1. Single-Dose Tafenoquine to Prevent Relapse ofPlasmodium vivaxMalaria
- Author
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Kalehiwot M Wubie, Marcus V. G. Lacerda, Françoise Brand, Kim Fletcher, Alemseged Abdissa, Nillawan Buathong, Elizabeth Hardaker, Harald Noedl, Victoria M Rousell, Ermias Diro, Jörg-Peter Kleim, Monica R. F. Costa, Brian Angus, John J Breton, Alejandro Llanos-Cuentas, Lynda Kellam, Reginaldo Z Mia, Marcelo A M Brito, Martin Casapia, Hans-Peter Beck, Fe Espino, Raul Chuquiyauri, Wuelton Marcelo Monteiro, Rezika Mohammed, Donna D Clover, Fernando Val, Sisay Getie, Justin A. Green, Dhelio Batista Pereira, Daniel Yilma, Stephan Duparc, Mauro Shugiro Tada, Cherinet Abebe, Ahmed Zeynudin, Siôn W. Jones, Khadeeja Mohamed, David L. Saunders, Cletus O Ugwuegbulam, Gavin C. K. W. Koh, Chanthap Lon, and Srivicha Krudsood
- Subjects
Male ,double blind procedure ,drug safety ,Primaquine ,Kaplan Meier method ,Tafenoquine ,Philippines ,Plasmodium vivax ,Kaplan-Meier Estimate ,tafenoquine ,Parasitemia ,aminoquinoline derivative ,030204 cardiovascular system & hematology ,chloroquine ,Hemoglobins ,chemistry.chemical_compound ,0302 clinical medicine ,Chloroquine ,Peru ,Secondary Prevention ,030212 general & internal medicine ,Antimalarial Agent ,disease free survival ,methemoglobin ,relapse ,glucose 6 phosphate dehydrogenase ,parasite clearance ,biology ,adult ,Plasmodium vivax malaria ,single drug dose ,food and beverages ,clinical trial ,General Medicine ,Thailand ,enzyme activity ,Intention to Treat Analysis ,G6PD protein, human ,female ,Cytochrome P-450 CYP2D6 ,priority journal ,retinal hypopigmentation ,Aminoquinolines ,disease severity ,Drug Therapy, Combination ,Cambodia ,hypopigmentation ,Brazil ,recurrence risk ,medicine.drug ,combination drug therapy ,Adolescent ,hematocrit ,Glucosephosphate Dehydrogenase ,Disease-Free Survival ,Article ,Antimalarials ,03 medical and health sciences ,Pharmacotherapy ,Double-Blind Method ,retina disease ,parasitic diseases ,Malaria, Vivax ,medicine ,Humans ,controlled study ,human ,procedures ,cytochrome P450 2D6 ,dizziness ,keratopathy ,treatment duration ,phase 3 clinical trial ,antimalarial agent ,isolation and purification ,business.industry ,statistical model ,fungi ,hemoglobin ,medicine.disease ,biology.organism_classification ,major clinical study ,Virology ,purl.org/pe-repo/ocde/ford#3.02.00 [https] ,phase 2 clinical trial ,Logistic Models ,multicenter study ,chemistry ,randomized controlled trial ,placebo ,Ethiopia ,business ,metabolism ,Malaria - Abstract
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 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 (P Conclusions 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. opens in new tab.)
- Published
- 2019
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