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Single-dose tafenoquine to prevent relapse of Plasmodium vivax malaria

Lacerda, Marcus V. G. and Llanos-Cuentas, Alejandro and Krudsood, Srivicha and Lon, Chanthap and Saunders, David L. and Mohammed, Rezika and Yilma, Daniel and Batista Pereira, Dhelio and Espino, Fe E. J. and Mia, Reginaldo Z. and Chuquiyauri, Raul and Val, Fernando and Casapía, Martín and Monteiro, Wuelton M. and Brito, Marcelo A. M. and Costa, Mônica R. F. and Buathong, Nillawan and Noedl, Harald and Diro, Ermias and Getie, Sisay and Wubie, Kalehiwot M. and Abdissa, Alemseged and Zeynudin, Ahmed and Abebe, Cherinet and Tada, Mauro S. and Brand, Françoise and Beck, Hans-Peter and Angus, Brian and Duparc, Stephan and Kleim, Jörg-Peter and Kellam, Lynda M. and Rousell, Victoria M. and Jones, Siôn W. and Hardaker, Elizabeth and Mohamed, Khadeeja and Clover, Donna D. and Fletcher, Kim and Breton, John J. and Ugwuegbulam, Cletus O. and Green, Justin A. and Koh, Gavin C. K. W.. (2019) Single-dose tafenoquine to prevent relapse of Plasmodium vivax malaria. The New England journal of medicine, 380 (3). pp. 215-228.

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Official URL: https://edoc.unibas.ch/68745/

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Abstract

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.; 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.; 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 (P<0.001) and 0.26 (95% CI, 0.18 to 0.39) with primaquine as compared with placebo (P<0.001). Tafenoquine was associated with asymptomatic declines in hemoglobin levels, which resolved without intervention.; Single-dose tafenoquine resulted in a significantly lower risk of P. vivax recurrence than placebo in patients with phenotypically normal G6PD activity. (Funded by GlaxoSmithKline and Medicines for Malaria Venture; DETECTIVE ClinicalTrials.gov number, NCT01376167 .).
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Former Units within Swiss TPH > Molecular Parasitology and Epidemiology (Beck)
UniBasel Contributors:Brand, Françoise and Beck, Hans-Peter
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Massachusetts Medical Society
ISSN:1533-4406
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:29 Jan 2019 14:45
Deposited On:29 Jan 2019 14:45

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