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Clin Infect Dis. 2015 Aug 1;61(3):403-8. doi: 10.1093/cid/civ296. Epub 2015 Apr 13.

The lipid-lowering effect of tenofovir/emtricitabine: a randomized, crossover, double-blind, placebo-controlled trial.

Author information

1
Lluita contra la SIDA Foundation, Germans Trias i Pujol University Hospital Universitat Autònoma de Barcelona.
2
HIV Unit, Infectious Diseases Service, Bellvitge University Hospital, Bellvitge Biomedical Research Institute, Hospitalet de Llobregat.
3
Universitat Autònoma de Barcelona Infectious Diseases Department, Hospital Universitari Vall d'Hebron, Barcelona.
4
Lluita contra la SIDA Foundation, Germans Trias i Pujol University Hospital.
5
Lluita contra la SIDA Foundation, Germans Trias i Pujol University Hospital Universitat de Vic-Universitat Central de Catalunya, Vic.
6
Lluita contra la SIDA Foundation, Germans Trias i Pujol University Hospital Universitat Autònoma de Barcelona Universitat de Vic-Universitat Central de Catalunya, Vic IrsiCaixa AIDS Research Institute, Barcelona, Spain.

Abstract

BACKGROUND:

It is unknown if tenofovir disoproxil fumarate (TDF), which is often coformulated with the lipid-neutral emtricitabine (FTC), has a lipid-lowering effect.

METHODS:

We performed a randomized, crossover, double-blind, placebo-controlled clinical trial on human immunodeficiency virus type 1 (HIV-1)-infected subjects with HIV-1 RNA < 50 copies/mL during ≥6 months on stable darunavir/ritonavir (800/100 mg once daily) or lopinavir/ritonavir (400/100 mg twice daily) monotherapy, fasting total cholesterol (TC) ≥200 mg/dL or low-density lipoprotein cholesterol (LDL-c) ≥130 mg/dL, and no lipid-lowering drugs. In arm 1, TDF/FTC was added for 12 weeks, followed by 12 weeks of placebo (washout) and 12 additional weeks of placebo (placebo period). Subjects in arm 2 added placebo for 12 weeks (placebo period) followed by TDF/FTC for 12 weeks and placebo for 12 additional weeks (washout). The primary endpoint was change in median fasting TC levels.

RESULTS:

Of 46 subjects enrolled, 56% received darunavir/ritonavir and 44% lopinavir/ritonavir. Exposure to TDF/FTC reduced TC from 234 to 205 mg/dL (P < .001), LDL-c from 155 to 128 mg/dL (P < .001), and high-density lipoprotein cholesterol (HDL-c) from 50.3 to 44.5 mg/dL (P < .001). It also decreased the proportion of subjects with fasting TC ≥200 mg/dL from 86.7% to 56.8% (P = .001), and LDL-c ≥130 mg/dL from 87.8% to 43.9% (P < .001). After 12 weeks, TDF/FTC exposure was associated with lower TC and LDL-c levels than placebo (P = .001 and P = .002, respectively). The TC/HDL-c ratio and triglyceride levels did not change with TDF/FTC exposure.

CONCLUSIONS:

Coformulated TDF/FTC has an intrinsic lipid-lowering effect, likely attributable to TDF.

CLINICAL TRIALS REGISTRATION:

NCT01458977.

KEYWORDS:

LDL cholesterol; boosted protease inhibitor monotherapy; coformulated tenofovir/emtricitabine; lipid-lowering effect; total cholesterol

PMID:
25870325
DOI:
10.1093/cid/civ296
[Indexed for MEDLINE]

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