期刊
CLINICAL INFECTIOUS DISEASES
卷 68, 期 4, 页码 597-606出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciy505
关键词
HIV; Dolutegravir; protease inhibitors; lipids; cholesterol
资金
- NEAT-ID Foundation, a not-for-profit private foundation
- St Stephen AIDS Trust
- ViiV Healthcare
- ISCIII-Subdireccion General de Evaluacion
- ERDF
- Plan Nacional I+D+i [RD12/0017]
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.
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