New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients

Autores
Álvarez, María Gabriela; Hernández, Yolanda; Bertocchi, Graciela; Fernández, Marisa Mariel; Lococo, Bruno; Ramirez Gomez, Juan Carlos; Cura, Carolina Inés; Lopez Albizu, Constanza; Schijman, Alejandro Gabriel; Abril, Marcelo; Sosa-Estani, Sergio Alejandro; Viotti, Rodolfo Jorge
Año de publicación
2015
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
There is a clinical need to test new schemes of benznidazole administration that are expected to be at least as effective as the current therapeutic scheme but safer. This study assessed a new scheme of benznidazole administration in chronic Chagas disease patients. A pilot study with intermittent doses of benznidazole at 5 mg/kg/day in two daily doses every 5 days for a total of 60 days was designed. The main criterion of response was the comparison of quantitative PCR (qPCR) findings prior to and 1 week after the end of treatment. The safety profile was assessed by the rate of suspensions and severity of adverse effects. Twenty patients were analyzed for safety, while qPCR was tested for 17 of them. The average age was 43 ± 7.9 years; 55% were female. Sixty-five percent of treated subjects showed detectable qPCR results prior to treatment of 1.45 (0.63 to 2.81) and 2.1 (1.18 to 2.78) parasitic equivalents per milliliter of blood (par.eq/ml) for kinetoplastic DNA (kDNA) qPCR and nuclear repetitive sequence satellite DNA (SatDNA) qPCR, respectively. One patient showed detectable PCR at the end of treatment (1/17), corresponding to 6% treatment failure, compared with 11/17 (65%) patients pretreatment (P = 0.01). Adverse effects were present in 10/20 (50%) patients, but in only one case was treatment suspended. Eight patients showed mild adverse effects, whereas moderate reactions with increased liver enzymes were observed in two patients. The main accomplishment of this pilot study is the promising low rate of treatment suspension. Intermittent administration of benznidazole emerges a new potential therapeutic scheme, the efficacy of which should be confirmed by long-term assessment posttreatment.
Fil: Álvarez, María Gabriela. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; Argentina
Fil: Hernández, Yolanda. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina
Fil: Bertocchi, Graciela. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; Argentina
Fil: Fernández, Marisa Mariel. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Lococo, Bruno. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; Argentina
Fil: Ramirez Gomez, Juan Carlos. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Fil: Cura, Carolina Inés. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina
Fil: Lopez Albizu, Constanza. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina
Fil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular ; Argentina
Fil: Abril, Marcelo. Fundación Mundo Sano; Argentina
Fil: Sosa-Estani, Sergio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina
Fil: Viotti, Rodolfo Jorge. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; Argentina
Materia
Chagas disease
Chronic patients
Benznidazole
qPCR
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/37956
Acceder
id CONICETDig_6fc11f7c25ac97a72b3607c9fcf458b6
oai_identifier_str oai:ri.conicet.gov.ar:11336/37956
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patientsÁlvarez, María GabrielaHernández, YolandaBertocchi, GracielaFernández, Marisa MarielLococo, BrunoRamirez Gomez, Juan CarlosCura, Carolina InésLopez Albizu, ConstanzaSchijman, Alejandro GabrielAbril, MarceloSosa-Estani, Sergio AlejandroViotti, Rodolfo JorgeChagas diseaseChronic patientsBenznidazoleqPCRhttps://purl.org/becyt/ford/3.2https://purl.org/becyt/ford/3There is a clinical need to test new schemes of benznidazole administration that are expected to be at least as effective as the current therapeutic scheme but safer. This study assessed a new scheme of benznidazole administration in chronic Chagas disease patients. A pilot study with intermittent doses of benznidazole at 5 mg/kg/day in two daily doses every 5 days for a total of 60 days was designed. The main criterion of response was the comparison of quantitative PCR (qPCR) findings prior to and 1 week after the end of treatment. The safety profile was assessed by the rate of suspensions and severity of adverse effects. Twenty patients were analyzed for safety, while qPCR was tested for 17 of them. The average age was 43 ± 7.9 years; 55% were female. Sixty-five percent of treated subjects showed detectable qPCR results prior to treatment of 1.45 (0.63 to 2.81) and 2.1 (1.18 to 2.78) parasitic equivalents per milliliter of blood (par.eq/ml) for kinetoplastic DNA (kDNA) qPCR and nuclear repetitive sequence satellite DNA (SatDNA) qPCR, respectively. One patient showed detectable PCR at the end of treatment (1/17), corresponding to 6% treatment failure, compared with 11/17 (65%) patients pretreatment (P = 0.01). Adverse effects were present in 10/20 (50%) patients, but in only one case was treatment suspended. Eight patients showed mild adverse effects, whereas moderate reactions with increased liver enzymes were observed in two patients. The main accomplishment of this pilot study is the promising low rate of treatment suspension. Intermittent administration of benznidazole emerges a new potential therapeutic scheme, the efficacy of which should be confirmed by long-term assessment posttreatment.Fil: Álvarez, María Gabriela. