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| Autor | Bosch-Nicolau, Pau | |
| Autor | Fernández, Maria L. | |
| Autor | Sulleiro, Elena | |
| Autor | Villar, Juan Carlos | |
| Autor | Perez-Molina, José A. | |
| Autor | Oliveira, Rodrigo Correa de | |
| Autor | Sosa-Estani, Sergio | |
| Autor | Sánchez-Montalvá, Adrián | |
| Autor | Bangher, Maria Del Carmen | |
| Autor | Moreira, Otacilio C. | |
| Autor | Salvador, Fernando | |
| Autor | Ferreira, Ariela Mota | |
| Autor | Eloi-Santos, Silvana Maria | |
| Autor | Serre-Delcor, Núria | |
| Autor | Ramírez, Juan Carlos | |
| Autor | Silgado, Aroa | |
| Autor | Oliveira, Inés | |
| Autor | Martín, Oihane | |
| Autor | Aznar, Maria Luisa | |
| Autor | Ribeiro, Antonio Luiz P. | |
| Autor | Almeida, Paulo Emilio Clementino | |
| Autor | Chamorro-Tojeiro, Sandra | |
| Autor | Espinosa-Pereiro, Juan | |
| Autor | Paula, Alfredo Mauricio Batista de | |
| Autor | Váquiro-Herrera, Eliana | |
| Autor | Tur, Carmen | |
| Autor | Molina, Israel | |
| Fecha de acceso | 2024-02-16T17:35:39Z | |
| Fecha de disponibilización | 2024-02-16T17:35:39Z | |
| Fecha de publicación | 2024 | |
| Referencia | BOSCH-NICOLAU, Pau et al. Efficacy of three benznidazole dosing strategies for adults living with chronic Chagas disease (MULTIBENZ): an international, randomised, double-blind, phase 2b trial. The Lancet Infectious Diseases, p. 1-9, Jan. 2024. | en_US |
| ISSN | 1473-3099 | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/62654 | |
| Promoción | European Community's 7th Framework Programme. | en_US |
| Idioma | eng | en_US |
| Editor | Elsevier Science | en_US |
| Derechos de autor | restricted access | |
| Título | Efficacy of three benznidazole dosing strategies for adults living with chronic Chagas disease (MULTIBENZ): an international, randomised, double-blind, phase 2b trial | en_US |
| Tipo del documento | Article | |
| DOI | 10.1016/S1473-3099(23)00629-1 | |
| Resumen en Inglés | Background: Treatment with benznidazole for chronic Chagas disease is associated with low cure rates and substantial toxicity. We aimed to compare the parasitological efficacy and safety of 3 different benznidazole regimens in adult patients with chronic Chagas disease. Methods: The MULTIBENZ trial was an international, randomised, double-blind, phase 2b trial performed in Argentina, Brazil, Colombia, and Spain. We included participants aged 18 years and older diagnosed with Chagas disease with two different serological tests and detectable T cruzi DNA by qPCR in blood. Previously treated people, pregnant women, and people with severe cardiac forms were excluded. Participants were randomly assigned 1:1:1, using a balanced block randomisation scheme stratified by country, to receive benznidazole at three different doses: 300 mg/day for 60 days (control group), 150 mg/day for 60 days (low dose group), or 400 mg/day for 15 days (short treatment group). The primary outcome was the proportion of patients with a sustained parasitological negativity by qPCR during a follow-up period of 12 months. The primary safety outcome was the proportion of people who permanently discontinued the treatment. Both primary efficacy analysis and primary safety analysis were done in the intention-to-treat population. The trial is registered with EudraCT, 2016-003789-21, and ClinicalTrials.gov, NCT03191162, and is completed. Findings: From April 20, 2017, to Sept 20, 2020, 245 people were enrolled, and 234 were randomly assigned: 78 to the control group, 77 to the low dose group, and 79 to the short treatment group. Sustained parasitological negativity was observed in 42 (54%) of 78 participants in the control group, 47 (61%) of 77 in the low dose group, and 46 (58%) of 79 in the short treatment group. Odds ratios were 1·41 (95% CI 0·69-2·88; p=0·34) when comparing the low dose and control groups and 1·23 (0·61-2·50; p=0·55) when comparing short treatment and control groups. 177 participants (76%) had an adverse event: 62 (79%) in the control group, 56 (73%) in the low dose group, and 59 (77%) in the short treatment group. However, discontinuations were less frequent in the short treatment group compared with the control group (2 [2%] vs 11 [14%]; OR 0·20, 95% CI 0·04-0·95; p=0·044). Interpretation: Participants had a similar parasitological responses. However, reducing the usual treatment from 8 weeks to 2 weeks might maintain the same response while facilitating adherence and increasing treatment coverage. These findings should be confirmed in a phase 3 clinical trial. | en_US |
| Afiliación | Department of Infectious Diseases. Vall d'Hebron University Hospital. PROSICS Barcelona. Medicine Department Universitat Autònoma de Barcelona. Barcelona, Spain / Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III. Madrid, Spain. | en_US |
| Afiliación | Instituto Nacional de Parasitología Dr M Fatala Chaben. ANLIS Dr C Malbran. Ministerio de Salud. Buenos Aires, Argentina. | en_US |
| Afiliación | Department of Microbiology. Vall d'Hebron University Hospital. PROSICS Barcelona. Medicine Department Universitat Autònoma de Barcelona. Barcelona, Spain /Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III. Madrid, Spain. | en_US |
