Shorter combination treatment for people with black fever or visceral leishmaniasis is more effective than routine toxic daily injections and extended hospitalisation, according to new research in East Africa.

The new treatment was also found to lower the risk of the occurrence of some unsightly lesions on the skin that remain after treatment with the toxic medication.

The new shorter, and less toxic treatment is a combination of two drugs: miltefosine, the only oral drug available for leishmaniasis treatment, and paromomycin, an injectable antibiotic.

The current first-line treatment in East Africa consists of paromomycin, an injectable antibiotic used in combination with sodium stibogluconate, administered through injection or intravenously.

“It is sub-optimal, as patients may suffer from rare but heavy side effects, such as cardiotoxicity, hepatotoxicity, and pancreatitis associated with SSG,” said the researchers in results published in The Clinical Infectious Diseases Journal.

“The treatment is also difficult to administer as patients endure two painful injections daily for 17 days,” they said.

“This new treatment is great news for the thousands of patients affected by visceral leishmaniasis in the region. It will eliminate one painful and toxic injection from the treatment and is therefore safer for those affected,” said Deputy Vice Chancellor at the University of Khartoum and Principal Investigator of the clinical trial conducted in Sudan, Prof Ahmed Musa.

“The current treatment has significant socio-economic impacts as patients must stay in hospital for extended periods and to miss work or school,” said Prof Musa.

Patient-friendly

The results announced September 29, stem from a clinical trial initiated in 2017 in Kenya, Ethiopia, Sudan, and Uganda by the non-profit medical research organisations Drugs for Neglected Diseases initiative and the AfriKADIA Consortium with funding from The European & Developing Countries Clinical Trials Partnership compared a new combination of miltefosine and paromomycin, given for 14 days, to the standard of care of sodium stibogluconate and paromomycin given for 17 days.

Leishmaniasis is a vector-borne disease that is transmitted by sandflies, and is the deadliest parasitic killer after malaria. Its most severe form, visceral leishmaniasis, is fatal if left untreated.

The disease affects people in resource-limited settings, arid and semi-arid areas.

Half of them are children under 15. It is associated with malnutrition, population displacement, poor housing, and a weak immune system. Leishmaniasis is also a climate-sensitive disease, and it is predicted that its impact could get worse.

“This treatment is more patient-friendly. Children, who are the majority of visceral leishmaniasis patients – were also shown to respond very well to it and will benefit from it,” said the scientists.