Limited Weight Impact After Switching From Boosted Protease Inhibitors to Dolutegravir in Persons With Human Immunodeficiency Virus With High Cardiovascular Risk : A Post Hoc Analysis of the 96-Week NEAT-022 Randomized Trial
© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com..
BACKGROUND: In the NEAT022 trial, virologically suppressed persons with human immunodeficiency virus (HIV) at high cardiovascular risk switching from protease inhibitors to dolutegravir either immediately (DTG-I) or after 48 weeks (DTG-D) showed noninferior virological suppression and significant lipid and cardiovascular disease risk reductions on switching to dolutegravir relative to continuing protease inhibitors.
METHODS: In post hoc analysis, major endpoints were 48-week and 96-week weight and body mass index (BMI) changes. Factors associated with weight/BMI changes within the first 48 weeks of DTG exposure, proportion of participants by category of percentage weight change, proportions of BMI categories over time, and impact on metabolic outcomes were also assessed.
RESULTS: Between May 2014 and November 2015, 204 (DTG-I) and 208 (DTG-D) participants were included. Weight significantly increased (mean, +0.810 kg DTG-I arm, and +0.979 kg DTG-D arm) in the first 48 weeks postswitch, but remained stable from 48 to 96 weeks in DTG-I arm. Switching from darunavir, White race, total to high-density lipoprotein cholesterol ratio <3.7, and normal/underweight BMI were independently associated with higher weight/BMI gains. The proportion of participants with ≥5% weight change increased similarly in both arms over time. The proportions of BMI categories, use of lipid-lowering drugs, diabetes and/or use of antidiabetic agents, and hypertension and/or use of antihypertensive agents did not change within or between arms at 48 and 96 weeks.
CONCLUSIONS: Switching from protease inhibitors to dolutegravir in persons with HIV with high cardiovascular risk led to modest weight gain limited to the first 48 weeks, which involved preferentially normal-weight or underweight persons and was not associated with negative metabolic outcomes.
CLINICAL TRIALS REGISTRATION: NCT02098837 and EudraCT 2013-003704-39.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:76 |
|---|---|
| Enthalten in: |
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America - 76(2023), 5 vom: 04. März, Seite 861-870 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Waters, Laura [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Anti-HIV Agents |
|---|
| Anmerkungen: |
Date Completed 08.03.2023 Date Revised 28.02.2024 published: Print ClinicalTrials.gov: NCT02098837 Citation Status MEDLINE |
|---|
| doi: |
10.1093/cid/ciac827 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM347742785 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM347742785 | ||
| 003 | DE-627 | ||
| 005 | 20240229165948.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1093/cid/ciac827 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1310.xml |
| 035 | |a (DE-627)NLM347742785 | ||
| 035 | |a (NLM)36259527 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Waters, Laura |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Limited Weight Impact After Switching From Boosted Protease Inhibitors to Dolutegravir in Persons With Human Immunodeficiency Virus With High Cardiovascular Risk |b A Post Hoc Analysis of the 96-Week NEAT-022 Randomized Trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 08.03.2023 | ||
