201. 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
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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, Wit, Stephane De, Florence, Eric, Esser, Stefan, Raffi, François, Stephan, Christoph, Rockstroh, Juergen, Giacomelli, Andrea, and Vera, Jaime
- Subjects
THERAPEUTIC use of protease inhibitors ,ANTIRETROVIRAL agents ,CARDIOVASCULAR diseases risk factors ,CHOLESTEROL ,CONFIDENCE intervals ,GENERIC drug substitution ,HIV infections ,LIPIDS ,GENETIC mutation ,RNA ,VIRAL load ,RANDOMIZED controlled trials ,TREATMENT effectiveness - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2019
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