Leishmaniasis Implementation

 

  • Target disease: VL
  • Main partners (since project start): Ministries of Health of Uganda, Sudan, Kenya, and Ethiopia; Institute of Endemic Disease, Khartoum University, Sudan; Kenya Medical Research Institute, Kenya; Médecins Sans Frontières, Switzerland and Holland; London School of Hygiene and Tropical Medicine, UK; IDA Foundation, the Netherlands; Gondar University Hospital, Ethiopia; Addis Ababa University, Ethiopia; Arba Minch Hospital, Ethiopia; Makerere University, Uganda; Amudat Hospital, Uganda; LEAP.
  • Project start: April 2011
  • Funding (since project start): Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), the Netherlands; Federal Ministry of Education and Research (BMBF through KfW), Germany; Fondation André & Cyprien, Switzerland; Médecins Sans Frontières/Doctors without Borders, International; Medicor Foundation, Liechtenstein; Ministry of Foreign and European Affairs (MAEE), France; Region of Tuscany, Italy; Republic and Canton of Geneva, International Solidarity Office, Switzerland; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; BBVA Foundation, Spain; Other private foundations and individuals.

 

Overall Objective:

  • Continue to support implementation of and access to SSG&PM in key endemic areas of East Africa by supporting registration of paromomycin (PM) and facilitate uptake with local partners.

 

  • Read Press Release on results of large-scale roll-out of SSG&PM
  • Read Press Release on SSG&PM
  • See SSG&PM Product page
  • Results presented in PLOS NTDs
    • Sodium Stibogluconate (SSG) & Paromomycin Combination Compared to SSG for Visceral Leishmaniasis in East Africa: A Randomised Controlled Trial by Musa et al., PLOS NTDs 2012, 6(6): e1674. Read here.
    • Paromomycin for the Treatment of Visceral Leishmaniasis in Sudan: A Randomized, Open-Label, Dose-finding Study by Musa A.M. et al., PLOS NTDs 2010, 4(10):e855. Read here.
    • Geographical Variation in the Response of Visceral Leishmaniasis to Paromomycin in East Africa: A Multicentre, Open-Label, Randomized Trial by Hailu A. et al. PLOS NTDs 2010, 4(10):e709. Read here.

 

In 2010, DNDi and the Leishmaniasis East Africa Platform (LEAP) successfully showed that the combination of SSG and PM (17 days) was as efficacious as SSG monotherapy (30 days); this shorter course lessens the burden on patients and health systems, and is more cost effective. WHO recommended SSG&PM combination as first line treatment for primary VL in Eastern Africa in March of the same year, and a large pharmacovigilance (PV) study was implemented in Sudan, Ethiopia, Uganda, and Kenya between April 2011 and May 2014.

The PV study results showed a 95% cure rate at the end of treatment with the SSG&PM therapy with no new safety concerns. SSG&PM is recommended as first-line treatment for VL in Sudan, Ethiopia, South Sudan, Somalia, and Kenya.

SSG&PM has been included in the national guidelines of Sudan, South Sudan, Ethiopia, Somalia, and Kenya, and the guidelines are under review in Uganda. PM is registered in Uganda (2011) and Kenya (2013), and is in the process of registration in Sudan and Ethiopia. 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.

 

Last update: February 2017