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Randomized Controlled Trial
. 2014 Sep 18;8(9):e3169.
doi: 10.1371/journal.pntd.0003169. eCollection 2014 Sep.

Efficacy and safety of amphotericin B emulsion versus liposomal formulation in Indian patients with visceral leishmaniasis: a randomized, open-label study

Shyam Sundar  1 , Krishna Pandey  2 , Chandreshwar Prasad Thakur  3 , Tara Kant Jha  4 , Vidya Nand Ravi Das  2 , Neena Verma  5 , Chandra Shekhar Lal  6 , Deepak Verma  7 , Shahnawaz Alam  7 , Pradeep Das  8
Affiliations
Randomized Controlled Trial

Efficacy and safety of amphotericin B emulsion versus liposomal formulation in Indian patients with visceral leishmaniasis: a randomized, open-label study

Shyam Sundar et al. PLoS Negl Trop Dis. .

Abstract

Background: India is home to 60% of the total global visceral leishmaniasis (VL) population. Use of long-term oral (e.g. miltefosine) and parenteral drugs, considered the mainstay for treatment of VL, is now faced with increased resistance, decreased efficacy, low compliance and safety issues. The authors evaluated the efficacy and safety of an alternate treatment option, i.e. single infusion of preformed amphotericin B (AmB) lipid emulsion (ABLE) in comparison with that of liposomal formulation (LAmB).

Methods: In this multicentric, open-label study, 500 patients with VL were randomly assigned in a 3:1 ratio to receive 15 mg/kg single infusion of either ABLE (N = 376) or LAmB (N = 124). Initial cure (Day 30/45), clinical improvement (Day 30) and long term definitive cure (Day 180) were assessed.

Findings: A total of 326 (86.7%) patients in the ABLE group and 122 (98.4%) patients in the LAmB group completed the study. Initial cure was achieved by 95.9% of patients in the ABLE group compared to 100% in the LAmB group (p = 0.028; 95% CI: -0.0663, -0.0150). Clinical improvement was comparable between treatments (ABLE: 98.9% vs. LAmB: 98.4%). Definitive cure was achieved in 85.9% with ABLE compared to 98.4% with LAmB. Infusion-related pyrexia (37.2% vs. 32.3%) and chills (18.4% vs. 18.5%) were comparable between ABLE and LAmB, respectively. Treatment-related serious adverse events were fewer in ABLE (0.3%) compared to LAmB (1.6%). Two deaths occurred in the ABLE group, of which one was probably related to the study drug. Nephrotoxicity and hepatotoxicity was not observed in either group.

Conclusions: ABLE 15 mg/kg single infusion had favorable efficacy and was well tolerated. Considering the demographic profile of the population in this region, a single dose treatment offers advantages in terms of compliance, cost and applicability.

Trial registration: www.clinicaltrials.gov NCT00876824.

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Conflict of interest statement

I have read the journal's policy and the authors of this manuscript have the following competing interests: Bharat Serum and Vaccines supplied the study drug. This does not alter our adherence to all PLOS NTDs policies on sharing data and materials.

Figures

Figure 1
Figure 1. Study design.
Figure 2
Figure 2. CONSORT patient flowchart.
Figure 3
Figure 3. Increase in Hb levels (A) and body weight (B) from baseline after treatment with lipid and liposomal formulations of amphotericin B (mITT population).
See this image and copyright information in PMC

References

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