The WWARN Lumefantrine Pharmacokinetic / Pharmacodynamic (PK / PD) Study Group received a Brian Sharp Award during the closing ceremony at the 6th MIM Pan-African Malaria Conference in Durban, South Africa on October 11, 2013.
On behalf of the WWARNLumefantrine PK / PD Study Group, Professor Karen I Barnes presented “Defining adequate lumefantrine exposure in patients with uncomplicated malaria treated with artemether-lumefantrine” during the October 8th session entitled “Malaria Elimination”.
Achieving adequate antimalarial drug exposure is critical for eradicating malaria. Drug exposure (pharmacokinetic, PK) and treatment response (pharmacodynamic, PD) data from individual studies are generally insufficient to accurately define the minimum drug exposure required to achieve a cure. The ‘therapeutic’ day 7 lumefantrine concentrations published to date range widely (170 to 500 ng / mL), suggesting that this threshold needs to be better defined to differentiate whether treatment failure is due to drug resistance or inadequate drug exposure.
To address this question the WWARN Pharmacology Module has led the largest pooled analysis of individual patient antimalarial PK-PD data to date. With the cooperation of over 36 researchers globally, PK-PD data from 26 studies in 3,926 patients was contributed to the analysis, comprising 92.6% of all patients enrolled in lumefantrine PK-PD studies. This Lumefantrine PK-PD Study Group has focused initially on examining the relationship between day 7 lumefantrine concentrations and treatment response as a simple measure of drug exposure associated with patient treatment response. A day 7 lumefantrine concentration of 200 ng / mL was sufficient for most populations, but higher concentrations appear needed to prevent treatment failure in some vulnerable populations, including underweight-for-age young children. These results will be submitted for publication soon.
The WWARN Pharmacology Module was established with members of the WWARN malaria community in order to help both with defining drug resistance accurately, and contribute to the evidence base needed to inform optimal dosing for each key target population. In order to address these questions, research study groups have worked together to share clinical trial results, pool and analyse data, and provide evidence that can inform decision-makers on the optimal antimalarial dosing regimen for different target populations, such as young children.
This Brian Sharp Award acknowledges the value of a pooled analysis approach to answering critical research questions, and the continued contribution this approach could make in monitoring therapeutic efficacy and developing strategies to prolong the useful therapeutic life of our most widely-used antimalarial treatments.
Through continued collaboration we can also contribute to the international effort to diminish the threat of antimalarial resistance emerging in or spreading across Africa.
For further information or to ask a question related to the WWARN Pharmacology Module and the Lumefantrine PK-PD Study Group, please contact email: email@example.com