Neat96Accepted.pdf (914.6 kB)
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
journal contribution
posted on 2023-06-09, 13:53 authored by José M Gatell, Lambert Assoumou, Graeme Moyle, Laura Waters, Margaret Johnson, Pere Domingo, Julie Fox, Esteban Martinez, Hans – Jürgen Stellbrink, Giovanni Guaraldi, Mar Masia, Mark Gompels, Stephane De Wit, Eric Florence, Stefan Esser, François Raffi, Christoph Stephan, Juergen Rockstroh, Andrea Giacomelli, Jaime Vera RojasJaime Vera Rojas, José Ignacio Bernardino, Alan Winston, Maria Saumoy, Julien Gras, Christine Katlama, Anton L PozniakBackground 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.
History
Publication status
- Published
File Version
- Accepted version
Journal
Clinical Infectious DiseasesISSN
1058-4838Publisher
Oxford University PressExternal DOI
Issue
4Volume
68Department affiliated with
- Global Health and Infection Publications
Full text available
- Yes
Peer reviewed?
- Yes
Legacy Posted Date
2018-06-22First Open Access (FOA) Date
2019-06-14First Compliant Deposit (FCD) Date
2018-06-21Usage metrics
Categories
No categories selectedKeywords
Licence
Exports
RefWorks
BibTeX
Ref. manager
Endnote
DataCite
NLM
DC