Nuventra’s Virginia (Ginny) Schmith, Ph.D., FCP, Jie (Jessie) Zhou, Ph.D., and Lauren Lohmer, Ph.D., have written a manuscript discussing the feasibility of using ivermectin as a treatment for SARS-CoV-2. The article, “The Approved Dose of Ivermectin Alone is not the Ideal Dose for the Treatment of COVID-19” has been approved for publication in Clinical Pharmacology and Therapeutics, the journal associated with the American Society for Clinical Pharmacology and Therapeutics (ASCPT).
Previously, a published study reported that ivermectin inhibited SARS-CoV-2 in vitro for up to 48 hours using the drug at 5 uM. Using an available population pharmacokinetic model, the team simulated plasma and lung concentration‑time profiles after a single and repeat dose of the administration of the approved dose of ivermectin and doses up to 10x the approved dose.
The article concludes that the likelihood of a successful clinical trial using the approved dose of ivermectin is low, as the predicted plasma and lung ivermectin concentrations are lower than the concentration needed to result in 50% inhibition. It goes on to suggest that combination therapy should be evaluated, and that re-purposing drugs for use in COVID-19 treatment is an ideal strategy but is only feasible when product safety has been established and experiments of re-purposed drugs are conducted at clinically relevant concentrations.
“Every time there is a re-purposed drug showing in vitro data against SARS-COV-2, I am always curious as to how the IC50 compares with the expected lung concentrations,” says Dr. Schmith. “Ivermectin is more interesting than most because it has a wide safety margin and has the potential for conducting a placebo-controlled dose-response study looking at therapeutic doses (in case in vitro concentrations are not relevant) and higher doses (where less safety data is available) in a well-controlled environment.”
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