| 500 | |a Date Revised 28.02.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT02098837 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com. | ||
| 520 | |a BACKGROUND: In the NEAT022 trial, virologically suppressed persons with human immunodeficiency virus (HIV) at high cardiovascular risk switching from protease inhibitors to dolutegravir either immediately (DTG-I) or after 48 weeks (DTG-D) showed noninferior virological suppression and significant lipid and cardiovascular disease risk reductions on switching to dolutegravir relative to continuing protease inhibitors | ||
| 520 | |a METHODS: In post hoc analysis, major endpoints were 48-week and 96-week weight and body mass index (BMI) changes. Factors associated with weight/BMI changes within the first 48 weeks of DTG exposure, proportion of participants by category of percentage weight change, proportions of BMI categories over time, and impact on metabolic outcomes were also assessed | ||
| 520 | |a RESULTS: Between May 2014 and November 2015, 204 (DTG-I) and 208 (DTG-D) participants were included. Weight significantly increased (mean, +0.810 kg DTG-I arm, and +0.979 kg DTG-D arm) in the first 48 weeks postswitch, but remained stable from 48 to 96 weeks in DTG-I arm. Switching from darunavir, White race, total to high-density lipoprotein cholesterol ratio <3.7, and normal/underweight BMI were independently associated with higher weight/BMI gains. The proportion of participants with ≥5% weight change increased similarly in both arms over time. The proportions of BMI categories, use of lipid-lowering drugs, diabetes and/or use of antidiabetic agents, and hypertension and/or use of antihypertensive agents did not change within or between arms at 48 and 96 weeks | ||
| 520 | |a CONCLUSIONS: Switching from protease inhibitors to dolutegravir in persons with HIV with high cardiovascular risk led to modest weight gain limited to the first 48 weeks, which involved preferentially normal-weight or underweight persons and was not associated with negative metabolic outcomes | ||
| 520 | |a CLINICAL TRIALS REGISTRATION: NCT02098837 and EudraCT 2013-003704-39 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a dolutegravir | |
| 650 | 4 | |a switch | |
| 650 | 4 | |a weight | |
| 650 | 7 | |a Protease Inhibitors |2 NLM | |
| 650 | 7 | |a dolutegravir |2 NLM | |
| 650 | 7 | |a DKO1W9H7M1 |2 NLM | |
| 650 | 7 | |a Anti-HIV Agents |2 NLM | |
| 650 | 7 | |a Heterocyclic Compounds, 3-Ring |2 NLM | |
| 650 | 7 | |a Lipids |2 NLM | |
| 700 | 1 | |a Assoumou, Lambert |e verfasserin |4 aut | |
| 700 | 1 | |a González-Cordón, Ana |e verfasserin |4 aut | |
| 700 | 1 | |a Rusconi, Stefano |e verfasserin |4 aut | |
| 700 | 1 | |a Domingo, Pere |e verfasserin |4 aut | |
| 700 | 1 | |a Gompels, Mark |e verfasserin |4 aut | |
| 700 | 1 | |a de Wit, Stephane |e verfasserin |4 aut | |
| 700 | 1 | |a Raffi, François |e verfasserin |4 aut | |
| 700 | 1 | |a Stephan, Christoph |e verfasserin |4 aut | |
| 700 | 1 | |a Masiá, Mar |e verfasserin |4 aut | |
| 700 | 1 | |a Rockstroh, Jürgen |e verfasserin |4 aut | |
| 700 | 1 | |a Katlama, Christine |e verfasserin |4 aut | |
| 700 | 1 | |a Behrens, Georg M N |e verfasserin |4 aut | |
| 700 | 1 | |a Moyle, Graeme |e verfasserin |4 aut | |
| 700 | 1 | |a Johnson, Margaret |e verfasserin |4 aut | |
| 700 | 1 | |a Fox, Julie |e verfasserin |4 aut | |
