The Lipid-Lowering Effect of Tenofovir/Emtricitabine: A Randomized, Crossover, Double-Blind, Placebo-Controlled Trial

Clinical Infectious Diseases

Volumn 61, Issue 3, 2015, Pages 403-408

  Santos, José R ^a,b   Saumoy, María ^c   Curran, Adrian ^b,d   Bravo, Isabel ^a   Llibre, Josep M ^a,b   Navarro, Jordi ^b,d   Estany, Carla ^a   Podzamczer, Daniel ^c   Ribera, Esteban ^b,d   Negredo, Eugènia ^a,e   Clotet, Bonaventura ^a,b,e,f   Paredes, Roger ^a,b,e,f  

^a HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^b UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^c HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^d HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^e UNIVERSITY OF VIC CENTRAL UNIVERSITY OF CATALONIA   (Spain)

^f AIDS Research Institute IrsiCaixa HIVACAT   (Spain)

Author keywords

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

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; CHOLESTEROL; CREATININE; DARUNAVIR PLUS RITONAVIR; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; GAMMA GLUTAMYLTRANSFERASE; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; LOPINAVIR PLUS RITONAVIR; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PHOSPHATE; PLACEBO; TRIACYLGLYCEROL; VIRUS RNA; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; EMTRICITABINE; LIPID; TENOFOVIR;

ADD ON THERAPY; ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALKALINE PHOSPHATASE BLOOD LEVEL; ANTILIPEMIC ACTIVITY; ANTIVIRAL THERAPY; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CD4 LYMPHOCYTE COUNT; CHOLESTEROL BLOOD LEVEL; CLINICAL ARTICLE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; CROSSOVER PROCEDURE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG ACTIVITY; DRUG EFFECT; DRUG SAFETY; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; GLOMERULUS FILTRATION RATE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HYPERCHOLESTEROLEMIA; LOW FAT DIET; MALE; MONOTHERAPY; MULTICENTER STUDY; NUTRITIONAL COUNSELING; PHOSPHATE BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVIEW; SIDE EFFECT; TREATMENT DURATION; TRIACYLGLYCEROL BLOOD LEVEL; BLOOD; CLINICAL TRIAL; HIV INFECTIONS; MIDDLE AGED; PATHOPHYSIOLOGY;

ADULT; ANTI-HIV AGENTS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; EMTRICITABINE; FEMALE; HIV INFECTIONS; HUMANS; LIPIDS; MALE; MIDDLE AGED; PLACEBOS; TENOFOVIR;

EID: 84938585202     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/civ296     Document Type: Review

References (27)

