Simplification of antiretroviral therapy to a single-tablet regimen consisting of efavirenz, emtricitabine, and tenofovir disoproxil fumarate versus unmodified antiretroviral therapy in virologically suppressed HIV-1-infected patients

Journal of Acquired Immune Deficiency Syndromes

Volumn 51, Issue 2, 2009, Pages 163-174

  Dejesus, Edwin ^a   Young, Benjamin ^b   Morales Ramirez, Javier O ^c   Sloan, Louis ^d   Ward, Douglas J ^e   Flaherty, John F ^f   Ebrahimi, Ramin ^f   Maa, Jen Fue ^g   Reilly, Karen ^g   Ecker, Janet ^f   McColl, Damian ^f   Seekins, Daniel ^g   Farajallah, Awny ^g  

^a ORLANDO IMMUNOLOGY CENTER   (United States)

^b Denver Infectious Disease Consultants   (United States)

^c Clinical Research Puerto Rico Inc   (Puerto Rico)

^d North Texas Infectious Diseases Consultants   (United States)

^e Dupont Circle Physician's Group   (United States)

^f GILEAD SCIENCES   (United States)

^g BRISTOL MYERS SQUIBB   (United States)

Author keywords

EFV FTC TDF single tablet regimen; Once daily antiretroviral regimens; Treatment simplification

Indexed keywords

CREATININE; EFAVIRENZ PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; HEMOGLOBIN; PROTEINASE INHIBITOR; RNA DIRECTED DNA POLYMERASE INHIBITOR; TRIACYLGLYCEROL; VIRUS RNA; ADENINE; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; BENZOXAZINE DERIVATIVE; DEOXYCYTIDINE; DRUG DERIVATIVE; EFAVIRENZ; EMTRICITABINE; PHOSPHONIC ACID DERIVATIVE; TENOFOVIR DISOPROXIL;

ACUTE HEPATITIS; ACUTE PANCREATITIS; ADULT; ANXIETY; ARTICLE; BRONCHITIS; CD4 LYMPHOCYTE COUNT; CD4+ T LYMPHOCYTE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DEPRESSION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG ERUPTION; DRUG FEVER; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; GLOMERULUS FILTRATION RATE; HEADACHE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HYPERLIPIDEMIA; INSOMNIA; LIPID ANALYSIS; MAJOR CLINICAL STUDY; MALE; MENTAL DISEASE; MULTICENTER STUDY; NAUSEA; NOSE CONGESTION; OUTCOME ASSESSMENT; PATIENT COMPLIANCE; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SINUS CONGESTION; SINUSITIS; SOMNOLENCE; SORE THROAT; TABLET FORMULATION; VISUAL ANALOG SCALE; DRUG COMBINATION; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MIDDLE AGED;

ADENINE; ADULT; ANTI-HIV AGENTS; BENZOXAZINES; DEOXYCYTIDINE; DRUG COMBINATIONS; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; MIDDLE AGED; PATIENT COMPLIANCE; PHOSPHONIC ACIDS;

EID: 67649185287     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAI.0b013e3181a572cf     Document Type: Article

References (23)

