Comparison of once-daily versus twice-daily combination antiretroviral therapy in treatmentNaive patients: Results of AIDS clinical trials group (ACTG) A5073, a 48-week randomized controlled trial

Clinical Infectious Diseases

Volumn 50, Issue 7, 2010, Pages 1041-1052

  Flexner, Charles ^a   Tierney, Camlin ^c   Gross, Robert ^d   Andrade, Adriana ^a   Lalama, Christina ^c   Eshleman, Susan H ^a   Aberg, Judith ^e   Sanne, Ian ⁱ   Parsons, Teresa ^a   Kashuba, Angela ^h   Rosenkranz, Susan L ^c   Kmack, Anne ^g   Ferguson, Elaine ^b   Dehlinger, Marjorie ^b   Mildvan, Donna ^f  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^d UNIVERSITY OF PENNSYLVANIA   (United States)

^e NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f BETH ISRAEL MEDICAL CENTER   (United States)

^g FRONTIER SCIENCE AND TECHNOLOGY RESEARCH FOUNDATION   (United States)

^h UNIVERSITY OF NORTH CAROLINA   (United States)

ⁱ UNIVERSITY OF THE WITWATERSRAND   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

EMTRICITABINE; LOPINAVIR; RITONAVIR; STAVUDINE; TENOFOVIR; VIRUS RNA;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ADULT; ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE REGIMEN; DRUG EFFICACY; FEMALE; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; NONHUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; TREATMENT RESPONSE;

ANTI-RETROVIRAL AGENTS; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HIV; HIV INFECTIONS; HUMANS; MALE; PROPORTIONAL HAZARDS MODELS; PYRIMIDINONES; RITONAVIR; RNA, VIRAL; TREATMENT OUTCOME; VIRAL LOAD;

EID: 77749329017     PISSN: 10584838     EISSN: None     Source Type: Journal    
DOI: 10.1086/651118     Document Type: Article

References (22)

1. Claxton AJ, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001; 23: 1296-1310.
2. Moyle G.Overcoming obstacles to the success of protease inhibitors in highly active antiretroviral therapy regimens. AIDS Patient Care STDS 2002; 16: 585-597.
3. Maitland D, Jackson A, Osório J, Mandalia S, Gazzard BG, Moyle GJ; Epivir-Ziagen (EZ) Switch Study Team. Switching from twice-daily abacavir and lamivudine to the once-daily fixed-dose combination tablet of abacavir and lamivudine improves patient adherence and satisfaction with therapy. HIV Med 2008; 9: 667-672.
4. Cramer JA, Mattson RH, Prevey ML, Scheyer RD, Ouellette VL.How often is medication taken as prescribed? A novel assessment technique. JAMA 1989; 261: 3273-3277.
5. 5. Hughes D. Less is more: medicines that require less frequent administration improve adherence, but are they better?. Pharmacoeconomics 2006; 24: 211-213. (Pubitemid 43374373)
6. Iskedjian M, Einarson TR, MacKeigan LD, et al.: Relationship between daily dose frequency and adherence to antihypertensive pharmacotherapy: evidence from a meta-analysis. Clin Ther 2002; 24: 302-316.
7. 7. Comté L, Vrijens B, Tousset E, Gérard P, Urquhart J. Estimation of the comparative therapeutic superiority of QD and BID dosing regimens, based on integrated analysis of dosing history data and pharmacokinetics. J Pharmacokinet Pharmacodyn 2007; 34: 549-558. (Pubitemid 47038128)
8. 8. Vrijens B, Urquhart J. Patient adherence to prescribed antimicrobial drug dosing regimens. J Antimicrob Chemother 2005; 55: 616-627. (Pubitemid 40691838)
9. 9. Flexner C. HIV drug development: the next 25 years. Nat Rev Drug Discov 2007; 6: 959-966. (Pubitemid 350201786)
10. 10. Paterson DL, Swindells S, Mohr J, et al. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med 2000; 133: 21-30. (Pubitemid 30432540)
11. Gross R, Bilker WB, Friedman HM, Strom BL. Effect of adherence to newly initiated antiretroviral therapy on plasma viral load. AIDS 2001; 15: 2109-12017
12. Carrieri MP, Leport C, Protopopescu C, et al. Factors associated with nonadherence to highly active antiretroviral therapy: a 5-year followup analysis with correction for the bias induced by missing data in the treatment maintenance phase. J Acquir Immune Defic Syndr 2006; 41: 477-485.
13. Mills EJ, Nachega JB, Bangsberg DR, et al. Adherence to HAART: a systematic review of developed and developing nation patient-reported barriers and facilitators. PLoS Med 2006; 3: e438.
14. Gross R, Bilker WB, Friedman HM, Coyne JC, Strom BL. Provider inaccuracy in assessing adherence and outcomes with newly initiated antiretroviral therapy. AIDS 2002; 16: 1835-1837.
15. Gross R, Tierney C, Andrade A, et al. Modified directly observed antiretroviral therapy compared with self-administered therapy in treatment naive HIV-1 infected patients: a randomized trial. Arch Intern Med 2009; 169: 1224-1232.
16. Stanford HIV Resistance Database, version 4.2.1. Created 31 July 2006. http://hivdb.stanford.edu/. Accessed 11 May 2009.
17. National Institute of Allergy and Infectious Diseases (NIAID). Table for grading the severity of adult and pediatric adverse events, version 1.0, December 2004. In: AIDS Clinical Trials Group (ACTG) toxicity tables, appendix II-B. Bethesda, MD: NIAID, 2004. http://rcc.tech-res-intl.com. Accessed 9 February 2010.
18. Rezk NL, Tidwell RR, Kashuba AD. High-performance liquid chromatography assay for the quantification of HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2004; 805: 241-247.
19. Eron JJ, Feinberg J, Kessler HA, et al. Once-daily versus twice-daily lopinavir/ritonavir in antiretroviral-naive HIV-positive patients: a 48week randomized clinical trial. J Infect Dis 2004; 189: 265-272. (Pubitemid 38147251)
20. 20. Johnson MA, Gathe JC Jr, Podzamczer D, et al. A once-daily lopinavir/ ritonavir-based regimen provides noninferior antiviral activity compared with a twice-daily regimen. J Acquir Immune Defic Syndr 2006; 43: 153-160. (Pubitemid 44454808)
21. Gathe J, Silva BA, Cohen DE, et al. A once-daily lopinavir/ritonavirbased regimen is noninferior to twice-daily dosing and results in similar safety and tolerability in antiretroviral-naive subjects through 48 weeks. J Acquir Immune Defic Syndr 2009; 50: 474-481.
22. Klein CE, Chiu Y-L, Awni W, et al. The tablet formulation of lopinavir/ ritonavir provides similar bioavailability to the soft gelatin capsule formulation with less pharmacokinetic variability and diminished food effect. J Acquir Immune Defic Syndr 2007; 44: 401-410.