- Target disease: VL
- Partners (since project start): Ministry of Health and Family Welfare, Bangladesh; International Centre for Diarrhoeal Disease Research (ICDDR,B), Bangladesh; Shaheed Suhrawardy Medical College and Hospital (ShSMC), 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; Institute of Tropical Medicine-Antwerp, Belgium; MSF; Pvt Ltd, India and Bangladesh
- Project start: July 2010 (Bangladesh)/December 2006 (India)
- 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; Other private foundations and individuals.
The Phase III trial conducted in India in 2008-2010 demonstrated the efficacy of combination therapies based on AmBisome®, miltefosine, and paromomycin, and an additional study by Sundar et al. 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 safety and 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 conducted between 2012 – 2015 is monitoring pharmacovigilance as well as treatment effectiveness of the different treatment options when used outside a clinical trial within the public sector.
Based on the study results, the Indian National Roadmap for Kala-Azar Elimination in August 2014 recommended use of single dose Ambisome® as a first option treatment for the treatment of VL patients, with paromomycin and miltefosine as a second option at all levels; a policy also reflected in Bangladesh and Nepal. This removal of miltefosine monotherapy is an important policy change. The implementation study stopped recruiting patients in Oct 2014 and DNDi continued following up patients for 12 months at the request of the national program; follow up was completed in Sep 2015.
In Bangladesh, a two-step Phase III study conducted from 2010 to 2014 in 602 patients (first in hospital settings, then in primary healthcare centres) used the same combination therapies as those tested in India. Six-month follow-up was completed in March 2014 and sites were closed in June. Results, presented in Dhaka in October 2014 in presence of health ministry officials, showed that all tested treatments demonstrated excellent cure rates and were well tolerated by patients, in support of policy change in the country.
Last update: October 2015