Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment

Detalhes bibliográficos
Autor(a) principal: Pereira, Dhelio
Data de Publicação: 2016
Outros Autores: Daher, André, Zanini, Graziela, Maia, Ivan, Fonseca, Lais, Pitta, Luciana, Ruffato, Rosilene, Marchesini, Paola, Fontes, Cor Jesus
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/32587
Resumo: Tropical Medicine Research Center of Rondônia. Porto Velho, RO, Brazil / Fundação Oswaldo Cruz. Instituto Nacional Institute de Infectologia Evandro Chagas. Laboratório de Parasitologia. Rio de Janeiro, RJ, Brasil / Federal University of Rondônia. Porto Velho, RO, Brazil.
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spelling Pereira, DhelioDaher, AndréZanini, GrazielaMaia, IvanFonseca, LaisPitta, LucianaRuffato, RosileneMarchesini, PaolaFontes, Cor Jesus2019-04-18T13:44:09Z2019-04-18T13:44:09Z2016PEREIRA, Dhelio et al. Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment. Malaria Journal, v. 15, p. 1-10, 2016.1475-2875https://www.arca.fiocruz.br/handle/icict/3258710.1186/s12936-016-1530-01475-2875engBMCSafety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatmentinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleTropical Medicine Research Center of Rondônia. Porto Velho, RO, Brazil / Fundação Oswaldo Cruz. Instituto Nacional Institute de Infectologia Evandro Chagas. Laboratório de Parasitologia. Rio de Janeiro, RJ, Brasil / Federal University of Rondônia. Porto Velho, RO, Brazil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos. Rio de Janeiro, RJ, Brasil / Fundação Oswaldo Cruz. Vice-Presidência de Pesquisa e Laboratórios de Referência. Rio de Janeiro, RJ, Brasil / Liverpool School of Tropical Medicine. Liverpool, UK.Fundação Oswaldo Cruz. Instituto Nacional Institute de Infectologia Evandro Chagas. Laboratório de Parasitologia. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Vice-Presidência de Pesquisa e Laboratórios de Referência. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Centro de Desenvolvimento de Tecnologia em Saúde. Serviço de Equivalência Farmacêutica e Farmacocinética. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos. Rio de Janeiro, RJ, Brasil.Tropical Medicine Research Center of Rondônia. Porto Velho, RO, Brazil.Ministry of Health. National Programme of Malaria Control. Brasília, DF, Brazil.Federal University of Mato Grosso. Julio Müller Hospital. Cuiabá, MT, Brazil.Background: Malaria remains a major public health problem, with half the world population at risk of contracting malaria. The effects of Plasmodium vivax on prosperity and longevity have been highlighted in several recent clinical case reports. The first line of vivax treatment drugs has seen no radical innovation for more than 60 years. This study introduces a subtle incremental innovation to vivax treatment: a chloroquine and primaquine co-blister. The co-blister includes a new chloroquine formulation incorporating coated tablets to mask the drug’s bitter taste and user-friendly packaging containing tablets of each drug, which may improve patient adherence and facilitate the appropriate use of the drugs. This new formulation will replace the non-coated chloroquine distributed in Brazil. Methods: Patients were orally treated with 150 mg coated chloroquine tablets for 3 days: an initial 450 mg dose, followed by two 300 mg doses. The patients were treated concomitantly with two 15 mg primaquine tablets for 7–9 days, according to their weight. The primary objective of this study was to prove parasitological and clinical cure rates above 90 % by day 28. Results: This single-arm open-label non-comparative trial was conducted according to the WHO recommended methodology for the surveillance of anti-malarial drug efficacy in the Brazilian Amazon. On day 28, the parasitological and clinical response was adequate in 98.8 % of patients (CI 95 % 93.4–100 %). The success rate on day 3 was 100 %, and the cumulative success rate by day 28 was 98.8 % (CI 95 % 91.7–99.8 %). There were no serious adverse events, with most adverse events classified as mild. The pharmacokinetic parameters of chloroquine analysed in whole blood dry spot samples showed mean (coefficient of variation) Cmax and AUC0–t values of 374.44 (0.35) and 3700.43 (0.36) ng/mL, respectively. Discussion: This study reports an appropriate