1. Chesney M. Adherence to HAART regimens. AIDS Patient Care STDS. 2003;17:169-177.
2. Stone VE, Jordan J, Tolson J, et al. Perspectives on adherence and simplicity for HIV-infected patients on antiretroviral therapy. J Acquir Immune Defic Syndr. 2004;36:808-816.
3. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Department of Health and Human Services; 2008:1-128. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed November 3, 2008.
4. Gallant JE, DeJesus E, Arribas JR, et al. Tenofovir DF, emtricitabine, and efavirenz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med. 2006;354:251-260.
5. Pozniak AL, Gallant JE, DeJesus E, et al. Tenofovir disoproxil fumarate, emtricitabine, and efavirenz versus fixed-dose zidovudine/lamivudine and efavirenz in antiretroviral naïve patients. Virologic, immunologic, and morphologic changes: a 96 week analysis. J Acquir Immune Defic Syndr. 2006;43:535-540.
6. Mathias AA, Hinkle J, Menning M, et al. Bioequivalence of efavirenz/emtricitabine/tenofovir disoproxil fumarate single-tablet regimen. J Acquir Immune Defic Syndr. 2007;46:167-173.
7. Bucher HC, Kofler A, Nuesch R, et al. Meta-analysis of randomized controlled trials of simplified versus continued protease inhibitor-based antiretroviral therapy in HIV-1-infected patients. AIDS. 2003;17:2451-2459.
8. Martinez E, Arnaiz J, Podzamczer D, et al. Substitution of nevirapine, efavirenz or abacavir for protease inhibitors in patients with human immunodeficiency virus infection. N Engl J Med. 2003;349:1036-1046.
9. Maggiolo F, Ripamonti D, Suter F. Switch strategies in patients on effective HAART. J Antimicrob Chemother. 2005;55:821-823.
10. DeJesus E, Ruane P, McDonald C, et al. Impact of switching virologically-suppressed, HIV-1-infected patients from twice daily fixed-dose zidovudine/lamivudine to once daily fixed-dose tenofovir disoproxil fumarate/emtricitabine. HIV Clin Trials. 2008;9:103-114.
11. Fisher M, Moyle G, Ebrahimi R; and the SWEET Study Group. Switching from combivir (CBV, AZT/3TC) to truvada (TVD, TDF/FTC) maintains viral suppression, prevents and reverses limb fat loss, and improves biochemical parameters: results of a 48 week randomised study. In: 11th European AIDS Conference; October 24-27, 2007; Madrid, Spain. Abstract PS5/7.
12. Molina JM, Journot V, Morand-Joubert L, et al. Simplification therapy with once daily emtricitabine, didanosine, and efavirenz in HIV-1-infected adults with viral suppression receiving a protease inhibitor-based regimen: a randomized trial. Clin Infect Dis. 2005;191:830-839.
13. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16:31-41.
14. Levey AS, Bosch JP, Lewis JB, et al. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med. 1999;130:461-470.
15. Justice A, Holmes W, Gifford A, et al. Development and validation of a self-completed HIV symptom index. J Clin Epidemiol. 2001;54:S77-S90.
16. Giordano T, Guzman D, Clark R, et al. Measuring adherence to antiretroviral therapy in a diverse population using a visual analogue scale. HIV Clin Trials. 2004;5:74-79.
17. Ware J, Snow K, Kosinski M, et al. Health Survey: Manual and Interpretation Guide. Boston, MA: The Health Institute, New England Medical Center; 1993.
18. Riddler SA, Haubrich R, DiRienzo AG, et al. Class-sparing regimens for initial treatment of HIV-1 infection. N Engl J Med. 2008;358:2095-2106.
19. Zimmerman AE, Pizzoferrato T, Bedford J, et al. Tenofovir-associated acute and chronic kidney disease: a case of multiple drug interactions. Clin Infect Dis. 2006;42:283-290.
20. Cassetti I, Madruga JVR, Suleiman JMAH, et al. The safety and efficacy of tenofovir DF in combination with lamivudine and efavirenz through 6 years in antiretroviral naïve HIV-1 infected patients. HIV Clin Trials. 2007;8:164-172.
21. Madruga JVR, Cassetti I, Suleiman JMAH, et al. The safety and efficacy of switching stavudine to tenofovir DF in combination with lamivudine and efavirenz in HIV-1-infected patients: three-year follow-up after switching therapy. HIV Clin Trials. 2007;8:381-390.
22. Molina JM, Bentata M, Garré M, et al; and the ALIZE study group. Hematologic benefit of switching from regimens combining protease inhibitors and zidovudine plus lamivudine to once-daily emtricitabine, didanosine, and efavirenz. A sub-study of the ANRS 099 ALIZE trial. In: Program and Abstracts of the 12th Conference on Retroviruses and Opportunistic Infections; February 22-25, 2005; Boston, MA. Abstract 830.
23. Conway B. The role of adherence to antiretroviral therapy in the management of HIV infection. J Acquir Immune Defic Syndr. 2007;45: S14-S18.