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Authors
Mounzer, Karam
Brunet, Laurence
Sension, Michael
Hsu, Ricky K.
Osterman, Michael D.
Fusco, Jennifer S.
Whiteside, Yohance O.
Fusco, Gregory P.
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Article History
Received: 5 May 2025
Accepted: 11 June 2025
First Online: 21 June 2025
Declarations
:
: Institutional review board (IRB) approval covering patient data contained in the OPERA database was received from Advarra IRB; a waiver of informed consent and authorization for the use of protected health information for patient data was granted (Pro00023648). The study was conducted in accordance with HIPAA and HITECH requirements, which expand upon the ethical principles detailed in the 1964 Declaration of Helsinki.
: Not applicable.
: KM has received research grants from Gilead Sciences, Merck, Janssen, and GSK/ViiV Healthcare and honoraria for Speakers Bureau and Advisory Boards from Gilead Sciences, Merck, Janssen and GSK/ViiV Healthcare; and advisory board participation with Epividian. LB, MDO, JSF, and GPF are employed by Epividian, Inc.; Epividian has had research funded by AIDS Healthcare Foundation, EMD Serono, Gilead Sciences, Janssen Scientific Affairs, LLC, Merck & Co., Theratechnologies Inc., and ViiV Healthcare. MS is on the Speakers Bureau for ViiV Healthcare and Gilead Sciences, and on the advisory board for ViiV Healthcare and Epividian. RKH has received research grants from Gilead Sciences, Janssen, and ViiV Healthcare, speaker honoraria from ViiV Healthcare, Merck, Gilead Sciences, and Janssen, and advisory board participation with ViiV Healthcare, Gilead Sciences, Janssen, and Epividian. YOW is employed by Merck & Co., Inc.
: µl Microliter.3TC Lamivudine.AIDS Acquired immunodeficiency syndrome.ARV Antiretroviral.BMI Body mass index.CI Confidence interval.dL Deciliter.DOR Doravirine.EFV Efavirenz.eGFR Estimated glomerular filtration rate.FDA Food and Drug Administration.HIPAA Health Insurance Portability and Accountability Act.HITECH Health Information Technology for Economic and Clinical Health.HIV Human immunodeficiency virus.INSTI Integrase strand transfer inhibitor.IQR Interquartile range.IRB Institutional Review Board.kg Kilogram.N Number.NNRTI Non-nucleoside reverse transcriptase inhibitor.NRTI Nucleoside reverse transcriptase inhibitor.OPERA Observational Pharmaco-Epidemiology Research and Analysis.PI Protease inhibitor.TAF Tenofovir alafenamide.TDF Tenofovir disoproxil fumarate.US United States.
