Population Pharmacokinetics and Pharmacodynamics of the Neutralizing Antibodies Bamlanivimab and Etesevimab in Patients With Mild to Moderate COVID-19 Infection.

ABSTRACT: Bamlanivimab and etesevimab are neutralizing antibodies indicated for treatment of coronavirus disease 2019 (COVID-19) in patients with early mild or moderate disease. We present the use of pharmacokinetic/pharmacodynamic (PK/PD) modeling that characterizes the timecourse of viral load obtained from 2,970 patients from 2 phase II clinical trials. The model was used for identification of optimal doses that would result in at least 90% of patients achieving serum drug concentrations that result in 90% of maximum drug effect (IC90) for at least 28 days. The serum IC90 (95% confidence interval) was estimated to be 4.2 (3.2-4.3) µg/mL for bamlanivimab and 12.6 (9.7-12.8) µg/mL for etesevimab. Observed clinical trial data confirmed PK and PK/PD model predictions that doses of 700 mg bamlanivimab

SUBMITTER: Chigutsa E 

PROVIDER: S-EPMC8652670 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature