Changes in patient-reported neuropsychiatric outcomes during the SENSE trial: First-line treatment with two nucleoside analogues plus etravirine or efavirenz

Health Outcomes Research in Medicine

Volumn 3, Issue 3, 2012, Pages

  Orkin, Chloe ^a   Nelson, Mark ^b,c   Katlama, Christine ^d   Morlat, Philippe ^e   Furrer, Hansjakob ^f   Van Delft, Yvon ^g   Janssen, Marjolein ^g   Hill, Andrew ^h   Marks, Stephan ^g  

^a QUEEN MARY UNIVERSITY OF LONDON   (United Kingdom)

^b St Stephens Centre   (United Kingdom)

^c CHELSEA AND WESTMINSTER HOSPITAL   (United Kingdom)

^d SORBONNE UNIVERSITÉ   (France)

^e HÔPITAL SAINT ANDRÉ   (France)

^f UNIVERSITY OF BERN   (Switzerland)

^g Janssen   (Netherlands)

^h UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

AIDS; Antiretroviral treatment; Efavirenz; Etravirine; HIV; Nervous system; Nonnucleosides; Nucleoside analogues; Psychiatric; Quality of life

Indexed keywords

ABACAVIR PLUS LAMIVUDINE; EFAVIRENZ; EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; ETRAVIRINE; LAMIVUDINE PLUS ZIDOVUDINE; PLACEBO;

ADULT; ARTICLE; CD4 LYMPHOCYTE COUNT; CONTROLLED STUDY; DIZZINESS; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SLEEP DISORDER; TREATMENT OUTCOME;

EID: 85027932899     PISSN: None     EISSN: 18771319     Source Type: Journal    
DOI: 10.1016/j.ehrm.2012.06.002     Document Type: Article

References (19)

1. Robertson KR, Smurzynski M, Parsons TD, et al. The prevalence and incidence of neurocognitive impairment in the HAART era. AIDS. 2007; 21(14):1915-1921.
2. Bing E, Burnham MA, Longshore D, et al. Psychiatric disorders and drug use among human immunodeficiency virus-infected adults in the United States. Arch Gen Psychiatry. 2001;58(8):721-728.
3. Justice AC, McGinnis KH, Atkinson JH, et al; Veterans Aging Cohort 5-Site Study Project Team. Psychiatric and neurocognitive disorders among HIV-positive and negative veterans in care: Veterans Aging Cohort Five-Site Study. AIDS. 2004;18(Suppl 1):49-59.
4. Squires K, Lazzarin A, Gatell JM, et al. Comparison of once-daily atazanavir with efavirenz, each in combination with fixed-dose zidovudine and lamivudine, as initial therapy for patients infected with HIV. J Acquir Immune Defic Syndr. 2004;36(5):1011-1019.
5. Saag M, Ive P, Heera J, et al. A multicentre, randomised, double-blind, comparative trial of a novel CCR5 antagonist, maraviroc versus efavirenz, both in combination with Combivir (zidovudine [ZDV]/lamivudine[3TC], for the treatment of antiretroviral naïve patients infected with R5 HIV1: week 48 results of the MERIT Study [abstr WESS104]. Sydney, Australia: 4th IAS Conference on HIV pathogenesis, treatment and prevention; July 2007.
6. Pozniak AL, Morales-Ramirez J, Katabira E, et al; TMC278-C204 Study Group. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS. 2010; 24(1):55-65.
7. Gazzard B, Balkin A, Hill A. Analysis of neuropsychiatric adverse events during clinical trials of efavirenz in antiretroviral naïve patients: a systematic review. AIDS Rev. 2010;12(2):67-75.
8. Division of AIDS (DAIDS) 2004. Division of AIDS table for grading the severity of adult and paediatric adverse events. Available at: http://rsc.techres.com/safetyandpharmacovigilance/gradingtables.aspx. Accessed July 5, 2012.
9. Waters L, Fisher M, Winston A, et al. A phase IV, double-blind, multi-centre, randomized, placebo-controlled, pilot study to assess the feasibility of switching individuals receiving efavirenz with continuing central nervous system adverse events to etravirine. AIDS. 2011;25(1):65-71.
10. Marzolini C, Telenti A, Decosterd LA, Greub G, Biollaz J, Buclin T. Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1-infected patients. AIDS. 2001;15(1):71-75.
11. Haas DW, Ribaudo HJ, Kim RB, et al. Pharmacogenetics of efavirenz and central nervous system side effects: an Adult AIDS Clinical Trials Group study. AIDS. 2004;18(18):2391-2400.
12. Cabrera SE, Santos D, Valverde MP, et al. Influence of the cytochrome P450 2B6 genotype on population pharmacokinetics of efavirenz in human immunodeficiency virus patients. Antimicrob Agents Chemother. 2009;53(7):2791-2798.
13. Katlama C, Haubrich R, Lalezari R, et al; DUET-1, DUET-2 study groups. Efficacy and safety of etravirine in treatment-experienced, HIV-1 patients: pooled 48 week analysis of two randomized, controlled trials. AIDS. 2009; 23(17):2289-2300.
14. Nelson M, Stellbrink HJ, Podzamczer D, et al. A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naïve, HIV-1 infected population. AIDS. 2011;25(3):335-350.
15. Gazzard B, Duvivier C, Zagler C, et al. Phase 2 double-blind, randomized trial of etravirine versus efavirenz in treatment-naïve patients: 48-week results. AIDS. 2011;25(18):2249-2258.
16. Fumaz C, Tuldrà A, Ferrer J, et al. Quality of life, emotional status and adherence of HIV-1-infected patients treated with efavirenz versus protease inhibitor-containing regimens. J Acquir Immune Defic Syndr. 2002;29(3): 244-253.
17. Clifford DB, Evans S, Yang Y, et al. Impact of efavirenz on neuropsychological performance and symptoms in HIV-infected individuals. Ann Intern Med. 2005;143(10):714-721.
18. Brown E, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf. 1999;20(2):109-117.
19. Gutiérrez-Valencia A, Viciana P, Palacios R, et al; Sociedad Andaluza de Enfermedades Infecciosas. Stepped-dose versus full-dose efavirenz for HIV infection and neuropsychiatric adverse events: a randomized trial. Ann Intern Med. 2009;151(3):149-156.