aClinical Pharmacokinetic Research Laboratory, Clinical Center Pharmacy Department, NIH Clinical Center, Bethesda, MD, USA;

bCurrently, Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, CO;

cNational Institute of Allergy and Infectious Diseases, Bethesda, MD;

dClinical Research Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD;

eCurrently, Pumas-AI, Inc., Centreville, VA;

fCurrently, Arcus Biosciences, Hayward, CA;

gUniversity of Florida College of Pharmacy and Emerging Pathogens Institute, Gainesville, FL;

hCurrently, Gilead Sciences, Inc., Foster City, CA;

iCritical Care Medicine Department, NIH Clinical Center, Bethesda, MD; and

jCurrently, Office of Regulatory Affairs, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD.

Correspondence to: Jomy M. George, PharmD, BCPS, Office of Regulatory Affairs (ORA), Division of Microbiology and Infectious Diseases (DMID), NIH/NIAID/DMID/ORA, 5601 Fishers Lane Rm 7G17, Rockville, MD 20852 (e-mail: [email protected]).

Supported by the Intramural Research Program of the NIH Clinical Center and the National Institute of Allergy and Infectious Diseases. This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under Contract No. 75N91019D00024. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government.

These results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in Denver, CO, in February 12–16, 2022.

K. M. Brooks received consulting fees from ViiV Healthcare. P. Kumar is currently an employee of Gilead Sciences, Inc. The remaining authors have nothing to declare.