| Afiliación | Departamento de Investigaciones. Fundación Cardioinfantil. Instituto de Cardiología. Bogotá, Colombia. | en_US |
| Afiliación | Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III.Madrid, Spain /National Referral Centre for Tropical Diseases. Infectious Diseases Department. Hospital Universitario Ramón y Cajal IRYCIS. Madrid, Spain. | en_US |
| Afiliación | Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brazil. | en_US |
| Afiliación | Instituto Nacional de Parasitología Dr M Fatala Chaben. ANLIS Dr C Malbran. Ministerio de Salud. Buenos Aires, Argentina / Centro de Investigaciones Epidemiológicas y Salud Pública. Consejo Nacional de Investigaciones Científicas y Técnicas. Buenos Aires, Argentina. | en_US |
| Afiliación | Department of Infectious Diseases. Vall d'Hebron University Hospital. PROSICS Barcelona. Medicine Department Universitat Autònoma de Barcelona. Barcelona, Spain / Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III. Madrid, Spain. | en_US |
| Afiliación | Instituto de Cardiología de Corrientes Juana Francisca Cabral. Corrientes, Argentina. | en_US |
| Afiliación | Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Virologia Molecular e Parasitologia. Rio de Janeiro, RJ, Brazil. | en_US |
| Afiliación | Department of Infectious Diseases. Vall d'Hebron University Hospital. PROSICS Barcelona. Medicine Department Universitat Autònoma de Barcelona. Barcelona, Spain / Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III. Madrid, Spain. | en_US |
| Afiliación | Universidade Estadual de Montes Claros. Graduate Program in Health Sciences. Montes Claros, MG, Brazil. | en_US |
| Afiliación | Universidade Federal de Minas Gerais. Faculdade de Medicina. Belo Horizonte, MG, Brazil | en_US |
| Afiliación | Department of Infectious Diseases. Vall d'Hebron University Hospital. PROSICS Barcelona. Medicine Department Universitat Autònoma de Barcelona. Barcelona, Spain / Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III. Madrid, Spain. | en_US |
| Afiliación | Instituto Multidisciplinario de Investigaciones en Patologías Pediátricas. Buenos Aires, Argentina. | en_US |
| Afiliación | Department of Microbiology. Vall d'Hebron University Hospital. PROSICS Barcelona. Medicine Department Universitat Autònoma de Barcelona. Barcelona, Spain /Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III. Madrid, Spain. | en_US |
| Afiliación | Department of Infectious Diseases. Vall d'Hebron University Hospital. PROSICS Barcelona. Medicine Department Universitat Autònoma de Barcelona. Barcelona, Spain / Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III. Madrid, Spain. | en_US |
| Afiliación | Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III.Madrid, Spain /National Referral Centre for Tropical Diseases. Infectious Diseases Department. Hospital Universitario Ramón y Cajal IRYCIS. Madrid, Spain. | en_US |
| Afiliación | Department of Infectious Diseases. Vall d'Hebron University Hospital. PROSICS Barcelona. Medicine Department Universitat Autònoma de Barcelona. Barcelona, Spain / Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III. Madrid, Spain. | en_US |
| Afiliación | Universidade Federal de Minas Gerais. Faculdade de Medicina. Hospital das Clínicas. Belo Horizonte, MG, Brazil. | en_US |
| Afiliación | Universidade Estadual de Montes Claros. Graduate Program in Health Sciences. Montes Claros, MG, Brazil. | en_US |
| Afiliación | Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III.Madrid, Spain / National Referral Centre for Tropical Diseases. Infectious Diseases Department. Hospital Universitario Ramón y Cajal IRYCIS. Madrid, Spain. | en_US |
| Afiliación | Department of Infectious Diseases. Vall d'Hebron University Hospital. PROSICS Barcelona. Medicine Department Universitat Autònoma de Barcelona. Barcelona, Spain / Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III. Madrid, Spain. | en_US |
| Afiliación | Universidade Estadual de Montes Claros. Graduate Program in Health Sciences. Montes Claros, MG, Brazil. | en_US |
| Afiliación | Departamento de Investigaciones. Fundación Cardioinfantil. Instituto de Cardiología. Bogotá, Colombia. | en_US |
| Afiliación | Multiple Sclerosis Centre of Catalonia. Neurology Department. Vall d'Hebron University Hospital. Universitat Autònoma de Barcelona. Barcelona, Spain /Queen Square MS Centre. Department of Neuroinflammation. UCL Queen Square Institute of Neurology. University College London. London, UK. | en_US |
| Afiliación | Department of Infectious Diseases. Vall d'Hebron University Hospital. PROSICS Barcelona. Medicine Department Universitat Autònoma de Barcelona. Barcelona, Spain /Centro de Investigación Biomédica en Red de Enfermedades Infecciosas. Instituto de Salud Carlos III. Madrid, Spain. | en_US |
| Palavras clave en Inglês | Chronic Chagas disease | |
| Palavras clave en Inglês | Benznidazole regimens | |
| Palavras clave en Inglês | Neglected tropical disease | |
| Palavras clave en Inglês | MULTIBENZ | |
| Fecha de embargo | 3100-12-31 |
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