TOTEM Switching the NRTI Backbone to Tenofovir DF-Emtricitabine - PowerPoint PPT Presentation

Switching the NRTI Backbone to Tenofovir DF-Emtricitabine TOTEM

Switching the NRTI Backbone to Tenofovir DF-Emtricitabine TOTEM: Study Design Study Design: TOTEM • Background : 12-week, multicenter, open-label, randomized trial of substituting the NRTI backbone with TDF-FTC for virologically TDF-FTC + Continue suppressed patients with elevated lipids 3 rd Agent • Inclusion Criteria (n = 91) (n = 46) - Adults with HIV infection - HIV RNA <400 copies/mL for >6 months - Elevated fasting LDL or triglycerides Continue Current ART - Receiving 2 NRTI’s (not TDF-FTC) (n = 45) plus an NNRTI or boosted PI • Treatment Arms (Randomized 1:1) - Replace NRTI backbone with TDF-FTC - Continue current regimen Source: Valantin MA, et al. J Antimicrob Chemother. 2010;65:556-61.

Switching the NRTI Backbone to Tenofovir DF-Emtricitabine TOTEM: Results Week 12: Change in Plasma Lipids from Baseline TDF-FTC + 3rd Agent Continue Current ART 0.50 Change in Mean Value (mmol/L) P < 0.001 P = 0.031 P = 0.009 P = 0.034 0.25 0.00 0.0 -0.1 -0.1 -0.1 -0.1 -0.25 -0.50 -0.4 -0.5 -0.75 -0.8 -1.00 -1.25 Total Cholesterol LDL HDL Triglycerides Source: Valantin MA, et al. J Antimicrob Chemother. 2010;65:556-61.

Switching the NRTI Backbone to Tenofovir DF-Emtricitabine TOTEM: Results Conclusions : “Switching to tenofovir disoproxil fumarate + emtricitabine in dyslipidaemic HIV-infected patients improves triglycerides and LDL- cholesterol.” Source: Valantin MA, et al. J Antimicrob Chemother. 2010;65:556-61.

Acknowledgment The National HIV Curriculum is an AIDS Education and Training Center (AETC) Program resource funded by the United States Health Resources and Services Administration. The project is led by the University of Washington and the AETC National Coordinating Resource Center. The content in this slide set does not represent the official views of the U.S. Department of Health and Human Services, Health Resources & Services Administration.