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Title:
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Randomized, crossover, double-blind, placebo-controlled trial to assess the lipid lowering effect of co-formulated TDF/FTC
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Author:
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Santos, José R.; Saumoy, M.; Curran, Adrian; Bravo, Isabel; Navarro, Jordi; Estany, Carla; Podzamczer Palter, Daniel; Ribera, Esteban; Negredo, Eugenia; Clotet, Bonaventura; Paredes, Roger
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Other authors:
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Universitat de Vic. Càtedra de la Sida i Malalties Relacionades |
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Notes:
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Abstract
INTRODUCTION:
Previous studies have described improvements on lipid parameters when switching from other antiretroviral drugs to tenofovir (TDF) and impairments in lipid profile when discontinuing TDF. [1-3] It is unknown, however, if TDF has an intrinsic lipid-lowering effect or such findings are due to the addition or removal of other offending agents or other reasons.
MATERIALS AND METHODS:
RESULTS:
46 subjects with a median age of 43 (40-48) years were enrolled in the study: 70% were male, 56% received DRV/r and 44% LPV/r. One subject withdrew the study voluntarily at week 4 and another one interrupted due to diarrhoea at week 24. Treatment with TDF/FTC decreased total, LDL and HDL-cholesterol from 235.9 to 204.9 (p<0.001), 154.7 to 127.6 (p<0.001) and 50.3 to 44.5 mg/dL (p<0.001), respectively. In comparison, total, LDL and HDL-cholesterol levels remained stable during placebo exposure. Week 12 total cholesterol (p<0.001), LDL-cholesterol (p<0.001) and HDL-cholesterol (p=0.011) levels were significantly lower in TDF/FTC versus placebo. Treatment with TDF/FTC reduced the fraction of subjects with abnormal fasting total-cholesterol (≥200 mg/dL) from 86.7% to 56.8% (p=0.001) and LDL-cholesterol (≥130 mg/dL) from 87.8% to 43.9% (p<0.001), which was not observed with placebo. There were no virological failures, and CD4 and triglyceride levels remained stable regardless of exposure.
CONCLUSION:
Coformulated TDF/FTC has an intrinsic lipid-lowering effect, likely attributable to TDF. |
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Subject(s):
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-Sida -- Tractament |
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Rights:
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Aquest document està subjecte a aquesta llicència Creative Commons
http://creativecommons.org/licenses/by/3.0/es/
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Document type:
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Article
info:eu-repo/publishedVersion |
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Published by:
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International AIDS Society
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