1921
Volume 101, Issue 4
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract.

Liposomal amphotericin B (LAmB) is recommended for treatment of Indian visceral leishmaniasis (VL), with a cure rate of more than 95% in the Indian subcontinent. A prospective observational study of 1,143 subjects was performed with a longer follow-up than prior studies (12 months) to evaluate the long-term effectiveness and safety of LAmB for the treatment of VL. Patients received a single dose of 10 mg/kg LAmB and were evaluated for initial cure at day 30 and final cure at 6 and 12 months to see the response to the therapy. Furthermore, predictors of relapse were also calculated. At day 30, the initial cure rate was 100%; however, at 6 months and 12 months, cure rates were 97.0% and 94.2% by per-protocol analysis and 96.9% and 93.9% by intension-to-treat analysis, respectively. Fever was the most common adverse event (AE). There were no deaths and serious AEs. Male gender, weight less than 30 kg, and spleen size more than 4 cm at the start of the treatment were significant risk factors of relapse. Liposomal amphotericin B was found to be very effective and safe in the treatment of VL. A longer follow-up period of 12 months is recommended to pick up late relapses.

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  • Received : 03 Mar 2019
  • Accepted : 05 Jul 2019
  • Published online : 19 Aug 2019
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