Immediate vs. deferred switching from a boosted protease inhibitor (PI/r) based regimen to a Dolutegravir (DTG) based regimen in virologically suppressed patients with high cardiovascular risk or Age ≥50 years: final 96 weeks results of NEAT 022 study

Gatell, José M, Assoumou, Lambert, Moyle, Graeme, Waters, Laura, Johnson, Margaret, Domingo, Pere, Fox, Julie, Martinez, Esteban, Stellbrink, Hans – Jürgen, Guaraldi, Giovanni, Masia, Mar, Gompels, Mark, De Wit, Stephane, Florence, Eric, Esser, Stefan, Raffi, François, Stephan, Christoph, Rockstroh, Juergen, Giacomelli, Andrea, Vera, Jaime, Bernardino, José Ignacio, Winston, Alan, Saumoy, Maria, Gras, Julien, Katlama, Christine and Pozniak, Anton L (2019) Immediate vs. deferred switching from a boosted protease inhibitor (PI/r) based regimen to a Dolutegravir (DTG) based regimen in virologically suppressed patients with high cardiovascular risk or Age ≥50 years: final 96 weeks results of NEAT 022 study. Clinical Infectious Diseases, 68 (4). ISSN 1058-4838

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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.

Item Type: Article
Schools and Departments: Brighton and Sussex Medical School > Global Health and Infection
Subjects: R Medicine
Depositing User: Jaime Vera Rojas
Date Deposited: 22 Jun 2018 10:33
Last Modified: 01 Jul 2019 12:31
URI: http://sro.sussex.ac.uk/id/eprint/76672

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