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. 

*Project cost includes direct and indirect costs, but it does not include in-kind contributions.