A Randomized, open-label trial to evaluate switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide plus darunavir in treatment-experienced HIV-1-infected adults

Journal of Acquired Immune Deficiency Syndromes

Volumn 74, Issue 2, 2017, Pages 193-200

  Huhn, Gregory D ^a   Tebas, Pablo ^b   Gallant, Joel ^c   Wilkin, Timothy ^d   Cheng, Andrew ^e   Yan, Mingjin ^e   Zhong, Lijie ^e   Callebaut, Christian ^e   Custodio, Joseph M ^e   Fordyce, Marshall W ^e   Das, Moupali ^e   McCallister, Scott ^e  

^a Ruth M Rothstein CORE Center   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c Southwest CARE Center   (United States)

^d WEILL CORNELL MEDICAL COLLEGE   (United States)

^e GILEAD SCIENCES   (United States)

Author keywords

Darunavir; HIV; Regimen simplification; Tenofovir alafenamide

Indexed keywords

COBICISTAT PLUS ELVITEGRAVIR PLUS EMTRICITABINE PLUS TENOFOVIR ALAFENAMIDE; DARUNAVIR; DARUNAVIR PLUS RITONAVIR; VIRUS RNA; ANTIRETROVIRUS AGENT;

ADULT; AGED; AREA UNDER THE CURVE; BACKACHE; BRONCHITIS; CONFERENCE PAPER; CONTROLLED STUDY; COUGHING; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FEMALE; FLU LIKE SYNDROME; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; KIDNEY TUBULE DISORDER; MAJOR CLINICAL STUDY; MALE; MINIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; OPEN STUDY; PATIENT SATISFACTION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; SINUSITIS; UPPER RESPIRATORY TRACT INFECTION; ADOLESCENT; CLINICAL TRIAL; DRUG EFFECT; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MIDDLE AGED; PROCEDURES; SUSTAINED VIROLOGIC RESPONSE; TREATMENT OUTCOME; VIROLOGY; VIRUS LOAD; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTI-RETROVIRAL AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; MIDDLE AGED; SUSTAINED VIROLOGIC RESPONSE; TREATMENT OUTCOME; VIRAL LOAD; YOUNG ADULT;

EID: 84991493062     PISSN: 15254135     EISSN: 10779450     Source Type: Journal    
DOI: 10.1097/QAI.0000000000001193     Document Type: Conference Paper

References (30)

