Injectable Paromomycin for Visceral Leishmaniasis in India

• Published in: The New England journal of medicine Vol. 356; no. 25; pp. 2571 - 2581
• Main Authors: Sundar, Shyam, Jha, T.K, Thakur, Chandreshwar P, Sinha, Prabhat K, Bhattacharya, Sujit K
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 21-06-2007
• Subjects: Adolescent; Adult; Amphotericin B - adverse effects; Amphotericin B - therapeutic use; Animals; Antiprotozoal Agents - administration & dosage; Antiprotozoal Agents - adverse effects; Antiprotozoal Agents - therapeutic use; Audiometry; Biological and medical sciences; Child; Child, Preschool; Disease Reservoirs; Drug therapy; Female; General aspects; Hearing Disorders - chemically induced; Hearing Disorders - diagnosis; Human immunodeficiency virus; Human immunodeficiency virus 1; Human protozoal diseases; Humans; India; Infectious diseases; Infusions, Intravenous; Injections, Intramuscular; Kidney Diseases - chemically induced; Leishmania donovani; Leishmaniasis, Visceral - drug therapy; Leishmaniasis, Visceral - mortality; Leshmaniasis; Male; Medical sciences; Middle Aged; Parasitic diseases; Paromomycin - administration & dosage; Paromomycin - adverse effects; Paromomycin - therapeutic use; Prospective Studies; Protozoal diseases; Treatment Outcome; Asia; India; Brazil; Infection; Medicine; Protozoal disease; Antibiotic; Aminoglycoside; Kala azar; Protein synthesis inhibitor; Leishmaniasis; Parasitosis; Injection; Antibacterial agent; Paromomycin
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMoa066536

Visceral leishmaniasis (kala-azar) disproportionately affects the rural poor, with approximately 500,000 cases worldwide. Treatment options are limited, especially in resource-poor settings. In this open label, comparator-controlled trial, intramuscular paromomycin was found to be noninferior to intravenous amphotericin B in the treatment of visceral leishmaniasis, with cure rates of 94.6% and 98.8%, respectively.
Intramuscular paromomycin was found to be noninferior to intravenous amphotericin B in the treatment of visceral leishmaniasis, with cure rates of 94.6% and 98.8%, respectively.
Visceral leishmaniasis (kala-azar) is primarily a fatal vectorborne parasitic disease characterized by fever, hepatosplenomegaly, and pancytopenia. Most of the approximately 500,000 cases of visceral leishmaniasis reported worldwide affect the rural poor in India, Nepal, Bangladesh, Sudan, and Brazil.
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Treatment options for visceral leishmaniasis are limited. Sodium stibogluconate, a historically effective and affordable pentavalent antimonial compound, is associated with fatal toxic effects,
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–
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and in some regions its use has led to the development of resistant strains of
Leishmania donovani,
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with the result that fewer than 50% of treated patients are cured.
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,
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–
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In regions where antimony resistance is prevalent, . . .