Format

Send to

Choose Destination
Clin Infect Dis. 2019 Feb 1;68(4):597-606. doi: 10.1093/cid/ciy505.

Immediate Versus Deferred Switching From a Boosted Protease Inhibitor-based Regimen to a Dolutegravir-based Regimen in Virologically Suppressed Patients With High Cardiovascular Risk or Age ≥50 Years: Final 96-Week Results of the NEAT022 Study.

Author information

1
Hospital Clinic/Institut d'Investigacions Biomediques August Pi i Suñer, University of Barcelona and ViiV Healthcare, Spain.
2
Institut national de la santé et de la recherche médicale (INSERM), Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique, Unite Medical pour la Recherche Scientifique 1136, Paris, France.
3
Chelsea and Westminster Hospital and St Stephens AIDS Trust, London, United Kingdom.
4
Mortimer Market Center, London, United Kingdom.
5
Royal Free Hospital, London, United Kingdom.
6
Hospital de Sant Pau, Barcelona, Spain.
7
Guys and St Thomas` Hospital, London, United Kingdom.
8
Infektionsmedizinisches Study Centrum, Hamburg, Germany.
9
University of Modena and Reggio Emilia, Modena, Italy.
10
Hospital de Elche, Spain.
11
Southmead Hospital, Bristol, United Kingdom.
12
Saint Pierre Hospital, Université Libre de Bruxelles, Brussels.
13
Institute of Tropical Medicine, Antwerp, Belgium.
14
Universitatsklinikum, Essen, Germany.
15
Infectious Diseases University Hospital and Centre d'Investigation Clinique, Unite d'Investigation Clinique 1413 INSERM, Centre Hopitalier Universitaire Nantes, France.
16
Klinikum der Goethe Universitat, Frankfurt.
17
Medizinische Klinik und Poliklinik, Bonn, Germany.
18
Hospital Luigi Sacco, Milan, Italy.
19
Global Health and Infection, Brighton and Sussex Medical School, United Kingdom.
20
Hospital La Paz, Madrid, Spain.
21
St Mary's Hospital, London, United Kingdom.
22
Hospital de Bellvitge, Barcelona, Spain.
23
Hopital St Louis.
24
Pitie-Salpetriere Hospital, Paris, France.

Abstract

Background:

Both immediate and deferred switching from a ritonavir-boosted protease inhibitor (PI/r)-based regimen to a dolutegravir (DTG)-based regimen may improve lipid profile.

Methods:

European Network for AIDS Treatment 022 Study (NEAT022) is a European, open-label, randomized trial. Human immunodeficiency virus (HIV)-infected adults aged ≥50 years or with a Framingham score ≥10% were eligible if HIV RNA was <50 copies/mL. Patients were randomized to switch from PI/r to DTG immediately (DTG-I) or to deferred switch at week 48 (DTG-D). Week 96 endpoints were proportion of patients with HIV RNA <50 copies/mL, percentage change of lipid fractions, and adverse events (AEs).

Results:

Four hundred fifteen patients were randomized: 205 to DTG-I and 210 DTG-D. The primary objective of noninferiority at week 48 was met. At week 96, treatment success rate was 92.2% in the DTG-I arm and 87% in the DTG-D arm (difference, 5.2% [95% confidence interval, -.6% to 11%]). There were 5 virological failures in the DTG-I arm and 5 (1 while on PI/r and 4 after switching to DTG) in the DTG-D arm without selection of resistance mutations. There was no significant difference in terms of grade 3 or 4 AEs or treatment-modifying AEs. Total cholesterol and other lipid fractions (except high-density lipoprotein) significantly (P < .001) improved both after immediate and deferred switching to DTG overall and regardless of baseline PI/r strata.

Conclusions:

Both immediate and deferred switching from a PI/r to a DTG regimen in virologically suppressed HIV-infected patients ≥50 years old or with a Framingham score ≥10% was highly efficacious and well tolerated, and improved the lipid profile.

Clinical Trials Registration:

NCT02098837 and EudraCT: 2013-003704-39.

PMID:
29912307
DOI:
10.1093/cid/ciy505

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center