By Frank Mugabi

A trial combining two drugs for sleeping sickness has been successful. The trial was conducted between 2003 and 2009, at Omugo Health Centre in Maracha/Terego district, the Democratic Republic of Congo and Congo Brazzaville.

“Our findings have shown that the co-administration of oral nifurtimox and injectible eflornithineoral is effective and much easier to apply, unlike the previous treatment (eflornithine and melarsoprol) that required a lot of nursing care, staff and logistics,” says Dr. Jose Franco Ramon, a medical officer with the Neglected Tropical Diseases Department at the World Health Organisation (WHO) headquarters in Geneva.

He says the new combination is less lethal than the previous treatments. The new regiment reduces intravenous infusions of eflornithine from 56 to 14 and shortens hospitalisation from 14 to 10 days, making treatment more convenient for patients.

Dr. Charles Wamboga of the National Sleeping Sickness Control Programme in Koboko, Yumbe and Moyo districts, says kits of the new treatment supplied by the WHO have been distributed by the Ministry of Health in the affected areas. The kits are available in Adjumani, Moyo and Omugo hospitals, the main centres for treating the disease in West Nile. The stock will last for about a year.

Wamboga says treatment is free, courtesy of the donations from Sanofi-aventis and Bayer pharmaceutical companies that produce the medicine.

Ramon says production has not been easy since most pharmaceutical companies are reluctant to invest in production of drugs that are consumed by a small and poor population. Sanofi-aventis and Bayer donated the drugs.

Historical background
Of the 300 cases of sleeping sickness reported in Uganda each year, about 200 are in the West Nile. However, Adjumani has registered a gradual decline in sleeping sickness cases.

Wamboga says the prevalence of the disease in West Nile has a historical perspective to it.

“When people from West Nile took refuge in the Democratic Republic of Congo during the 1970s insurgency, they succumbed to the outbreak and when it was time to return, the strain struck again,” Wamboga says, adding that West Nile was initially free of the disease.

For a long time, residents have suffered with the fatal but neglected disease. Death and pain was exacerbated by failures that were reported in the line of drugs that were prescribed, especially in the treatment of advanced stages of sleeping sickness. Overtime, they found out that the drugs, eflornithine and melarsoprol were registering increasing failure rates of up to 17 and 30%, respectively. The drugs were used singularly in separate health centres.

Eflornithine was specifically used in Omugo and Yumbe hospitals, while melarsopro was used in Adjumani and Moyo.

Besides the ineffectiveness, melarsoprol which was discovered in 1949, has many undesired side effects.

Though less toxic than melarsoprol, eflornithine is strict and difficult to apply. Each of these drugs requires careful monitoring to ensure that the drugs do not cause complications which include fatal hypersensitive reaction, kidney or liver damage and inflammation of the brain.

Faced with the challenge of side effects, the health ministry sought the intervention of WHO. “They came up with a protocol of a combination of drugs to be tested in a clinical trial,” Wamboga says.

Subsequently, an international training workshop on the use of the new therapy, organised by the Vector Control Department of the Ministry of Health in collaboration with WHO, was held in Arua in February.

Participants came from Juba, Yei and Yambio in southern Sudan and West Nile, where gambiense, a form of sleeping sickness is endemic.

Uganda and southern Sudan are the first African countries to adopt the new treatment.

Phases of sleeping sickness
Dr. Charles Wamboga of the National Sleeping Sickness Control Programme in Koboko, Yumbe and Moyo districts, says West Nile is affected by chronic sleeping sickness (trypanosomiasis gambiense), which takes several months to years to present signs and symptoms.

Most patients get on-and-off bouts of fever, headache, joint pain, weight loss and itching in the early stages of the disease.

The second stage, the neurological phase, begins when the parasite crosses the blood-brain barrier and invades the central nervous system causing confusion, sensory disturbance and poor coordination. Disturbance of the sleep cycle is a dominant feature of this stage. A person can get drowsy while eating or become violent.

All medication for sleeping sickness has side effects although the effects reduce with new innovations. Eflornithine and nifurtimox combination could trigger diarrhoea, stomach ache, vomiting and sometimes convulsions.