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Tytuł:
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Efficacy and safety of replacing lopinavir with atazanavir in HIV-infected patients with undetectable plasma viraemia: final results of the SLOAT trial.
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Autorzy:
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Soriano V; Department of Infectious Diseases, Hospital Carlos III, Calle Sinesio Delgado 10, 28029 Madrid, Spain. />García-Gasco P
Vispo E
Ruiz-Sancho A
Blanco F
Martín-Carbonero L
Rodríguez-Novoa S
Morello J
de Mendoza C
Rivas P
Barreiro P
González-Lahoz J
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Źródło:
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The Journal of antimicrobial chemotherapy [J Antimicrob Chemother] 2008 Jan; Vol. 61 (1), pp. 200-5. Date of Electronic Publication: 2007 Nov 13.
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Typ publikacji:
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Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: 1997- : London : Oxford University Press
Original Publication: London, New York, Academic Press.
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MeSH Terms:
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HIV Infections/*drug therapy
HIV Protease Inhibitors/*therapeutic use
HIV-1/*drug effects
Oligopeptides/*therapeutic use
Pyridines/*therapeutic use
Pyrimidinones/*therapeutic use
Adult ; Aged ; Antiretroviral Therapy, Highly Active ; Atazanavir Sulfate ; Blood Glucose/analysis ; CD4 Lymphocyte Count ; Drug Administration Schedule ; Female ; Follow-Up Studies ; HIV Infections/blood ; HIV Infections/virology ; HIV Protease Inhibitors/administration & dosage ; HIV Protease Inhibitors/adverse effects ; HIV-1/isolation & purification ; Humans ; Lipids/blood ; Lopinavir ; Male ; Middle Aged ; Oligopeptides/administration & dosage ; Oligopeptides/adverse effects ; Prospective Studies ; Pyridines/administration & dosage ; Pyridines/adverse effects ; Pyrimidinones/administration & dosage ; Pyrimidinones/adverse effects ; RNA, Viral/blood ; Treatment Outcome
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Substance Nomenclature:
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0 (Blood Glucose)
0 (HIV Protease Inhibitors)
0 (Lipids)
0 (Oligopeptides)
0 (Pyridines)
0 (Pyrimidinones)
0 (RNA, Viral)
2494G1JF75 (Lopinavir)
4MT4VIE29P (Atazanavir Sulfate)
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Entry Date(s):
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Date Created: 20071115 Date Completed: 20080228 Latest Revision: 20151119
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Update Code:
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20240104
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DOI:
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10.1093/jac/dkm413
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PMID:
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17999977
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Background: Atazanavir seems to be a protease inhibitor (PI) with a more favourable metabolic profile. Information regarding the potential benefit of replacing lopinavir/ritonavir by atazanavir in HIV-infected patients with prolonged viral suppression is scarce. If proved, this strategy could be particularly attractive for the subset of patients with greater cardiovascular risk.
Methods: SLOAT was a prospective, open, comparative trial in which patients receiving lopinavir/ritonavir-based regimens and having undetectable plasma HIV-RNA for longer than 24 weeks were randomized to continue on the same therapy or switch to atazanavir. Outcomes in viral rebound, CD4 counts, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides and glucose were compared in both groups of patients at 48 weeks of follow-up.
Results: A total of 189 patients were recruited and took at least the first dose of the assigned treatment arm. Overall, 102 switched to atazanavir (49 on 400 mg once daily, and 53 on 300 mg plus 100 mg of ritonavir once daily due to concomitant tenofovir use) and 87 continued on lopinavir/ritonavir. All patients received the PI along with two nucleoside analogues. Virological failure occurred in 12 patients switched to atazanavir and 9 continuing on lopinavir/ritonavir. A reduction (P < 0.001) in median total cholesterol (-19 mg/dL) and triglycerides (-80 mg/dL) was observed after 48 weeks of atazanavir switching, whereas no significant changes occurred in the lopinavir/ritonavir arm. Greater reductions in total cholesterol and triglycerides were seen in patients switched to atazanavir without ritonavir boosting.
Conclusions: The replacement of lopinavir/ritonavir by atazanavir provides an overall significant reduction in total cholesterol and triglycerides, without increased risk of virological failure.
