study drugs Efavirenz QD + ZDV-3TC BID - HIV RNA <400 copies/mL for ≥ 3 months and (n = 117) HIV RNA <50 copies/mL on 2 occasions • Treatment Arms - Efavirenz + TDF-FTC - Efavirenz + ZDV-3TC Source: Fisher M, et al. J Acquir Immune Defic Syndr. 2009;51:562-8.

Switch to Efavirenz + TDF-FTC SWEET: Result Week 48 Virologic Response (ITT Analysis, M=F) EVF + TDF-FTC (switch arm) EFV + ZDV-3TC (maintain arm) 100 88 HIV RNA <50 copies/mL (%) 85 80 60 40 20 103/117 95/117 0 Source: Fisher M, et al. J Acquir Immune Defic Syndr. 2009;51:562-8.

Switch to Efavirenz + TDF-FTC SWEET: Result Week 48: Patients with Change in Absolute Hemoglobin from Baseline EFV + TDF-FTC (switch arm) EFV + ZDV-3TC (maintain arm) 40 30 Patients (%) 22 20 9 10 2 2 0 > 1 g/dL increase > 1 g/dL decrease Change in Hemoglobin Source: Fisher M, et al. J Acquir Immune Defic Syndr. 2009;51:562-8.

Switch to Efavirenz + TDF-FTC SWEET: Result Week 24: Change in Limb Fat from Baseline EFV + TDF-FTC (switch arm) EFV + ZDV-3TC (maintain arm) 400 Mean Change from Baseline (g) 300 261 200 100 0 -100 -200 -189 -300 -400 Limb Fat Source: Fisher M, et al. J Acquir Immune Defic Syndr. 2009;51:562-8.

Switch to Efavirenz + TDF-FTC SWEET: Result Week 24: Change in Plasma Lipids from Baseline EFV + TDF-FTC (switch arm) EFV + ZDV-3TC (maintain arm) 0.4 Change in Median Value (mmol/L) 0.2 0.05 0.0 -0.02 -0.03 -0.06 -0.09 -0.10 -0.2 -0.24 -0.4 -0.39 -0.6 Total Cholesterol HDL LDL Triglycerides Source: Fisher M, et al. J Acquir Immune Defic Syndr. 2009;51:562-8.

Switch to Efavirenz + TDF-FTC SWEET: Result Week 24: Change in Plasma Lipids, by Baseline Cholesterol (Treated Analysis) EFV + TDF-FTC (switch arm) EFV + ZDV-3TC (maintain arm) Median Change from Baseline 0.5 0.04 0.0 (mmol/L) -0.11 -0.30 -0.35 -0.5 -0.44 -1.0 -1.04 -1.5 ≥6.3 mmol/L < 5.2 mmol/L 5.2-6.3 mmol/L (desirable) (borderline) (high) Baseline Cholesterol Category (NCEP) Source: Fisher M, et al. J Acquir Immune Defic Syndr. 2009;51:562-8.

Switch to Efavirenz + TDF-FTC SWEET: Result Week 48: Change in Plasma Lipids from Baseline EFV + TDF-FTC (switch arm) EFV + ZDV-3TC (maintain arm) Change in Median Value (mmol/L) 0.5 0.3 0.1 0.04 0.04 0.01 -0.1 -0.06 -0.08 -0.14 -0.17 -0.22 -0.3 -0.5 Total Cholesterol HDL LDL Triglycerides Source: Fisher M, et al. J Acquir Immune Defic Syndr. 2009;51(5):562-8.

Switch to Efavirenz + TDF-FTC SWEET: Result Interpretation : “Switching from zidovudine/lamivudine to tenofovir disoproxil fumarate/emtricitabine in persons on efavirenz therapy maintains virological control, establishes a once-daily regimen, results in improvements in hemoglobin and key lipid parameters, and preserves and restores limb fat relative to continuation of zidovudine/lamivudine.” Source: Fisher M, et al. J Acquir Immune Defic Syndr. 2009;51(5):562-8.

Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $800,000 with 0% financed with non-governmental sources. This project is led by the University of Washington’s Infectious Diseases Education and Assessment (IDEA) Program. The content in this presentation are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government.