1921
Volume 94, Issue 1
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract

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™) for VL caused by in India. An open-label, randomized, single-center comparative study was undertaken from 2008 to 2011, involving 120 treatment naive non–human immunodeficiency virus VL patients randomly allocated to two groups. Fungisome™ was given, in groups A ( = 60), 5 mg/kg daily for 2 days and B ( = 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): 80.55–95.72%); group B: 100% (95% CI: 95.92–100%); ( = 0.027). No serious adverse events occurred in either group. The short-course, 2-day regimen of 15 mg/kg Fungisome™ infusion is easy to administer, effective, and safe for treatment of VL caused by in India.

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2016-01-06
2017-09-25
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References

  1. Alvar J, Velez ID, Bern C, Herrero M, Desjeux P, Cano J, Jannin J, Boer MD, WHO Leishmaniasis Control Team; , 2012. Leishmaniasis worldwide and global estimates of its incidence. PLoS One 7: e35671.[Crossref]
  2. Singh SP, Reddy DC, Rai M, Sundar S, , 2006. Serious underreporting of visceral leishmaniasis through passive case reporting in Bihar, India. Trop Med Int Health 11: 899905.[Crossref]
  3. 2014. National Roadmap for Kala-Azar Elimination in India. Directorate National Vector Borne Disease Control Programme (India). New Delhi, India: Directorate General of Health Services, Ministry of Health and Family Welfare.
  4. Sundar S, Jha TK, Thakur CP, Mishra M, Singh VP, Buffels R, , 2003. Single-dose liposomal amphotericin B in the treatment of visceral leishmaniasis in India: a multicenter study. Clin Infect Dis 37: 800804.[Crossref]
  5. Bern C, Adler-Moore J, Berenguer J, Boelaert M, den Boer M, Davidson RN, Figueras C, Gradoni L, Kafetzis DA, Ritmeijer K, Rosenthal E, Royce C, Russo R, Sundar S, Alvar J, , 2006. Liposomal amphotericin B for the treatment of visceral leishmaniasis. Clin Infect Dis 43: 917924.[Crossref]
  6. Balasegaram M, Ritmeijer K, Lima MA, Burza S, Ortiz Genovese G, Milani B, Gaspani S, Potet J, Chappuis F, , 2012. Liposomal amphotericin B as a treatment for human leishmaniasis. Expert Opin Emerg Drugs 17: 493510.[Crossref]
  7. Meyerhoff A, , 1999. US Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis. Clin Infect Dis 28: 4248.[Crossref]
  8. Davidson RN, di Martino L, Gradoni L, Giacchino R, Gaeta GB, Pempinello R, Scotti S, Cascio A, Castagnola E, Maisto A, Gramiccia M, di Caprio D, Wilkinson RJ, Bryceson AD, , 1996. Short-course treatment of visceral leishmaniasis with liposomal amphotericin B (AmBisome). Clin Infect Dis 22: 938943.[Crossref]
  9. den Boer ML, Alvar J, Davidson RN, Ritmeijer K, Balasegaram M, , 2009. Developments in the treatment of visceral leishmaniasis. Expert Opin Emerg Drugs 14: 395410.[Crossref]
  10. Olliaro PL, Guerin PJ, Gerstl S, Haaskjold AA, Rottingen JA, Sundar S, , 2005. Treatment options for visceral leishmaniasis: a systematic review of clinical studies done in India, 1980–2004. Lancet Infect Dis 5: 763774.[Crossref]
  11. WHO, 2010. Control of the Leishmaniasis: Report of a Meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22–26 March 2010. Geneva, Switzerland: WHO Press.
  12. Meheus F, Balasegaram M, Olliaro P, Sundar S, Rijal S, Faiz MA, Boelaert M, , 2010. Cost-effectiveness analysis of combination therapies for visceral leishmaniasis in the Indian subcontinent. PLoS Negl Trop Dis 4: e818.[Crossref]