safety and efficacy profile of a new formulation of coated chloroquine tablets for vivax malaria treatment in the Brazilian Amazon. The cure rates meet the WHO efficacy criteria, supporting current Brazilian guidelines and the use of the formulation for vivax malaria treatment. Nevertheless, further studies should be conducted to address adherence and the effectiveness of the formulation.MalariaPlasmodium vivax,Antimalarial treatmentChloroquinePharmacokineticsAdherenceClinical trialinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83104https://www.arca.fiocruz.br/bitstream/icict/32587/1/license.txt79178e5f2a0eb066867a274556814938MD51ORIGINALve_Pereira_Dhelio_etal_INI_2016.pdfve_Pereira_Dhelio_etal_INI_2016.pdfapplication/pdf1144838https://www.arca.fiocruz.br/bitstream/icict/32587/2/ve_Pereira_Dhelio_etal_INI_2016.pdf32ecd8433cb9ae0703c643d9adeb1838MD52TEXTve_Pereira_Dhelio_etal_INI_2016.pdf.txtve_Pereira_Dhelio_etal_INI_2016.pdf.txtExtracted texttext/plain46922https://www.arca.fiocruz.br/bitstream/icict/32587/3/ve_Pereira_Dhelio_etal_INI_2016.pdf.txt0f223e34fc79fa8e8e4303d67820d485MD53icict/325872019-04-22 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dc.title.pt_BR.fl_str_mv Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment
title Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment
spellingShingle Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment
Pereira, Dhelio
Malaria
Plasmodium vivax,
Antimalarial treatment
Chloroquine
Pharmacokinetics
Adherence
Clinical trial
title_short Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment
title_full Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment
title_fullStr Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment
title_full_unstemmed Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment
title_sort Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment
author Pereira, Dhelio
author_facet Pereira, Dhelio
Daher, André
Zanini, Graziela
Maia, Ivan
Fonseca, Lais
Pitta, Luciana
Ruffato, Rosilene
Marchesini, Paola
Fontes, Cor Jesus
author_role author
author2 Daher, André
Zanini, Graziela
Maia, Ivan
Fonseca, Lais
Pitta, Luciana
Ruffato, Rosilene
Marchesini, Paola
Fontes, Cor Jesus
author2_role author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Pereira, Dhelio
Daher, André
Zanini, Graziela
Maia, Ivan
Fonseca, Lais
Pitta, Luciana
Ruffato, Rosilene
Marchesini, Paola
Fontes, Cor Jesus
dc.subject.en.pt_BR.fl_str_mv Malaria
Plasmodium vivax,
Antimalarial treatment
Chloroquine
Pharmacokinetics
Adherence
Clinical trial
topic Malaria
Plasmodium vivax,
Antimalarial treatment
Chloroquine
Pharmacokinetics
Adherence
Clinical trial
description Tropical Medicine Research Center of Rondônia. Porto Velho, RO, Brazil / Fundação Oswaldo Cruz. Instituto Nacional Institute de Infectologia Evandro Chagas. Laboratório de Parasitologia. Rio de Janeiro, RJ, Brasil / Federal University of Rondônia. Porto Velho, RO, Brazil.
publishDate 2016
dc.date.issued.fl_str_mv 2016
dc.date.accessioned.fl_str_mv 2019-04-18T13:44:09Z
dc.date.available.fl_str_mv 2019-04-18T13:44:09Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv PEREIRA, Dhelio et al. Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment. Malaria Journal, v. 15, p. 1-10, 2016.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/32587
dc.identifier.issn.pt_BR.fl_str_mv 1475-2875
dc.identifier.doi.none.fl_str_mv 10.1186/s12936-016-1530-0
dc.identifier.eissn.none.fl_str_mv 1475-2875
identifier_str_mv PEREIRA, Dhelio et al. Safety, efficacy and pharmacokinetic evaluations of a new coated chloroquine tablet in a single-arm open-label non-comparative trial in Brazil: a step towards a user-friendly malaria vivax treatment. Malaria Journal, v. 15, p. 1-10, 2016.
1475-2875
10.1186/s12936-016-1530-0
url https://www.arca.fiocruz.br/handle/icict/32587
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BMC
publisher.none.fl_str_mv BMC
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
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bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/32587/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/32587/2/ve_Pereira_Dhelio_etal_INI_2016.pdf
https://www.arca.fiocruz.br/bitstream/icict/32587/3/ve_Pereira_Dhelio_etal_INI_2016.pdf.txt
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