The Drugs for Neglected Diseases initiative (DNDi) welcomes the publication of new recommendations for the treatment of leishmaniasis in the Americas by the Pan American Health Organization (PAHO).
Leishmaniasis is a neglected tropical disease and serious public health problem. It is endemic in 20 Latin American countries, recording each year an average of around 53,000 new cases of the cutaneous and mucosal forms of the disease and 3,400 cases of visceral leishmaniasis. Transmitted by the bite of sandflies infected with the Leishmania parasite, manifestations of the disease range from single or multiple ulcerated lesions on the skin, which can cause mutilations and social stigma, to visceral disease with severe manifestations, which is potentially fatal without treatment.
Due to the particular challenges and the scale of leishmaniasis, the new PAHO guidelines take into account evidence available in the region to provide recommendations and strengthen local systems for the treatment of the disease in its various clinical forms.
‘The Ministries of Health, through their respective technical areas and with the support of local experts, should revise the recommendations in the national context and determine the possibility of incorporating, guaranteeing and expanding patient access to treatment of leishmaniasis using safer and shorter-term therapeutic alternatives,’ explains Ana Nilce Silveira Maia-Elkhoury, Regional Advisor for Leishmaniasis, PAHO/WHO.
For the treatment of visceral leishmaniasis, the new guidelines now incorporate liposomal amphotericin B as a strong recommendation against the use of pentavalent antimonials. This treatment is more accessible for people because of its shorter duration, fewer side effects and reduced hospitalization time.
The change in first-line treatment is based on evidence generated by a collaborative study sponsored by the Brazilian Ministry of Health and coordinated by the University of Brasilia (UnB), the Oswaldo Cruz Foundation of Brazil (Fiocruz), and DNDi. The study assessed the efficacy and safety of different treatment options compared to the standard, antimonial-based treatment.
The LV Brasil study included the cooperative work of the Federal University of Piauí, State University of Montes Claros, Federal University of Sergipe, Hospital Infantil João Paulo II – Fundação Hospitalar do Estado de Minas Gerais, and Hospital São José de Doenças Infecciosas, from Fortaleza.
However, the full adoption of this recommendation in Brazil, the country with the highest number of visceral leishmaniasis cases in the Americas, requires coordinated efforts to address current drug supply issues, which are impacting people’s access to treatment.
For cutaneous leishmaniasis, for patients with 1 to 3 lesions ≤3 cm in diameter, the new guidelines recommend the intralesional use of antimonials (strong recommendation) or thermotherapy (conditional recommendation). For patients requiring systemic treatment, the use of miltefosine (strong recommendation) or pentamidine (conditional recommendation and only for patients with lesions caused by L. guyanensis) is recommended.
‘These recommendations go hand in hand with DNDi’s strategy, which has promoted the need to replace antimonials as a first treatment option and recommend miltefosine instead, be it by itself or in combination with local therapies, which are safer for patients and less costly for health systems,’ said Joelle Rode, Clinical Manager for Leishmaniasis at DNDi Latin America.
In addition to the main risk factors resulting from social, economic, and environmental factors, which favour leishmaniasis transmission and hinder its control, patients under treatment face serious side effects of the medications. The disease also has devastating effects on communities, including work difficulties, economic losses, and social stigma in populations already living with limited resources.
The needs of these neglected populations guide DNDi’s strategy, which, in collaboration with the countries in the region, has been generating evidence on the safety and effectiveness of treatments for patients with visceral leishmaniasis and cutaneous leishmaniasis, seeking to improve existing treatment options. DNDi is currently studying a combination of an oral treatment with local heat application (or thermotherapy) for cutaneous leishmaniasis in four countries in the region to confirm preliminary results from our Phase II trial in Peru and Colombia, which showed positive outcomes combining thermotherapy and miltefosine compared to treatment with thermotherapy alone.
At the same time, DNDi continues its search for a new short course, oral treatment which is safe, effective, affordable, through international, multidisciplinary and innovative consortia. Some examples are Lead Optimization Latin America (LOLA), a structure-based drug discovery project for leishmaniasis, and a translational research project to find new tools to help with the clinical development of active molecules for cutaneous leishmaniasis. We are studying the development of an ‘immunomodulator’ that can stimulate the innate immune system to fight the problems caused by the cutaneous leishmaniasis parasites.
By advancing multiple strategies and building capacity in the Americas, DNDi hopes to identify new drugs to treat leishmaniasis in the next few years. At the same time, DNDi is urging health and regulatory authorities of the countries in the region to prioritize their drug procurement strategies and the internalization of these new treatment guidelines in order to guarantee greater access to treatment to the most vulnerable population.
The Drugs for Neglected Diseases initiative (DNDi) is a patient needs-driven, not-for-profit research and development (R&D) organization. Together with its partners, the initiative develops safe, effective and affordable treatments for millions of people affected by neglected tropical and viral diseases. Some of these diseases that disproportionately affect communities that are already vulnerable and neglected are Chagas disease, leishmaniasis, sleeping sickness, paediatric HIV, hepatitis C, filarial disease and mycetoma. DNDi aims to deliver a total of 25 new treatments in its first 25 years, by 2028. dndi.org
+55 21 981149429
Photo credit: Vinicius Berger-DNDi