Shivam Giri was sick. The four-year-old boy weighed only 17 pounds. For more than a month Shivam suffered fever and cold, chills and rigor before his family could take him to the local rural village medical center. The Giri family, which makes about $56 a month selling clothes in nearby villages with only a bicycle for transportation, borrowed money from relatives to pay for tests and treatment.

According to Shivam's mother, Bawli Devi, the rural medical practitioner “gave injections and pills to no avail. The illness showed no sign of relenting even after weeks.” Thankfully, the local treating practitioner referred Shivam to the OneWorld Health Patori Satellite Clinic.

Dr. A. K. Thakur, a trained medical doctor at the clinic, immediately suspected kala-azar, also known as black fever disease or visceral leishmaniasis. Left untreated kala-azar is almost always fatal, especially in children Shivam's age. Dr. Thakur conducted lab tests, and proposed a 21-day course of treatment using Paromomycin IM Injection (PMIM) an affordable, safe therapy recently developed by OneWorld Health.

While Shivam began his treatment regimen, his mother traveled every day from their remote village to the clinic. When Harenda Giri, Shivam's father could manage it, the family used his bicycle. Otherwise Bawli and her two-year-old child walked through monsoon rains and driving winds that tore the umbrella from her hands so she had to cover her child with her sari. The roads were so inundated the only recourse was to follow railroad tracks and then wade through flooded roadways to safely reach the treatment site.

21 days later Shivam has made a complete recovery, Bawli reports. The boy has shown no sign of illness, and just as importantly now weighs a robust 33 pounds. “Thanks to OneWorld Health my child is doing fine,” Bawli says.

Each year kala-azar, also known as black fever or visceral leishmaniasis (VL), which is transmitted by the bite of a sandfly, infects 500,000 people. Each year it kills 50,000. Over 90% of VL cases occur in India, Bangladesh, Sudan, Ethiopia, Brazil, and Nepal. Left untreated kala-azar is almost always fatal.

Paromomycin Intramuscular Injection (PMIM)

In a few short years OneWorld Health has developed the antibiotic Paromomycin Intramuscular Injection (PMIM) as an effective, inexpensive treatment for kala-azar visceral leishmaniasis). We’ve worked with the Indian Government and Indian pharmaceutical company Gland Pharma to manufacture and deploy the antibiotic PMIM in Bihar, one of the most remote regions in India. Based on our results in India, we are expanding PMIM trials to serve as a model of an affordable, innovative program dedicated to impoverished patients suffering from kala-azar in Nepal and Bangladesh. The efforts of our team already resulted in PMIM approval for the Essential Drug List of Bangladesh in 2008 and of Nepal in 2011. In 2012, PMIM has been registered by the government of Nepal - its second registration in South Asia.

Read about PMIM's impact

New VL treatments

Our ultimate goal is to use PMIM in combination with other treatments (such as AmBisome or Miltefosine) as a key tool to eliminate kala-azar from India, and shortly thereafter, Bangladesh and Nepal.

VL South Asia Consortium

The collaboration project led by DNDi, in partnership with OWH and TDR, aims at establishing and implementing new treatment modalities as successful tools to control and support the elimination of VL in most endemic regions of South Asia.

» OneWorld Health's Role

OneWorld Health will investigate the rationale for use of combination therapies with miltefosine, paromomycin and AmBisome® in the private sector in India as tools to control and support the elimination of VL.

Project activities include pilot implementation of VL combination treatments at selected private sector clinics in India (target: 2,500 patients). In addition to development of the combination kits, this will include working on drug inventory management and supply, site selection, site initiation (practicum and training), tracking of patients for compliance and pharmacovigilance, establishing adequate safe waste disposal methods and establishing passive disease surveillance by the end of the project period.

After completing the study, a feasibility report will be published. It will include recommendations for the private sector engagement in using new treatment modalities.

For more information on the project, please visit: http://dndi.org/component/content/article/1001.html.

Listen to the Podcast

Beginning in 2004, OneWorld Health completed a phase 3 clinical trial of 666 patients, the largest trial ever performed for this disease, in collaboration with the Special Programme for Research and Training in Tropical Diseases of the World Health Organization (WHO/TDR). Since then we've worked with partners, medical researchers, and funders from around the world to make enormous strides to eliminate kala-azar from India , Bangladesh and Nepal .

A grant from the Bill & Melinda Gates Foundation will support the goal of the governments of Nepal and Bangladesh to eliminate kala-azar.

Funding from the Department for International Development, United Kingdom is helping OneWorld Health develop safe, effective, and affordable medicine to treat visceral leishmaniasis.

OneWorld Health has been engaged in a unique public-private partnership with Gland Pharma Limited, based in Hyderabad , India to supply the needs of the worldwide Paromomycin Injection market for the treatment of kala-azar.

OneWorld Health is also working with the World Bank, WHO, and the Government of India to support the country's National Vector Borne Disease Control Programme and its National Plan for Regional Kala Azar Elimination Programme.

Tropical Medicine and International Health:
“The economic impact of visceral leishmaniasis on rural households in one endemic district of Bihar , India .” Volume 15 Suppl. 2 pp 42-49 April 2010 (Available under News Room/OWH Publications)

Tropical Medicine and International Health:
“Annual incidence of visceral leishmaniasis in an endemic area of Bihar , India .” Volume 15 Suppl. 2 pp 4-11 April 2010 Wiley Blackwell Publisher (Available under News Room/ OWH Publications)