Publication:
Single-dose tafenoquine to prevent relapse of plasmodium vivax malaria

Issued Date

2019-01-17

Resource Type

Article

ISSN

15334406
00284793

DOI

10.1056/NEJMoa1710775

Other identifier(s)

2-s2.0-85060126699

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

New England Journal of Medicine. Vol.380, No.3 (2019), 215-228

Suggested Citation

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 Single-dose tafenoquine to prevent relapse of plasmodium vivax malaria. New England Journal of Medicine. Vol.380, No.3 (2019), 215-228. doi:10.1056/NEJMoa1710775 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/51961

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Title

Single-dose tafenoquine to prevent relapse of plasmodium vivax malaria

Author(s)

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

Other Contributor(s)

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

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.

Keyword(s)

Medicine

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URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/51961

Collections

Scopus 2019