Chagas Implementation

 

  • Target disease: Chagas disease
  • Main partners (since project start): BRAZIL: LAFEPE; ARGENTINA: Fundación Mundo Sano and ELEA; Centro Nacional de Diagnóstico e Investigación de Endemo-epidemias, Administración Nacional de Laboratorios e Institutos de Salud; Centro de Chagas y Patologia Regional, Hospital Independencia, Santiago del Estero; Hospital de Niños de Jujuy; Hospital de Niños Dr. Ricardo Gutiérrez; Hospital Público Materno Infantil – Salta; Instituto Nacional de Parasitología Dr M Fatala Chabén; Ministry of Health; Ministério de Salud, Província de Jujuy.
  • Project start: May 2011
  • Funding (since project start): Associação Bem-Te-Vi Diversidade, Brazil; Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), the Netherlands; Médecins Sans Frontières/Doctors without Borders, International, Italy, Brazil; Ministry of Health, Brazil; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Starr International Foundation, Switzerland; the United States Agency for International Development, via the 4th Sector Health Project implemented by Abt Associates, Inc., USA; Other private foundations and individuals.

 

Overall Objective:

  • Continue to support implementation and registration of the paediatric dosage form of benznidazole; secure second source of benznidazole.

 

 

 

In July 2008, DNDi and LAFEPE entered a joint development programme that led to the determination and production of the most appropriate paediatric dosage formulation, strength, and dosing regimen of benznidazole. A population pharmacokinetic study involving 81 children aged 0 to 12 years with Chagas disease was conducted and showed complete parasitic clearance in all children after treatment and that those assessed 12 months later were still clear of T. cruzi parasites. The study also showed that children have lower blood levels of benznidazole than previously documented in adults, suggesting a reduction of adult dosing regimens may be possible. The paediatric formulation, adapted for babies and children up to two years of age, was registered in Brazil (2011). In July 2013, the treatment was included on the WHO Essential Medicines List for children. In November 2013, the Mundo Sano Foundation and DNDi signed a collaboration agreement to deliver a second source of the treatment in partnership with ELEA (producers of Abarax®). Submission process for reguloraty approval in Argentina was still ongoing in 2016. Through this project, DNDi has also stepped up efforts to support the scale up of treatment with benznidazole for adult patients with Chagas disease.

 

Last update: February 2017