Randomized, crossover, double-blind, placebo-controlled trial to assess the lipid lowering effect of co-formulated TDF/FTC
Ramón Santos, José (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Saumoy, María (Hospital Universitari Vall d'Hebron)
Bravo, Isabel (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Navarro, Jordi (Hospital Universitari Vall d'Hebron)
Estany Quera, Carla (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Podzamczer, Daniel (Hospital Universitari de Bellvitge)
Ribera, Esteban (Hospital Universitari Vall d'Hebron)
Negredo Puigmal, Eugènia (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Clotet Sala, Bonaventura (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Paredes, Roger (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Universitat Autònoma de Barcelona

Data:	2014
Resum:	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. [-] 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. This was a randomized, crossover, double-blind, placebo-controlled clinical trial (NCT 01458977). Subjects with HIV-1 RNA <50 copies/mL during at least 6 months on stable DRV/r (800/100 mg QD) or LPV/r (400/100 mg BID) monotherapy, with confirmed fasting total cholesterol ≥200 or LDL-cholesterol ≥130 mg/dL and not taking lipid-lowering drugs were randomized to (A) adding TDF/FTCduring 12 weeks followed by 24 weeks without TDF/FTC, or (B) continuing without TDF/FTC for 12 weeks, adding TDF/FTC for 12 weeks and then withdrawing TDF/FTC for 12 additional weeks. Randomization was stratified by DRV/r or LPV/r use at study entry. All subjects received a specific dietary counselling. Primary endpoints were changes in median fasting total, LDL and HDL-cholesterol 12 weeks after TDF/FTC addition. Analyses were performed by ITT. 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. Coformulated TDF/FTC has an intrinsic lipid-lowering effect, likely attributable to TDF.
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Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	Journal of the International AIDS Society, Vol. 17 (november 2014) , ISSN 1758-2652

DOI: 10.7448/IAS.17.4.19550
PMID: 25394057

1 p, 76.3 KB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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