Safety, Pharmacokinetics, and Activity of High-Dose Ivermectin and Chloroquine against the Liver Stage of Plasmodium cynomolgi Infection in Rhesus Macaques

Antimicrob Agents Chemother. 2020 Aug 20;64(9):e00741-20. doi: 10.1128/AAC.00741-20. Print 2020 Aug 20.

Abstract

Previously, ivermectin (1 to 10 mg/kg of body weight) was shown to inhibit the liver-stage development of Plasmodium berghei in orally dosed mice. Here, ivermectin showed inhibition of the in vitro development of Plasmodium cynomolgi schizonts (50% inhibitory concentration [IC50], 10.42 μM) and hypnozoites (IC50, 29.24 μM) in primary macaque hepatocytes when administered as a high dose prophylactically but not when administered in radical cure mode. The safety, pharmacokinetics, and efficacy of oral ivermectin (0.3, 0.6, and 1.2 mg/kg) with and without chloroquine (10 mg/kg) administered for 7 consecutive days were evaluated for prophylaxis or radical cure of P. cynomolgi liver stages in rhesus macaques. No inhibition or delay to blood-stage P. cynomolgi parasitemia was observed at any ivermectin dose (0.3, 0.6, and 1.2 mg/kg). Ivermectin (0.6 and 1.2 mg/kg) and chloroquine (10 mg/kg) in combination were well-tolerated with no adverse events and no significant pharmacokinetic drug-drug interactions observed. Repeated daily ivermectin administration for 7 days did not inhibit ivermectin bioavailability. It was recently demonstrated that both ivermectin and chloroquine inhibit replication of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro Further ivermectin and chloroquine trials in humans are warranted to evaluate their role in Plasmodium vivax control and as adjunctive therapies against COVID-19 infections.

Keywords: COVID-19; Plasmodium; SARS-CoV-2; chloroquine; ivermectin; macaque; pharmacokinetics; safety.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antimalarials / blood
  • Antimalarials / pharmacokinetics
  • Antimalarials / pharmacology*
  • Biological Availability
  • Chloroquine / blood
  • Chloroquine / pharmacokinetics
  • Chloroquine / pharmacology*
  • Drug Administration Schedule
  • Drug Combinations
  • Drug Synergism
  • Female
  • Hepatocytes / drug effects
  • Hepatocytes / parasitology
  • Ivermectin / blood
  • Ivermectin / pharmacokinetics
  • Ivermectin / pharmacology*
  • Liver / drug effects*
  • Liver / parasitology
  • Macaca mulatta
  • Malaria / drug therapy*
  • Malaria / parasitology
  • Male
  • Parasitemia / drug therapy
  • Plasmodium cynomolgi / drug effects*
  • Plasmodium cynomolgi / growth & development
  • Plasmodium cynomolgi / pathogenicity
  • Primary Cell Culture
  • Schizonts / drug effects
  • Schizonts / growth & development

Substances

  • Antimalarials
  • Drug Combinations
  • Ivermectin
  • Chloroquine