Scientists at the Drugs for Neglected Disease initiative (DNDi) have successfully completed trials for a new drug to treat visceral leishmaniasis or Kala-azar disease.
Kala-azar is the most severe form of leishmaniasis and is a life-threatening disease caused by Leishmania protozoa parasites, which are transmitted through the bite of infected female phlebotomine sandflies.
Visceral leishmaniasis causes fever, weight loss, and spleen and liver enlargement. If not treated, it causes death.
DNDi is an international, not-for-profit research and development organization.
It seeks to translate research into action by discovering, developing and delivering treatments for neglected patients around the world.
One in seven people on the planet lives in leishmaniasis-endemic areas, with Eastern Africa shouldering 57 percent of the global disease burden.
Around 30,000-40,000 new cases occur here every year. Some 600m people are at risk of getting infected.
There are three main forms of leishmaniases: visceral leishmaniasis (VL) or kala-azar, cutaneous and mucocutaneous leishmaniasis.
VL attacks a person’s immune system and damages the spleen and liver, in addition to weakening the immune system.
It usually kills the patient within two years if not effectively treated.
Over 70 percent of VL patients are children.
Among the factors contributing to the infection risks in endemic areas are poverty, migration, climate change which changes the breeding and habitats of sandflies, and malnutrition due to drought and famine.
According to Simon Bolo, who is the Head of Leishmaniasis Access for the Eastern Africa region at DNDi, the new drug combination shortens the treatment time for patients by 18 percent.
“The new regimen, which takes 17 days, shortens the hospital stay for patients by 18 percent. Previous treatment regimens would keep the patient hospitalized for a month or more while receiving long toxic antimonial therapy,” he said.
“We are recommending the regimen as an effective alternative to current treatment plans that involve long toxic antimonial therapy.
This is because the duration of PKDL treatment will be greatly reduced,” added Mr. Bolo.
PKDL is a common complication of visceral leishmaniasis (VL) caused by the protozoan Leishmania donovani.
He was addressing participants at the fifth annual Media for Environment, Science, Health and Agriculture (MESHA) science congress recently when he revealed the findings.
Between 2018 and 2021, researchers have been studying the efficacy of three new treatment combinations.
The combinations studied were paromomycin and miltefosine for VL, liposomal amphotericin-B and miltefosine for HIV/VL, as well as paromomycin, miltefosine or liposomal amphotericin-B and miltefosine for PKDL.
Mr. Bolo confirmed that the amb/Mf combination had been recommended as a preferred option to treat VL in patients with HIV in Africa and Asia, followed by secondary medication.
The trials were conducted across seven sites in Kenya, Ethiopia, Sudan, and Uganda.
In Ethiopia, the trials took place through the Leishmaniasis East Africa Platform (LEAP).
Leap is a clinical research network that brings together experts from leishmaniasis endemic eastern African countries to facilitate clinical testing and improved access to better treatments for the disease in the region.
“Leap is one of our partners in Ethiopia, along with the ministry of health as well as the Addis Ababa and Gondar Universities. Some cases of HIV-induced cases of VL have been recorded in Northern Ethiopia, which is among the top three countries with a high burden of HIV-VL coinfections,” said Mr. Bolo.
According to the World Health Organization (WHO), people living with HIV have high chances of developing full-blown clinical disease and high relapse and mortality rates.
Antiretroviral treatment, however, reduces the development of the disease, delays possible relapses, and increases the survival chances of co-infected patients.
Some of the VL symptoms as listed by the WHO include prolonged fever, enlarged spleen and liver, progressive anemia, and substantial weight loss.
While some people may not show any symptoms, others may experience swelling of the spleen or liver, weight loss, or fever.
Patients may experience loss of appetite, diarrhea, low blood counts, hyperpigmentation, swollen lymph nodes, night sweats, pain in the abdomen or the whole body, and general discomfort.
People who have been treated for VL can sometimes develop a condition called post-kala-azar dermal leishmaniasis (PKDL).
“PKDL is also a reservoir of VL transmission,” added Mr. Bolo.
PKDL is endemic in Sudan, with 50 to 60 percent of patients developing the condition between 0 to 6 months after getting treated for VL.
In Sudan, all 110 patients enrolled in the study’s second phase were followed up by May 2021. The Phase II study tested both liposomal amphotericin B in combination with miltefosine and paromomycin in combination with miltefosine.
According to Mr. Bolo, the “promising” research results have been sent to a major scientific journal for publication.
“We have completed the study and submitted the results for publication in a scientific journal. We expect the promising findings to be published next month,” said Mr. Bolo.
WHO treatment guidelines for HIV are expected to be published soon, followed by revised guidelines in Ethiopia.
DNDi and its 60 partners in the LEAP collective seek to play a role in the sustainable elimination of VL in Asia and the control of the disease in Africa and Latin America.
It is also working on plans to deliver a safe, effective short-course oral treatment for visceral leishmaniasis, a new treatment for PKDL, and treatment options for HIV/VL co-infected patients.
“We are seeking approval for the regimen across the East African region,” Prof Bolo said.
Shrinking donor funding, however, is one of the challenges to achieving the goal of effectively managing VL.
“Most of the big donors pulled out from the region, and this has reduced funding for the development of VL and PKDL medication. Governments in Eastern Africa need to quickly find alternative sources of funding to sustain these projects,” he noted.
Mr. Bolo is also proposing the provision of incentives for manufacturers of VL and PKDL medication to encourage the efficient production of affordable drugs.
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