Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial.

BACKGROUND: Switching to dolutegravir/lamivudine (DTG/3TC) was non-inferior to continuing tenofovir alafenamide (TAF)-based regimens for maintaining virologic suppression at Week 48 of the TANGO study. Here we present Week 144 outcomes (efficacy, safety, weight, and biomarkers). METHODS: TANGO is a...

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Autores: Osiyemi O, De Wit S, Ajana F, Bisshop F, Portilla J, Routy JP, Wyen C, Ait-Khaled M, Leone P, Pappa KA, Wang R, Wright J, George N, Wynne B, Aboud M, van Wyk J, Smith KY
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2022
País:España
Institución:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
Repositorio:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
OAI Identifier:oai:isabial.fundanetsuite.com:p8228
Acceso en línea:https://isabial.portalinvestigacion.com/publicaciones8228
Access Level:acceso abierto
Palabra clave:2-drug regimen
dolutegravir/lamivudine
durable
integrase strand transfer inhibitor
treatment-experienced
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spelling Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial.Osiyemi ODe Wit SAjana FBisshop FPortilla JRouty JPWyen CAit-Khaled MLeone PPappa KAWang RWright JGeorge NWynne BAboud Mvan Wyk JSmith KY2-drug regimendolutegravir/lamivudinedurableintegrase strand transfer inhibitortreatment-experiencedBACKGROUND: Switching to dolutegravir/lamivudine (DTG/3TC) was non-inferior to continuing tenofovir alafenamide (TAF)-based regimens for maintaining virologic suppression at Week 48 of the TANGO study. Here we present Week 144 outcomes (efficacy, safety, weight, and biomarkers). METHODS: TANGO is a randomized (1:1, stratified by baseline third agent class), open-label, non-inferiority phase 3 study. Virologically suppressed (>6 months) adults with HIV-1 switched to once-daily DTG/3TC or continued TAF-based regimens. RESULTS: 741 participants received study treatment (DTG/3TC, n=369; TAF-based regimen, n=372). At Week 144, proportion of participants with HIV-1 RNA =50 copies/mL (primary endpoint, Snapshot, intention-to-treat-exposed population) after switching to DTG/3TC was 0.3% (1/369) vs 1.3% (5/372) of those continuing TAF-based regimens, demonstrating non-inferiority (adjusted treatment difference, -1.1; 95% CI, -2.4, 0.2), and favored DTG/3TC in the per-protocol analysis (adjusted treatment difference, -1.1; 95% CI, -2.3, -0.0; P=0.044). Few participants met confirmed virologic withdrawal criteria (DTG/3TC, n=0; TAF-based regimen, n=3), with no resistance observed. Drug-related adverse events were more frequent with DTG/3TC (15%; 4% led to discontinuation) than TAF-based regimens (5%; 1% led to discontinuation) through Week 144 and were comparable post-Week 48 (4%; 1% led to discontinuation in both groups). Change from baseline in lipids generally favored DTG/3TC; no clinical impact on renal function and comparable changes in inflammatory and bone biomarkers across groups were observed. CONCLUSIONS: Switching to DTG/3TC demonstrated non-inferior and durable efficacy vs continuing TAF-based regimens in treatment-experienced adults with HIV-1, with good safety and tolerability, and no resistance through 144 weeks.OXFORD UNIV PRESS INC2022info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://isabial.portalinvestigacion.com/publicaciones8228CLINICAL INFECTIOUS DISEASESISSN: 10584838ISSNe: 15376591reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicanteinstname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)Inglésinfo:eu-repo/semantics/openAccessoai:isabial.fundanetsuite.com:p82282026-06-12T10:20:37Z
dc.title.none.fl_str_mv Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial.
title Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial.
spellingShingle Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial.
Osiyemi O
2-drug regimen
dolutegravir/lamivudine
durable
integrase strand transfer inhibitor
treatment-experienced
title_short Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial.
title_full Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial.
title_fullStr Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial.
title_full_unstemmed Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial.
title_sort Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial.
dc.creator.none.fl_str_mv Osiyemi O
De Wit S
Ajana F
Bisshop F
Portilla J
Routy JP
Wyen C
Ait-Khaled M
Leone P
Pappa KA
Wang R
Wright J
George N
Wynne B
Aboud M
van Wyk J
Smith KY
author Osiyemi O
author_facet Osiyemi O
De Wit S
Ajana F
Bisshop F
Portilla J
Routy JP
Wyen C
Ait-Khaled M
Leone P
Pappa KA
Wang R
Wright J
George N
Wynne B
Aboud M
van Wyk J
Smith KY
author_role author
author2 De Wit S
Ajana F
Bisshop F
Portilla J
Routy JP
Wyen C
Ait-Khaled M
Leone P
Pappa KA
Wang R
Wright J
George N
Wynne B
Aboud M
van Wyk J
Smith KY
author2_role author
author
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
durable
integrase strand transfer inhibitor
treatment-experienced
topic 2-drug regimen
dolutegravir/lamivudine
durable
integrase strand transfer inhibitor
treatment-experienced
description BACKGROUND: Switching to dolutegravir/lamivudine (DTG/3TC) was non-inferior to continuing tenofovir alafenamide (TAF)-based regimens for maintaining virologic suppression at Week 48 of the TANGO study. Here we present Week 144 outcomes (efficacy, safety, weight, and biomarkers). METHODS: TANGO is a randomized (1:1, stratified by baseline third agent class), open-label, non-inferiority phase 3 study. Virologically suppressed (>6 months) adults with HIV-1 switched to once-daily DTG/3TC or continued TAF-based regimens. RESULTS: 741 participants received study treatment (DTG/3TC, n=369; TAF-based regimen, n=372). At Week 144, proportion of participants with HIV-1 RNA =50 copies/mL (primary endpoint, Snapshot, intention-to-treat-exposed population) after switching to DTG/3TC was 0.3% (1/369) vs 1.3% (5/372) of those continuing TAF-based regimens, demonstrating non-inferiority (adjusted treatment difference, -1.1; 95% CI, -2.4, 0.2), and favored DTG/3TC in the per-protocol analysis (adjusted treatment difference, -1.1; 95% CI, -2.3, -0.0; P=0.044). Few participants met confirmed virologic withdrawal criteria (DTG/3TC, n=0; TAF-based regimen, n=3), with no resistance observed. Drug-related adverse events were more frequent with DTG/3TC (15%; 4% led to discontinuation) than TAF-based regimens (5%; 1% led to discontinuation) through Week 144 and were comparable post-Week 48 (4%; 1% led to discontinuation in both groups). Change from baseline in lipids generally favored DTG/3TC; no clinical impact on renal function and comparable changes in inflammatory and bone biomarkers across groups were observed. CONCLUSIONS: Switching to DTG/3TC demonstrated non-inferior and durable efficacy vs continuing TAF-based regimens in treatment-experienced adults with HIV-1, with good safety and tolerability, and no resistance through 144 weeks.
publishDate 2022
dc.date.none.fl_str_mv 2022
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://isabial.portalinvestigacion.com/publicaciones8228
url https://isabial.portalinvestigacion.com/publicaciones8228
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv OXFORD UNIV PRESS INC
publisher.none.fl_str_mv OXFORD UNIV PRESS INC
dc.source.none.fl_str_mv CLINICAL INFECTIOUS DISEASES
ISSN: 10584838
ISSNe: 15376591
reponame:r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
instname:Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
instname_str Instituto de Investigación Biomédica y Sanitaria de Alicante (ISABIAL)
reponame_str r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
collection r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,811543

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