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; ArgentinaFil: Hernández, Yolanda. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; ArgentinaFil: Bertocchi, Graciela. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; ArgentinaFil: Fernández, Marisa Mariel. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Lococo, Bruno. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; ArgentinaFil: Ramirez Gomez, Juan Carlos. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaFil: Cura, Carolina Inés. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; ArgentinaFil: Lopez Albizu, Constanza. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; ArgentinaFil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular ; ArgentinaFil: Abril, Marcelo. Fundación Mundo Sano; ArgentinaFil: Sosa-Estani, Sergio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; ArgentinaFil: Viotti, Rodolfo Jorge. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; ArgentinaAmerican Society for Microbiology2015-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/37956Álvarez, María Gabriela; Hernández, Yolanda; Bertocchi, Graciela; Fernández, Marisa Mariel; Lococo, Bruno; et al.; New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients; American Society for Microbiology; Antimicrobial Agents and Chemotherapy; 60; 2; 11-2015; 833-8370066-4804CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/doi/10.1128/AAC.00745-15info:eu-repo/semantics/altIdentifier/url/http://aac.asm.org/content/60/2/833info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-10T13:24:53Zoai:ri.conicet.gov.ar:11336/37956instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-10 13:24:53.433CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients
title New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients
spellingShingle New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients
Álvarez, María Gabriela
Chagas disease
Chronic patients
Benznidazole
qPCR
title_short New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients
title_full New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients
title_fullStr New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients
title_full_unstemmed New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients
title_sort New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients
dc.creator.none.fl_str_mv Álvarez, María Gabriela
Hernández, Yolanda
Bertocchi, Graciela
Fernández, Marisa Mariel
Lococo, Bruno
Ramirez Gomez, Juan Carlos
Cura, Carolina Inés
Lopez Albizu, Constanza
Schijman, Alejandro Gabriel
Abril, Marcelo
Sosa-Estani, Sergio Alejandro
Viotti, Rodolfo Jorge
author Álvarez, María Gabriela
author_facet Álvarez, María Gabriela
Hernández, Yolanda
Bertocchi, Graciela
Fernández, Marisa Mariel
Lococo, Bruno
Ramirez Gomez, Juan Carlos
Cura, Carolina Inés
Lopez Albizu, Constanza
Schijman, Alejandro Gabriel
Abril, Marcelo
Sosa-Estani, Sergio Alejandro
Viotti, Rodolfo Jorge
author_role author
author2 Hernández, Yolanda
Bertocchi, Graciela
Fernández, Marisa Mariel
Lococo, Bruno
Ramirez Gomez, Juan Carlos
Cura, Carolina Inés
Lopez Albizu, Constanza
Schijman, Alejandro Gabriel
Abril, Marcelo
Sosa-Estani, Sergio Alejandro
Viotti, Rodolfo Jorge
author2_role author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Chagas disease
Chronic patients
Benznidazole
qPCR
topic Chagas disease
Chronic patients
Benznidazole
qPCR
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.2
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv There is a clinical need to test new schemes of benznidazole administration that are expected to be at least as effective as the current therapeutic scheme but safer. This study assessed a new scheme of benznidazole administration in chronic Chagas disease patients. A pilot study with intermittent doses of benznidazole at 5 mg/kg/day in two daily doses every 5 days for a total of 60 days was designed. The main criterion of response was the comparison of quantitative PCR (qPCR) findings prior to and 1 week after the end of treatment. The safety profile was assessed by the rate of suspensions and severity of adverse effects. Twenty patients were analyzed for safety, while qPCR was tested for 17 of them. The average age was 43 ± 7.9 years; 55% were female. Sixty-five percent of treated subjects showed detectable qPCR results prior to treatment of 1.45 (0.63 to 2.81) and 2.1 (1.18 to 2.78) parasitic equivalents per milliliter of blood (par.eq/ml) for kinetoplastic DNA (kDNA) qPCR and nuclear repetitive sequence satellite DNA (SatDNA) qPCR, respectively. One patient showed detectable PCR at the end of treatment (1/17), corresponding to 6% treatment failure, compared with 11/17 (65%) patients pretreatment (P = 0.01). Adverse effects were present in 10/20 (50%) patients, but in only one case was treatment suspended. Eight patients showed mild adverse effects, whereas moderate reactions with increased liver enzymes were observed in two patients. The main accomplishment of this pilot study is the promising low rate of treatment suspension. Intermittent administration of benznidazole emerges a new potential therapeutic scheme, the efficacy of which should be confirmed by long-term assessment posttreatment.
