{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T23:51:18Z","timestamp":1793404278633,"version":"4.5.0"},"reference-count":26,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2016,1,6]]},"abstract":"<jats:p>India bears the burden of about half of global visceral leishmaniasis (VL) cases with emerging problems of stibanate resistance. Liposomal preparations have improved treatment outcome through shorter duration of therapy and lower toxicity compared with conventional amphotericin B. We report the efficacy of two short-course regimens of an Indian preparation of liposomal amphotericin B (Fungisome\u2122) for VL caused by <jats:italic>Leishmania donovani<\/jats:italic> in India. An open-label, randomized, single-center comparative study was undertaken from 2008 to 2011, involving 120 treatment naive non\u2013human immunodeficiency virus VL patients randomly allocated to two groups. Fungisome\u2122 was given, in groups A (<jats:italic>N<\/jats:italic> = 60), 5 mg\/kg daily for 2 days and B (<jats:italic>N<\/jats:italic> = 60), 7.5 mg\/kg daily for 2 days, as intravenous infusion. Initial cure rate was 100% in both the groups after 1 month posttreatment. At 6 months after completion of treatment, definitive cure rate was group A 90% (54\/60, 95% confidence interval (CI): 80.55\u201395.72%); group B: 100% (95% CI: 95.92\u2013100%); (<jats:italic>P<\/jats:italic> = 0.027). No serious adverse events occurred in either group. The short-course, 2-day regimen of 15 mg\/kg Fungisome\u2122 infusion is easy to administer, effective, and safe for treatment of VL caused by <jats:italic>L. donovani<\/jats:italic> in India.<\/jats:p>","DOI":"10.4269\/ajtmh.14-0657","type":"journal-article","created":{"date-parts":[[2015,11,3]],"date-time":"2015-11-03T03:14:00Z","timestamp":1446520440000},"page":"93-98","source":"Crossref","is-referenced-by-count":15,"title":["Short-Course Treatment Regimen of Indian Visceral Leishmaniasis with an Indian Liposomal Amphotericin B Preparation (Fungisome\u2122)"],"prefix":"10.4269","volume":"94","author":[{"given":"Rama P.","family":"Goswami","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rudra P.","family":"Goswami","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sukhen","family":"Das","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aditya","family":"Satpati","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehebubar","family":"Rahman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"ref1","series-title":"PLoS One","first-page":"e35671","article-title":"Leishmaniasis worldwide and global estimates of its incidence","volume":"7","author":"Alvar","year":"2012"},{"key":"ref2","series-title":"Trop Med Int Health","first-page":"899","article-title":"Serious underreporting of visceral leishmaniasis through passive case reporting in Bihar, India","volume":"11","author":"Singh","year":"2006"},{"key":"ref3","series-title":"National Roadmap for Kala-Azar Elimination in India","year":"2014"},{"key":"ref4","series-title":"Clin Infect Dis","first-page":"800","article-title":"Single-dose liposomal amphotericin B in the treatment of visceral leishmaniasis in India: a multicenter study","volume":"37","author":"Sundar","year":"2003"},{"key":"ref5","series-title":"Clin Infect Dis","first-page":"917","article-title":"Liposomal amphotericin B for the treatment of visceral leishmaniasis","volume":"43","author":"Bern","year":"2006"},{"key":"ref6","series-title":"Expert Opin Emerg Drugs","first-page":"493","article-title":"Liposomal amphotericin B as a treatment for human leishmaniasis","volume":"17","author":"Balasegaram","year":"2012"},{"key":"ref7","series-title":"Clin Infect Dis","first-page":"42","article-title":"US Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis","volume":"28","author":"Meyerhoff","year":"1999"},{"key":"ref8","series-title":"Clin Infect Dis","first-page":"938","article-title":"Short-course treatment of visceral leishmaniasis with liposomal amphotericin B (AmBisome)","volume":"22","author":"Davidson","year":"1996"},{"key":"ref9","series-title":"Expert Opin Emerg Drugs","first-page":"395","article-title":"Developments in the