1. Palella FJ Jr, Baker RK, Moorman AC, et al. Mortality in the highly active antiretroviral therapy era: changing causes of death and disease in the HIV outpatient study. J Acquir Immune Defic Syndr. 2006;43: 27-34.
2. Lee LM, Karon JM, Selik R, et al. Survival after AIDS diagnosis in adolescents and adults during the treatment era, United States 1984-1997. JAMA. 2001;285:1308-1315.
3. Valdez H, Chowdhry TK, Asaad R, et al. Changing spectrum of mortality due to human immunodeficiency virus: analysis of 260 deaths during 1995-1999. Clin Infect Dis. 2001;32:1487-1493.
4. Lucas G. Antiretroviral adherence, drug resistance, viral fitness and HIV disease progression: A tangled web is woven. J Antimicrob Chemother. 2005;55:413-416.
5. Taiwo B, Murphy RL, Katlama C. Novel antiretroviral combinations in treatment-experienced patients with HIV infection. Drugs. 2010;70: 1629-1642.
6. Imaz A, FalcóV, Ribera E. Antiretroviral salvage therapy for multiclass drug-resistant HIV-1-infected patients: from clinical trials to daily clinical practice. AIDS Rev. 2011;13:180-193.
7. 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; Washington, DC: 2016. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL. pdf. Accessed April 15, 2016.
8. European AIDS Clinical Society (EACS). Guidelines Version 8.0 (English); 2015. Available at: http://www.eacsociety.org/files/2015-eacsguidelines-8-0-english-rev-20160124.pdf. Accessed April 15, 2016.
9. Ricard F, Wong A, Lebouché B, et al. Low darunavir concentrations in patients receiving Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) and darunavir once daily. Poster presented at: 16th International Workshop on Clinical Pharmacology of HIV and Hepatitis Therapy; May 26-28, 2015; Washington, DC.
10. Sax PE, Wohl D, Yin MT, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015;385:2606-2615.
11. Wohl D, Oka S, Clumeck N, et al. Brief report: A randomized, doubleblind comparison of tenofovir alafenamide versus tenofovir disoproxil fumarate, each coformulated with elvitegravir, cobicistat, and emtricitabine for initial HIV-1 treatment: week 96 results. J Acquir Immune Defic Syndr. 2016;72:58-64.
12. Mills A, Arribas JR, Andrade-Villanueva J, et al. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: A randomised, active-controlled, multicentre, open-label, phase 3, noninferiority study. Lancet Infect Dis. 2016;16:43-52.
13. Rivero A, Pulido F, Caylá J, et al; Grupo de Estudio de Sida (GESIDA); Secretaría del Plan Nacional sobre el Sida. The Spanish AIDS Study Group and Spanish National AIDS Plan (GESIDA/Secretaría del Plan Nacional sobre el Sida) recommendations for the treatment of tuberculosis in HIV-infected individuals (Updated January 2013) [in Spanish]. Enferm Infecc Microbiol Clin. 2013;31:672-684.
14. Ministry of Health, National Committee on AIDS-Commissione Nazionale per la lotta contro l'AIDS, Linee Guida Italiane sull'utilizzo dei farmaci antiretrovirali e sulla gestione diagnosticoclinica delle persone con infezione da HIV-1, Ministero della Salute, luglio, December 2015 [in Italian]. Available at: http://www.salute.gov.it/imgs/C-17-pubblicazioni-2442-allegato.pdf. Accessed April 15, 2016.
15. Danish Society of Infectious Diseases. Antiviral behandling af HIV smittede personer, Odense C, DK, August 2015 [in Danish]. Available at: http://www.infmed.dk/guidelines. Accessed April 15, 2016.
16. Snopková S, Rozsypal H, Aster V, et al. Doporu-cený postup pé-ce o dosp-elé infikované HIV a postexpozi-cní profylaxe infekce HIV. 2016.
17. DAIG Deutsche AIDS-Gesellschaft e.V. Deutsch-Osterreichische Leitlinien zur antiretroviralen Therapie der HIV-Infektion, Version 6. Hamburg, DE. Dezember 2015 [in German]. Available at: http://www.daignet.de/sitecontent/hiv-therapie/leitlinien-1. Accessed April 15, 2016.
18. Mills A, Crofoot G Jr, McDonald C, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate in the first protease inhibitor-based singletablet regimen for initial HIV-1 therapy: A randomized phase 2 study. J Acquir Immune Defic Syndr. 2015;69:439-445.
19. Clotet B, Bellos N, Molina JM, et al. Efficacy and safety of darunavirritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: A pooled subgroup analysis of data from two randomised trials. Lancet. 2007;369:1169-1178.
20. Kalichman SC, Amaral CM, Swetzes C, et al. A simple single item rating scale to measure medication adherence: further evidence for convergent validity. J Int Assoc Physicians AIDS Care (Chic). 2009;8:367-374.
21. Woodcock A, Bradley C. Validation of the HIV treatment satisfaction questionnaire (HIVTSQ). Qual Life Res. 2001;10:517-531.
22. Amico KR, Fisher WA, Cornman DH, et al. Visual analog scale of ART adherence: association with 3-Day self-report and adherence barriers. J Acquir Immune Defic Syndr. 2006;42:455-459.
23. Smith F, Hammerstorm T, Soon G, et al. A meta-analysis to assess the FDA DAVP's TLOVR algorithm in HIV submissions. Drug Inf J. 2011; 45:291-300.
24. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER). Guidance for Industry Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (Revision 1); 2015;1-43. Available at: http://www. fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM355128.pdf. Accessed April 15, 2016.
25. George E, Lucas GM, Nadkarni GN, et al. Kidney function and the risk of cardiovascular events in HIV-1 infected patients. AIDS. 2010;24:387-394.
26. Currie G, Delles C. Proteinuria and its relation to cardiovascular disease. Int J Nephrol Renovasc Dis. 2013;7:13-24.
27. Agrawal V, Marinescu V, Agarwal M, et al. Cardiovascular implications of proteinuria: an indicator of chronic kidney disease. Nat Rev Cardiol. 2009;6:301-311.
28. Gallant J, Brunetta J, Crofoot G, et al. Efficacy and safety of switching to a single-tablet regimen of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV-1/hepatitis B coinfected adults. J Acquir Immune Defic Syndr. 2016;73:294-298.
29. Ray AS, Cihlar T, Robinson KL, et al. Mechanism of active renal tubular efflux of tenofovir. Antimicrob Agents Chemother. 2006;50:3297-3304.
30. Bam RA, Yant SR, Cihlar T. Tenofovir alafenamide is not a substrate for renal organic anion transporters (OATs) and does not exhibit OATdependent cytotoxicity. Antivir Ther. 2014;19:687-692.