In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia.

<h4>Background</h4>In vivo efficacy assessments of antimalarials are essential for ensuring effective case management. In Ethiopia, chloroquine (CQ) without primaquine is the first-line treatment for Plasmodium vivax in malarious areas, but artemether-lumefantrine (AL) is also commonly u...

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Autores principales:	Jimee Hwang, Bereket Hailegiorgis Alemayehu, Richard Reithinger, Samuel Girma Tekleyohannes, Takele Teshi, Sintayehu Gebresillasie Birhanu, Leykun Demeke, David Hoos, Zenebe Melaku, Moges Kassa, Daddi Jima, Joseph L Malone, Henry Nettey, Michael Green, Amanda Poe, Sheila Akinyi, Venkatachalam Udhayakumar, S Patrick Kachur, Scott Filler
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2013
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/7f15c0baf4054c65ac7db520d8ae91dc
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spelling	oai:doaj.org-article:7f15c0baf4054c65ac7db520d8ae91dc2021-11-18T07:44:44ZIn vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia.1932-620310.1371/journal.pone.0063433https://doaj.org/article/7f15c0baf4054c65ac7db520d8ae91dc2013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23717423/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>In vivo efficacy assessments of antimalarials are essential for ensuring effective case management. In Ethiopia, chloroquine (CQ) without primaquine is the first-line treatment for Plasmodium vivax in malarious areas, but artemether-lumefantrine (AL) is also commonly used.<h4>Methods and findings</h4>In 2009, we conducted a 42-day efficacy study of AL or CQ for P. vivax in Oromia Regional State, Ethiopia. Individuals with P. vivax monoinfection were enrolled. Primary endpoint was day 28 cure rate. In patients with recurrent parasitemia, drug level and genotyping using microsatellite markers were assessed. Using survival analysis, uncorrected patient cure rates at day 28 were 75.7% (95% confidence interval (CI) 66.8-82.5) for AL and 90.8% (95% CI 83.6-94.9) for CQ. During the 42 days of follow-up, 41.6% (47/113) of patients in the AL arm and 31.8% (34/107) in the CQ arm presented with recurrent P. vivax infection, with the median number of days to recurrence of 28 compared to 35 days in the AL and CQ arm, respectively. Using microsatellite markers to reclassify recurrent parasitemias with a different genotype as non-treatment failures, day 28 cure rates were genotype adjusted to 91.1% (95% CI 84.1-95.1) for AL and to 97.2% (91.6-99.1) for CQ. Three patients (2.8%) with recurrent parasitemia by day 28 in the CQ arm were noted to have drug levels above 100 ng/ml.<h4>Conclusions</h4>In the short term, both AL and CQ were effective and well-tolerated for P. vivax malaria, but high rates of recurrent parasitemia were noted with both drugs. CQ provided longer post-treatment prophylaxis than AL, resulting in delayed recurrence of parasitemia. Although the current policy of species-specific treatment can be maintained for Ethiopia, the co-administration of primaquine for treatment of P. vivax malaria needs to be urgently considered to prevent relapse infections.<h4>Trial registration</h4>ClinicalTrials.gov NCT01052584.Jimee HwangBereket Hailegiorgis AlemayehuRichard ReithingerSamuel Girma TekleyohannesTakele TeshiSintayehu Gebresillasie BirhanuLeykun DemekeDavid HoosZenebe MelakuMoges KassaDaddi JimaJoseph L MaloneHenry NetteyMichael GreenAmanda PoeSheila AkinyiVenkatachalam UdhayakumarS Patrick KachurScott FillerPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 5, p e63433 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Jimee Hwang Bereket Hailegiorgis Alemayehu Richard Reithinger Samuel Girma Tekleyohannes Takele Teshi Sintayehu Gebresillasie Birhanu Leykun Demeke David Hoos Zenebe Melaku Moges Kassa Daddi Jima Joseph L Malone Henry Nettey Michael Green Amanda Poe Sheila Akinyi Venkatachalam Udhayakumar S Patrick Kachur Scott Filler In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia.
description	<h4>Background</h4>In vivo efficacy assessments of antimalarials are essential for ensuring effective case management. In Ethiopia, chloroquine (CQ) without primaquine is the first-line treatment for Plasmodium vivax in malarious areas, but artemether-lumefantrine (AL) is also commonly used.<h4>Methods and findings</h4>In 2009, we conducted a 42-day efficacy study of AL or CQ for P. vivax in Oromia Regional State, Ethiopia. Individuals with P. vivax monoinfection were enrolled. Primary endpoint was day 28 cure rate. In patients with recurrent parasitemia, drug level and genotyping using microsatellite markers were assessed. Using survival analysis, uncorrected patient cure rates at day 28 were 75.7% (95% confidence interval (CI) 66.8-82.5) for AL and 90.8% (95% CI 83.6-94.9) for CQ. During the 42 days of follow-up, 41.6% (47/113) of patients in the AL arm and 31.8% (34/107) in the CQ arm presented with recurrent P. vivax infection, with the median number of days to recurrence of 28 compared to 35 days in the AL and CQ arm, respectively. Using microsatellite markers to reclassify recurrent parasitemias with a different genotype as non-treatment failures, day 28 cure rates were genotype adjusted to 91.1% (95% CI 84.1-95.1) for AL and to 97.2% (91.6-99.1) for CQ. Three patients (2.8%) with recurrent parasitemia by day 28 in the CQ arm were noted to have drug levels above 100 ng/ml.<h4>Conclusions</h4>In the short term, both AL and CQ were effective and well-tolerated for P. vivax malaria, but high rates of recurrent parasitemia were noted with both drugs. CQ provided longer post-treatment prophylaxis than AL, resulting in delayed recurrence of parasitemia. Although the current policy of species-specific treatment can be maintained for Ethiopia, the co-administration of primaquine for treatment of P. vivax malaria needs to be urgently considered to prevent relapse infections.<h4>Trial registration</h4>ClinicalTrials.gov NCT01052584.
format	article
author	Jimee Hwang Bereket Hailegiorgis Alemayehu Richard Reithinger Samuel Girma Tekleyohannes Takele Teshi Sintayehu Gebresillasie Birhanu Leykun Demeke David Hoos Zenebe Melaku Moges Kassa Daddi Jima Joseph L Malone Henry Nettey Michael Green Amanda Poe Sheila Akinyi Venkatachalam Udhayakumar S Patrick Kachur Scott Filler
author_facet	Jimee Hwang Bereket Hailegiorgis Alemayehu Richard Reithinger Samuel Girma Tekleyohannes Takele Teshi Sintayehu Gebresillasie Birhanu Leykun Demeke David Hoos Zenebe Melaku Moges Kassa Daddi Jima Joseph L Malone Henry Nettey Michael Green Amanda Poe Sheila Akinyi Venkatachalam Udhayakumar S Patrick Kachur Scott Filler
author_sort	Jimee Hwang
title	In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia.
title_short	In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia.
title_full	In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia.
title_fullStr	In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia.
title_full_unstemmed	In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia.
title_sort	in vivo efficacy of artemether-lumefantrine and chloroquine against plasmodium vivax: a randomized open label trial in central ethiopia.
publisher	Public Library of Science (PLoS)
publishDate	2013
url	https://doaj.org/article/7f15c0baf4054c65ac7db520d8ae91dc
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In vivo efficacy of artemether-lumefantrine and chloroquine against Plasmodium vivax: a randomized open label trial in central Ethiopia.

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