1921
Volume 80, Issue 5
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Amphotericin B deoxycholate is used as a first-line drug for visceral leishmaniasis (VL) in India. Its major drawbacks are prolonged hospitalization of treated patients and toxicity. An open label phase II study with pre-formed amphotericin B lipid emulsion (ABLE) was conducted to evaluate safety and efficacy of four regimens of 15 mg/kg each administered in 1–2 doses. Regimen 1 was 7.5 mg/kg/day on day 1 and day 3, and regimen 4 was a single bolus infusion of 15 mg/kg. The safety profile was excellent with mild infusion reactions seen in 38% of the patients. Definitive cure was achieved in 100% of the patients treated with regimen 4. The overall cure rate was 87% (95% confidence interval = 75–94%). In this study, ABLE was safe and had excellent efficacy when given as a bolus of 15 mg/kg. More studies with larger number of patients and higher doses are needed to establish acceptable, safe and efficacious regimen.

Loading

Article metrics loading...

The graphs shown below represent data from March 2017
/content/journals/10.4269/ajtmh.2009.80.700
2009-05-01
2019-11-19
Loading full text...

Full text loading...

/deliver/fulltext/14761645/80/5/0800700.html?itemId=/content/journals/10.4269/ajtmh.2009.80.700&mimeType=html&fmt=ahah

References

  1. Sundar S, More DK, Singh MK, Singh VP, Sharma S, Makharia A, Kumar PC, Murray HW, 2000. Failure of pentavalent antimony in visceral leishmaniasis in India: report from the center of the Indian epidemic. Clin Infect Dis 31 : 1104–1107. [Google Scholar]
  2. Sundar S, Singh VP, Sharma S, Makharia MK, Murray HW, 1997. Response to interferon-gamma plus pentavalent antimony in Indian visceral leishmaniasis. J Infect Dis 176 : 1117–1119. [Google Scholar]
  3. Thakur CP, Narayan S, 2004. A comparative evaluation of amphotericin B and sodium antimony gluconate, as first-line drugs in the treatment of Indian visceral leishmaniasis. Ann Trop Med Parasitol 98 : 129–138. [Google Scholar]
  4. Sundar S, Jha TK, Thakur CP, Sinha PK, Bhattacharya SK, 2007. Injectable paromomycin for visceral leishmaniasis in India. N Engl J Med 356 : 2571–2581. [Google Scholar]
  5. Sundar S, Rai M, 2005. Treatment of visceral leishmaniasis. Expert Opin Pharmacother 6 : 2821–2829. [Google Scholar]
  6. Sundar S, Agrawal G, Rai M, Makharia MK, Murray HW, 2001. Treatment of Indian visceral leishmaniasis with single or daily infusions of low dose liposomal amphotericin B: randomised trial. BMJ 323 : 419–422. [Google Scholar]
  7. Sundar S, Chakravarty J, Agarwal D, Shah A, Agarwal N, Rai M, 2008. Safety of a preformed amphotericin B lipid emulsion for the treatment of Indian kala-azar. Trop Med Int Health 13 : 1208–1212. [Google Scholar]
  8. Sundar S, Jha TK, Thakur CP, Engel J, Sindermann H, Fischer C, Junge K, Bryceson A, Berman J, 2002. Oral miltefosine for Indian visceral leishmaniasis. N Engl J Med 347 : 1739–1746. [Google Scholar]
  9. Chulay JD, Bryceson AD, 1983. Quantitation of amastigotes of Leishmania donovani in smears of splenic aspirates from patients with visceral leishmaniasis. Am J Trop Med Hyg 32 : 475–479. [Google Scholar]
  10. Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events. Bethesda, MD: National Cancer Institute. Available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf.
  11. 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 : 800–804. [Google Scholar]
  12. Sundar S, Jha TK, Thakur CP, Mishra M, Singh VR, Buffels R, 2002. Low-dose liposomal amphotericin B in refractory Indian visceral leishmaniasis: a multicenter study. Am J Trop Med Hyg 66 : 143–146. [Google Scholar]
  13. Sundar S, Mehta H, Suresh AV, Singh SP, Rai M, Murray HW, 2004. Amphotericin B treatment for Indian visceral leishmaniaasis: conventional versus lipid formulations. Clin Infect Dis 38 : 377–383. [Google Scholar]
  14. 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 oal mltefosine. Clin Infect Dis 47 : 1000–1006. [Google Scholar]
http://instance.metastore.ingenta.com/content/journals/10.4269/ajtmh.2009.80.700
Loading
/content/journals/10.4269/ajtmh.2009.80.700
Loading

Data & Media loading...

  • Received : 25 Jul 2008
  • Accepted : 17 Dec 2008

Most Cited This Month

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error