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Title: Development of weight and age-based dosing of daily primaquine for radical cure of vivax malaria
Authors: Walter Robert Taylor
Richard M. Hoglund
Pimnara Peerawaranun
Thuy Nhien Nguyen
Tran Tinh Hien
Arnaud Tarantola
Lorenz von Seidlein
Rupam Tripura
Thomas J. Peto
Arjen M. Dondorp
Jordi Landier
Francois H.Nosten
Frank Smithuis
Koukeo Phommasone
Mayfong Mayxay
Soy Ty Kheang
Chy Say
Kak Neeraj
Leang Rithea
Lek Dysoley
Sim Kheng
Sinoun Muth
Arantxa Roca-Feltrer
Mark Debackere
Rick M. Fairhurst
Ngak Song
Philippe Buchy
Didier Menard
Nicholas J. White
Joel Tarning
Mavuto Mukaka
Faculty of Tropical Medicine, Mahidol University
University Research Co., LLC
Amsterdam Institute for Global Health and Development
Oxford University Clinical Research Unit
FHI 360
Sciences Economiques et Sociales de la Santé et Traitement de l'Information Médicale
Malaria Consortium
Institut Pasteur du Cambodge
Shoklo Malaria Research Unit
National Institute of Allergy and Infectious Diseases (NIAID)
Mahosot Hospital, Lao
Nuffield Department of Medicine
Institut Pasteur, Paris
Amsterdam UMC - University of Amsterdam
AQUITY Global Inc.
Myanmar Oxford Clinical Research Unit
University of Health Sciences
MSF Belgium Cambodia Malaria Program
GSK Vaccines
National Center for Parasitology
National Institute of Public Health
Keywords: Immunology and Microbiology;Medicine
Issue Date: 1-Dec-2021
Citation: Malaria Journal. Vol.20, No.1 (2021)
Abstract: Background: In many endemic areas, Plasmodium vivax malaria is predominantly a disease of young adults and children. International recommendations for radical cure recommend fixed target doses of 0.25 or 0.5 mg/kg/day of primaquine for 14 days in glucose-6-phosphate dehydrogenase normal patients of all ages. However, for many anti-malarial drugs, including primaquine, there is evidence that children have lower exposures than adults for the same weight-adjusted dose. The aim of the study was to develop 14-day weight-based and age-based primaquine regimens against high-frequency relapsing tropical P. vivax. Methods: The recommended adult target dose of 0.5 mg/kg/day (30 mg in a 60 kg patient) is highly efficacious against tropical P. vivax and was assumed to produce optimal drug exposure. Primaquine doses were calculated using allometric scaling to derive a weight-based primaquine regimen over a weight range from 5 to 100 kg. Growth curves were constructed from an anthropometric database of 53,467 individuals from the Greater Mekong Subregion (GMS) to define weight-for-age relationships. The median age associated with each weight was used to derive an age-based dosing regimen from the weight-based regimen. Results: The proposed weight-based regimen has 5 dosing bands: (i) 5–7 kg, 5 mg, resulting in 0.71–1.0 mg/kg/day; (ii) 8–16 kg, 7.5 mg, 0.47–0.94 mg/kg/day; (iii) 17–40 kg, 15 mg, 0.38–0.88 mg/kg/day; (iv) 41–80 kg, 30 mg, 0.37–0.73 mg/kg/day; and (v) 81–100 kg, 45 mg, 0.45–0.56 mg/kg/day. The corresponding age-based regimen had 4 dosing bands: 6–11 months, 5 mg, 0.43–1.0 mg/kg/day; (ii) 1–5 years, 7.5 mg, 0.35–1.25 mg/kg/day; (iii) 6–14 years, 15 mg, 0.30–1.36 mg/kg/day; and (iv) ≥ 15 years, 30 mg, 0.35–1.07 mg/kg/day. Conclusion: The proposed weight-based regimen showed less variability around the primaquine dose within each dosing band compared to the age-based regimen and is preferred. Increased dose accuracy could be achieved by additional dosing bands for both regimens. The age-based regimen might not be applicable to regions outside the GMS, which must be based on local anthropometric data. Pharmacokinetic data in small children are needed urgently to inform the proposed regimens.
ISSN: 14752875
Appears in Collections:Scopus 2021

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