The data collection and curation was completed by the end of 2012, and includes data from 4,357 individuals (4122 malaria patients and 235 healthy volunteers) with a total of 18,440 lumefantrine and 1,099 desbutyl-lumefantrine concentrations.
In addition, a population PK/PD analysis is currently ongoing, including patients contributing two or more venous samples. This subset of data consist of a total of 1,347 patients, from Africa (n=650), Southeast Asia (n=596) and Oceania (n=101). The remaining pharmacokinetic data, comprising sparse sampled data (i.e. fewer than 2 samples per patient) and/or data from different biological matrices such as capillary plasma, venous blood and capillary blood is used for external validation of the model. The population pharmacokinetic model will subsequently be linked to outcome data with a time-to-event model to describe recurrent malaria infections. Ultimately, this pharmacokinetic-pharmacodynamic model will be used to conduct in-silico dose optimisations.
The group published: Artemether-lumefantrine treatment of uncomplicated Plasmodium falciparum malaria: a systematic review and meta-analysis of day 7 lumefantrine concentrations and therapeutic response using individual patient data in BMC Medicine in 2015.
A follow-on was then published in which the group developed a secondary analysis: Artemether-lumefantrine dosing for malaria treatment in young children and pregnant women: A pharmacokinetic-pharmacodynamic meta-analysis in PLOS Medicine in 2018.