The Global Need

Visceral leishmaniasis (VL) affects some 12 million people, the vast majority of whom live in developing countries. It is the world's second-deadliest parasitic disease (after malaria), with an estimated 500,000 new cases and approximately 50,000 deaths annually. VL is caused by several species of Leishmania protozoan parasites that infect both humans and animals, and are most often transmitted via the bite of the female sand fly. The disease is prevalent in the Indian sub-continent, China, the Middle East, east Africa, the Mediterranean basin and South America. Approximately 90 percent of all cases occur in Bangladesh, Brazil, Ethiopia, India, Nepal and Sudan.

Beyond the damage VL causes on its own, it can also accelerate the onset of disease progression in HIV-positive people by suppressing the immune system and allowing viral replication to occur. Conversely, HIV infection substantially increases the risk of acquiring VL in endemic areas, leading to VL outbreaks, particularly where access to antiretroviral therapy is inadequate.

Gilead's Role

Experts from the World Health Organization (WHO) and other public health institutions around the world recommend Gilead's antifungal medicine AmBisome® (amphotericin B) liposome for injection as a first-line treatment against VL in many parts of the world.

We work closely with WHO and non-governmental organizations such as Médecins Sans Frontières (MSF) to provide AmBisome at a preferential price for the treatment of leishmaniasis, and we supply the treatment at not-for-profit pricing to projects addressing VL in India, where the disease is endemic.

Gilead has supported clinical research studies aimed at identifying the best treatment course for VL, and has donated AmBisome to support clinical studies assessing combination therapies and the cost-effectiveness of multiple VL treatment interventions. In December of 2011, Gilead signed a partnership agreement with WHO to donate 445,000 vials of AmBisome over five years. This donation, which is equivalent to $8 million in product if sold at the no-profit access price, will be used to treat more than 50,000 patients in resource-limited countries.

We are also collaborating with MSF to make drug available for other serious medical conditions in Bangladesh, Ethiopia, India, Kenya, Nepal and Sudan - countries where the prevalence of serious fungal infections is high, particularly among HIV-infected immune-compromised patients.