1. European AIDS Clinical Society (EACS). Clinical management and treatment of HIV-infected adults in Europe. Guidelines 2014. Version 7.1. Available at: http://www.eacsociety.org. Accessed 16 December 2014.
2. Panel de expertos de GeSIDA y Plan Nacionalsobre el SIDA. Documento de consenso de GeSIDA/Plan Nacional sobre el Sida respecto al tratamiento antirretroviral en adultos infectados por el virus de la inmunodeficiencia humana. Actualización enero 2014. Available at: http://www.gesida-seimc.org. Accessed 16 December 2014.
3. Oldfield V, Plosker GL. Lopinavir/ritonavir: a review of its use in the management of HIV infection. Drugs 2006; 66:1275-99.
4. Ortiz R, Dejesus E, Khanlou H, et al. Efficacy and safety of once-daily darunavir/ritonavir versus lopinavir/ritonavir in treatment-naive HIV-1-infected patients at week. AIDS 2008; 22:1389-97.
5. Arribas JR, Horban A, Gerstoft J, et al. The MONET trial: darunavir/ ritonavir with or without nucleoside analogues, for patients with HIV RNA below 50 copies/ml. AIDS 2010; 24:223-30.
6. Santos JR, Moltó J, Llibre JM, et al. Antiretroviral simplification with darunavir/ritonavir monotherapy in routine clinical practice: safety, effectiveness, and impact on lipid profile. PLoS One 2012; 7:e37442.
7. Valantin MA, Bittar R, de Truchis P, et al. Switching the nucleoside reverse transcriptase inhibitor backbone to tenofovir disoproxil fumarate + emtricitabine promptly improves triglycerides and low-density lipoprotein cholesterol in dyslipidaemic patients. J Antimicrob Chemother 2010; 65:556-61.
8. Ribera E, Paradiñeiro JC, Curran A, et al. Improvements in subcutaneous fat, lipid profile, and parameters of mitochondrial toxicity in patients with peripheral lipoatrophy when stavudine is switched to tenofovir (LIPOTEST study). HIV Clin Trials 2008; 9:407-17.
9. Palacios R, Rivero A, Santos I, et al. Rapid improvement in fasting lipids and hepatic toxicity after switching from didanosine/lamivudine to tenofovir/ emtricitabine in patients with toxicity attributable to didanosine. HIV Clin Trials 2010; 11:118-20.
10. Llibre JM, Domingo P, Palacios R, et al. Sustained improvement of dyslipidaemia in HAART-treated patients replacing stavudine with tenofovir. AIDS 2006; 20:1407-14.
11. Fisher M, Moyle GJ, Shahmanesh M, et al. A randomized comparative trial of continued zidovudine/lamivudine or replacement with tenofovir disoproxil fumarate/emtricitabine in efavirenz-treated HIV-1-infected individuals. J Acquir Immune Defic Syndr 2009; 51:562-8.
12. Ananworanich J, Nuesch R, Côté HCF, et al. Changes in metabolic toxicity after switching from stavudine/didanosine to tenofovir/lamivudine-a Staccato trial substudy. J Antimicrob Chemother 2008; 61:1340-3.
13. Gallant JE, Pozniak AL, Miller MD, Coakley DF, Lu B. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviralnaive patients. JAMA 2004; 292:191-201.
14. Arribas JR, Pozniak AL, Gallant JE, et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz compared with zidovudine/lamivudine and efavirenz in treatment-naive patients: 144-week analysis. J Acquir Immune Defic Syndr 2008; 47:74-8.
15. Frampton JE, Perry CM. Emtricitabine. A review of its use in the management of HIV infection. Drugs 2005; 65:1427-48.
16. National Heart, Lung and Blood Institute. Third report of the National Cholesterol Education Program (NCEP) on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). NIH Publication No. 02-5215 2002. Available at: http://www. nhlbi.nih.gov. Accessed 16 December 2014.
17. Team RDC. R: A language and environment for statistical computing, 2010. Available at: http://www.r-project.org. Accessed 12 January 2015.
18. Tungsiripat M, Kitch D, Glesby MJ, et al. A pilot study to determine the impact on dyslipidemia of adding tenofovir to stable background antiretroviral therapy: ACTG 5206. AIDS 2010; 24:1781-4.
19. Behrens G, Maserati R, Rieger A, et al. Switching to tenofovir/emtricitabine from abacavir/lamivudine in HIV-infected adults with raised cholesterol: effect on lipid profiles. Antivir Ther 2012; 17:1011-20.
20. Bedimo R, Maalouf NM, Zhang S, Drechsler H, Tebas P. Osteoporotic fracture risk associated with cumulative exposure to tenofovir and other antiretroviral agents. AIDS 2012; 26:825-31.
21. McComsey GA, Kitch D, Daar ES, et al. Bone mineral density and fractures in antiretroviral-naive persons randomized to receive abacavirlamivudine or tenofovir disoproxil fumarate-emtricitabine along with efavirenz or atazanavir-ritonavir: AIDS Clinical Trials Group A5224s, a substudy of ACTG. J Infect Dis 2011; 203:1791-801.
22. Scherzer R, Estrella M, Li Y, et al. Association of tenofovir exposure with kidney disease risk in HIV infection. AIDS 2012; 26:867-75.
23. Young J,Weber R, Rickenbach M, et al. Lipid profiles for antiretroviralnaive patients starting PI-and NNRTI-based therapy in the Swiss HIV cohort study. Antivir Ther 2005; 10:585-91.
24. Fontas E, van Leth F, Sabin CA, et al. Lipid profiles in HIV-infected patients receiving combination antiretroviral therapy: are different antiretroviral drugs associated with different lipid profiles? J. Infect Dis 2004; 189:1056-74.
25. Duro M, Sarmento-Castro R, Almeida C, et al. Lipid profile changes by high activity anti-retroviral therapy. Clin Biochem 2013; 46:740-4.
26. Hill A, Khoo S, Back D, Pozniak A, Boffito M. Should the dose of tenofovir be reduced to 200-250 mg/day, when combined with protease inhibitors? J Int AIDS Soc 2014; 17:19583.
27. Back D, Sekar V, Hoetelmans RMW. Darunavir: pharmacokinetics and drug interactions. Antivir Ther 2008; 13:1-13.