By Mary Hearty

A new treatment option for Visceral leishmaniasis (VL) also known as kala-azar which is easier to administer and reduces hospital stay is expected to come in the Eastern Africa market soon.

The newly developed miltefosine is the first oral drug to be used in treating kala-azar in combination with Paromomycin.

The clinical trial for the current treatment commenced in 2016 and ended in 2022, in seven sites in four different countries in Eastern Africa (Kenya, Uganda, Ethiopia and Sudan), where the first line treatment was conducted as well.

Speaking during the 5th African Conference of Science Journalists on May 24, 2022, Simon Bolo, Head of Leishmanisis Access Eastern Africa, DNDi African Regional Office revealed that a study on the treatment’s cost-effectiveness is currently being conducted.

“Analysis for some of the studies are still ongoing but the results for the main study have already been presented for publication because they are promising,” Bolo stated.

The clinical trial for the first line treatment for kala-azar – Sodium Stibogluconate (SSG) and Paromomycin (PM) was conducted between 2004 and 2010 in seven sites in the four different countries, with the aim of developing a cheaper and shorter treatment for kala-azar in East Africa (EA).

Prior to that, the treatment for VL was a 30-day injection by SSG, which Bolo termed as a ‘toxic drug’. “We were able to shorten the duration to 17-day course by combining it with PM to reduce the toxicity that patients could be exposed to,” he said.

Bolo explained that the aim of the clinical research of the new treatment option was to compare the efficacy of PM and miltefosine combination for 14 days with the current standard of care which is 17-day course of SSG and PM for treatment of primary kala-azar patients in EA.

This is because, Eastern Africa harbors the highest burden of kala-azar worldwide as the region records about 30,000 to 40,000 new cases every year.

The head of Leishmaniasis Access in Eastern Africa noted that the disease is caused by Leishmania parasites which are spread through the bite of infected female sand flies.

In addition, he explained, it is considered one of the deadliest parasitic diseases after malaria, and is characterized by prolonged fever; enlarged spleen and liver; substantial weight loss; and progressive anaemia.

Overall, Bolo clarified that Leishmaniasis presents itself in different forms, however, the three major forms are: cutaneous leishmaniasis (CL) which causes skin lesions, mainly ulcers on exposed parts of the body;

Mucocutaneous leishmaniasis (ML) that leads to partial or total destruction of mucous membrane of the nose, throat and mouth; kala-azar which is fatal if left untreated; and Post-kala-azar dermal leishmaniasis (PKDL) which is a complication of the VL and is characterized by rash in a patient who has recovered from VL and who is otherwise well.

Focusing on kala-azar , he noted that the parasitic disease mainly affects poor communities in remote rural areas and arid regions with limited resources for treating it.

In addition, Bolo said majority of the patients are children except Northern Ethiopia where the disease affects mainly young male adults in work-related settings.

Ethiopia is among the top three countries globally where a high burden of HIV-VL co-infection is reported, while in Sudan, up to 50-60% of VL cases develop PKDL within 6 months after treatment unlike other countries like Kenya, Uganda and Ethiopia.

DNDi aims to deliver safe, effective and short-course oral treatment for other forms leishmaniasis such as PKDL as well as HIV-VL co-infection patients.

For instance, treatment option for HIV- VL- Liposomal amphotericin B -have been developed as the preferred option to treat VL in patients with HIV in Africa and Asia, followed by secondary prophylaxis. Guidelines from WHO for using this treatment are expected.

For PKDL, he said a combination of PM and miltefosine, or Liposomal amphotericin B and miltefosine have been recommended.

Over the years, clinical research activities of Leishmaniasis have been conducted in the eastern African region through Leishmaniasis East African 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 leishmaniasis in Africa.

The platform was founded in 2003 in Khartoum, Sudan, with over 60 members from over 20 institutions, where it facilitates clinical testing, and strengthening local capacities by developing infrastructure, offering trainings and communication engagement activities.

Since inception, the platform has been able to conduct more than 10 clinical trials, including the current first line treatment for kala-azar .

Also, LEAP is working with ministries of health to support country adoption and implementation, where research findings are translated into policy, revision of various treatment guidelines and routine treatment of non-trial patients.

“We realized our patients were still not receiving the required medication on time, so an access program was developed,” he recalled.

The program address various challenges including changing the policies, weak health systems, under-diagnosis, and lack of effective prevention methods, weak supply chain management systems, higher prices of commodities, potential stigma associated with the leishmaniasis patients, among others.

The access activities aim to facilitate translation of evidence generated from the clinical trials into revised national policies and WHO guidelines; and ensure new treatments are approved for use in the endemic countries

Additionally, LEAP intends to strengthen supply chain management and distribution planning; support ministries of health in coordination, capacity building of healthcare workers and surveillance activities; as well as conduct operational research to understand implementation challenges.

Therefore, he suggested that there is need to work hand in hand with various ministries of health and kala-azar national programs to ensure success of access programs.