| 700 | 1 | |a Stellbrink, Hans-Jürgen |e verfasserin |4 aut | |
| 700 | 1 | |a Guaraldi, Giovanni |e verfasserin |4 aut | |
| 700 | 1 | |a Florence, Eric |e verfasserin |4 aut | |
| 700 | 1 | |a Esser, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Gatell, José M |e verfasserin |4 aut | |
| 700 | 1 | |a Pozniak, Anton |e verfasserin |4 aut | |
| 700 | 1 | |a Martínez, Esteban |e verfasserin |4 aut | |
| 700 | 0 | |a NEAT 022 Study Group |e verfasserin |4 aut | |
| 700 | 1 | |a Vandekerckhove, Linos |e investigator |4 oth | |
| 700 | 1 | |a Caluwé, Els |e investigator |4 oth | |
| 700 | 1 | |a de Wit, Stephane |e investigator |4 oth | |
| 700 | 1 | |a Necsoi, Coca |e investigator |4 oth | |
| 700 | 1 | |a Florence, Eric |e investigator |4 oth | |
| 700 | 1 | |a Frankenhuijsen, Maartje Van |e investigator |4 oth | |
| 700 | 1 | |a Raffi, François |e investigator |4 oth | |
| 700 | 1 | |a Allavena, Clotilde |e investigator |4 oth | |
| 700 | 1 | |a Reliquet, Véronique |e investigator |4 oth | |
| 700 | 1 | |a Boutoille, David |e investigator |4 oth | |
| 700 | 1 | |a Cavellec, Morane |e investigator |4 oth | |
| 700 | 1 | |a André-Garnier, Elisabeth |e investigator |4 oth | |
| 700 | 1 | |a Rodallec, Audrey |e investigator |4 oth | |
| 700 | 1 | |a Tourneau, Thierry Le |e investigator |4 oth | |
| 700 | 1 | |a Connault, Jérôme |e investigator |4 oth | |
| 700 | 1 | |a Molina, Jean-Michel |e investigator |4 oth | |
| 700 | 1 | |a Ferret, Samuel |e investigator |4 oth | |
| 700 | 1 | |a Previlon, Miresta |e investigator |4 oth | |
| 700 | 1 | |a Yazdanpanah, Yazdan |e investigator |4 oth | |
| 700 | 1 | |a Landman, Roland |e investigator |4 oth | |
| 700 | 1 | |a Joly, Véronique |e investigator |4 oth | |
| 700 | 1 | |a Pinto, Adriana |e investigator |4 oth | |
| 700 | 1 | |a Katlama, Christine |e investigator |4 oth | |
| 700 | 1 | |a Caby, Fabienne |e investigator |4 oth | |
| 700 | 1 | |a Ktorza, Nadine |e investigator |4 oth | |
| 700 | 1 | |a Schneider, Luminita |e investigator |4 oth | |
| 700 | 1 | |a Stephan, Christoph |e investigator |4 oth | |
| 700 | 1 | |a Wolf, Timo |e investigator |4 oth | |
| 700 | 1 | |a Schüttfort, Gundolf |e investigator |4 oth | |
| 700 | 1 | |a Rockstroh, Juergen |e investigator |4 oth | |
| 700 | 1 | |a Wasmuth, Jan-Christian |e investigator |4 oth | |
| 700 | 1 | |a Schwarze-Zander, Carolynne |e investigator |4 oth | |
| 700 | 1 | |a Boesecke, Christoph |e investigator |4 oth | |
| 700 | 1 | |a Stellbrink, Hans-Jurgen |e investigator |4 oth | |
| 700 | 1 | |a Hoffmann, Christian |e investigator |4 oth | |
| 700 | 1 | |a Sabranski, Michael |e investigator |4 oth | |
| 700 | 1 | |a Esser, Stephan |e investigator |4 oth | |
| 700 | 1 | |a Jablonka, Robert |e investigator |4 oth | |
| 700 | 1 | |a Wiehler, Heidi |e investigator |4 oth | |
| 700 | 1 | |a Behrens, Georg M N |e investigator |4 oth | |
| 700 | 1 | |a Stoll, Matthias |e investigator |4 oth | |
| 700 | 1 | |a Ahrenstorf, Gerrit |e investigator |4 oth | |
| 700 | 1 | |a Guaraldi, Giovanni |e investigator |4 oth | |
| 700 | 1 | |a Nardini, Giulia |e investigator |4 oth | |
| 700 | 1 | |a Beghetto, Barbara |e investigator |4 oth | |
| 700 | 1 | |a Montforte, Antonella D'Arminio |e investigator |4 oth | |
| 700 | 1 | |a Bini, Teresa |e investigator |4 oth | |
| 700 | 1 | |a Cogliandro, Viola |e investigator |4 oth | |
| 700 | 1 | |a Di Pietro, Massimo |e investigator |4 oth | |
