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.

<h4>Background</h4>Nifurtimox-eflornithine combination therapy (NECT) for the treatment of second stage gambiense human African trypanosomiasis (HAT) was added to the World Health Organization's Essential Medicines List in 2009 after demonstration of its non-inferior efficacy compar...

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Autores principales:	Andrea Kuemmerle, Caecilia Schmid, Sonja Bernhard, Victor Kande, Wilfried Mutombo, Medard Ilunga, Ismael Lumpungu, Sylvain Mutanda, Pathou Nganzobo, Digas Ngolo Tete, Mays Kisala, Christian Burri, Severine Blesson, Olaf Valverde Mordt
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/f63dc777b6de4a5784745592064afb8e
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spelling	oai:doaj.org-article:f63dc777b6de4a5784745592064afb8e2021-12-02T20:23:58ZEffectiveness 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.1935-27271935-273510.1371/journal.pntd.0009903https://doaj.org/article/f63dc777b6de4a5784745592064afb8e2021-11-01T00:00:00Zhttps://doi.org/10.1371/journal.pntd.0009903https://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735<h4>Background</h4>Nifurtimox-eflornithine combination therapy (NECT) for the treatment of second stage gambiense human African trypanosomiasis (HAT) was added to the World Health Organization's Essential Medicines List in 2009 after demonstration of its non-inferior efficacy compared to eflornithine therapy. A study of NECT use in the field showed acceptable safety and high efficacy until hospital discharge in a wide population, including children, pregnant and breastfeeding women, and patients with a HAT treatment history. We present here the effectiveness results after the 24-month follow-up visit.<h4>Methodology/principal findings</h4>In a multicenter, open label, single arm phase IIIb study, second stage gambiense HAT patients were treated with NECT in the Democratic Republic of Congo. Clinical cure was defined 24 months after treatment as survival without clinical and/or parasitological signs of HAT. Of the 629 included patients, 619 (98.4%) were discharged alive after treatment and were examined for the presence of trypanosomes, white blood cell count in cerebro-spinal fluid, and disease symptoms. The clinical cure rate of 94.1% was comparable for all subpopulations analyzed at the 24-month follow-up visit. Self-reported adverse events during follow-up were few and concerned mainly nervous system disorders, infections, and gastro-intestinal disorders. Overall, 28 patients (4.3%) died during the course of the trial. The death of 16 of the 18 patients who died during the follow-up period was assessed as unlikely or not related to NECT. Within 24 months, eight patients (1.3%) relapsed and received rescue treatment. Sixteen patients were completely lost to follow-up.<h4>Conclusions/significance</h4>NECT treatment administered under field conditions was effective and sufficiently well tolerated, no major concern arose for children or pregnant or breastfeeding women. Patients with a previous HAT treatment history had the same response as those who were naïve. In conclusion, NECT was confirmed as effective and appropriate for use in a broad population, including vulnerable subpopulations.<h4>Trial registration</h4>The trial is registered at ClinicalTrials.gov, number NCT00906880.Andrea KuemmerleCaecilia SchmidSonja BernhardVictor KandeWilfried MutomboMedard IlungaIsmael LumpunguSylvain MutandaPathou NganzoboDigas Ngolo TeteMays KisalaChristian BurriSeverine BlessonOlaf Valverde MordtPublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 15, Iss 11, p e0009903 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
spellingShingle	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Andrea Kuemmerle Caecilia Schmid Sonja Bernhard Victor Kande Wilfried Mutombo Medard Ilunga Ismael Lumpungu Sylvain Mutanda Pathou Nganzobo Digas Ngolo Tete Mays Kisala Christian Burri Severine Blesson Olaf Valverde Mordt 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.
description	<h4>Background</h4>Nifurtimox-eflornithine combination therapy (NECT) for the treatment of second stage gambiense human African trypanosomiasis (HAT) was added to the World Health Organization's Essential Medicines List in 2009 after demonstration of its non-inferior efficacy compared to eflornithine therapy. A study of NECT use in the field showed acceptable safety and high efficacy until hospital discharge in a wide population, including children, pregnant and breastfeeding women, and patients with a HAT treatment history. We present here the effectiveness results after the 24-month follow-up visit.<h4>Methodology/principal findings</h4>In a multicenter, open label, single arm phase IIIb study, second stage gambiense HAT patients were treated with NECT in the Democratic Republic of Congo. Clinical cure was defined 24 months after treatment as survival without clinical and/or parasitological signs of HAT. Of the 629 included patients, 619 (98.4%) were discharged alive after treatment and were examined for the presence of trypanosomes, white blood cell count in cerebro-spinal fluid, and disease symptoms. The clinical cure rate of 94.1% was comparable for all subpopulations analyzed at the 24-month follow-up visit. Self-reported adverse events during follow-up were few and concerned mainly nervous system disorders, infections, and gastro-intestinal disorders. Overall, 28 patients (4.3%) died during the course of the trial. The death of 16 of the 18 patients who died during the follow-up period was assessed as unlikely or not related to NECT. Within 24 months, eight patients (1.3%) relapsed and received rescue treatment. Sixteen patients were completely lost to follow-up.<h4>Conclusions/significance</h4>NECT treatment administered under field conditions was effective and sufficiently well tolerated, no major concern arose for children or pregnant or breastfeeding women. Patients with a previous HAT treatment history had the same response as those who were naïve. In conclusion, NECT was confirmed as effective and appropriate for use in a broad population, including vulnerable subpopulations.<h4>Trial registration</h4>The trial is registered at ClinicalTrials.gov, number NCT00906880.
format	article
author	Andrea Kuemmerle Caecilia Schmid Sonja Bernhard Victor Kande Wilfried Mutombo Medard Ilunga Ismael Lumpungu Sylvain Mutanda Pathou Nganzobo Digas Ngolo Tete Mays Kisala Christian Burri Severine Blesson Olaf Valverde Mordt
author_facet	Andrea Kuemmerle Caecilia Schmid Sonja Bernhard Victor Kande Wilfried Mutombo Medard Ilunga Ismael Lumpungu Sylvain Mutanda Pathou Nganzobo Digas Ngolo Tete Mays Kisala Christian Burri Severine Blesson Olaf Valverde Mordt
author_sort	Andrea Kuemmerle
title	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.
title_short	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.
title_full	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.
title_fullStr	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.
title_full_unstemmed	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.
title_sort	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.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/f63dc777b6de4a5784745592064afb8e
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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.

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