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Please use this identifier to cite or link to this item: http://repository.li.mahidol.ac.th/dspace/handle/123456789/51961
Title: Single-dose tafenoquine to prevent relapse of plasmodium vivax malaria
Authors: Marcus V.G. Lacerda
Alejandro Llanos-Cuentas
Srivicha Krudsood
Chanthap Lon
David L. Saunders
Rezika Mohammed
Daniel Yilma
Dhelio Batista Pereira
Fe E.J. Espino
Reginaldo Z. Mia
Raul Chuquiyauri
Fernando Val
Martín Casapía
Wuelton M. Monteiro
Marcelo A.M. Brito
Mônica R.F. Costa
Nillawan Buathong
Harald Noedl
Ermias Diro
Sisay Getie
Kalehiwot M. Wubie
Alemseged Abdissa
Ahmed Zeynudin
Cherinet Abebe
Mauro S. Tada
Françoise Brand
Hans Peter Beck
Brian Angus
Stephan Duparc
Jörg Peter Kleim
Lynda M. Kellam
Victoria M. Rousell
Siôn W. Jones
Elizabeth Hardaker
Khadeeja Mohamed
Donna D. Clover
Kim Fletcher
John J. Breton
Cletus O. Ugwuegbulam
Justin A. Green
Gavin C.K.W. Koh
GlaxoSmithKline, USA
University of Gondar
Gokila
Universidad Peruana Cayetano Heredia
Jimma University
University of Oxford
Fundacao Oswaldo Cruz
Universitat Basel
Mahidol University
Medizinische Universitat Wien
Medicines for Malaria Venture
Rio Tuba Nickel Foundation Hospital
Centro de Pesquisas em Medicina Tropical
Keywords: Medicine
Issue Date: 17-Jan-2019
Citation: New England Journal of Medicine. Vol.380, No.3 (2019), 215-228
Abstract: Copyright © 2019 Massachusetts Medical Society. BACKGROUND Treatment of Plasmodium vivax malaria requires the clearing of asexual parasites, but relapse can be prevented only if dormant hypnozoites are cleared from the liver (a treatment termed “radical cure”). Tafenoquine is a single-dose 8-aminoquinoline that has recently been registered for the radical cure of P. vivax. METHODS This multicenter, double-blind, double-dummy, parallel group, randomized, placebo-controlled trial was conducted in Ethiopia, Peru, Brazil, Cambodia, Thailand, and the Philippines. We enrolled 522 patients with microscopically confirmed P. vivax infection (100 to 100,000 parasites per microliter) and normal glucose-6-phosphate dehydrogenase (G6PD) activity (with normal activity defined as ≥70% of the median value determined at each trial site among 36 healthy male volunteers who were otherwise not involved in the trial). All patients received a 3-day course of chloroquine (total dose of 1500 mg). In addition, patients were assigned to receive a single 300-mg dose of tafenoquine on day 1 or 2 (260 patients), placebo (133 patients), or a 15-mg dose of primaquine once daily for 14 days (129 patients). The primary outcome was the Kaplan-Meier estimated percentage of patients who were free from recurrence at 6 months, defined as P. vivax clearance without recurrent parasitemia. RESULTS In the intention-to-treat population, the percentage of patients who were free from recurrence at 6 months was 62.4% in the tafenoquine group (95% confidence interval [CI], 54.9 to 69.0), 27.7% in the placebo group (95% CI, 19.6 to 36.6), and 69.6% in the primaquine group (95% CI, 60.2 to 77.1). The hazard ratio for the risk of recurrence was 0.30 (95% CI, 0.22 to 0.40) with tafenoquine as compared with placebo (P0.001) and 0.26 (95% CI, 0.18 to 0.39) with primaquine as compared with placebo (P0.001). Tafenoquine was associated with asymptomatic declines in hemoglobin levels, which resolved without intervention. CONCLUSIONS Single-dose tafenoquine resulted in a significantly lower risk of P. vivax recurrence than placebo in patients with phenotypically normal G6PD activity.
URI: http://repository.li.mahidol.ac.th/dspace/handle/123456789/51961
metadata.dc.identifier.url: https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85060126699&origin=inward
ISSN: 15334406
00284793
Appears in Collections:Scopus 2019

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