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Injectable paromomycin for Visceral leishmaniasis in India.

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Paromomycin is a viable alternative to amphotericin B for treating visceral leishmaniasis (kala-azar) in India. This study found paromomycin to be noninferior to amphotericin B, offering a potentially safer and more accessible treatment option.

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Area of Science:

  • Tropical medicine
  • Infectious diseases
  • Clinical pharmacology

Background:

  • Visceral leishmaniasis (kala-azar) disproportionately affects underserved populations in endemic regions.
  • Current therapies for visceral leishmaniasis face challenges regarding safety, efficacy, and cost.
  • There is a critical need for novel and improved therapeutic agents.

Purpose of the Study:

  • To compare the efficacy and safety of paromomycin with amphotericin B for visceral leishmaniasis treatment.
  • To evaluate paromomycin as a potential alternative to the current standard of care.
  • To assess cure rates and adverse events in a phase 3 clinical trial.

Main Methods:

  • A randomized, controlled, open-label, phase 3 study was conducted in four visceral leishmaniasis treatment centers in India.
  • 667 patients (ages 5-55) with confirmed visceral leishmaniasis were randomized (3:1) to receive either paromomycin (11 mg/kg daily for 21 days) or amphotericin B (1 mg/kg every other day for 30 days).
  • Noninferiority testing was used to compare 6-month cure rates, with a 10% noninferiority margin. Safety was monitored through clinical and laboratory evaluations.

Main Results:

  • Paromomycin demonstrated noninferiority to amphotericin B, with cure rates of 94.6% and 98.8%, respectively.
  • Mortality rates were low (<1%) in both treatment groups.
  • Adverse events were more frequent with paromomycin (6%) than amphotericin B (2%), but included more injection-site pain and transient liver enzyme elevations. Amphotericin B was associated with higher rates of nephrotoxicity, fever, rigors, and vomiting.

Conclusions:

  • Paromomycin is a noninferior treatment option to amphotericin B for visceral leishmaniasis in the studied Indian population.
  • Paromomycin offers a potentially favorable safety profile compared to amphotericin B, with fewer severe adverse events.
  • The findings support the use of paromomycin as an accessible and effective therapy for visceral leishmaniasis.