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2014-11-02

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cc by (c) Santos, 2014
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/126182

Randomized, crossover, double‐blind, placebo‐controlled trial to assess the lipid lowering effect of co‐formulated TDF/FTC

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https://doi.org/10.7448/IAS.17.4.19550

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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. [13] 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: This was a randomized, crossover, double-blind, placebo-controlled clinical trial (NCT 01458977). Subjects with HIV-1 RNA B50 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. Results: 46 subjects with a median age of 43 (4048) 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 (pB0.001), 154.7 to 127.6 (pB0.001) and 50.3 to 44.5 mg/dL (pB0.001), respectively. In comparison, total, LDL and HDL-cholesterol levels remained stable during placebo exposure. Week 12 total cholesterol (pB0.001), LDL-cholesterol (pB0.001) and HDL-cholesterol (p0.011) 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% (p0.001) and LDL-cholesterol (]130 mg/dL) from 87.8% to 43.9% (pB0.001), 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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Antiretrovirals, Lípids de la sang

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Antiretroviral agents, Blood lipids

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Citació

SANTOS, José ramón, SAUMOY, Maria, CURRAN, Adrian, BRAVO, Isabel, NAVARRO, Jordi, ESTANY, Carla, PODZAMCZER PALTER, Daniel, RIBERA, Esteban, NEGREDO, Eugènia, CLOTET, Bonaventura, PAREDES, Roger. Randomized, crossover, double‐blind, placebo‐controlled trial to assess the lipid lowering effect of co‐formulated TDF/FTC. _Journal of the International AIDS Society_. 2014. Vol. 17 (suppl. [consulta: 23 de gener de 2026]. [Disponible a: https://hdl.handle.net/2445/126182]

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