Nifurtimox-eflornithine combination therapy for second-stage African Trypanosoma brucei gambiense trypanosomiasis: a multicentre, randomised, phase III, non-inferiority trial

by Priotto G, Kasparian S, Mutombo W, Ngouama D, Ghorashian S, Arnold U, Ghabri S, Baudin E, Buard V, Kazadi-Kyanza S, Ilunga M, Mutangala W, Pohlig G, Schmid C, Karunakara U, Torreele E, Kande V. The Lancet, July 2009, 374:56-64.

Summary: This pivotal Phase III study assessed the efficacy and safety of nifurtimox-eflornithine combination therapy (NECT) for second-stage disease compared with the gold-standard regimen of eflornithine in 287 patients at four HAT treatments centres in the Republic of the Congo and the Democratic Republic of Congo. The results showed NECT to be comparable with eflornithine in efficacy (>90% cure in both treatment arms at 18-month follow-up) and to be well tolerated. Patient follow-up at 18 months after treatment was 93%, which is exceptionally high for these types of studies in HAT and further contributes to the robustness of the study. In comparison with eflornithine, NECT is easier to administer, more affordable and with simpler logistics, and potentially protective against the emergence of resistant parasites. The authors conclude that NECT represents an improved alternative for stage 2 HAT treatment and is suitable for first-line use in HAT control programmes.

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An accompanying Lancet editorial calls the NECT study ‘more than a small victory over sleeping sickness‘.

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