Switching from boosted PIs to dolutegravir in HIV-infected patients with high cardiovascular risk: 48 week effects on subclinical cardiovascular disease.
Journal
The Journal of antimicrobial chemotherapy
ISSN: 1460-2091
Titre abrégé: J Antimicrob Chemother
Pays: England
ID NLM: 7513617
Informations de publication
Date de publication:
01 11 2020
01 11 2020
Historique:
received:
29
04
2020
accepted:
02
06
2020
pubmed:
2
8
2020
medline:
25
6
2021
entrez:
2
8
2020
Statut:
ppublish
Résumé
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. NEAT022 is a European, multicentre, open-label, randomized, non-inferiority trial. HIV-infected adults aged >50 years or with a Framingham score >10% were eligible if plasma HIV RNA was <50 copies/mL for >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. 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. 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.
Sections du résumé
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 >50 years or with a Framingham score >10% were eligible if plasma HIV RNA was <50 copies/mL for >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.
Identifiants
pubmed: 32737482
pii: 5879495
doi: 10.1093/jac/dkaa292
doi:
Substances chimiques
Anti-HIV Agents
0
Heterocyclic Compounds, 3-Ring
0
Oxazines
0
Piperazines
0
Pyridones
0
dolutegravir
DKO1W9H7M1
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
3334-3343Investigateurs
Linos Vandekerckhove
(L)
Els Caluwé
(E)
Stephane De Wit
(S)
Coca Necsoi
(C)
Eric Florence
(E)
Maartje Van Frankenhuijsen
(M)
François Raffi
(F)
Clotilde Allavena
(C)
Véronique Reliquet
(V)
David Boutoille
(D)
Morane Cavellec
(M)
Elisabeth André-Garnier
(E)
Audrey Rodallec
(A)
Thierry Le Tourneau
(T)
Jérôme Connault
(J)
Jean-Michel Molina
(JM)
Samuel Ferret
(S)
Miresta Previlon
(M)
Yazdan Yazdanpanah
(Y)
Roland Landman
(R)
Véronique Joly
(V)
Adriana Pinto Martinez
(AP)
Christine Katlama
(C)
Fabienne Caby
(F)
Nadine Ktorza
(N)
Luminita Schneider
(L)
Christoph Stephan
(C)
Timo Wolf
(T)
Gundolf Schüttfort
(G)
Juergen Rockstroh
(J)
Jan-Christian Wasmuth
(JC)
Carolynne Schwarze-Zander
(C)
Christoph Boesecke
(C)
Hans-Jurgen Stellbrink
(HJ)
Christian Hoffmann
(C)
Michael Sabranski
(M)
Stephan Esser
(S)
Robert Jablonka
(R)
Heidi Wiehler
(H)
Georg Behrens
(G)
Matthias Stoll
(M)
Gerrit Ahrenstorf
(G)
Giovanni Guaraldi
(G)
Giulia Nardini
(G)
Barbara Beghetto
(B)
Antonella D'Arminio Montforte
(AD)
Teresa Bini
(T)
Viola Cogliandro
(V)
Massimo Di Pietro
(M)
Francesco Maria Fusco
(FM)
Massimo Galli
(M)
Stefano Rusconi
(S)
Andrea Giacomelli
(A)
Paola Meraviglia
(P)
Esteban Martinez
(E)
Ana González-Cordón
(A)
José Maria Gatell
(JM)
Berta Torres
(B)
Pere Domingo
(P)
Gracia Mateo
(G)
Mar Gutierrez
(M)
Joaquin Portillo
(J)
Esperanza Merino
(E)
Sergio Reus
(S)
Vicente Boix
(V)
Mar Masia
(M)
Félix Gutiérrez
(F)
Sergio Padilla
(S)
Bonaventura Clotet
(B)
Eugenia Negredo
(E)
Anna Bonjoch
(A)
José L Casado
(JL)
Sara Bañón-Escandell
(S)
Jose Saban
(J)
Africa Duque
(A)
Daniel Podzamczer
(D)
Maria Saumoy
(M)
Laura Acerete
(L)
Juan Gonzalez-Garcia
(J)
José Ignacio Bernardino
(J)
José Ramón Arribas
(J)
Victor Hontañón
(V)
Graeme Moyle
(G)
Nicole Pagani
(N)
Margherita Bracchi
(M)
Jaime Vera
(J)
Amanda Clarke
(A)
Tanya Adams
(T)
Celia Richardson
(C)
Alan Winston
(A)
Borja Mora-Peris
(B)
Scott Mullaney
(S)
Laura Waters
(L)
Nahum de Esteban
(N)
Ana Milinkovic
(A)
Sarah Pett
(S)
Julie Fox
(J)
Juan Manuel Tiraboschi
(JM)
Margaret Johnson
(M)
Mike Youle
(M)
Chloe Orkin
(C)
Simon Rackstraw
(S)
James Hand
(J)
Mark Gompels
(M)
Louise Jennings
(L)
Jane Nicholls
(J)
Sarah Johnston
(S)
Informations de copyright
© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For permissions, please email: journals.permissions@oup.com.