Mental HealthPromising New Drug Combination For Patients With Sleeping Sickness
Human African trypanosomiasis (HAT) or sleeping sickness affects tens of thousands of people every year in sub-Saharan Africa. It is a fatal disease with few treatment options. According to an article in this week"s issue of The Lancet, Nifurtimox in combination with eflornithine is safe, effective, and more affordable than current treatments for sleeping sickness. This new drug combination should be implemented as a matter of priority by control programmes across sub-Saharan Africa.
Melarsoprol has been the most frequently used treatment for the last sixty years. But it is an extremely toxic drug which causes severe adverse reactions. A recent alternative is eflornithine. It has proven to have a higher effectiveness and is better tolerated. But, it is not easy to administer since it requires one slow infusion every six hours for fourteen days. This has limited its use in underprivileged settings. Nifurtimox is another drug, administered orally and currently used in the treatment of Chagas disease. It is not yet registered for the treatment of sleeping sickness but has shown some promising results in combination with eflornithine.
In order to find out more, Gerardo Priotto and his team conducted a randomised trial. All patients had second-stage sleeping sickness, where the infection has reached the brain and prognosis is usually very poor. They compared the efficacy and safety of nifurtimox-eflornithine combination therapy (NECT) with standard eflornithine. This is the best available treatment presently.
Between 2003 and 2006, a total of 287 patients were recruited from four treatment centres in Congo and the Democratic Republic of Congo. They were 15 years or older. Patients were assigned at random to either intravenous eflornithine (400mg/kg per day, every six hours) for fourteen days or intravenous eflornithine (400mg/kg per day, every twelve hours) for seven days with oral nifurtimox (15mg/kg per day, every eight hours) for ten days (NECT). For eighteen months patients were monitored and examined at regular intervals for relapses.
In general, the study suggested that NECT is not inferior to eflornithine, the best current treatment up to now. Rates of healing were significantly superior in the NECT group (96.5 percent to 97.9 percent) compared with rates of 91.6 percent to 92.3 percent in the group given eflornithine alone.
Also, NECT was reasonably well tolerated. Reports of major adverse events were reduced by half. There was lower frequency of infections such as diarrhoea and fever in the NECT group compared to the eflornithine group.
The researchers conclude that NECT shows safety advantages. It is easier to administer (infusion every twelve hours for seven days versus every six hours for fourteen days) and it is more affordable. Since it is a combination of drugs, it might be safeguarded from the development of drug resistance. As a result the authors request its first-line use in sleeping sickness control programmes.
In an associated note, Charles Woodrow from St George"s, University of London, UK, and Jimmy Opigo from Moyo District Hospital, Uganda, mention that the results of the study supply a good foundation to confirm the promotion of NECT within national treatment strategies. They carry on by examining further challenges, such as the critical need to build better treatments for patients with first-stage sleeping sickness.
"Nifurtimox-eflornithine combination therapy for second-stage African Trypanosoma brucei gambiense trypanosomiasis: a multicentre, randomised, phase III, non-inferiority trial"
Gerardo Priotto, Serena Kasparian, Wilfried Mutombo, Daniel Ngouama, Sara Ghorashian, Ute Arnold, Salah Ghabri, Elisabeth Baudin, Vincent Buard, Serge Kazadi-Kyanza, Mç©dard Ilunga, Willy Mutangala, Gabriele Pohlig, Caecilia Schmid, Unni Karunakara, Els Torreele, Victor Kande
DOI: 10.1016/S0140-6736(09)61117-X
thelancet
Written by Stephanie Brunner (B.A.)
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