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Nifurtimox Plus Eflornithine Better Than Current Therapies for Sleeping Sickness

NEW YORK -- June 24, 2009 -- Nifurtimox in combination with eflornithine is safe, effective, and more affordable than current treatments for sleeping sickness and should be implemented as a matter of priority by control programmes across sub-Saharan Africa, according to a study published in this week's issue of The Lancet.

Human African trypanosomiasis (HAT) or sleeping sickness affects tens of thousands of people every year in sub-Saharan Africa and is a fatal disease with few treatment options. For 60 years melarsoprol has been the most commonly used treatment, but it is a highly toxic drug which causes severe adverse reactions.

A newer alternative, eflornithine, has been shown to be more effective and better tolerated, but is difficult to administer requiring 1 slow infusion every 6 hours for 14 days -- which has limited its use in resource-poor settings. A third orally administered drug, nifurtimox, has shown some promising results in combination with eflornithine.

To investigate further, Gerardo Priotto, Epicentre, Paris, France and colleagues conducted a randomised trial of patients with second-stage sleeping sickness to compare the efficacy and safety of nifurtimox-eflornithine combination therapy (NECT) with standard eflornithine, the best currently available treatment.

In total, 287 patients aged 15 years or older were recruited from 4 treatment centres in Congo and the Democratic Republic of Congo between 2003 and 2006.

Patients were randomly assigned to either intravenous eflornithine 400mg/kg per day, every 6 hours for 14 days or intravenous eflornithine 400mg/kg per day, every 12 hours for 7 days with oral nifurtimox 15mg/kg per day, every 8 hours for 10 days.

Patients were followed up for 18 months and examined at regular intervals for relapses.

Overall, results showed that NECT is non-inferior to the best current treatment, eflornithine. Cure rates were substantially higher in the NECT group (96.5-97.9%) compared with rates of 91.6% to 92.3% in patients given eflornithine alone.

In addition, NECT was fairly well tolerated with half as many major adverse events reported and a lower frequency of infections such as diarrhoea and fever in the NECT group compared with the eflornithine group.

The authors concluded that because NECT has safety advantages, is easier to administer (infusion every 12 h for 7 days vs every 6 h for 14 days), is more affordable, and as a combination of drugs might potentially be protected against the development of drug resistance, call for its first-line use in sleeping sickness control programmes.

SOURCE: The Lancet

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