Lamivudine/abacavir maintains virological superiority over zidovudine/lamivudine and zidovudine/abacavir beyond 5 years in children

AIDS

Volumn 21, Issue 8, 2007, Pages 947-955

  Green, H ^a   Gibb, D M ^a   Walker, A S ^a   Pillay, D ^a   Butler, K ^a   Candeias, F ^a   Castelli Gattinara, G ^a   Compagnucci, A ^a   Della Negra, M ^a   De Rossi, A ^a   Feiterna Sperling, C ^a   Giaquinto, C ^a   Harper, L ^a   Levy, J ^a   Saidi, Y ^a   Wintergerst, U ^a  

^a MRC CLINICAL TRIALS UNIT   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; ABACAVIR PLUS LAMIVUDINE; LAMIVUDINE PLUS ZIDOVUDINE; NELFINAVIR; PLACEBO; RNA DIRECTED DNA POLYMERASE INHIBITOR; ZIDOVUDINE;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ARTICLE; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SUBSTITUTION; FOLLOW UP; GENE MUTATION; GENE REPRESSION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADOLESCENT; ANTI-HIV AGENTS; ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; CD4 LYMPHOCYTE COUNT; CHILD; CHILD, PRESCHOOL; DIDEOXYNUCLEOSIDES; DRUG RESISTANCE, VIRAL; FOLLOW-UP STUDIES; GROWTH; HIV INFECTIONS; HIV-1; HUMANS; INFANT; LAMIVUDINE; REVERSE TRANSCRIPTASE INHIBITORS; RNA, VIRAL; TREATMENT OUTCOME; VIRAL LOAD; ZIDOVUDINE;

EID: 34247584016     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAD.0b013e3280e087e7     Document Type: Article

References (29)

