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.

SSG&PM treatment

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.

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.

Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: A randomized controlled trial. PLOS Neglected Tropical Diseases, June 2012
by Musa A, Khalil E, Hailu A, Olobo J, Balasegaram M, et al.

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.

Press releases

Additional information

Launch dossier:

*Project cost includes direct and indirect costs, but it does not include in-kind contributions.