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Single-dose tafenoquine to prevent relapse of plasmodium vivax malaria

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dc.contributor.author Lacerda, M.V.G.
dc.contributor.author Llanos-Cuentas, A.
dc.contributor.author Krudsood, S.
dc.contributor.author Lon, C.
dc.contributor.author Saunders, D.L.
dc.contributor.author Mohammed, R.
dc.contributor.author Yilma, D.
dc.contributor.author Pereira, D.B.
dc.contributor.author Espino, F.E.J.
dc.contributor.author Mia, R.Z.
dc.contributor.author Chuquiyauri, R.
dc.contributor.author Val, F.
dc.contributor.author Casapía, M.
dc.contributor.author Monteiro, W.M.
dc.contributor.author Brito, M.A.M.
dc.contributor.author Costa, M.R.F.
dc.contributor.author Buathong, N.
dc.contributor.author Noedl, H.
dc.contributor.author Diro, E.
dc.contributor.author Getie, S.
dc.contributor.author Wubie, K.M.
dc.contributor.author Abdissa, A.
dc.contributor.author Zeynudin, A.
dc.contributor.author Abebe, C.
dc.contributor.author Tada, M.S.
dc.contributor.author Brand, F.
dc.contributor.author Beck, H.-P.
dc.contributor.author Angus, B.
dc.contributor.author Duparc, S.
dc.contributor.author Kleim, J.-P.
dc.contributor.author Kellam, L.M.
dc.contributor.author Rousell, V.M.
dc.contributor.author Jones, S.W.
dc.contributor.author Hardaker, E.
dc.contributor.author Mohamed, K.
dc.contributor.author Clover, D.D.
dc.contributor.author Fletcher, K.
dc.contributor.author Breton, J.J.
dc.contributor.author Ugwuegbulam, C.O.
dc.contributor.author Green, J.A.
dc.contributor.author Koh, G.C.K.W.
dc.date.accessioned 2019-07-04T17:00:24Z
dc.date.available 2019-07-04T17:00:24Z
dc.date.issued 2019
dc.identifier.uri https://hdl.handle.net/20.500.12866/6905
dc.description.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 <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 (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. CONCLUSIONS: Single-dose tafenoquine resulted in a significantly lower risk of P. vivax recurrence than placebo in patients with phenotypically normal G6PD activity. en_US
dc.language.iso eng
dc.publisher Massachusetts Medical Society
dc.relation.ispartof urn:issn:1533-4406
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 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 Brazil en_US
dc.subject Cambodia 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 controlled study en_US
dc.subject Cytochrome P-450 CYP2D6 en_US
dc.subject cytochrome P450 2D6 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 safety en_US
dc.subject Drug Therapy, Combination en_US
dc.subject enzyme activity en_US
dc.subject Ethiopia en_US
dc.subject female en_US
dc.subject Female en_US
dc.subject G6PD protein, human en_US
dc.subject glucose 6 phosphate dehydrogenase en_US
dc.subject Glucosephosphate Dehydrogenase en_US
dc.subject hematocrit en_US
dc.subject hemoglobin en_US
dc.subject Hemoglobins en_US
dc.subject human en_US
dc.subject Humans en_US
dc.subject hypopigmentation en_US
dc.subject intention to treat analysis en_US
dc.subject Intention to Treat Analysis 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 keratopathy en_US
dc.subject Logistic Models 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 methemoglobin en_US
dc.subject multicenter study en_US
dc.subject parasite clearance en_US
dc.subject parasitemia en_US
dc.subject Parasitemia en_US
dc.subject Peru en_US
dc.subject phase 2 clinical trial en_US
dc.subject phase 3 clinical trial en_US
dc.subject Philippines en_US
dc.subject placebo en_US
dc.subject Plasmodium vivax en_US
dc.subject Plasmodium vivax malaria 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 randomized controlled trial en_US
dc.subject recurrence risk en_US
dc.subject relapse en_US
dc.subject retina disease en_US
dc.subject retinal hypopigmentation en_US
dc.subject secondary prevention en_US
dc.subject Secondary Prevention en_US
dc.subject single drug dose en_US
dc.subject statistical model en_US
dc.subject tafenoquine en_US
dc.subject Thailand en_US
dc.subject treatment duration en_US
dc.title Single-dose tafenoquine to prevent relapse of plasmodium vivax malaria en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1056/NEJMoa1710775
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00 es_PE
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00

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