Imperial College London
Alternate

Dr Lionel Tan

Faculty of Medicine, Department of Infectious Disease

Honorary Clinical Senior Lecturer
 
 
 
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Contact

 

+44 (0)20 3313 2065lionel.tan

 
 
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Location

 

Commonwealth BuildingHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Vélez:2022:10.1016/S2352-4642(21)00328-X,
author = {Vélez, ID and Hien, TT and Green, JA and Martin, A and Sharma, H and Rousell, VM and Breton, JJ and Ernest, TB and Rolfe, K and Taylor, M and Mohamed, K and Jones, SW and Chau, NH and Hoa, NT and Duparc, S and Tan, LK and Goyal, N},
doi = {10.1016/S2352-4642(21)00328-X},
journal = {Lancet Child Adolesc Health},
pages = {86--95},
title = {Tafenoquine exposure assessment, safety, and relapse prevention efficacy in children with Plasmodium vivax malaria: open-label, single-arm, non-comparative, multicentre, pharmacokinetic bridging, phase 2 trial.},
url = {http://dx.doi.org/10.1016/S2352-4642(21)00328-X},
volume = {6},
year = {2022}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - BACKGROUND: Single-dose tafenoquine 300 mg is approved for Plasmodium vivax malaria relapse prevention in patients at least 16 years old. We aimed to determine appropriate oral tafenoquine paediatric dosing regimens, including a dispersible formulation, and evaluated tafenoquine efficacy and safety in children infected with P vivax. METHODS: This open-label, single-arm, non-comparative, multicentre, pharmacokinetic bridging, phase 2 study enrolled children (2-15 years) who weighed 5 kg or more, with glucose-6-phosphate dehydrogenase activity more than 70% of the local population median, and P vivax malaria infection, from three community health centres in Vietnam and one in Colombia. Patients received 3-day chloroquine plus oral single-dose tafenoquine as dispersible tablets (50 mg) or film-coated tablets (150 mg). Dosing groups were assigned by body weight, predicted to achieve similar median exposures as the approved 300 mg dose for adults: patients who weighed 5 kg or more to 10 kg received 50 mg, those who weighed more than 10 to 20 kg received 100 or 150 mg, those who weighed more than 20 to 35 kg received 200 mg, and patients who weighed more than 35 kg received 300 mg. Population pharmacokinetic analysis was done to develop a paediatric population pharmacokinetic model. The primary outcome was the tafenoquine area under the concentration-time curve extrapolated to infinity (AUC[0-∞]) by patient body weight in the pharmacokinetic population (all patients who received tafenoquine with at least one valid pharmacokinetic sample) estimated from a paediatric population pharmacokinetic model. A key prespecified secondary outcome was 4-month recurrence-free efficacy. This trial is registered with ClinicalTrials.gov, NCT02563496. FINDINGS: Between Feb 6, 2017, and Feb 17, 2020, 60 patients were enrolled into the study: 14 (23%) received tafenoquine 100 mg, five (8%) 150 mg, 22 (36%) 200 mg, and 19 (32%) 300 mg. The paediatric population pharmacokinetic model pre
AU  - Vélez,ID
AU  - Hien,TT
AU  - Green,JA
AU  - Martin,A
AU  - Sharma,H
AU  - Rousell,VM
AU  - Breton,JJ
AU  - Ernest,TB
AU  - Rolfe,K
AU  - Taylor,M
AU  - Mohamed,K
AU  - Jones,SW
AU  - Chau,NH
AU  - Hoa,NT
AU  - Duparc,S
AU  - Tan,LK
AU  - Goyal,N
DO  - 10.1016/S2352-4642(21)00328-X
EP  - 95
PY  - 2022///
SP  - 86
TI  - Tafenoquine exposure assessment, safety, and relapse prevention efficacy in children with Plasmodium vivax malaria: open-label, single-arm, non-comparative, multicentre, pharmacokinetic bridging, phase 2 trial.
T2  - Lancet Child Adolesc Health
UR  - http://dx.doi.org/10.1016/S2352-4642(21)00328-X
UR  - https://www.ncbi.nlm.nih.gov/pubmed/34871570
VL  - 6
ER  -
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