New antimalarial drug requires higher doses to cure infection, suggests study elife elife
for the benefit of readers; ii) feedback on the manuscript for the authors, including requests for revisions, shown below. We also include an acceptance summary that explains what the editors found interesting or important about the work.Thank you for submitting your article"The clinical pharmacology of tafenoquine in the radical cure of.
"MetHb concentration was associated with an odds ratio for recurrence of 0.81 . Furthermore, consistent with this association between MetHb and vivax malaria recurrence , the day 7 MetHb levels were weakly inversely correlated with the tafenoquine weight-adjusted t1_2 values ." "The phase 1 study was a drug-drug interaction study, with volunteers randomised to either tafenoquine alone or tafenoquine in combination with DHA-PQP or artemether-lumefantrine , the standard antimalarial treatment regimens in both cases."
A review of all studies that have given tafenoquine as treatment for vivax malaria. This shows we have 77% of all studied patients in our individual patient data meta-analysis.I do not have any significant comments concerning the PK/PD modelling; they are clear and well-explored taking into consideration the retrospective nature of the report and the available data. That said, I feel that the manuscript can be improved, especially in what concerns the possibly overlooked importance of CYP2D6.
Production of methemoglobin is associated with the therapeutic effects of tafenoquine . This might be related to the fact that the tafenoquine clinically active metabolites that kill the parasite are also involved in oxidative stress creating higher levels of methemoglobin. In this scenario, I suggest that the authors investigate associations between the available CYP2D6 status and D7 methemoglobin levels.
An analysis looking at the relationship between CYP2D6 and the terminal half-life is of course restricted to patients who received tafenoquine. Out of the 651 patients treated with tafenoquine, only 391 were genotyped for CYP2D6 mutations and had sufficient drug levels to estimate a terminal half-life. Of these 391 patients, only 35 had an activity score of 0.5 or less. This would only provide statistical power to detect very large changes in terminal half-life or recurrence probability.
"The phase 1 study was a drug-drug interaction study, with volunteers randomised to either tafenoquine alone or tafenoquine in combination with DHA-PQP or artemether-lumefantrine , the standard antimalarial treatment regimens in both cases."
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