Sodium stibogluconate & paramomycin (SSG&PM) Visceral leishmaniasis
Cheaper, shorter, more effective combination therapy for visceral leishmaniasis in Africa
Shortening treatment length for people with visceral leishmaniasis in Africa
Although treatment options for visceral leishmaniasis in Africa had increased over the last 20 years, they had serious limitations: liposomal amphotericin B was very costly and antimonials such as sodium stibogluconate had lengthy treatment times, difficult treatment administration, emerging resistance, and poor tolerability that caused frequent side effects.
DNDi partnered with the Leishmaniasis East Africa (LEAP) Platform in clinical trials that showed 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 with SSG on its own, and it costs less. This shorter treatment is easier for patients and health centres, and it means more patients can be treated during outbreaks. By combining two different drugs, SSG&PM is less likely to become ineffective due to resistance.
Since 2010, SSG&PM has been recommended by WHO as first-line treatment for visceral leishmaniasis in East Africa.
At a glance
Indication: Visceral leishmaniasis in Africa
Dosage: Sodium stibogluconate & paramomycin given intramuscularly once a day for 17 days
Project start: 2004
Project cost: EUR 11.5 million (2003-2014)*
- 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.”
Key scientific articles
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, January 2017
by Kimutai R, Musa AM, Njoroge S, Omollo R, Alves F, Hailu A, Khalil EAG, Diro E, Soipei P, Musa B, Salman K, Ritmeijer K, Chappuis F, Rashid J, Mohammed R, Jameneh A, Makonnen E, Olobo J, Okello L, Sagaki P, Strub N, Ellis S, Alvar J, Balasegaram M, Alirol E, Wasunna M
The Leishmaniasis East Africa Platform (LEAP): strengthening clinical trial capacity in resource-limited countries to deliver new treatments for visceral leishmaniasis. The Royal Society of Tropical Medicine & Hygiene, April 2016
by Wasunna M, Musa, A, Hailu A, Khalil EAG, Olobo J, Juma R, Wells S, Alvar J, Balasegaram M.
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, June 2011
by Omollo R, Alexander N, Edwards T, Khalil EAG, Younis BM, Abuzaid AA, Wasunna M, Njoroge N, Kinoti D, Kirigi G, PC Dorlo TPC, Ellis S, Balasegaram M and Musa AM.
Paromomycin for the treatment of visceral leishmaniasis in Sudan: a randomized, open-label, dose-finding study. PLOS Neglected Tropical Diseases, October 2010
by Musa A, Younis B, Fadlalla A, Royce C, Balasegaram M, Wasunna M, Hailu A, Edwards T, Omollo R, Mudawi M, Kokwaro G, El-Hassan A, Khalil E.
Geographical variation in the response of visceral leishmaniasis to paromomycin in East Africa: a multicentre, open-label, randomized trial. PLOS Neglected Tropical Diseases, October 2010
by Hailu A, Musa A, Wasunna M, Balasegaram M, Yifru S, Mengistu G, Hurissa Z, Hailu W, Weldegebreal T, Tesfaye S, Makonnen E, Khalil E, Ahmed O, Fadlalla A, El-Hassan A, Raheem M, Muellerm, Koummuki Y, Rashid J, Mbui J, Mucee G, Njoroge S, Manduku V, Musibi A, Mutuma G, Kirui F, Lodenyo H, Mutea D, Kirigi G, Edwards T, Smith P, Muthami L, Royce C, Ellis S, Alobo M, Omollo R, Kesusu J, Owiti R, Kinuthia J, for the Leishmaniasis East Africa Platform (LEAP) group.
Ministries of Health of Ethiopia, Kenya, Sudan, and Uganda; 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.
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.
*Project cost includes direct and indirect costs, but it does not include in-kind contributions.
Photo credit: Abraham Ali-DNDi
Last updated: January 2019