Fil: Álvarez, María Gabriela. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; Argentina
Fil: Hernández, Yolanda. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina
Fil: Bertocchi, Graciela. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; Argentina
Fil: Fernández, Marisa Mariel. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina
Fil: Lococo, Bruno. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; Argentina
Fil: Ramirez Gomez, Juan Carlos. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; Argentina
Fil: Cura, Carolina Inés. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina
Fil: Lopez Albizu, Constanza. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina
Fil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular ; Argentina
Fil: Abril, Marcelo. Fundación Mundo Sano; Argentina
Fil: Sosa-Estani, Sergio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud. Instituto Nacional de Parasitología; Argentina
Fil: Viotti, Rodolfo Jorge. Provincia de Buenos Aires. Ministerio de Salud. Hospital Interzonal de Agudos ; Argentina
description There is a clinical need to test new schemes of benznidazole administration that are expected to be at least as effective as the current therapeutic scheme but safer. This study assessed a new scheme of benznidazole administration in chronic Chagas disease patients. A pilot study with intermittent doses of benznidazole at 5 mg/kg/day in two daily doses every 5 days for a total of 60 days was designed. The main criterion of response was the comparison of quantitative PCR (qPCR) findings prior to and 1 week after the end of treatment. The safety profile was assessed by the rate of suspensions and severity of adverse effects. Twenty patients were analyzed for safety, while qPCR was tested for 17 of them. The average age was 43 ± 7.9 years; 55% were female. Sixty-five percent of treated subjects showed detectable qPCR results prior to treatment of 1.45 (0.63 to 2.81) and 2.1 (1.18 to 2.78) parasitic equivalents per milliliter of blood (par.eq/ml) for kinetoplastic DNA (kDNA) qPCR and nuclear repetitive sequence satellite DNA (SatDNA) qPCR, respectively. One patient showed detectable PCR at the end of treatment (1/17), corresponding to 6% treatment failure, compared with 11/17 (65%) patients pretreatment (P = 0.01). Adverse effects were present in 10/20 (50%) patients, but in only one case was treatment suspended. Eight patients showed mild adverse effects, whereas moderate reactions with increased liver enzymes were observed in two patients. The main accomplishment of this pilot study is the promising low rate of treatment suspension. Intermittent administration of benznidazole emerges a new potential therapeutic scheme, the efficacy of which should be confirmed by long-term assessment posttreatment.
publishDate 2015
dc.date.none.fl_str_mv 2015-11
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/37956
Álvarez, María Gabriela; Hernández, Yolanda; Bertocchi, Graciela; Fernández, Marisa Mariel; Lococo, Bruno; et al.; New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients; American Society for Microbiology; Antimicrobial Agents and Chemotherapy; 60; 2; 11-2015; 833-837
0066-4804
CONICET Digital
CONICET
url http://hdl.handle.net/11336/37956
identifier_str_mv Álvarez, María Gabriela; Hernández, Yolanda; Bertocchi, Graciela; Fernández, Marisa Mariel; Lococo, Bruno; et al.; New scheme of intermittent benznidazole administration in patients chronically infected with Trypanosoma cruzi. A pilot short-term follow-up study in adult patients; American Society for Microbiology; Antimicrobial Agents and Chemotherapy; 60; 2; 11-2015; 833-837
0066-4804
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/doi/10.1128/AAC.00745-15
info:eu-repo/semantics/altIdentifier/url/http://aac.asm.org/content/60/2/833
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv American Society for Microbiology
publisher.none.fl_str_mv American Society for Microbiology
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 12.48226

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