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Home > Research and development > Portfolio

Sleeping sickness 

Nifurtimox-eflornithine combination therapy (NECT)

Home > Research and development > Portfolio

Sleeping sickness

Nifurtimox-eflornithine combination therapy (NECT)

objective

Develop a new treatment for sleeping sickness to replace the complex and toxic melarsoprol arsenic-based drug that kills 5% of those treated

project start
2004
project status
Treatment delivered in 2009

current phase of drug development

Discovery project phase
Drug Discovery
Translation project phase
Translational research
clinical trials icon
Clinical trials
Treatment Access
Registration & access

updated 1 Mar 2022

Better, simpler, shorter treatment for sleeping sickness patients and health staff

The first improved treatment for sleeping sickness

Before 2009, the best treatment for sleeping sickness, eflornithine, was very complex to distribute and administer in regions affected by the disease. All too often, doctors would have no choice but to use melarsoprol, a highly toxic, arsenic-based drug that killed one of every 20 patients it was meant to cure.

In 2009, results from a pivotal clinical trial sponsored by DNDi and Médecins Sans Frontières (MSF) showed that NECT, a combined treatment of Bayer’s nifurtimox and Sanofi’s eflornithine, was a safe and effective treatment for sleeping sickness. NECT has significant practical benefits in comparison to eflornithine: there are fewer intravenous infusions (14 instead of 56), treatment length is shorter, and it is more cost effective than using eflornithine alone. NECT is not only better for patients, but it also simplifies the logistics and staffing needed at treatment centres, which are often in remote areas.

Between 2009 and 2012, DNDi sponsored a new, larger trial (NECT-Field) to assess whether the results of the clinical trial conducted in 2009 were sustained when the treatment was administered in field conditions. Results from the NECT-Field study confirmed the effectiveness and safety of NECT as a treatment for stage 2 sleeping sickness caused by T.b. gambiense in field conditions.

In August 2019, fexinidazole was included in the World Health Organization’s (WHO) treatment guidelines, making NECT the second-line treatment for T.b. gambiense sleeping sickness, though it remains the recommended first-line treatment in cases of advanced disease. Endemic countries will continue to receive free supplies of NECT through WHO via drug donations.

Treatment regimens

  • Indication: Stage 2 T.b. gambiense sleeping sickness (human African trypanosomiasis)
  • Dosage: 14 intravenous eflornithine infusions for 7 days and 3-times-a-day oral nifurtimox for 10 days 

Impact

  • Between 2009 and 2019, recommended as first-line treatment in all 13 endemic countries, all of which receive free supplies from WHO via drug donations by Sanofi and Bayer 
  • NECT fully replaced melarsoprol as treatment for advanced g-HAT until the introduction of fexinidazole
  • Added to the WHO Essential Medicines List in 2009, and the WHO Essential Medicines List for Children in 2013.
  • Developed in partnership between DNDi, Médecins Sans Frontières, Epicentre, the HAT Platform, Swiss Tropical & Public Health Institute, national control programmes of the Democratic Republic of the Congo and Republic of Congo, with the support of WHO and drugs donated by Sanofi and Bayer

‘It was 2007 when I began to feel tired and weak. I’d sleep during the day but not at night. I was so weak. I received malaria treatment in 2008, but it didn’t work. I tried traditional medicines, but it didn’t work either. Finally, in 2012 a mobile team came to the village, and we found out I had sleeping sickness. I went to the hospital and received NECT. I’m cured and feel fine now.’

Jean de Dieu Liyande Walo, remote village of Yalikombo

Project updates

2021

The final study report was published in November 2021.  

2019

With the revision of WHO treatment guidelines for HAT in 2019 and the inclusion of fexinidazole, NECT will become the second-line treatment, though it remains the recommended first-line treatment in cases of advanced disease. Endemic countries will continue to receive free supplies from WHO via drug donations by Sanofi and Bayer.  

2016

NECT was included on the WHO Essential Medicines List in 2009 and extended to the Essential Medicines List for Children in 2013. With the recommendation of NECT as first-line treatment in all endemic countries, all of which receive free supplies from WHO via drug donations by Sanofi and Bayer, 100% of stage-2 HAT patients are now treated with NECT. 

2015

NECT has been included in the WHO Essential Medicines List since 2009 and on the Essential Medicines List for children since 2013. Since June 2014, NECT has become available in all endemic countries, which receive free supplies from WHO via drug donations by Sanofi and Bayer. 

