1. Tafenoquine versus primaquine to prevent relapse of plasmodium vivax malaria
- Author
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Iván D. Vélez, Wuelton Marcelo Monteiro, Lindsay Kendall, Siôn W. Jones, Victoria M Rousell, Raul Chuquiyauri, Chayadol S Namaik-Larp, Justin A. Green, Marcus V. G. Lacerda, Graham Craig, Marcelo A M Brito, François Nosten, Gavin C. K. W. Koh, Fernando Val, Cindy S. Chu, Elizabeth Hardaker, Ratchadaporn Papwijitsil, Tran Tinh Hien, Sandra Aruachan, Donna D Clover, Martin Casapia, Alejandro Llanos-Cuentas, Germana Bancone, Brian Angus, Viviana M Wilches, Maria F Villegas, Chau H Nguyen, John J Breton, Stephan Duparc, Monica R. F. Costa, and Khadeeja Mohamed
- Subjects
Male ,double blind procedure ,Kaplan Meier method ,insomnia ,Plasmodium vivax ,diarrhea ,Parasitemia ,Primaquine ,tafenoquine ,aminoquinoline derivative ,chloroquine ,0302 clinical medicine ,Secondary Prevention ,Prospective Studies ,disease free survival ,comparative study ,upper abdominal pain ,adult ,clinical trial ,General Medicine ,nausea ,backache ,priority journal ,disease severity ,Drug Therapy, Combination ,prospective study ,complication ,QT prolongation ,Relapse prevention ,Article ,Disease-Free Survival ,03 medical and health sciences ,Antimalarials ,blurred vision ,Humans ,human ,procedures ,glucose 6 phosphate dehydrogenase deficiency ,treatment duration ,hemoglobin ,medicine.disease ,major clinical study ,drug efficacy ,multicenter study ,chemistry ,Immunology ,randomized controlled trial ,asthenia ,urinary tract infection ,Malaria ,methemoglobinemia ,vomiting ,drug safety ,Tafenoquine ,recurrent disease ,Kaplan-Meier Estimate ,030204 cardiovascular system & hematology ,chemistry.chemical_compound ,Hemoglobins ,Chloroquine ,Recurrence ,creatine kinase blood level ,030212 general & internal medicine ,Antimalarial Agent ,fever ,glucose 6 phosphate dehydrogenase ,biology ,Plasmodium vivax malaria ,rhinopharyngitis ,single drug dose ,enzyme activity ,G6PD protein, human ,female ,Aminoquinolines ,Original Article ,enzyme deficiency ,headache ,medicine.drug ,combination drug therapy ,Adolescent ,side effect ,alanine aminotransferase ,Glucosephosphate Dehydrogenase ,Double-Blind Method ,parasitic diseases ,medicine ,hypokalemia ,Malaria, Vivax ,pneumonia ,controlled study ,coughing ,dizziness ,hemoglobin blood level ,phase 3 clinical trial ,business.industry ,antimalarial agent ,creatine kinase ,isolation and purification ,pharyngitis ,pruritus ,biology.organism_classification ,purl.org/pe-repo/ocde/ford#3.02.00 [https] ,Glucosephosphate Dehydrogenase Deficiency ,business ,metabolism ,alanine aminotransferase blood level - Abstract
BACKGROUND Tafenoquine, a single-dose therapy for Plasmodium vivax malaria, has been associated with relapse prevention through the clearance of P. vivax parasitemia and hypnozoites, termed “radical cure.” METHODS We performed a phase 3, prospective, double-blind, double-dummy, randomized, controlled trial to compare tafenoquine with primaquine in terms of safety and efficacy. The trial was conducted at seven hospitals or clinics in Peru, Brazil, Colombia, Vietnam, and Thailand and involved patients with normal glucose-6-phosphate dehydrogenase (G6PD) enzyme activity and female patients with moderate G6PD enzyme deficiency; all patients had confirmed P. vivax parasitemia. The patients were randomly assigned, in a 2:1 ratio, to receive a single 300-mg dose of tafenoquine or 15 mg of primaquine once daily for 14 days (administered under supervision); all patients received a 3-day course of chloroquine and were followed for 180 days. The primary safety outcome was a protocol-defined decrease in the hemoglobin level (>3.0 g per deciliter or ≥30% from baseline or to a level of
- Published
- 2019