Switching from boosted PIs to dolutegravir in HIV-infected patients with high cardiovascular risk: 48 week effects on subclinical cardiovascular disease
Authors: Gonzalez-Cordon Ana , Assoumou Lambert , Camafort Miguel , Domenech Monica , Guaraldi Giovanni , Domingo Pere , Rusconi Stefano , Raffi François , Katlama Christine , Masia Mar , Bernardino Jose I , Saumoy Maria , Pozniak Anton , Gatell Jose M , Martinez Esteban ,   the NEAT022 Study Group, Vandekerckhove Linos , Caluwé Els , De Wit Stephane , Necsoi Coca , Florence Eric , Van Frankenhuijsen Maartje , Raffi François , Allavena Clotilde , Reliquet Véronique , Boutoille David , Cavellec Morane , André-Garnier Elisabeth , Rodallec Audrey , Le Tourneau Thierry , Connault Jérôme , Molina Jean-Michel , Ferret Samuel , Previlon Miresta , Yazdanpanah Yazdan , Landman Roland , Joly Véronique , Martinez Adriana Pinto , 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 , 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 , Portillo 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 , Ignacio Bernardino José , Ramón Arribas José , 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 , de Esteban Nahum , 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 , Vandekerckhove Linos , Caluwé Els , De Wit Stephane , Necsoi Coca , Florence Eric , Van Frankenhuijsen Maartje , Raffi François , Allavena Clotilde , Reliquet Véronique , Boutoille David , Cavellec Morane , André-Garnier Elisabeth , Rodallec Audrey , Le Tourneau Thierry , Connault Jérôme , Molina Jean-Michel , Ferret Samuel , Previlon Miresta , Yazdanpanah Yazdan , Landman Roland , Joly Véronique , Martinez Adriana Pinto , 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 , 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 , Portillo 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 , Ignacio Bernardino José , Ramón Arribas José , 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 , de Esteban Nahum , 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: June 2020

Abstract

Background
Switching from boosted PIs to dolutegravir in virologically suppressed HIV-infected patients with high cardiovascular risk significantly decreased total cholesterol and other proatherogenic lipid fractions at 48 weeks. The impact of this strategy on subclinical cardiovascular disease is unknown.

Methods
NEAT022 is a European, multicentre, open-label, randomized, non-inferiority trial. HIV-infected adults aged &gt;50 years or with a Framingham score &gt;10% were eligible if plasma HIV RNA was &lt;50 copies/mL for &gt;24 weeks on a boosted PI-based regimen. Patients were randomized 1:1 to switch from boosted PIs to dolutegravir or to continue on boosted PIs. Common carotid arteries intima–media thickness (CIMT) and pulse wave velocity (PWV) were measured following a standardized protocol in a subgroup of NEAT022 study participants at baseline and at Week 48.

Results
One hundred and fifty-six patients participated in the ultrasonography and arterial stiffness substudies, respectively. In each substudy, population characteristics did not differ between arms and matched those of the main study. At 48 weeks, patients who switched to dolutegravir had lower mean progression of both right (+4 versus +14.6 μm) and left (−6.1 versus +1.6 μm) CIMT and also a smaller increase in mean PWV (+0.18 versus +0.39 m/s) than patients continuing on boosted PIs, although differences were not statistically significant. CIMT trends were consistent across Framingham score, age and country. Inconsistent effects were seen in arterial stiffness.

Conclusions
Relative to continuing on boosted PIs, switching to dolutegravir in virologically suppressed patients with high cardiovascular risk showed consistent favourable although non-significant trends on CIMT progression at 48 weeks.