Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables

Background. We compared proportions of participants with target detected, target not detected (TND), and elevated viral load (VL) and assessed baseline variables associated with week 144 inflammatory biomarker levels between dolutegravir-lamivudine (DTG/3TC) and tenofovir alafenamide-based regimens...

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Autores: Wang, Ruolan|||0009-0005-2338-8209, Underwood, Mark, Llibre, Josep M.|||0000-0002-7158-6753, Morell, Enrique Bernal, Brinson, Cynthia, Moreno, José Sanz, Scholten, Stefan, Moore, Richard, Saggu, Parminder, Oyee, James, Moodley, Riya, Wynne, Brian, Kisare, Michelle, Jones, Bryn, Ait-Khaled, Mounir
Tipo de recurso: artículo
Fecha de publicación:2024
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:302153
Acceso en línea:https://ddd.uab.cat/record/302153
https://dx.doi.org/urn:doi:10.1093/ofid/ofad626
Access Level:acceso abierto
Palabra clave:2-drug regimen
Dolutegravir-lamivudine
Inflammation
Integrase strand transfer inhibitor
Virologic suppression
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spelling Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline VariablesThree-Year Results of the Randomized TANGO StudyWang, Ruolan|||0009-0005-2338-8209Underwood, MarkLlibre, Josep M.|||0000-0002-7158-6753Morell, Enrique BernalBrinson, CynthiaMoreno, José SanzScholten, StefanMoore, RichardSaggu, ParminderOyee, JamesMoodley, RiyaWynne, BrianKisare, MichelleJones, BrynAit-Khaled, Mounir2-drug regimenDolutegravir-lamivudineInflammationIntegrase strand transfer inhibitorVirologic suppressionBackground. We compared proportions of participants with target detected, target not detected (TND), and elevated viral load (VL) and assessed baseline variables associated with week 144 inflammatory biomarker levels between dolutegravir-lamivudine (DTG/3TC) and tenofovir alafenamide-based regimens (TBRs) in the TANGO study (post hoc). Methods. TANGO is an open-label, multicenter, phase 3 study that randomized adults with VL <50 copies/mL to switch to once-daily fixed-dose DTG/3TC or continue TBR. At baseline and each study visit, the VL was measured. Elevated VL event frequencies were assessed, including "blips." Interleukin 6, D-dimer, high-sensitivity C-reactive protein, soluble CD14, and soluble CD163 were measured at baseline and at week 144. Log-transformed week 144 biomarker levels were compared between treatment groups using an analysis of covariance model adjusting for baseline variables. Results. High, comparable proportions of participants had VL <40 copies/mL and TND at week 144 (DTG/3TC, 279 of 369 [76%]; TBR, 267 of 372 [72%], intention-to-treat exposed Snapshot analysis; adjusted difference, 3.9% [95% confidence interval, -2.5% to 10.2%]), with similar TND proportions at all postbaseline visits (123 of 369 [33%] vs 101 of 372 [27%], respectively). Similar proportions of DTG/3TC participants had ≥1 postbaseline VL ≥50 copies/mL (28 of 369 [8%] vs 42 of 372 [11%] for TBR), primarily blips (18 of 369 [5%] and 26 of 372 [7%], respectively). Week 144 inflammatory biomarker levels were low and comparable between groups and associated with multiple demographic and baseline characteristics, including baseline biomarker levels, indicating a multifactorial inflammatory response. Conclusions. Week 144 biomarker levels were low and generally comparable between treatment groups, reflecting similar, robust, and durable viral suppression observed using the stringent TND end point. 22024-01-0120242024-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/302153https://dx.doi.org/urn:doi:10.1093/ofid/ofad626reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.https://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:3021532026-06-06T12:50:31Z
dc.title.none.fl_str_mv Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables
Three-Year Results of the Randomized TANGO Study
title Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables
spellingShingle Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables
