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
Authors: Waters Laura , Assoumou Lambert , González-Cordón Ana , Rusconi Stefano , Domingo Pere , Gompels Mark , de Wit Stephane , Raffi François , Stephan Christoph , Masiá Mar , Rockstroh Jürgen , Katlama Christine , Behrens Georg M N , Moyle Graeme , Johnson Margaret , Fox Julie , Stellbrink Hans-Jürgen , Guaraldi Giovanni , Florence Eric , Esser Stefan , Gatell José M , Pozniak Anton , Martínez Esteban ,   for the NEAT 022 Study Group, 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 
Published: October 2022

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 &lt;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.