| 700 | 1 | |a Fusco, Francesco Maria |e investigator |4 oth | |
| 700 | 1 | |a Galli, Massimo |e investigator |4 oth | |
| 700 | 1 | |a Rusconi, Stefano |e investigator |4 oth | |
| 700 | 1 | |a Giacomelli, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Meraviglia, Paola |e investigator |4 oth | |
| 700 | 1 | |a Martinez, Esteban |e investigator |4 oth | |
| 700 | 1 | |a González-Cordón, Ana |e investigator |4 oth | |
| 700 | 1 | |a Gatell, José Maria |e investigator |4 oth | |
| 700 | 1 | |a Torres, Berta |e investigator |4 oth | |
| 700 | 1 | |a Domingo, Pere |e investigator |4 oth | |
| 700 | 1 | |a Mateo, Gracia |e investigator |4 oth | |
| 700 | 1 | |a Gutierrez, Mar |e investigator |4 oth | |
| 700 | 1 | |a Portilla, Joaquin |e investigator |4 oth | |
| 700 | 1 | |a Merino, Esperanza |e investigator |4 oth | |
| 700 | 1 | |a Reus, Sergio |e investigator |4 oth | |
| 700 | 1 | |a Boix, Vicente |e investigator |4 oth | |
| 700 | 1 | |a Masia, Mar |e investigator |4 oth | |
| 700 | 1 | |a Gutiérrez, Félix |e investigator |4 oth | |
| 700 | 1 | |a Padilla, Sergio |e investigator |4 oth | |
| 700 | 1 | |a Clotet, Bonaventura |e investigator |4 oth | |
| 700 | 1 | |a Negredo, Eugenia |e investigator |4 oth | |
| 700 | 1 | |a Bonjoch, Anna |e investigator |4 oth | |
| 700 | 1 | |a Casado, José L |e investigator |4 oth | |
| 700 | 1 | |a Bañón-Escandell, Sara |e investigator |4 oth | |
| 700 | 1 | |a Saban, Jose |e investigator |4 oth | |
| 700 | 1 | |a Duque, Africa |e investigator |4 oth | |
| 700 | 1 | |a Podzamczer, Daniel |e investigator |4 oth | |
| 700 | 1 | |a Saumoy, Maria |e investigator |4 oth | |
| 700 | 1 | |a Acerete, Laura |e investigator |4 oth | |
| 700 | 1 | |a Gonzalez-Garcia, Juan |e investigator |4 oth | |
| 700 | 1 | |a Bernardino, José Ignacio |e investigator |4 oth | |
| 700 | 1 | |a Arribas, José Ramón |e investigator |4 oth | |
| 700 | 1 | |a Hontañón, Victor |e investigator |4 oth | |
| 700 | 1 | |a Moyle, Graeme |e investigator |4 oth | |
| 700 | 1 | |a Pagani, Nicole |e investigator |4 oth | |
| 700 | 1 | |a Bracchi, Margherita |e investigator |4 oth | |
| 700 | 1 | |a Vera, Jaime |e investigator |4 oth | |
| 700 | 1 | |a Clarke, Amanda |e investigator |4 oth | |
| 700 | 1 | |a Adams, Tanya |e investigator |4 oth | |
| 700 | 1 | |a Richardson, Celia |e investigator |4 oth | |
| 700 | 1 | |a Winston, Alan |e investigator |4 oth | |
| 700 | 1 | |a Mora-Peris, Borja |e investigator |4 oth | |
| 700 | 1 | |a Mullaney, Scott |e investigator |4 oth | |
| 700 | 1 | |a Waters, Laura |e investigator |4 oth | |
| 700 | 1 | |a Esteban, Nahum de |e investigator |4 oth | |
| 700 | 1 | |a Milinkovic, Ana |e investigator |4 oth | |
| 700 | 1 | |a Pett, Sarah |e investigator |4 oth | |
| 700 | 1 | |a Fox, Julie |e investigator |4 oth | |
| 700 | 1 | |a Tiraboschi, Juan Manuel |e investigator |4 oth | |
| 700 | 1 | |a Johnson, Margaret |e investigator |4 oth | |
| 700 | 1 | |a Youle, Mike |e investigator |4 oth | |
| 773 | 0 | 8 | |i Enthalten in |t Clinical infectious diseases : an official publication of the Infectious Diseases Society of America |d 1992 |g 76(2023), 5 vom: 04. März, Seite 861-870 |w (DE-627)NLM012603007 |x 1537-6591 |7 nnns |
| 773 | 1 | 8 | |g volume:76 |g year:2023 |g number:5 |g day:04 |g month:03 |g pages:861-870 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1093/cid/ciac827 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 76 |j 2023 |e 5 |b 04 |c 03 |h 861-870 | ||