Combination treatment for visceral leishmaniasis effective in Eastern Africa

A shorter and less toxic treatment for people with visceral leishmaniasis was shown to be effective thanks to a study conducted in Eastern Africa by the non-profit medical research organization Drugs for Neglected Diseases initiative (DNDi) and its partners. The results were published in The Clinical Infectious Diseases journal.
The new treatment consists of a combination of two drugs: miltefosine (MF), the only oral drug available for leishmaniasis treatment, and paromomycin (PM), an injectable antibiotic.
‘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 Prof. Ahmed Musa, Deputy Vice Chancellor at the University of Khartoum and Principal Investigator of the clinical trial conducted in Sudan.
Leishmaniasis is the deadliest parasitic killer after malaria. Its most severe form, visceral leishmaniasis (VL), is fatal if left untreated. There are 50,000 to 90,000 new cases of the disease annually, with the highest number of cases worldwide reported in Eastern African countries: Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Sudan, and Uganda. The disease affects people in resource-limited settings, arid and semi-arid areas. Half of them are children under 15. Leishmaniasis is also a climate-sensitive disease, and its impact could get worse. Therefore, if not addressed, the most vulnerable will continue to suffer.
The current first-line treatment in Eastern Africa consists of paromomycin (PM), an injectable antibiotic used in combination with sodium stibogluconate (SSG), administered either through injection or intravenously. It remains sub-optimal, as patients may suffer from rare but heavy side effects, such as cardiotoxicity, hepatotoxicity, and pancreatitis associated with SSG. The treatment is also difficult to administer since patients must endure two painful injections every day for 17 days.
‘The current treatment has significant socio-economic impact as patients are forced to stay in hospital for extended periods and have to miss work or school. With the new treatment patients will spend less time in hospital,’ said Prof. Musa.
The results announced today stem from a clinical trial initiated in 2017 in Kenya, Ethiopia, Sudan, and Uganda by the AfriKADIA Consortium with funding from The European & Developing Countries Clinical Trials Partnership (EDCTP). The study compared a new combination of two drugs, miltefosine and paromomycin, given for 14 days, to the standard of care of sodium stibogluconate and paromomycin given for 17 days.