News & resources

  • 13 November 2023 – Maladie du sommeil : l’élimination d’un fléau à portée de main, Le Monde
  • 8 November 2021 – Effectiveness of Nifurtimox Eflornithine Combination Therapy (NECT) in T. b. gambiense second stage sleeping sickness patients in the Democratic Republic of Congo: Report from a field study, PLOS Neglected Tropical Diseases
  • 30 April 2021 – Au bord du fleuve Congo : la maladie du sommeil en voie d’éradication, France Culture
  • 27 January 2020 – Prescription of concomitant medications in patients treated with Nifurtimox Eflornithine Combination Therapy (NECT) for T.b. gambiense second stage sleeping sickness in the Democratic Republic of the Congo, PLOS Neglected Tropical Diseases
  • 10 September 2014 – Treatment options for second-stage gambiense human African trypanosomiasis, Expert Review of Anti-infective Therapy
  • 11 July 2013 – Three Neglected-Disease Treatments Newly Added to WHO Essential Medicines List for Paediatric Use
  • 30 November 2012 – In-hospital safety in field conditions of Nifurtimox Eflornithine Combination Therapy (NECT) for T. b. gambiense sleeping sickness, PLoS Negl Trop Dis
  • 20 May 2010 – NECT is next: Implementing the new drug combination therapy for Trypanosoma brucei gambiense sleeping sickness, PLoS Negl Trop Dis
  • 22 September 2009 – Improved treatment for sleeping sickness now available
  • 30 July 2009 – Nifurtimox-eflornithine combination therapy for second-stage African Trypanosoma brucei gambiense trypanosomiasis: a multicentre, randomised, phase III, non-inferiority trial, The Lancet
  • 15 May 2009 – NECT Added to WHO Essential Medicines List as Combination Treatment Against Sleeping Sickness
  • 9 December 2008 – Positive Results for Improved Treatment Against Sleeping Sickness

More information

Nifurtimox-eflornithine combination therapy for second-stage gambiense human African trypanosomiasis: Médecins Sans Frontières experience in the Democratic Republic of the Congo. Clinical Infectious Diseases, January 2013
by Alirol E, Schrumpf D, Amici Heradi J, Riedel A, de Patoul C, Quere M, and Chappuis F.

Launch dossier:

  • NECT dossier – English
  • NECT dossier – Français

Partners

  • Bayer Healthcare AG, Germany
  • Epicentre (MSF) – France, France
  • HAT Platform
  • Médecins Sans Frontières (MSF), International
  • National Control Programme of the Republic of the Congo, Republic of the Congo
  • National HAT Control Programme of the Democratic Republic of Congo (PNLTHA), DRC
  • Sanofi, France
  • Swiss Tropical and Public Health Institute (Swiss TPH), Switzerland
  • World Health Organization (WHO), Switzerland
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  • Bayer Healthcare AG
  • ,Germany
  • Epicentre (MSF) – France
  • ,France
  • HAT Platform
  • Médecins Sans Frontières (MSF)
  • ,International
  • National Control Programme of the Republic of the Congo
  • ,Republic of the Congo
  • National HAT Control Programme of the Democratic Republic of Congo (PNLTHA)
  • ,DRC
  • Sanofi
  • ,France
  • Swiss Tropical and Public Health Institute (Swiss TPH)
  • ,Switzerland
  • World Health Organization (WHO)
  • ,Switzerland
  • Médecins Sans Frontières (MSF), International
  • Epicentre (MSF) – France, France
  • HAT Platform,
  • Swiss Tropical and Public Health Institute (Swiss TPH), Switzerland
  • National HAT Control Programme of the Democratic Republic of Congo (PNLTHA), DRC
  • Sanofi, France
  • National Control Programme of the Republic of the Congo, Republic of the Congo
  • World Health Organization (WHO), Switzerland
  • Bayer Healthcare AG, Germany

Funding

  • France - Ministry For Europe and Foreign Affairs
  • France - French Development Agency (AFD)
  • Spain - Spanish Agency for International Development Cooperation (AECID)
  • Switzerland - Swiss Agency for Development and Cooperation (SDC)
  • Switzerland - Republic and Canton of Geneva, International Solidarity Service
  • UK - UK International Development
​
  • Medicor Foundation
  • Médecins Sans Frontières International
  • Other private foundations and individuals
​

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