R&D MODEL & PORTFOLIO
New VL treatments - Asia
PROJECT START: July 2010 (Bangladesh)/December 2006 (India) OVERALL OBJECTIVE: Develop one to two new (combination)
treatments and support recommendations from the authorities in the main endemic countries. Provide evidence for adoption of combination treatment as a second line option in national policy in Bangladesh
2015 OBJECTIVE: Advocate for the adoption of combinations
as second line treatment in Bangladesh
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 pilot study continued following up patients, documenting 12 month treatment outcomes, at the request of the national programme; this follow up was completed in September 2015. Site close out activities will be completed in January 2016. In Bangladesh, a two-step Phase III study conducted from 20102014 in 602 patients (first in hospital settings, then in primary healthcare centres) used the same combination therapies as those tested in India. All tested treatments demonstrated excellent cure rates and were well tolerated by patients, in support of policy change in the country.
MAIN PARTNERS: INDIA: Indian Council of Medical Research (ICMR);
The Phase III trial conducted in India in 2008-2010 demonstrated the recruited at efficacy of combination therapies 12 sites in India 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 conducted safety and effectiveness studies, including a pilot project in the Bihar State of India (2012-2015) implementing combination therapies at the primary healthcare level, and single-dose AmBisome® at the hospital level.
These regimes were observed to be safe and effective and, 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
Rajendra Memorial Research Institute of Medical Sciences (RMRIMS); Bihar State Health Society; National Vector Borne Disease Control Programme (NVBDCP); Kala Azar Medical Research Centre; GVK Biosciences; BANGLADESH: Ministry of Health and Family Welfare; International Centre for Diarrhoeal Disease Research (ICDDR,B); Shaheed Suhrawardy Medical College and Hospital; OTHER: Médecins Sans Frontières (MSF), Spain; London School of Hygiene and Tropical Medicine (LSHTM), UK; WHO-TDR, Switzerland; Institute of Tropical Medicine-Antwerp, Belgium
DNDi Annual Report 2015 › 35