Evidence map›Paper›PMID 42466959›Full record

ArticleHIV medicine2026

Dolutegravir population pharmacokinetics in racially, sex- and age-diverse and antiretroviral therapy-experienced adults with HIV in the United States.

Adrian Khoei, Andrew Edmonds, Yen Chang, Catalina Ramirez, Mackenzie Vogan, Amanda Poliseno, Steven Wolinsky, Ken Ho, Todd T Brown, Joseph B Margolick and 20 more

Abstract readMulticenter Study
In one paragraph

Article in HIV medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

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0 citing papers in PubMed.

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4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

30 authors.

Adrian KhoeiDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.
Andrew EdmondsDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Yen ChangDepartment of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Catalina RamirezDivision of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Mackenzie VoganDivision of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Amanda PolisenoDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.
Steven WolinskyDivision of Infectious Diseases, Department of Medicine, The Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.
Ken HoDepartment of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
Todd T BrownJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Joseph B MargolickDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Jacquett BatsonDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Jennifer HoffmannJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Mark A MarzinkeJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Mirjam-Colette KempfSchools of Nursing, Public Health, and Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Maria L AlcaideDivision of Infectious Diseases, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.ORCID https://orcid.org/0000-0003-4648-0145
Joffi EffoeDivision of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
Cecile D LahiriDivision of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.ORCID https://orcid.org/0000-0002-5605-8266
Igho OfotokunDivision of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
Anandi N ShethDivision of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
Stephen GangeDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.
Audrey L FrenchDepartment of Internal Medicine, Division of Infectious Disease, University of Illinois Chicago, Chicago, Illinois, USA.
Bani TamrazSchool of Pharmacy, University of California, San Francisco, California, USA.
Bradley E AouizeratDepartment of Physiological Nursing, University of California, San Francisco, California, USA.
Phyllis C TienDepartment of Medicine, University of California, San Francisco, California, USA.
Seble G KassayeDepartment of Medicine, Georgetown University Medical Center, Washington, DC, USA.
Jack DeHovitzDownstate Health Sciences University, State University of New York, Brooklyn, New York, USA.ORCID https://orcid.org/0000-0001-7307-0614
Kathryn AnastosDepartment of Medicine, Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, New York, USA.
Kara W ChewDivision of Infectious Diseases, Department of Medicine, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California, USA.
Michelle Floris-MooreDivision of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Julie B DumondDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina, USA.ORCID https://orcid.org/0000-0002-3500-5819

