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.
Clin Infect Dis
; 68(4): 597-606, 2019 02 01.
Article
in En
| MEDLINE
| ID: mdl-29912307
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
HIV Infections
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HIV Protease Inhibitors
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HIV Integrase Inhibitors
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Antiretroviral Therapy, Highly Active
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Drug Substitution
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Heterocyclic Compounds, 3-Ring
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Lipids
Type of study:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Limits:
Adolescent
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Adult
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Aged
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Aged80
/
Female
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
Clin Infect Dis
Journal subject:
DOENCAS TRANSMISSIVEIS
Year:
2019
Document type:
Article
Affiliation country:
Spain