Wang, Ruolan|||0009-0005-2338-8209
2-drug regimen
Dolutegravir-lamivudine
Inflammation
Integrase strand transfer inhibitor
Virologic suppression
title_short Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables
title_full Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables
title_fullStr Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables
title_full_unstemmed Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables
title_sort Very-Low-Level Viremia, Inflammatory Biomarkers, and Associated Baseline Variables
dc.creator.none.fl_str_mv Wang, Ruolan|||0009-0005-2338-8209
Underwood, Mark
Llibre, Josep M.|||0000-0002-7158-6753
Morell, Enrique Bernal
Brinson, Cynthia
Moreno, José Sanz
Scholten, Stefan
Moore, Richard
Saggu, Parminder
Oyee, James
Moodley, Riya
Wynne, Brian
Kisare, Michelle
Jones, Bryn
Ait-Khaled, Mounir
author Wang, Ruolan|||0009-0005-2338-8209
author_facet Wang, Ruolan|||0009-0005-2338-8209
Underwood, Mark
Llibre, Josep M.|||0000-0002-7158-6753
Morell, Enrique Bernal
Brinson, Cynthia
Moreno, José Sanz
Scholten, Stefan
Moore, Richard
Saggu, Parminder
Oyee, James
Moodley, Riya
Wynne, Brian
Kisare, Michelle
Jones, Bryn
Ait-Khaled, Mounir
author_role author
author2 Underwood, Mark
Llibre, Josep M.|||0000-0002-7158-6753
Morell, Enrique Bernal
Brinson, Cynthia
Moreno, José Sanz
Scholten, Stefan
Moore, Richard
Saggu, Parminder
Oyee, James
Moodley, Riya
Wynne, Brian
Kisare, Michelle
Jones, Bryn
Ait-Khaled, Mounir
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv 2-drug regimen
Dolutegravir-lamivudine
Inflammation
Integrase strand transfer inhibitor
Virologic suppression
topic 2-drug regimen
Dolutegravir-lamivudine
Inflammation
Integrase strand transfer inhibitor
Virologic suppression
description Background. We compared proportions of participants with target detected, target not detected (TND), and elevated viral load (VL) and assessed baseline variables associated with week 144 inflammatory biomarker levels between dolutegravir-lamivudine (DTG/3TC) and tenofovir alafenamide-based regimens (TBRs) in the TANGO study (post hoc). Methods. TANGO is an open-label, multicenter, phase 3 study that randomized adults with VL <50 copies/mL to switch to once-daily fixed-dose DTG/3TC or continue TBR. At baseline and each study visit, the VL was measured. Elevated VL event frequencies were assessed, including "blips." Interleukin 6, D-dimer, high-sensitivity C-reactive protein, soluble CD14, and soluble CD163 were measured at baseline and at week 144. Log-transformed week 144 biomarker levels were compared between treatment groups using an analysis of covariance model adjusting for baseline variables. Results. High, comparable proportions of participants had VL <40 copies/mL and TND at week 144 (DTG/3TC, 279 of 369 [76%]; TBR, 267 of 372 [72%], intention-to-treat exposed Snapshot analysis; adjusted difference, 3.9% [95% confidence interval, -2.5% to 10.2%]), with similar TND proportions at all postbaseline visits (123 of 369 [33%] vs 101 of 372 [27%], respectively). Similar proportions of DTG/3TC participants had ≥1 postbaseline VL ≥50 copies/mL (28 of 369 [8%] vs 42 of 372 [11%] for TBR), primarily blips (18 of 369 [5%] and 26 of 372 [7%], respectively). Week 144 inflammatory biomarker levels were low and comparable between groups and associated with multiple demographic and baseline characteristics, including baseline biomarker levels, indicating a multifactorial inflammatory response. Conclusions. Week 144 biomarker levels were low and generally comparable between treatment groups, reflecting similar, robust, and durable viral suppression observed using the stringent TND end point.
publishDate 2024
dc.date.none.fl_str_mv 2
2024-01-01
2024
2024-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/302153
https://dx.doi.org/urn:doi:10.1093/ofid/ofad626
url https://ddd.uab.cat/record/302153
https://dx.doi.org/urn:doi:10.1093/ofid/ofad626
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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