treatment of visceral leishmaniasis","volume":"14","author":"den Boer","year":"2009"},{"key":"ref10","series-title":"Lancet Infect Dis","first-page":"763","article-title":"Treatment options for visceral leishmaniasis: a systematic review of clinical studies done in India, 1980\u20132004","volume":"5","author":"Olliaro","year":"2005"},{"key":"ref11","series-title":"Control of the Leishmaniasis: Report of a Meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22\u201326 March 2010","author":"WHO","year":"2010"},{"key":"ref12","series-title":"PLoS Negl Trop Dis","first-page":"e818","article-title":"Cost-effectiveness analysis of combination therapies for visceral leishmaniasis in the Indian subcontinent","volume":"4","author":"Meheus","year":"2010"},{"key":"ref13","series-title":"Bull World Health Organ","first-page":"25","article-title":"Efficacy and safety of liposomal amphotericin B (AmBisome) for visceral leishmaniasis in endemic developing countries","volume":"76","author":"Berman","year":"1998"},{"key":"ref14","series-title":"BMJ","first-page":"419","article-title":"Treatment of Indian visceral lesihmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomized trial","volume":"323","author":"Sundar","year":"2001"},{"key":"ref15","series-title":"J Postgrad Med","first-page":"S53","article-title":"Management of visceral leishmaniasis: Indian perspective","volume":"51","author":"Agrawal","year":"2005"},{"key":"ref16","series-title":"Trans R Soc Trop Med Hyg","first-page":"314","article-title":"Dose-ranging studies on liposomal amphotericin B (L-AMP-LRC-1) in the treatment of visceral leishmaniasis","volume":"93","author":"Bodhe","year":"1999"},{"key":"ref17","series-title":"PLoS Negl Trop Dis","first-page":"e764","article-title":"A curative immune profile one week after treatment of Indian kala-azar patients predicts success with a short-course liposomal amphotericin B therapy","volume":"27","author":"Mondal","year":"2010"},{"key":"ref18","series-title":"BMJ","first-page":"307","article-title":"Clinicoepidemiological study of drug resistance in Indian kala-azar","volume":"308","author":"Sundar","year":"1994"},{"key":"ref19","series-title":"Principles and Practice of Infectious Diseases","article-title":"Systemic antifungal agents","author":"Rex","year":"2010"},{"key":"ref20","series-title":"Am J Trop Med Hyg","first-page":"700","article-title":"Safety and efficacy of high-dose infusions of a preformed amphotericin B fat emulsion for treatment of Indian visceral leishmaniasis","volume":"80","author":"Sundar","year":"2009"},{"key":"ref21","series-title":"N Engl J Med","first-page":"504","article-title":"Single-dose liposomal amphotericin B for visceral leishmaniasis in India","volume":"362","author":"Sundar","year":"2010"},{"key":"ref22","series-title":"Clin Infect Dis","first-page":"1000","article-title":"New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine","volume":"47","author":"Sundar","year":"2008"},{"key":"ref23","series-title":"PLoS Negl Trop Dis","first-page":"e2613","article-title":"Safety and efficacy of single dose versus multiple doses of AmBisome for treatment of visceral leishmaniasis in eastern Africa: a randomised trial","volume":"8","author":"Khalil","year":"2014"},{"key":"ref24","series-title":"J Postgrad Med","first-page":"S58","article-title":"Post-marketing study to assess the safety, tolerability and effectiveness of Fungisome: an Indian liposomal amphotericin B preparation","volume":"51","author":"Sanath","year":"2005"},{"key":"ref25","series-title":"Trop Med Int Health","first-page":"918","article-title":"Cost-effectiveness projections of single and combination therapies for visceral leishmaniasis in Bihar, India","volume":"14","author":"Olliaro","year":"2009"},{"key":"ref26","series-title":"PLoS Negl Trop Dis","first-page":"e2603","article-title":"Five-year field results and long-term effectiveness of 20 mg\/kg liposomal amphotericin B (Ambisome) for visceral leishmaniasis in Bihar, India","volume":"8","author":"Burza","year":"2014"}],"container-title":["The American Society of Tropical Medicine and 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