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
Author:
Waters Laura1, Assoumou Lambert2, González-Cordón Ana34, Rusconi Stefano5, Domingo Pere46, Gompels Mark7, de Wit Stephane8, Raffi François9, Stephan Christoph10, Masiá Mar411, Rockstroh Jürgen12, Katlama Christine13, Behrens Georg M N14, Moyle Graeme15, Johnson Margaret16, Fox Julie17, Stellbrink Hans-Jürgen18, Guaraldi Giovanni19, Florence Eric20, Esser Stefan21, Gatell José M22, Pozniak Anton15, Martínez Esteban34, Vandekerckhove Linos, Caluwé Els, de Wit Stephane, Necsoi Coca, Florence Eric, Frankenhuijsen Maartje Van, Raffi François, Allavena Clotilde, Reliquet Véronique, Boutoille David, Cavellec Morane, André-Garnier Elisabeth, Rodallec Audrey, Tourneau Thierry Le, Connault Jérôme, Molina Jean-Michel, Ferret Samuel, Previlon Miresta, Yazdanpanah Yazdan, Landman Roland, Joly Véronique, Pinto Adriana, Katlama Christine, Caby Fabienne, Ktorza Nadine, Schneider Luminita, Stephan Christoph, Wolf Timo, Schüttfort Gundolf, Rockstroh Juergen, Wasmuth Jan-Christian, Schwarze-Zander Carolynne, Boesecke Christoph, Stellbrink Hans-Jurgen, Hoffmann Christian, Sabranski Michael, Esser Stephan, Jablonka Robert, Wiehler Heidi, Behrens Georg M N, Stoll Matthias, Ahrenstorf Gerrit, Guaraldi Giovanni, Nardini Giulia, Beghetto Barbara, Montforte Antonella D’Arminio, Bini Teresa, Cogliandro Viola, Di Pietro Massimo, Fusco Francesco Maria, Galli Massimo, Rusconi Stefano, Giacomelli Andrea, Meraviglia Paola, Martinez Esteban, González-Cordón Ana, Gatell José Maria, Torres Berta, Domingo Pere, Mateo Gracia, Gutierrez Mar, Portilla Joaquin, Merino Esperanza, Reus Sergio, Boix Vicente, Masia Mar, Gutiérrez Félix, Padilla Sergio, Clotet Bonaventura, Negredo Eugenia, Bonjoch Anna, Casado José L, Bañón-Escandell Sara, Saban Jose, Duque Africa, Podzamczer Daniel, Saumoy Maria, Acerete Laura, Gonzalez-Garcia Juan, Bernardino José Ignacio, Arribas José Ramón, Hontañón Victor, Moyle Graeme, Pagani Nicole, Bracchi Margherita, Vera Jaime, Clarke Amanda, Adams Tanya, Richardson Celia, Winston Alan, Mora-Peris Borja, Mullaney Scott, Waters Laura, Esteban Nahum de, Milinkovic Ana, Pett Sarah, Fox Julie, Tiraboschi Juan Manuel, Johnson Margaret, Youle Mike, Orkin Chloe, Rackstraw Simon, Hand James, Gompels Mark, Jennings Louise, Nicholls Jane, Johnston Sarah,
Affiliation:
1. Mortimer Market Centre, Central and North West London National Health Service (NHS) Foundation Trust , London , United Kingdom 2. Sorbonne Université, Inserm, Institut Pierre Louis d'Épidémiologie et de Santé Publique , Paris , France 3. Hospital Clínic, Consorci Institut D’Investigacions Biomediques August Pi i Sunyer, Universitat de Barcelona 4. Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III , Madrid , Spain 5. Unità Operativa Malattie Infettive, Ospedale Civile di Legnano, Azienda Socio Sanitaria Territoriale Ovest Milanese , Legnano (MI) , Italy 6. Hospital de Sant Pau , Barcelona , Spain 7. North Bristol NHS Trust , Bristol , United Kingdom 8. Centre Hospitalier Universitaire Saint-Pierre , Brussels , Belgium 9. Centre Hospitalier Universitaire , Nantes , France 10. Universitätsklinikum, Goethe-University, Abteilung für Infektionskrankheiten , Frankfurt , Germany 11. Hospital General Universitario de Elche , Spain 12. Universitätsklinikum , Bonn , Germany 13. Hôpital Universitaire Pitié Salpêtrière , Paris , France 14. Medizinische Hochschule , Hannover , Germany 15. Chelsea and Westminster Hospital NHS Foundation Trust 16. Royal Free London NHS Foundation Trust 17. Guy's and St Thomas’ NHS Foundation Trust/King’s College , London , United Kingdom 18. Infektionsmedizinisches Centrum , Hamburg , Germany 19. Università degli Studi di Modena e Reggio Emilia , Modena , Italy 20. Instituut voor Tropische Geneeskunde , Antwerp , Belgium 21. Universitätsklinikum , Essen , Germany 22. ViiV Healthcare , Barcelona , Spain
Abstract
AbstractBackgroundIn 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.MethodsIn 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.ResultsBetween 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.ConclusionsSwitching 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 RegistrationNCT02098837 and EudraCT 2013-003704-39.
Funder
NEAT-ID Foundation Spanish AIDS Research Network
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Microbiology (medical)
Cited by
4 articles.
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