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New VL treatments - Asia

Leishmaniasis Implementation

  • Target disease: VL
  • Partners (since project start): Ministry of Health and Family Welfare, Bangladesh; GVK Biosciences, Bangladesh; Indian Medical Research Council (ICMR); Rajendra Memorial Research Institute of Medical Sciences (RMRI), India; Kala-Azar Medical Research Centre, India; State Health Society, Bihar (BSHS), India; National Vector Borne Disease Control Programme (NVBDCP), India; MSF; Pvt Ltd, India and Bangladesh
  • Project start: December 2006 (VL treatments - India); July 2010 (VL treatments - Bangladesh)
  • Funding (since project start): 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; The Starr International Foundation, Switzerland; Other private foundations and individuals.

Overall Objective VL treatments - India:
  • To develop one to two new (combination) treatments and support recommendations from the authorities in the main endemic countries

Overall Objective VL treatments - Bangladesh:
  • Provide evidence for adoption of combination treatment as second line option in national policy

  • Read DNDi's Press Release on the launch of the project in India
  • Read about it on the WHO-TDR website
  • Listen to audio podcast about the consortium: 2011 interview with consortium partners: Dr. Bhawna Sharma (Head of DNDi India), Sally Ellis (Clinical Manager, DNDi), Dr. Philippe Desjeux (Senior Programme Officer, OWH), and Dr. Byron Arana (Scientist, TDR)
  • Read DNDi's Press Release on the results from the study in Bangladesh

VL treatments - India
The Phase III trial conducted by DNDi and its partners in 2010 demonstrated the efficacy of combination therapies based on AmBisome®, miltefosine, and paromomycin, and an additional study showed the efficacy of single-dose AmBisome® given as an intravenous infusion. To facilitate the introduction of these new treatments for VL in South Asia, DNDi is carrying out effectiveness studies, including a pilot project in the Bihar State of India implementing combination therapies at the primary healthcare level, and single-dose AmBisome® at the hospital level. The project is monitoring pharmacovigilance as well as treatment effectiveness of the different treatment options when used outside a clinical trial by the public sector. The study began in 2012 in two districts in India. A total of 919 patients were enrolled during the pilot phase. In 2014, the study entered into the implementation phase, which aims to treat 6,000 more patients. The trial was expected to end in 2015 and results made available.

In August 2014, the Indian National Roadmap for Kala-Azar Elimination recommended use of single dose Ambisome® (shown to be 96.7% efficacious in the implementation study) as a first option treatment for the treatment of VL patients in high endemicity areas, with paromomycin and miltefosine as a second option in areas of lower endemicity. This represents an important policy change in removing the use of miltefosine monotherapy. Following a Technical Advisory Committee meeting, it was agreed that the implementation study would stop recruiting. However, DNDi will continue the 12-month follow up of patients who were included in the study.

VL treatments - Bangladesh
The Phase III trial conducted by DNDi and its partners in India demonstrated the efficacy of combination therapies based on AmBisome®, miltefosine, and paromomycin. In Bangladesh, this two-step Phase III study (first in hospital settings, then in primary healthcare centres) in 602 patients uses the same combination therapies. Six-month follow-up was completed in April 2014 and sites closed in June. Results, presented in Dhaka in October 2014, showed all tested treatments demonstrated excellent cure rates and were well tolerated by patients, in support of policy change in the country. The Clinical Study Report was finalized by the end of the year.


Last update: August 2015

Tags: Leishmaniasis
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