PMID- 23074318
OWN - NLM
STAT- MEDLINE
DCOM- 20130610
LR  - 20131121
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Linking)
VI  - 56
IP  - 2
DP  - 2013 Jan
TI  - Nifurtimox-eflornithine combination therapy for second-stage gambiense human 
      African trypanosomiasis: Medecins Sans Frontieres experience in the Democratic 
      Republic of the Congo.
PG  - 195-203
LID - 10.1093/cid/cis886 [doi]
AB  - BACKGROUND: Existing diagnostic and treatment tools for human African 
      trypanosomiasis (HAT) are limited. The recent development of 
      nifurtimox-eflornithine combination therapy (NECT) has brought new hopes for 
      patients in the second stage. While NECT has been rolled out in most endemic 
      countries, safety data are scarce and derive only from clinical trials. The World 
      Health Organization (WHO) coordinates a pharmacovigilance program to collect 
      additional data on NECT safety and efficacy. We report here the results of 18 
      months of experience of NECT use in treatment centers run by Medecins Sans 
      Frontieres in the Democratic Republic of the Congo (DRC). METHODS: This cohort 
      study included 684 second-stage HAT patients (including 120 children) treated 
      with NECT in Doruma and Dingila hospitals, northeastern DRC, between January 2010 
      and June 2011. All treatment-emergent adverse events (AEs) were recorded and 
      graded according to the Common Terminology Criteria for Adverse Events version 
      3.0. Safety and efficacy data were retrieved from the WHO pharmacovigilance forms 
      and from Epitryps, a program monitoring database. RESULTS: Eighty-six percent of 
      the patients experienced at least 1 AE during treatment. On average, children 
      experienced fewer AEs than adults. Most AEs were mild (37.9%) or moderate 
      (54.7%). Severe AEs included vomiting (n = 32), dizziness (n = 16), headache (n = 
      11), and convulsions (n = 11). The in-hospital case fatality rate was low (0.15%) 
      and relapses were rare (n = 14). CONCLUSIONS: In comparison with previous 
      treatments, NECT was effective, safe, and well tolerated in nontrial settings in 
      DRC, further supporting the roll-out of NECT as first-line treatment in 
      second-stage Trypanosoma brucei gambiense HAT. Tolerance was particularly good in 
      children.
FAU - Alirol, Emilie
AU  - Alirol E
AD  - Division of International and Humanitarian Medicine, University Hospitals of 
      Geneva, Switzerland. emilie.alirol@hcuge.ch
FAU - Schrumpf, David
AU  - Schrumpf D
FAU - Amici Heradi, Josue
AU  - Amici Heradi J
FAU - Riedel, Andrea
AU  - Riedel A
FAU - de Patoul, Catherine
AU  - de Patoul C
FAU - Quere, Michel
AU  - Quere M
FAU - Chappuis, Francois
AU  - Chappuis F
LA  - eng
PT  - Journal Article
DEP - 20121016
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - M84I3K7C2O (Nifurtimox)
RN  - ZQN1G5V6SR (Eflornithine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Child, Preschool
MH  - Cohort Studies
MH  - Democratic Republic of the Congo
MH  - Drug Therapy, Combination
MH  - Eflornithine/adverse effects/*therapeutic use
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Infant
MH  - Male
MH  - Medication Adherence
MH  - Middle Aged
MH  - Nifurtimox/adverse effects/*therapeutic use
MH  - Risk Factors
MH  - Treatment Outcome
MH  - *Trypanosoma brucei gambiense
MH  - Trypanosomiasis, African/*drug therapy
MH  - Young Adult
EDAT- 2012/10/18 06:00
MHDA- 2013/06/12 06:00
CRDT- 2012/10/18 06:00
PHST- 2012/10/18 06:00 [entrez]
PHST- 2012/10/18 06:00 [pubmed]
PHST- 2013/06/12 06:00 [medline]
AID - cis886 [pii]
AID - 10.1093/cid/cis886 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2013 Jan;56(2):195-203. doi: 10.1093/cid/cis886. Epub 2012 Oct 
      16.