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Adoption of new visceral leishmaniasis treatments in South Asia  Visceral leishmaniasis

Providing evidence to change guidelines for visceral leishmaniasis treatment in South Asia

2011

 

Policy change for control and elimination of visceral leishmaniasis brings better treatments to patients in Bangladesh, India, and Nepal

In the early 21st century, treatments for visceral leishmaniasis (also known as kala-azar) in South Asia were difficult for patients to take or growing ineffective. Resistance was increasing, including to the oral drug miltefosine. Antimonials such as sodium stibogluconate had lengthy treatment times, difficult treatment administration, and poor tolerability that caused frequent side effects.

DNDi convened a consortium of partners to identify the best combination therapies for South Asia. The consortium conducted a four year-long implementation study in Bangladesh and India (2012 – 2015) to assess the safety, efficacy, and patient compliance of various new treatment options including single-dose liposomal amphotericin B, paromomycin and miltefosine, and liposomal amphotericin B and miltefosine. The results showed that these treatments were safe and effective. They also shortened treatment length, reduced the risk of resistance, allowed reaching patients closer to home, and therefore made it simpler for patients to take the full treatment course.

The research provided key evidence for policy change by the Bangladeshi, Indian, and Nepali Ministries of Health, which made the following recommendations: single-dose liposomal amphotericin B as a first option treatment for visceral leishmaniasis patients and paromomycin & miltefosine as a second option.

At a glance

  • Indication: visceral leishmaniasis in Asia
  • Dosage: First option: single-dose liposomal amphotericin B given as an intravenous infusion; Second option: paromomycin & miltefosine, both daily for 10 days
  • Project start: 2006

Impact

  • Treatments recommended by WHO Expert Committee on the Control of Leishmaniases in 2010 as safe and effective treatments for visceral leishmaniasis in Asia (liposomal amphotericin B single or multiple dose, and all combinations tested in DNDi’s clinical trial)
  • Supported policy change for the control and elimination of visceral leishmaniasis in highly endemic countries: Bangladesh, India, and Nepal
  • Result of partnership in India with the Bihar State Health Society, GVK Biosciences, Indian Council of Medical Research, Kala Azar Medical Research Centre, Médecins Sans Frontières, National Vector Borne Disease Control Programme, and Rajendra Memorial Research Institute of Medical Sciences
  • Result of partnership in Bangladesh with the International Centre for Diarrhoeal Disease Research, Médecins Sans Frontières, Ministry of Health and Family Welfare, Shaheed Suhrawardy Medical College and Hospital

 

“Earlier the ward used to be full of visceral leishmaniasis patients because of the long 28-day treatment. But since single-dose AmBisome® has been included in the national treatment protocol, the face of the disease has changed dramatically. Now patients come, take treatment, and go home the same day. This is an effective treatment, and now with this the number of patients have come down.”

Nutan Kumari, Sadar Hospital in Hajipur, Bihar

 

Additional information

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TDR News item

More about DNDi‘s leishmaniasis programme

DNDi‘s R&D programme for leishmaniasis
Leishmaniasis clinical trials

Key Scientific Articles

Field safety and effectiveness of new visceral leishmaniasis treatment regimens within public health facilities in Bihar, India. PLOS Neglected Tropical Diseases, October 2018
by Goyal V, Mahajan R, Pandey K, Singh SN, Singh RS, Strub-Wourgaft N, Alves F, Das VNR, Topno RK, Sharma B, Balasegaram M, Bern C, Hightower A, Rijal S,  Ellis S, Sunyoto T, Burza S, Lima N, Das P, Alvar J.

Safety and efficacy of short course combination regimens with AmBisome®, miltefosine, paromomycin for the treatment of visceral leishmaniasis (VL) in Bangladesh. PLOS Neglected Tropical Diseases, June 2017
by Rahman R, Goyal V, Haque R, Jamil K, Faiz A, Samad R, Ellis S, Balasegaram M, den Boer M, Rijal S, Strub-Wourgaft N, Alves F, Alvar J, Sharma B.

Investments in research and surveillance are needed to go beyond elimination and stop transmission of Leishmania in the Indian subcontinent. PLOS Neglected Tropical Diseases, January 2017
by Olliaro P, Shamsuzzaman TAKM, Marasini B, Dhariwal AC, Be-Nazir A, Mondal D, Banjara MR, Das P, Sundar S, Rijal S, Arana B, Alvar J, Argaw D, Peeling RW, Kroeger A, Matlashewski G.

How far are we from visceral leishmaniasis elimination in Bangladesh? an assessment of epidemiological surveillance data. PLOS Neglected Tropical Diseases, August 2014
by Chowdhury R, Mondal D, Chowdhury V, Faria S, Alvar J, Nabi SG, Boelaert M, Dash AP.

Comparison of short-course multidrug treatment with standard therapy for visceral leishmaniasis in India: an open-label, non-inferiority, randomised controlled trial. The Lancet, January 2011
by Sundar S, Sinha P.K, Rai M, Verma D.K, Nawin K, Alam S, Chakravarty J, Vaillant M, Verma N, Pandey K, Kumari P, Lal C.S, Arora R, Sharma B, Ellis S, Strub-Wourgaft N, Balasegaram M, Olliaro P, Das P, Modabber F.

Press releases

 

 

Partners

Bihar State Health Society, India; GVK Biosciences, India; Indian Council of Medical Research, India; Institute of Tropical Medicine-Antwerp, Belgium; International Centre for Diarrhoeal Disease Research, Bangladesh; Kala Azar Medical Research Centre, India; London School of Hygiene & Tropical Medicine, UK; Médecins Sans Frontières, Spain; Ministry of Health and Family Welfare, Bangladesh; National Vector Borne Disease Control Programme, India; OneWorld Health/PATH, USA; Rajendra Memorial Research Institute of Medical Sciences, India; Shaheed Suhrawardy Medical College and Hospital, Bangladesh; WHO-TDR, Switzerland.

Funding

Bill & Melinda Gates Foundation, USA; Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders, International; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Other private foundations and individuals.

 

 

Photo credit: Kishore Pandit-DNDi

Last updated: October 2018