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DNDi Strategy for Visceral Leishmaniasis


WHAT IS DNDi DOING TO ADDRESS UNMET TREATMENT NEEDS?

DNDi’s short-term approach for visceral leishmaniasis was to develop new treatments by combining existing drugs and/or shortening treatment duration in order to increase tolerability, reduce burden on health systems, and offer greater affordability, whilst also preventing or delaying emergence of resistance. Another objective is the geographical extension of existing drugs in other countries and regions. In 2010, DNDi and LEAP partners delivered the SSG&PM combination therapy for East Africa, now recommended as first-line treatment for VL in the region. SSG&PM has been included in the national guidelines of Sudan, South Sudan, Ethiopia, and Kenya. PM is registered in Uganda (2011) and Kenya (2013), and is in the process of registration in Sudan and Ethiopia. In India, a Phase III trial demonstrated the efficacy of combination therapies of already registered drugs. In 2014, the government of India recommended use of single-dose AmBisome® as a first option and paromomycin/miltefosine combination as the second option for treatment instead of using miltefosine as monotherapy. DNDi has collaborated with the National Control Programmes of India and Bangladesh, MSF, the Bihar State Health Society, and the Indian Council for Medical Research to assess the effectiveness and safety of these new treatments at the primary healthcare level and facilitate their introduction. In Latin America, DNDi is participating in a study sponsored by the Brazilian Innovation Agency (FINEP) to evaluate the safety and efficacy of Glucantime®, AmBisome®, and amphotericin B as monotherapies, and of AmBisome®/Glucantime® combination to treat VL patients. The national control programme has extended the use of AmBisome® as second-line treatment based on the interim safety data from this trial.

Leishmania and HIV co-infection is a growing problem, difficult to manage clinically due to poor response to treatment with frequent relapses of disease, and is eventually fatal. DNDi is working with partners towards better treatment for HIV/VL co-infected patients in Africa using existing drugs at different dose/regimen and in combination, and is collaborating with ITM-Antwerp in a secondary prophylaxis study.

In the medium term, DNDi is assessing the combination of fexinidazole and miltefosine for the treatment of visceral leishmaniasis patients in terms of efficacy and safety. This could be the first oral-only combination therapy for visceral leishmaniasis.

DNDi’s long-term strategy for visceral leishmaniasis is to bring new oral drug candidates into clinical development through its lead optimization programme with the ultimate goal of improving the safety profile and efficacy of the existing tools with a second oral-only combination treatment.

In addition, DNDi supports the Leishmaniasis East Africa Platform (LEAP). A new visceral leishmaniasis treatment for adults and children based on a new chemical entity would ideally be efficacious against all species of Leishmania in all regions as well as against resistant strains, have at least 95% efficacy, be short course (once a day for 10 days oral; or 3 shots over 10 days), easy to use, compatible for combination therapy, safe in pregnant and breastfeeding women and for immunocompetent/immunosuppressed patients, affordable, and adapted to tropical climates.

By 2020, DNDi aims to deliver from its VL-specific portfolio:
  • Potentially a safe, effective, low-cost, and short-course oral combination treatment
  • A new treatment for PKDL that is shorter course and better tolerated than current options
  • Treatment options for HIV/VL co-infected patients
  • A new first-line treatment regimen for visceral leishmaniasis in Latin America
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