Funding

UCLA Clinical Translational Science InstituteUL1TR001881 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI ARLEEN F. BROWN, ARASH NAEIM · 2016 to 2026
$118.1M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
QAQC Johns Hopkins Institute for Clinical and Translational ResearchUL1TR003098 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2019 to 2023
$57.7M
Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
SF Bay Area MACS/WIHS Combined Cohort StudyU01HL146242 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Bradley E Aouizerat, Jennifer Cohen Price · 2019 to 2026
$36.3M
Sex differences in the role of multi-omicsin HIV-associated carotid artery atherosclerosisU01HL146193 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI Stephen J Gange, Elizabeth Topper · 2019 to 2026
$35.8M
Clinical Research Sites for the MACS/WIHS Combined Cohort Study (MACS/WIHS-CCS) - Baltimore/Wash DC Center - Admin Supplement: Vision and dual sensory loss in HIV-infected older adultsU01HL146201 · NHLBI · JOHNS HOPKINS UNIVERSITY · PI TODD T BROWN, Joseph B. Margolick · 2019 to 2026
$33.7M
Sex differences in the role of multi-omics in HIV-associated carotid artery atherosclerosisU01HL146204 · NHLBI · ALBERT EINSTEIN COLLEGE OF MEDICINE · PI David B. Hanna, Anjali Sharma · 2019 to 2026
$33.2M
University of Pittsburgh MWCCS Clinical Research SiteU01HL146208 · NHLBI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Bernard Jonas C Macatangay, CHARLES R RINALDO · 2019 to 2026
$32.2M
Study of Hearing and Balance in Middle Aged and Aging Men and Women in the MACS-WIHS Combined Cohort StudyU01HL146333 · NHLBI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Roger Detels, Matthew James Mimiaga · 2019 to 2026
$32.2M
Northwestern CORE Clinical Research Site: Trans-omics for HIV/AIDS ResearchU01HL146240 · NHLBI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Frank J Palella, Valentina Stosor · 2019 to 2026
$31.5M
MACS/WIHS Combined Cohort Study Clinical Research SiteU01HL146241 · NHLBI · EMORY UNIVERSITY · PI Cecile Delille Lahiri, Anandi Nayan Sheth · 2019 to 2026
$24.2M
National Institute of Allergy and Infectious Diseases KL2-TR001432National Institute of Allergy and Infectious Diseases P30-AI-027767National Institute of Allergy and Infectious Diseases P30-AI-050410National Institute of Allergy and Infectious Diseases P30-AI-073961National Institute of Allergy and Infectious Diseases P30-AI-124414National Institute of Allergy and Infectious Diseases P30-MH-116867National Institute of Allergy and Infectious Diseases TL1-TR001431National Institute of Allergy and Infectious Diseases UL1-TR001409NCATS NIH HHS KL2 TR001432NCATS NIH HHS TL1 TR001431NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR001409NCATS NIH HHS UL1 TR001881NCATS NIH HHS UL1 TR003098NHLBI NIH HHS K24 HL176324NHLBI NIH HHS P30-AI-050409NHLBI NIH HHS U01 HL146192NHLBI NIH HHS U01-HL146192NHLBI NIH HHS U01 HL146193NHLBI NIH HHS U01 HL146194NHLBI NIH HHS U01-HL146194NHLBI NIH HHS U01 HL146201NHLBI NIH HHS U01 HL146202NHLBI NIH HHS U01 HL146203NHLBI NIH HHS U01-HL146203NHLBI NIH HHS U01 HL146204NHLBI NIH HHS U01 HL146205NHLBI NIH HHS U01-HL146205NHLBI NIH HHS U01 HL146208NHLBI NIH HHS U01-HL146208NHLBI NIH HHS U01 HL146240NHLBI NIH HHS U01 HL146241NHLBI NIH HHS U01 HL146242NHLBI NIH HHS U01 HL146245NHLBI NIH HHS U01 HL146333NHLBI NIH HHS U01-HL146333NHLBI NIH HHS UL1-TR000004NHLBI NIH HHS UL1-TR001881NHLBI NIH HHS UL1-TR003098NIAID NIH HHS R01 AI153007NIAID NIH HHS R56 AI153007NIH HHS 1-R01-AI153007-01A1NIH HHS K24 HL176324NIH HHS U01-HL146193NIH HHS U01-HL146201NIH HHS U01-HL146202NIH HHS U01-HL146204NIH HHS U01-HL146240NIH HHS U01-HL146241NIH HHS U01-HL146242NIH HHS U01-HL146245
6 · The paper itself

Abstract

objectivesDolutegravir (DTG) has been associated with weight gain in women with HIV, Black people with HIV and people with HIV60 years. This study aimed to characterise DTG population pharmacokinetics (PopPK) in a diverse population including these sub-populations.

methodsWe conducted an intensive PK study nested within the Multicenter AIDS Cohort Study (MACS)/Women's Interagency HIV Study (WIHS) Combined Cohort Study (MWCCS) and retrospectively quantified DTG plasma concentrations in historical specimens from participants in the WIHS and the MACS over several study visits. PopPK models were developed using NONMEM; covariate searches included relevant demographics and co-medications.

resultsThe analysis included 44 people with HIV from the MWCCS (56.8% women, 72.7% Black, 40.9% 60 years), 193 WIHS women (52.8% Black, 25.4% 60 years) and 137 MACS men (19.7% Black, 53.3% 60 years). A one-compartment model with first-order absorption and elimination and an absorption lag time (ALAG) best described DTG PK. Apparent clearance (CL/F) was 1.21, 1.26 and 0.95 L/h; apparent volume of distribution (V/F) was 21.2, 38.9 and 19.8 L, in the MWCCS, WIHS and MACS, respectively. For all three models, ALAG was 0.35 h. Sex, race and age were not statistically significant covariates. In the WIHS, lower total bilirubin and current cigarette smoking were significantly associated with higher CL/F, and higher body weight was significantly associated with higher V/F.

conclusionsOur analysis did not support different DTG PK in women with HIV, Black people with HIV and people with HIV aged 60 years compared to other sub-populations; causal analysis between DTG concentrations and weight gain over time are ongoing.

Indexed as

DolutegravirHIV InfectionsHIV Integrase InhibitorsAdultAgedAge FactorsCohort StudiesFemaleHumansMaleMiddle AgedOxazinesPiperazinesPyridonesRacial GroupsRetrospective StudiesDolutegravirHIV Integrase InhibitorsOxazinesPiperazinesPyridonesclinical pharmacologydolutegravir pharmacokineticsintegrase inhibitormen with HIVpopulation pharmacokineticswomen with HIV

Identifiers

PMID42466959
PMCPMC13547437

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