  13. Berman JD, Badaro R, Thakur CP, Wasunna KM, Behbehani K, Davidson R, Kuzoe F, Pang L, Weerasuriya K, Bryceson AD, , 1998. Efficacy and safety of liposomal amphotericin B (AmBisome) for visceral leishmaniasis in endemic developing countries. Bull World Health Organ 76: 2532.
  14. Sundar S, Agrawal G, Rai M, Makharia MK, Murray HW, , 2001. Treatment of Indian visceral lesihmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomized trial. BMJ 323: 419422.[Crossref]
  15. Agrawal S, Rai M, Sundar S, , 2005. Management of visceral leishmaniasis: Indian perspective. J Postgrad Med 51: S53S57.
  16. Bodhe PV, Kotwani RN, Kirodian BG, Pathare AV, Pandey AK, Thakur CP, Kshirsagar NA, , 1999. Dose-ranging studies on liposomal amphotericin B (L-AMP-LRC-1) in the treatment of visceral leishmaniasis. Trans R Soc Trop Med Hyg 93: 314318.[Crossref]
  17. Mondal S, Bhattacharya P, Rahaman M, Ali N, Goswami RP, , 2010. A curative immune profile one week after treatment of Indian kala-azar patients predicts success with a short-course liposomal amphotericin B therapy. PLoS Negl Trop Dis 27: e764.[Crossref]
  18. Sundar S, Thakur BB, Tandon AK, Agrawal NR, Mishra CP, Mahapatra TM, Singh VP, , 1994. Clinicoepidemiological study of drug resistance in Indian kala-azar. BMJ 308: 307.[Crossref]
  19. Rex JH, Stevens DA, Mandell GL, Bennett JE, Dolin R, , 2010. Systemic antifungal agents. , eds. Principles and Practice of Infectious Diseases, 7th edition. Philadelphia, PA: Churchill Livingstone Elsevier.
  20. Sundar S, Singh A, Agarwal D, Rai M, Agrawal N, Chakravarty J, , 2009. Safety and efficacy of high-dose infusions of a preformed amphotericin B fat emulsion for treatment of Indian visceral leishmaniasis. Am J Trop Med Hyg 80: 700703.
  21. Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW, , 2010. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 362: 504512.[Crossref]
  22. Sundar S, Rai M, Chakravarty J, Agarwal D, Agrawal N, Vaillant M, Olliaro P, Murray HW, , 2008. New treatment approach in Indian visceral leishmaniasis: single-dose liposomal amphotericin B followed by short-course oral miltefosine. Clin Infect Dis 47: 10001006.[Crossref]
  23. Khalil EA, Weldegebreal T, Younis BM, Omollo R, Musa AM, Hailu W, Abuzaid AA, Dorlo TP, Hurissa Z, Yifru S, Haleke W, Smith PG, Ellis S, Balasegaram M, El-Hassan AM, Schoone GJ, Wasunna M, Kimutai R, Edwards T, Hailu A, , 2014. Safety and efficacy of single dose versus multiple doses of AmBisome for treatment of visceral leishmaniasis in eastern Africa: a randomised trial. PLoS Negl Trop Dis 8: e2613.[Crossref]
  24. Sanath SS, Gogtay NJ, Kshirsagar NA, , 2005. Post-marketing study to assess the safety, tolerability and effectiveness of Fungisome: an Indian liposomal amphotericin B preparation. J Postgrad Med 51: S58S63.
  25. Olliaro P, Darley S, Laxminarayan R, Sundar S, , 2009. Cost-effectiveness projections of single and combination therapies for visceral leishmaniasis in Bihar, India. Trop Med Int Health 14: 918925.[Crossref]
  26. Burza S, Sinha PK, Mahajan R, Lima MA, Mitra G, Verma N, Balasegaram M, Das P, , 2014. Five-year field results and long-term effectiveness of 20 mg/kg liposomal amphotericin B (Ambisome) for visceral leishmaniasis in Bihar, India. PLoS Negl Trop Dis 8: e2603.[Crossref]
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  • Received : 19 Oct 2014
  • Accepted : 20 Sep 2015

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