1. Palella FJ, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med 1998; 338:853-860.
2. Gibb DM, Duong T, Tookey PA, Sharland M, Tudor-Williams G, Novelli et al. Decline in mortality, AIDS, and hospital admissions in perinatally HIV-1 infected children in the United Kingdom and Ireland. BMJ 2003; 327:1019-1023.
3. Van Rossum AM, Fraaij PL, de Groot R. Efficacy of highly active antiretroviral therapy in HIV-1 infected children. Lancet Infect Dis 2002; 2:93-102.
4. Walker AS, Doerholt K, Sharland M, Gibb DM, Collaborative HIV Paediatric Study (CHIPS) Steering Committee. Response to highly active antiretroviral therapy varies with age: the UK and Ireland Collaborative HIV Paediatric Study. AIDS 2004; 18:1915-1924.
5. Bartlett J, Fath M, DeMasi R, Quinn J, Hermes A, Rousseau F. An updated meta-analysis of triple combination therapy in antiretroviral-naïve HIV-infected adults. Twelfth Conference on Retroviruses and Opportunistic Infections. Boston, MA, February 2005 [abstract?].
6. Robbins GK, De Gruttola V, Shafer RW, Smeaton LM, Snyder SW, Pettinelli C, et al., AIDS Clinical Trials Group 384 Team. Comparison of sequential three-drug regimens as initial therapy for HIV-1 infection. N Engl J Med 2003; 349:2293-2303.
7. van Leth F, Phanuphak P, Ruxrungtham K, Baraldi E, Miller S, Gazzard B, et al. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet 2004; 363:1253-1263.
8. Gallant JE, DeJesus E, Arribas JR, Pozniak AL, Gazzard B, Campo RE, Study 934 Group. Tenofovir DF, emtricitabine, and efavrienz vs. zidovudine, lamivudine, and efavirenz for HIV. N Engl J Med 2006; 354:251-260.
9. McKinney RE Jr, Johnson GM, Stanley K, Yong FH, Keller A, O'Donnell KJ, et al. A randomised study of combined zidovudine-lamivudine versus didanosine monotherapy in children with symptomatic therapy-naïve HIV-1 infection. The Pediatric AIDS Clinical Trials Group Protocol 300 Study Team. J Pediatr 1998; 133:500-508.
10. Paediatric European Network for Treatment of AIDS (PENTA). A randomised trial to compare dual nucleoside-analogue reverse transcriptase inhibitor regimens (ZDV+3TC or ZDV+ABC or 3TC+ABC) with and without a protease inhibitor (nelfinavir) in previously untreated HIV-infected children: The PENTA 5 Trial. Lancet 2002; 359:733-740.
11. Gibb DM, Melvin A, Compagnucci A, McKinney R, Tudor-Williams G, Walker AS, et al. on behalf of the PENPACT 1 Trial. Choice of first-line ART regimen in PENPACT 1: a randomized trial of combination antiretroviral regimens and treatment switching strategies in antiretroviral naive children >30 days and <18 years of age. XV International Conference on AIDS. Bangkok, July 2004 [abstract TuPeB4442].
12. Gibb DM, Walker AS, Kaye S, De Rossi A, Ait-Khaled M, Pillay D, et al. Evolution of antiretroviral phenotypic and genotypic drug resistance in antiretroviral naïve HIV-1 infected children treated with abacavir/lamivudine, zidovudine/lamivudine or abacavir/zidovudine, with or without nelfinavir (the PENTA 5 trial). Antiviral Therapy 2002; 7:293-303.
13. Marschner IC, Betensky RA, DeGruttola V, Hammer SM, Kuritzkes DR. Clinical trials using HIV-1 RNA-based primary endpoints: Statistical analysis and potential biases. J Acquir Immune Defic Syndr 1999; 20:220-227.
14. Liang K-Y, Zeger SL. Longitudinal data analysis using generalized linear models. Biometrika 1986; 73:13-22.
15. Wade AM, Ades AE. Age related reference ranges: significance test for models and confidence intervals for centiles. Stat Med 1994; 13:2359-2367.
16. Freeman JV, Cole TJ, Chinn S, Jones PRM, White EM, Preece MA. Cross-sectional stature and weight references curves for the UK 1990. Arch Dis Child 1995; 73:17-24.
17. Gibb DM, Goodall RL, Giacomet V, McGee L, Compagnucci A, Lyall H, Paediatric European Network for Treatment of AIDS Steering Committee. Adherence to prescribed antiretroviral therapy in human immunodeficiency virus-infected children in the PENTA 5 trial. Pediatr Infect Dis J 2003; 22:56-62.
18. Cozzi-Lepri A, Ruiz L, Loveday C, Phillips AN, Clotet B, Reiss P, et al., EuroSIDA Study Group. Thymidine analogue mutation profiles: factors associated with acquiring specific profiles and their impact on the virological response to therapy. Antiviral Therapy 2005; 10:791-802.
19. Deval J, Navarro JM, Selmi B, Courcambeck J, Boretto J, Halfon P, et al. A loss of viral replicative capacity correlates with altered DNA polymerization kinetics by the human immunodeficiency virus reverse transcriptase bearing the K65R and L74V dideoxynucleoside resistance substitutions. J Biol Chem 2004; 279:25489-25496.
20. Sharma PL, Nurpeisov V, Lee K, Skaggs S, Di San Filippo CA, Schinazi RF. Replication-dependent 65R→K reversion in human immunodeficiency virus type 1 reverse transcriptase double mutant K65R R L74V. Virology 2004; 321:222-234.
21. Wirden M, Malet I, Derache A, Marcelin AG, Roquebert B, Simon A, et al. Clonal analyses of HIV quasispecies in patients harbouring plasma genotype with K65R mutation associated with thymidine analogue mutations or L74V substitution. AIDS 2005; 19:630-632.
22. Lanier ER, Givens N, Stone C, Griffin P, Gibb D, Walker S, et al. Effect of concurrent zidovudine use on the resistance pathway selected by abacavir-containing regimens. HIV Medicine 2004; 5:394-399.
23. Delaunay C, Brun-Vezinet F, Landman R, Collin G, Peytavin G, Trylesinski A, et al. Comparative selection of the K65R and M184V/I mutations in human immunodeficiency virus type 1-infected patients enrolled in a trial of first-line triple-nucleoside analog therapy (Tonus IMEA 021). J Virol 2005; 79:9572-9578.
24. White KL, Margot NA, Ly JK, Chen JM, Ray AS, Pavelko M, et al. A combination of decreased NRTI incorporation and decreased excision determines the resistance profile of HIV-1 K65R RT. AIDS 2005; 19:1751-1760.
25. World Health Organization. Antiretroviral therapy of HIV infection in infants and children in resource-limited settings, towards universal access: recommendations for a public health approach (2006 revision). Geneva: WHO; 2006.
26. Birkus G, Hitchcock JMH, Cihlar T. Assessment of mitochondrial toxicity in human cells treated with tenofovir: comparison with other nucleoside reverse transcriptase inhibitors. Antimicrob Agents Chemother 2002; 46:716-723.
27. Moyle G. Mechanisms of HIV and nucleoside reverse transcriptase inhibitor injury to mitochondria. Antivir Ther 2005; 10 (Suppl 2):M47-M52.
28. Munderi P on behalf of the DART trial team. Safety of nevirapine compared to abacavir on a background of zidovudine/lamivudine as first-line antiretroviral therapy: a randomised double-blind trial. Thirteenth Conference on Retroviruses and Opportunistic Infections. Denver, CO, February 2006 [abstract 109LB].
29. Bergshoeff A, Burger D, Verweij C, Farrelly L, Flynn J, Le Provost M, et al. Plasma pharmacokinetics of once- versus twice- daily lamivudine and abacavir: simplification of combination treatment in HIV-1 infected children (PENTA-13). Antiviral Ther 2005; 10:239-246.