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Switching NRTI Backbone to Tenofovir Plus Emtricitabine (Truvada, TVD) Promptly Improves Triglycerides and LDL-cholesterol Levels in Dyslipidemic HIV-1 Infected Patients: The TOTEM Randomised Trial
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Reported by Jules Levin
IAC Aug 3-8, 2008 Mexico City
MA Valantin,1 P de Truchis,2 R Bittar,1 D Bollens,3 L Slama,4 B Lebouche,5
P Petour,6 C Aubron-Olivier,6 D Costagliola,7 C Katlama,1 and the TOTEM Study Group. 1Pitie-Salpetriere Hospital, Paris, France; 2Raymond-Poincare Hospital, Garches, France; 3Saint-Antoine Hospital, Paris, France; 4Tenon Hospital, Paris, France; 5H™tel-Dieu CHU, Lyon, France; 6Gilead Sciences, France; 7Pierre et Marie Curie University, INSERM U720, Paris, France
AUTHOR CONCLUSIONS
Switching the NRTI backbone to TVD in dyslipidemic HIV-1 infected controlled patients, significantly improved TG and LDL-C levels over 12 weeks of follow-up.
This effect was observed from as early as 4 weeks post-switch.
Of note, the proportion of patients with LDL-C >4.1 mmol/L decreased from 48% at baseline to 26% at Week 12 in the TVD group vs no change in MBR group (49%)
INTRODUCTION & BACKGROUND
Dyslipidemia is a recognised toxicity associated with Combined Antiretroviral
Therapy (cART). Therefore, cardiovascular risk management is a primary concern for patients who will be treated for decades.
Current guidelines recommend changes in lifestyle for dyslipidemic patients
(smoking cessation, diet, physical activity) and modifying their antiretroviral regimen before using lipid-lowering treatments
Recent studies in HIV-1 infected controlled patients have shown low impact of tenofovir disoproxil fumarate (TDF) on lipid profiles
The TOTEM* trial was designed to evaluate whether switching the nucleoside
reverse transcriptase inhibitor (NRTI) backbone of a cART regimen to TDF/FTC
(Truvada, TVD) in dyslipidemic patients could improve their lipid parameters
*Trial On Tenofovir/Emtricitabine on lipid Metabolism
OBJECTIVES
Primary Objective:
To evaluate the impact of switching the NRTI backbone of a cART regimen to TVD on serum triglycerides (TG) and LDL cholesterol (LDL-C) in dyslipidemic HIV-infected controlled patients
Main Secondary Objectives:
To evaluate:
--Immunological changes
--Safety of the cART regimen
--Maintenance of virological control
METHODS
Statistical Analysis:
ITT population included all randomised patients who received at least one dose of study medication
Last Observation Carried Forward method was used for missing primary endpoint values at Week 12
Wilcoxon rank sum test used for comparison between groups
No adjustment of p-values for multiple comparisons (all tests were bilateral at the level 0.05)
Statistical analysis: SAS version 9.1
RESULTS
Serious Adverse Events:
TVD group:
-- 1 renal impairment. Decrease CrCL from 74ml/mn at screening to 63 ml/mn at W12. After 6 months, spontaneous and complete resolution without any treatment modification: 76 ml/mn.
MBR group: (none reported to be related to study drug)
--1 intestinal obstruction
--1 sciatica
--1 pneumopathy
No virological failure has been reported
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