New WHO treatment guidelines offer hope for people co-infected with HIV and visceral leishmaniasis

NEW DELHI  – Today, the World Health Organization (WHO) has released its new guidelines for the treatment of people co-infected with visceral leishmaniasis (VL) and  HIV.  The new guidelines are based on results of one study conducted in India by Médecins Sans Frontières (MSF) and partners, and another in Ethiopia by the Drugs for Neglected Diseases initiative (DNDi) and partners.

Visceral Leishmaniasis, also known as Kala Azar, is a neglected tropical parasitic disease transmitted by sandflies, causing fever, weight loss and is fatal if left untreated.  People living with HIV living in VL endemic areas are 100 to 2,300 times more likely to develop visceral leishmaniasis than those without HIV.

The previously recommended treatment for VL-HIV coinfection consisted of intermittent daily injections of liposomal amphotericin B (AmBisome) over a period of up to 38 days. The new treatment uses a combination of AmBisome and oral miltefosine. This has resulted in significantly better efficacy rates.

In India, the state of Bihar – India’s most endemic state – an estimated 6% of VL cases are co-infected with HIV. These co-infected patients are marginalised and stigmatised, face poor treatment outcomes and also serve as a reservoir for visceral leishmaniasis, which is hampering sustainable elimination efforts in the country.

“For the first time, patients with VL-HIV coinfection in India will be treated with an evidence-based treatment. This is an important step towards recognising these patients as highly vulnerable both from a clinical and social perspective; improving their management will benefit both patients and the VL elimination programme. However, there remains a lot to be done; these patients present with multiple complex medical issues that need to be addressed holistically, including a very high prevalence of TB”.
Dr Sakib Burza, Medical Advisor and study coordinator at MSF

In the Indian study, the new recommended treatment regimen demonstrated 96% efficacy at six months compared to 88% in the previous treatment, crucially with the duration of treatment reducing from five to two weeks. In the Ethiopian study, the new recommended treatment strategy was shown to have an 88% efficacy rate at the end of therapy (after 58 days), whereas efficacy of the current standard treatment was 55% in the trial.

"The new WHO guidelines are a significant step that will greatly improve the lives of patients who are affected by both diseases and who are suffering from stigma, ostracization, loss of income and repeated relapses.”
Dr Fabiana Alves, Director of NTD (Neglected Tropical Diseases) Leishmaniasis and Mycetoma at DNDi
"MSF invests in research into the most vulnerable populations and neglected diseases as part of our social mission. These successes also mean that we must invest further in generating actionable information from the field level that can support our patients with innovative, contextualized, better quality and simplified treatment regimes.”
Dr Farhat Mantoo, General Director, MSF South Asia

India, Ethiopia, and other countries where both diseases are endemic, must now urgently adapt their own treatment guidelines to adopt the new WHO recommended treatments.

“This new treatment is an excellent news as it reduces the use of injectable drugs and significantly increases the chances for patients to be cured. It recommends intermittent administration over 14 days, which earlier was 38 days. We are proud of this achievement,” said Dr Krishna Pandey, Director, Rajendra Memorial Research Institute and the Principal Investigator in the study. 

“Patients with visceral leishmaniasis still need improved, safe and efficacious treatments. That is why DNDi and its partners are continuing their efforts to develop a safe and effective orally administered treatment, which will be accessible by all people affected by visceral leishmaniasis.”
Dr Kavita Singh, India and South Asia Regional Director at DNDi

Dr Cristian Casademont, Medical Director of MSF-Spain, stated: “Once again we have proven that developing high quality research in complex environments with several institutional partners is feasible and has an enormous transformational impact: these new guidelines will mean life and substantial increase of quality of care for thousands of the most neglected.”

In India, the study was financially supported by MSF-Spain, with in-kind support from the DNDi and National Vector Borne Disease Control Programme.  The study in Ethiopia was financially supported by the European Union, the German Federal Ministry of Education and Research (BMBF) through KfW, MSF International, the Medicor Foundation, Liechtenstein, Spanish Agency for International Development Cooperation and the Swiss Development Cooperation (SDC).

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