SciDev.Net (London)
Julie Clayton
10 January 2007
Preliminary results from a sleeping sickness drug trial have been so overwhelmingly positive that two African nations want the drug available as soon as possible.
And more patients -- beyond the number needed -- are being enrolled on the trial in order to make the treatment available.
The governments of the Democratic Republic of Congo (DRC) and Uganda have asked for the treatment to be made available before the trial is completed next year, according to the Drugs for Neglected Diseases Initiative.
The trials test the effectiveness of combining two drugs, eflornithine and nifurtimox, against sleeping sickness. Trials began in Congo-Brazzaville and have since expanded to three sites in the DRC and two in Uganda.
Mid-way results, after 18 months follow-up on the first 103 patients enrolled at the Congo Brazzaville site, have impressed the National Programme for Sleeping Sickness Control in the DRC, who wish to increase access.
Without being enrolled in trials, patients have no access to nifurtimox as it is only licensed for use against Chagas disease, a related parasitic infection. As a result, extra patients are being enrolled.
According to Girardo Priotto of Doctors Without Borders, "The situation is so desperate in the field that we are not happy with two more years of waiting, so we are looking for ways of making this treatment more available earlier."
Nifurtimox is donated free to the World Health Organisation (WHO) by pharmaceutical company Bayer. But without further scientific evidence the WHO will not agree to its use for sleeping sickness. Other studies have also supported the use of nifurtimox-containing combination therapies for sleeping sickness.
Thousands of people each year are diagnosed with advanced-stage sleeping sickness, which is fatal if not treated. Current treatment, with the drug melarsoprol, itself causes the death of around six per cent of patients. In addition, some patients are also resistant.
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