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Tafenoquine versus primaquine to prevent relapse of plasmodium vivax malaria

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dc.contributor.author Llanos Cuentas, Elmer Alejandro
dc.contributor.author Lacerda, M.V.G.
dc.contributor.author Hien, T.T.
dc.contributor.author Vélez, I.D.
dc.contributor.author Namaik-Larp, C.
dc.contributor.author Chu, C.S.
dc.contributor.author Villegas, M.F.
dc.contributor.author Val, F.
dc.contributor.author Monteiro, W.M.
dc.contributor.author Brito, M.A.M.
dc.contributor.author Costa, M.R.F.
dc.contributor.author Chuquiyauri, R.
dc.contributor.author Casapía, M.
dc.contributor.author Nguyen, C.H.
dc.contributor.author Aruachan, S.
dc.contributor.author Papwijitsil, R.
dc.contributor.author Nosten, F.H.
dc.contributor.author Bancone, G.
dc.contributor.author Angus, B.
dc.contributor.author Duparc, S.
dc.contributor.author Craig, G.
dc.contributor.author Rousell, V.M.
dc.contributor.author Jones, S.W.
dc.contributor.author Hardaker, E.
dc.contributor.author Clover, D.D.
dc.contributor.author Kendall, L.
dc.contributor.author Mohamed, K.
dc.contributor.author Koh, G.C.K.W.
dc.contributor.author Wilches, V.M.
dc.contributor.author Breton, J.J.
dc.contributor.author Green, J.A.
dc.date.accessioned 2019-07-04T17:01:20Z
dc.date.available 2019-07-04T17:01:20Z
dc.date.issued 2019
dc.identifier.uri https://hdl.handle.net/20.500.12866/6917
dc.description.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 <6.0 g per deciliter). Freedom from recurrence of P. vivax parasitemia at 6 months was the primary efficacy outcome in a planned patient-level meta-analysis of the current trial and another phase 3 trial of tafenoquine and primaquine (per-protocol populations), and an odds ratio for recurrence of 1.45 (tafenoquine vs. primaquine) was used as a noninferiority margin. RESULTS: A protocol-defined decrease in the hemoglobin level occurred in 4 of 166 patients (2.4%; 95% confidence interval [CI], 0.9 to 6.0) in the tafenoquine group and in 1 of 85 patients (1.2%; 95% CI, 0.2 to 6.4) in the primaquine group, for a between-group difference of 1.2 percentage points (95% CI, -4.2 to 5.0). In the patient-level meta-analysis, the percentage of patients who were free from recurrence at 6 months was 67.0% (95% CI, 61.0 to 72.3) among the 426 patients in the tafenoquine group and 72.8% (95% CI, 65.6 to 78.8) among the 214 patients in the primaquine group. The efficacy of tafenoquine was not shown to be noninferior to that of primaquine (odds ratio for recurrence, 1.81; 95% CI, 0.82 to 3.96). CONCLUSIONS: Among patients with normal G6PD enzyme activity, the decline in hemoglobin level with tafenoquine did not differ significantly from that with primaquine. Tafenoquine showed efficacy for the radical cure of P. vivax malaria, although tafenoquine was not shown to be noninferior to primaquine. en_US
dc.language.iso eng
dc.publisher Massachusetts Medical Society
dc.relation.ispartofseries New England Journal of Medicine
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject adolescent en_US
dc.subject Adolescent en_US
dc.subject adult en_US
dc.subject Adult en_US
dc.subject alanine aminotransferase en_US
dc.subject alanine aminotransferase blood level en_US
dc.subject aminoquinoline derivative en_US
dc.subject Aminoquinolines en_US
dc.subject antimalarial agent en_US
dc.subject Antimalarials en_US
dc.subject Article en_US
dc.subject asthenia en_US
dc.subject backache en_US
dc.subject blurred vision en_US
dc.subject chloroquine en_US
dc.subject Chloroquine en_US
dc.subject clinical trial en_US
dc.subject combination drug therapy en_US
dc.subject comparative study en_US
dc.subject complication en_US
dc.subject controlled study en_US
dc.subject coughing en_US
dc.subject creatine kinase en_US
dc.subject creatine kinase blood level en_US
dc.subject diarrhea en_US
dc.subject disease free survival en_US
dc.subject disease severity en_US
dc.subject Disease-Free Survival en_US
dc.subject dizziness en_US
dc.subject double blind procedure en_US
dc.subject Double-Blind Method en_US
dc.subject drug efficacy en_US
dc.subject drug safety en_US
dc.subject Drug Therapy, Combination en_US
dc.subject enzyme activity en_US
dc.subject enzyme deficiency en_US
dc.subject female en_US
dc.subject Female en_US
dc.subject fever en_US
dc.subject G6PD protein, human en_US
dc.subject glucose 6 phosphate dehydrogenase en_US
dc.subject glucose 6 phosphate dehydrogenase deficiency en_US
dc.subject Glucosephosphate Dehydrogenase en_US
dc.subject Glucosephosphate Dehydrogenase Deficiency en_US
dc.subject headache en_US
dc.subject hemoglobin en_US
dc.subject hemoglobin blood level en_US
dc.subject Hemoglobins en_US
dc.subject human en_US
dc.subject Humans en_US
dc.subject hypokalemia en_US
dc.subject insomnia en_US
dc.subject isolation and purification en_US
dc.subject Kaplan Meier method en_US
dc.subject Kaplan-Meier Estimate en_US
dc.subject major clinical study en_US
dc.subject Malaria, Vivax en_US
dc.subject male en_US
dc.subject Male en_US
dc.subject metabolism en_US
dc.subject methemoglobinemia en_US
dc.subject multicenter study en_US
dc.subject nausea en_US
dc.subject parasitemia en_US
dc.subject Parasitemia en_US
dc.subject pharyngitis en_US
dc.subject phase 3 clinical trial en_US
dc.subject Plasmodium vivax en_US
dc.subject Plasmodium vivax malaria en_US
dc.subject pneumonia en_US
dc.subject primaquine en_US
dc.subject Primaquine en_US
dc.subject priority journal en_US
dc.subject procedures en_US
dc.subject Prospective Studies en_US
dc.subject prospective study en_US
dc.subject pruritus en_US
dc.subject QT prolongation en_US
dc.subject randomized controlled trial en_US
dc.subject recurrent disease en_US
dc.subject rhinopharyngitis en_US
dc.subject secondary prevention en_US
dc.subject Secondary Prevention en_US
dc.subject side effect en_US
dc.subject single drug dose en_US
dc.subject tafenoquine en_US
dc.subject treatment duration en_US
dc.subject upper abdominal pain en_US
dc.subject urinary tract infection en_US
dc.subject vomiting en_US
dc.title Tafenoquine versus primaquine to prevent relapse of plasmodium vivax malaria en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1056/NEJMoa1802537
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00
dc.relation.issn 1533-4406


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