Comparative effectiveness of initial antiretroviral therapy regimens: ACTG 5095 and 5142 clinical trials relative to ART-CC cohort study

Journal of Acquired Immune Deficiency Syndromes

Volumn 58, Issue 3, 2011, Pages 253-260

  Mugavero, Michael J ^a   May, Margaret ^b   Ribaudo, Heather J ^c   Gulick, Roy M ^d   Riddler, Sharon A ^e   Haubrich, Richard ^f   Napravnik, Sonia ^g   Abgrall, Sophie ^h   Phillips, Andrew ⁱ   Harris, Ross ^j   Gill, M John ^k   De Wolf, Frank ^l   Hogg, Robert ^m   Günthard, Huldrych F ⁿ   Chêne, Geneviève ^o   D'Arminio Monforte, Antonella ^h   Guest, Jodie L ^p   Smith, Colette ^q   Murillas, Javier ^r   Berenguer, Juan ^s   Wyen, Christoph ^t   Domingo, Pere ^u   Kitahata, Mari M ^v   Sterne, Jonathan A C ^b   Saag, Michael S ^a   more..

^a University of Alabama at Birmingham   (United States)

^b UNIVERSITY OF BRISTOL   (United Kingdom)

^c CENTER FOR BIOSTATISTICS IN AIDS RESEARCH   (United States)

^d WEILL CORNELL MEDICAL COLLEGE   (United States)

^e UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^f UNIVERSITY OF CALIFORNIA   (United States)

^g UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^h INSERM   (France)

ⁱ SORBONNE UNIVERSITÉ   (France)

^j ROYAL FREE AND UNIVERSITY COLLEGE MEDICAL SCHOOL   (United Kingdom)

^k PUBLIC HEALTH ENGLAND   (United Kingdom)

^l UNIVERSITY OF CALGARY   (Canada)

^m UNIVERSITY OF AMSTERDAM   (Netherlands)

ⁿ BRITISH COLUMBIA CENTRE FOR EXCELLENCE IN HIV AIDS   (Canada)

^o UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^p UNIVERSITY OF MILAN   (Italy)

^q ATLANTA VA MEDICAL CENTER   (United States)

^r HOSPITAL UNIVERSITARIO SON ESPASES   (Spain)

^s HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^t UNIVERSITY OF COLOGNE   (Germany)

^u HOSPITAL DE LA SANTA CREU I SANT PAU   (Spain)

^v UNIVERSITY OF WASHINGTON   (United States)

more..

Author keywords

AIDS; antiretroviral therapy; comparative effectiveness; HIV; viral load

Indexed keywords

ABACAVIR; EFAVIRENZ; LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; STAVUDINE; TENOFOVIR; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADOLESCENT; ADULT; ARTICLE; COHORT ANALYSIS; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; FEMALE; HAZARD RATIO; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; MAJOR CLINICAL STUDY; MALE; MORTALITY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK ASSESSMENT;

ADOLESCENT; ADULT; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; COHORT STUDIES; DOUBLE-BLIND METHOD; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; MALE; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

EID: 80054949845     PISSN: 15254135     EISSN: 10779450     Source Type: Journal    
DOI: 10.1097/QAI.0b013e318230372e     Document Type: Article

References (32)

1. Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Available at: http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed July 22, 2011.
2. Gazzard BG, Anderson J, Babiker A, et al. British HIV association guidelines for the treatment of HIV-1-infected adults with antiretroviral therapy 2008. HIV Med. 2008;9:563-608.
3. Thompson MA, Aberg JA, Cahn P, et al. Antiretroviral treatment of adult HIV infection: 2010 recommendations of the international AIDS Society-USA panel. JAMA. 2010;304:321-333.
4. D'Agostino RB Jr, D'Agostino RB Sr. Estimating treatment effects using observational data. JAMA. 2007;297:314-316. (Pubitemid 46143312)
5. Pocock SJ, Elbourne DR. Randomized trials or observational tribulations? N Engl J Med. 2000;342:1907-1909. (Pubitemid 30419058)
6. Chene G, Sterne JA, May M, et al. Prognostic importance of initial response in HIV-1 infected patients starting potent antiretroviral therapy: analysis of prospective studies. Lancet. 2003;362:679-686.
7. Egger M, May M, Chene G, et al. Prognosis of HIV-1-infected patients starting highly active antiretroviral therapy: a collaborative analysis of prospective studies. Lancet. 2002;360:119-129. (Pubitemid 34786200)
8. Walker AM. Confounding by indication. Epidemiology. 1996;7:335-336.
9. Wood E, Hogg RS, Heath KV, et al. Provider bias in the selection of nonnucleoside reverse transcriptase inhibitor and protease inhibitor-based highly active antiretroviral therapy and HIV treatment outcomes in observational studies. AIDS. 2003;17:2629-2634. (Pubitemid 38402341)
10. Sox HC, Greenfield S. Comparative effectiveness research: a report from the Institute of Medicine. Ann Intern Med. 2009;151:203-205.
11. Gulick RM, Ribaudo HJ, Shikuma CM, et al. Three-vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: a randomized controlled trial. JAMA. 2006;296:769-781. (Pubitemid 44223101)
12. Gulick RM, Ribaudo HJ, Shikuma CM, et al. Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 infection. N Engl J Med. 2004;350:1850-1861. (Pubitemid 38917251)
13. 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. (Pubitemid 351679596)
14. van Sighem A, Zhang S, Reiss P, et al. Immunologic, virologic, and clinical consequences of episodes of transient viremia during suppressive combination antiretroviral therapy. J Acquir Immune Defic Syndr. 2008;48:104-108. (Pubitemid 351600855)
15. Bonnet F, Thiebaut R, Chene G, et al. Determinants of clinical progression in antiretroviral-naive HIV-infected patients starting highly active antiretroviral therapy. Aquitaine Cohort, France, 1996-2002. HIV Med. 2005;6:198-205. (Pubitemid 40740337)
16. Kousignian I, Abgrall S, Grabar S, et al. Maintaining antiretroviral therapy reduces the risk of AIDS-defining events in patients with uncontrolled viral replication and profound immunodeficiency. Clin Infect Dis. 2008;46:296-304. (Pubitemid 351269173)
17. d'Arminio Monforte A, Lepri AC, Rezza G, et al. Insights into the reasons for discontinuation of the first highly active antiretroviral therapy (HAART) regimen in a cohort of antiretroviral naive patients. I.CO.N.A. Study Group. Italian Cohort of Antiretroviral-Naive Patients. AIDS. 2000;14:499-507. (Pubitemid 30209692)
18. Fatkenheuer G, Theisen A, Rockstroh J, et al. Virological treatment failure of protease inhibitor therapy in an unselected cohort of HIVinfected patients. AIDS. 1997;11:F113-F116. (Pubitemid 27470266)
19. Jaen A, Esteve A, Miro JM, et al. Determinants of HIV progression and assessment of the optimal time to initiate highly active antiretroviral therapy: PISCIS Cohort (Spain). J Acquir Immune Defic Syndr. 2008;47:212-220. (Pubitemid 351172189)
20. Caro-Murillo AM, Castilla J, Perez-Hoyos S, et al. Spanish cohort of naive HIV-infected patients (CoRIS): rationale, organization and initial results. [in Spanish] Enferm Infecc Microbiol Clin. 2007;25:23-31. (Pubitemid 46232687)
21. Booth CL, Garcia-Diaz AM, Youle MS, et al. Prevalence and predictors of antiretroviral drug resistance in newly diagnosed HIV-1 infection. J Antimicrob Chemother. 2007;59:517-524. (Pubitemid 47073459)
22. Alfonso V, Geller J, Bermbach N, et al. Becoming a "treatment success": what helps and what hinders patients from achieving and sustaining undetectable viral loads. AIDS Patient Care STDS. 2006;20:326-334. (Pubitemid 43800961)
23. Mocroft A, Gill MJ, Davidson W, et al. Predictors of a viral response and subsequent virological treatment failure in patients with HIV starting a protease inhibitor. AIDS. 1998;12:2161-2167. (Pubitemid 28495270)
24. Schoeni-Affolter F, Ledergerber B, Rickenbach M, et al. Cohort profile: the Swiss HIV cohort study. Int J Epidemiol. 2010;39:1179-1189.
25. Chen RY, Accortt NA, Westfall AO, et al. Distribution of health care expenditures for HIV-infected patients. Clin Infect Dis. 2006;42:1003-1010.
26. Anderson KB, Guest JL, Rimland D. Hepatitis C virus coinfection increases mortality in HIV-infected patients in the highly active antiretroviral therapy era: data from the HIV Atlanta VA Cohort Study. Clin Infect Dis. 2004;39:1507-1513. (Pubitemid 39518216)
27. Bahit MC, Cannon CP, Antman EM, et al. Direct comparison of characteristics, treatment, and outcomes of patients enrolled versus patients not enrolled in a clinical trial at centers participating in the TIMI 9 Trial and TIMI 9 Registry. Am Heart J. 2003;145:109-117. (Pubitemid 36034505)
28. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med. 2000;342:1878-1886. (Pubitemid 30419053)
29. Hallfors D, Cho H, Sanchez V, et al. Efficacy vs effectiveness trial results of an indicated "model" substance abuse program: implications for public health. Am J Public Health. 2006;96:2254-2259. (Pubitemid 44865121)
30. Steg PG, Lopez-Sendon J, Lopez de Sa E, et al. External validity of clinical trials in acute myocardial infarction. Arch Intern Med. 2007; 167:68-73. (Pubitemid 46072409)
31. Hansen AB, Gerstoft J, Kirk O, et al. Unmeasured confounding caused slightly better response to HAART within than outside a randomized controlled trial. J Clin Epidemiol. 2008;61:87-94.
32. Routman JS, Willig JH, Westfall AO, et al. Comparative efficacy versus effectiveness of initial antiretroviral therapy in clinical trials versus routine care. Clin Infect Dis. 2010;50:574-584.