Nifurtimox plus Eflornithine for Late-Stage Sleeping Sickness in Uganda: A Case Series.

Hdl Handle:
http://hdl.handle.net/10144/18316
Title:
Nifurtimox plus Eflornithine for Late-Stage Sleeping Sickness in Uganda: A Case Series.
Authors:
Checchi, F; Piola, P; Ayikoru, H; Thomas, F; Legros, D; Priotto, G
Journal:
PLoS Neglected Tropical Diseases
Abstract:
BACKGROUND: We report efficacy and safety outcomes from a prospective case series of 31 late-stage T.b. gambiense sleeping sickness (Human African Trypanosomiasis, HAT) patients treated with a combination of nifurtimox and eflornithine (N+E) in Yumbe, northwest Uganda in 2002-2003, following on a previously reported terminated trial in nearby Omugo, in which 17 patients received the combination under the same conditions. METHODOLOGY/PRINCIPAL FINDINGS: Eligible sequential late-stage patients received 400 mg/Kg/day eflornithine (Ornidyl, Sanofi-Aventis) for seven days plus 15 mg/Kg/day (20 mg for children <15 years old) nifurtimox (Lampit, Bayer AG) for ten days. Efficacy (primary outcome) was monitored for 24 months post discharge. Clinical and laboratory adverse events (secondary outcome) were monitored during treatment. All 31 patients were discharged alive, but two died post-discharge of non-HAT and non-treatment causes, and one was lost to follow-up. Efficacy ranged from 90.3% to 100.0% according to analysis approach. Five patients experienced major adverse events during treatment, and neutropenia was common (9/31 patients). CONCLUSIONS/SIGNIFICANCE: Combined with the previous group of 17 trial patients, this case series yields a group of 48 patients treated with N+E, among whom no deaths judged to be treatment- or HAT-related, no treatment terminations and no relapses have been noted, a very favourable outcome in the context of late-stage disease. N+E could be the most promising combination regimen available for sleeping sickness, and deserves further evaluation.
Advisors:
http://www.plosntds.org; http://www.plosntds.org
Affiliation:
Epicentre, Paris, France.
Publisher:
Public Library of Science
Issue Date:
2007
URI:
http://hdl.handle.net/10144/18316
DOI:
10.1371/journal.pntd.0000064
PubMed ID:
18060083
Language:
en
ISSN:
1935-2735
Appears in Collections:
Trypanosomiasis/Sleeping Sickness

Full metadata record

DC FieldValue Language
dc.contributor.advisorhttp://www.plosntds.org-
dc.contributor.advisorhttp://www.plosntds.orgen
dc.contributor.authorChecchi, F-
dc.contributor.authorPiola, P-
dc.contributor.authorAyikoru, H-
dc.contributor.authorThomas, F-
dc.contributor.authorLegros, D-
dc.contributor.authorPriotto, G-
dc.date.accessioned2008-02-14T14:42:27Z-
dc.date.available2008-02-14T14:42:27Z-
dc.date.issued2007-
dc.identifier.citationNifurtimox plus Eflornithine for Late-Stage Sleeping Sickness in Uganda: A Case Series. 2007, 1 (2):e64 PLoS Negl Trop Disen
dc.identifier.issn1935-2735-
dc.identifier.pmid18060083-
dc.identifier.doi10.1371/journal.pntd.0000064-
dc.identifier.urihttp://hdl.handle.net/10144/18316-
dc.description.abstractBACKGROUND: We report efficacy and safety outcomes from a prospective case series of 31 late-stage T.b. gambiense sleeping sickness (Human African Trypanosomiasis, HAT) patients treated with a combination of nifurtimox and eflornithine (N+E) in Yumbe, northwest Uganda in 2002-2003, following on a previously reported terminated trial in nearby Omugo, in which 17 patients received the combination under the same conditions. METHODOLOGY/PRINCIPAL FINDINGS: Eligible sequential late-stage patients received 400 mg/Kg/day eflornithine (Ornidyl, Sanofi-Aventis) for seven days plus 15 mg/Kg/day (20 mg for children <15 years old) nifurtimox (Lampit, Bayer AG) for ten days. Efficacy (primary outcome) was monitored for 24 months post discharge. Clinical and laboratory adverse events (secondary outcome) were monitored during treatment. All 31 patients were discharged alive, but two died post-discharge of non-HAT and non-treatment causes, and one was lost to follow-up. Efficacy ranged from 90.3% to 100.0% according to analysis approach. Five patients experienced major adverse events during treatment, and neutropenia was common (9/31 patients). CONCLUSIONS/SIGNIFICANCE: Combined with the previous group of 17 trial patients, this case series yields a group of 48 patients treated with N+E, among whom no deaths judged to be treatment- or HAT-related, no treatment terminations and no relapses have been noted, a very favourable outcome in the context of late-stage disease. N+E could be the most promising combination regimen available for sleeping sickness, and deserves further evaluation.en
dc.language.isoenen
dc.publisherPublic Library of Science-
dc.rightsArchived on this site by Open Access permissionen
dc.titleNifurtimox plus Eflornithine for Late-Stage Sleeping Sickness in Uganda: A Case Series.en
dc.contributor.departmentEpicentre, Paris, France.en
dc.identifier.journalPLoS Neglected Tropical Diseasesen

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