Develop a cheaper and shorter treatment for visceral leishmaniasis in East Africa
current phase of drug development
updated 1 Jun 2021
Cheaper, shorter, more effective combination therapy for visceral leishmaniasis in Africa
Shortening treatment length for people with visceral leishmaniasis in Africa
Before 2010, the treatments available for visceral leishmaniasis in Africa had serious limitations: liposomal amphotericin B was very costly, and antimonials such as sodium stibogluconate were difficult to administer – with long treatment times and frequent side effects – and had emerging resistance.
DNDi partnered with the Leishmaniasis East Africa (LEAP) Platform to conduct clinical trials showing that the combination of sodium stibogluconate and paramomycin (SSG&PM) was as safe and effective as the existing standard treatment. With SSG&PM, treatment now lasts 17 days instead of 30 days, and costs less. The shorter treatment is easier on patients and health centres, and more people can be treated during outbreaks. By combining two different drugs, SSG&PM is less likely to become ineffective due to resistance.
SSG&PM has been recommended by WHO as first-line treatment for visceral leishmaniasis in East Africa since 2010. DNDi continues to support the implementation of this treatment in East Africa.
Treatment regimens
- Indication: Approved to treat visceral leishmaniasis in Africa
- Dosage: Sodium stibogluconate & paramomycin given intramuscularly once a day for 17 days
Impact
- Recommended by the WHO Expert Committee on the Control of Leishmaniasis for East Africa
- Included in national treatment guidelines in Ethiopia, Kenya, South Sudan, Sudan, and Uganda
- Developed in partnership between DNDi, the LEAP Platform, national control programmes, Médecins Sans Frontières, and WHO
‘This disease has destroyed my life. At first, I was misdiagnosed for another disease and received the wrong treatment. I lost all my money and my wife divorced me. I had to suffer five years without treatment – finally I’m receiving the right one: SSG&PM. Many hospitals in rural areas of East Africa do not have the capacity to diagnose and treat people like me.’
Eltahir Eissa
Project updates
2018
KalaCORE, the UK Aid-funded partnership that includes DNDi and supports the control and elimination of visceral leishmaniasis in six countries (India, Nepal, Bangladesh, Ethiopia, Sudan and South Sudan), continued to support the implementation of SSG&PM in East Africa. Access has been considerably improved by strengthening the national control programmes of Ethiopia, South Sudan, and Sudan, and regular supply and distribution of diagnostics and medicines.
2016
In East Africa, DNDi continues to support the implementation of sodium stibogluconate-paromomycin (SSG&PM), a combination visceral leishmaniasis treatment for Africa delivered in 2010 by DNDi and the Leishmaniasis East Africa Platform (LEAP). DNDi continues to support registration efforts, notably of paromomycin, and treatment availability to visceral leishmaniasis patients in the region.
2015
DNDi continues to support the implementation of SSG&PM. Whereas this combination was recommended as first-line therapy for visceral leishmaniasis patients in East Africa by the WHO Expert Committee on the Control of Leishmaniases in 2010 and by the most affected countries, DNDi continues to support registration efforts, notably of paromomycin (PM), and treatment availability to visceral leishmaniasis patients in the region. PM is registered in Kenya and Uganda. In Sudan and Ethiopia, the registration dossier is still under submission to the regulatory authorities. SSG is registered in Kenya, Uganda, and Sudan, and a dossier was submitted in Ethiopia. In Ethiopia (SSG and PM) and Sudan (SSG), the drugs can be imported, as they were included in the national essential medicines lists.
News & resources
- 9 January 2017 - Safety and effectiveness of sodium stibogluconate and paromomycin combination for the treatment of visceral leishmaniasis in eastern Africa: Results from a pharmacovigilance programme, Clinical Drug Investigation
- 16 June 2016 - The Leishmaniasis East Africa Platform (LEAP): Strengthening clinical trial capacity in resource-limited countries to deliver new treatments for visceral leishmaniasis, Transactions of the Royal Society of Tropical Medicine and Hygiene
- 1 October 2014 - Results of Large-Scale Roll Out of Combination Treatment for Kala-Azar in Eastern Africa Points to Urgency to Treat Disease Victims as Outbreak Surges in South Sudan
- 10 June 2012 - Sodium Stibogluconate (SSG) & Paromomycin Combination Compared to SSG for Visceral Leishmaniasis in East Africa: A Randomised Controlled Trial, PLoS Negl Trop Dis
- 23 December 2011 - New treatment for kala azar, the most deadly parasitic disease after malaria
- 30 June 2011 - Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial, Trials
- 24 October 2010 - Paromomycin for the treatment of visceral leishmaniasis in Sudan: A randomized, open-label, dose-finding study, PLoS Negl Trop Dis
- 10 October 2010 - Geographical variation in the response of visceral leishmaniasis to Paromomycin in East Africa: A multicentre, open-label, randomized trial, PLoS Negl Trop Dis
*Project cost includes direct and indirect costs, but it does not include in-kind contributions.
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