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    Jan 17, 2021
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    Supervised versus unsupervised antimalarial treatment with six-dose artemether-lumefantrine: pharmacokinetic and dosage-related findings from a clinical trial in Uganda.

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    Authors
    Checchi, F
    Piola, P
    Fogg, C
    Bajunirwe, F
    Biraro, S
    Grandesso, F
    Ruzagira, E
    Babigumira, J
    Kigozi, I
    Kiguli, J
    Kyomuhendo, J
    Ferradini, L
    Taylor, W R J
    Guthmann, J P
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    Affiliation
    Epicentre, Paris, France. francesco.checchi@lshtm.ac.uk
    Issue Date
    2006
    
    Metadata
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    Journal
    Malaria Journal
    Abstract
    BACKGROUND: A six-dose antimalarial regimen of artemether-lumefantrine (A/L) may soon become one of the most widely used drug combination in Africa, despite possible constraints with adherence and poor absorption due to inadequate nutrition, and a lack of pharmacokinetic and effectiveness data. METHODS: Within a trial of supervised versus unsupervised A/L treatment in a stable Ugandan Plasmodium falciparum transmission setting, plasma lumefantrine concentrations were measured in a subset of patients on day 3 (C [lum]day3) and day 7 (C [lum]day7) post-inclusion. Predictors of lumefantrine concentrations were analysed to show how both C [lum]day7 and the weight-adjusted lumefantrine dose affect 28-day recrudescence and re-infection risks. The implications of these novel findings are discussed in terms of the emergence of lumefantrine-resistant strains in Africa. RESULTS: C [lum]day3 and C [lum]day7 distributions among 241 supervised and 238 unsupervised patients were positively skewed. Unsupervised treatment and decreasing weight-adjusted lumefantrine dose were negatively associated with C [lum]day3. Unsupervised treatment and decreasing age showed strong negative associations with C [lum]day7. Both models were poorly predictive (R-squared < 0.25). There were no recrudescences in either arm, but decreasing lumefantrine dose per Kg resulted in up to 13-fold higher adjusted risks of re-infection. Re-infections occurred only among patients with C [lum]day7 below 400 ng/mL (p < 0.001). CONCLUSION: Maintaining the present six-dose regimen and ensuring high adherence and intake are essential to maximize the public health benefits of this valuable drug combination.
    Publisher
    BioMed Central
    URI
    http://hdl.handle.net/10144/18902
    DOI
    10.1186/1475-2875-5-59
    PubMed ID
    16854236
    Additional Links
    http://www.malariajournal.com
    Language
    en
    ISSN
    1475-2875
    ae974a485f413a2113503eed53cd6c53
    10.1186/1475-2875-5-59
    Scopus Count
    Collections
    Malaria

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