PMID- 29912307 OWN - NLM STAT- MEDLINE DCOM- 20200317 LR - 20220409 IS - 1537-6591 (Electronic) IS - 1058-4838 (Linking) VI - 68 IP - 4 DP - 2019 Feb 1 TI - 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. PG - 597-606 LID - 10.1093/cid/ciy505 [doi] AB - 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. FAU - Gatell, Jose M AU - Gatell JM AD - Hospital Clinic/Institut d'Investigacions Biomediques August Pi i Suner, University of Barcelona and ViiV Healthcare, Spain. FAU - Assoumou, Lambert AU - Assoumou L AD - Institut national de la sante et de la recherche medicale (INSERM), Sorbonne Universite, Institut Pierre Louis d'epidemiologie et de Sante Publique, Unite Medical pour la Recherche Scientifique 1136, Paris, France. FAU - Moyle, Graeme AU - Moyle G AD - Chelsea and Westminster Hospital and St Stephens AIDS Trust, London, United Kingdom. FAU - Waters, Laura AU - Waters L AD - Mortimer Market Center, London, United Kingdom. FAU - Johnson, Margaret AU - Johnson M AD - Royal Free Hospital, London, United Kingdom. FAU - Domingo, Pere AU - Domingo P AD - Hospital de Sant Pau, Barcelona, Spain. FAU - Fox, Julie AU - Fox J AD - Guys and St Thomas; Hospital, London, United Kingdom. FAU - Martinez, Esteban AU - Martinez E AD - Hospital Clinic/Institut d'Investigacions Biomediques August Pi i Suner, University of Barcelona and ViiV Healthcare, Spain. FAU - Stellbrink, Hans-Jurgen AU - Stellbrink HJ AD - Infektionsmedizinisches Study Centrum, Hamburg, Germany. FAU - Guaraldi, Giovanni AU - Guaraldi G AD - University of Modena and Reggio Emilia, Modena, Italy. FAU - Masia, Mar AU - Masia M AD - Hospital de Elche, Spain. FAU - Gompels, Mark AU - Gompels M AD - Southmead Hospital, Bristol, United Kingdom. FAU - De Wit, Stephane AU - De Wit S AD - Saint Pierre Hospital, Universite Libre de Bruxelles, Brussels. FAU - Florence, Eric AU - Florence E AD - Institute of Tropical Medicine, Antwerp, Belgium. FAU - Esser, Stefan AU - Esser S AD - Universitatsklinikum, Essen, Germany. FAU - Raffi, Francois AU - Raffi F AD - Infectious Diseases University Hospital and Centre d'Investigation Clinique, Unite d'Investigation Clinique 1413 INSERM, Centre Hopitalier Universitaire Nantes, France. FAU - Stephan, Christoph AU - Stephan C AD - Klinikum der Goethe Universitat, Frankfurt. FAU - Rockstroh, Juergen AU - Rockstroh J AD - Medizinische Klinik und Poliklinik, Bonn, Germany. FAU - Giacomelli, Andrea AU - Giacomelli A AD - Hospital Luigi Sacco, Milan, Italy. FAU - Vera, Jaime AU - Vera J AD - Global Health and Infection, Brighton and Sussex Medical School, United Kingdom. FAU - Bernardino, Jose Ignacio AU - Bernardino JI AD - Hospital La Paz, Madrid, Spain. FAU - Winston, Alan AU - Winston A AD - St Mary's Hospital, London, United Kingdom. FAU - Saumoy, Maria AU - Saumoy M AD - Hospital de Bellvitge, Barcelona, Spain. FAU - Gras, Julien AU - Gras J AD - Hopital St Louis. FAU - Katlama, Christine AU - Katlama C AD - Pitie-Salpetriere Hospital, Paris, France. FAU - Pozniak, Anton L AU - Pozniak AL AD - Chelsea and Westminster Hospital and St Stephens AIDS Trust, London, United Kingdom. CN - European Network for AIDS Treatment 022 (NEAT022) Study Group LA - eng SI - ClinicalTrials.gov/NCT02098837 SI - EudraCT/2013-003704-39 PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Clin Infect Dis JT - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JID - 9203213 RN - 0 (HIV Integrase Inhibitors) RN - 0 (HIV Protease Inhibitors) RN - 0 (Heterocyclic Compounds, 3-Ring) RN - 0 (Lipids) RN - 0 (Oxazines) RN - 0 (Piperazines) RN - 0 (Pyridones) RN - DKO1W9H7M1 (dolutegravir) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antiretroviral Therapy, Highly Active/*methods MH - Cardiovascular Diseases/prevention & control MH - Drug Substitution/*methods MH - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology MH - Female MH - HIV Infections/*drug therapy MH - HIV Integrase Inhibitors/*administration & dosage/adverse effects MH - HIV Protease Inhibitors/*administration & dosage/adverse effects MH - Heterocyclic Compounds, 3-Ring/*administration & dosage/adverse effects MH - Humans MH - Lipids/*blood MH - Male MH - Middle Aged MH - Oxazines MH - Piperazines MH - Pyridones MH - Treatment Outcome MH - Young Adult FIR - Vandekerckhove, Linos IR - Vandekerckhove L FIR - Caluwe, Els IR - Caluwe E FIR - De Wit, Stephane IR - De Wit S FIR - Necsoi, Coca IR - Necsoi C FIR - Florence, Eric IR - Florence E FIR - Van Frankenhuijsen, Maartje IR - Van Frankenhuijsen M FIR - Raffi, Francois IR - Raffi F FIR - Allavena, Clotilde IR - Allavena C FIR - Reliquet, Veronique IR - Reliquet V FIR - Cavellec, Morane IR - Cavellec M FIR - Rodallec, Audrey IR - Rodallec A FIR - Le Tourneau, Thierry IR - Le Tourneau T FIR - Connault, Jerome IR - Connault J FIR - Molina, Jean-Michel IR - Molina JM FIR - Ferret, Samuel IR - Ferret S FIR - Previlon, Miresta IR - Previlon M FIR - Yazdanpanah, Yazdan IR - Yazdanpanah Y FIR - Landman, Roland IR - Landman R FIR - Joly, Veronique IR - Joly V FIR - Martinez, Adriana Pinto IR - Martinez AP FIR - Katlama, Christine IR - Katlama C FIR - Caby, Fabienne IR - Caby F FIR - Ktorza, Nadine IR - Ktorza N FIR - Schneider, Luminita IR - Schneider L FIR - Stephan, Christoph IR - Stephan C FIR - Wolf, Timo IR - Wolf T FIR - Schuttfort, Gundolf IR - Schuttfort G FIR - Rockstroh, Juergen IR - Rockstroh J FIR - Wasmuth, Jan-Christian IR - Wasmuth JC FIR - Schwarze-Zander, Carolynne IR - Schwarze-Zander C FIR - Boesecke, Christoph IR - Boesecke C FIR - Stellbrink, Hans-Jurgen IR - Stellbrink HJ FIR - Hoffmann, Christian IR - Hoffmann C FIR - Sabranski, Michael IR - Sabranski M FIR - Esser, Stephan IR - Esser S FIR - Jablonka, Robert IR - Jablonka R FIR - Wiehler, Heidi IR - Wiehler H FIR - Behrens, Georg IR - Behrens G FIR - Stoll, Matthias IR - Stoll M FIR - Ahrenstorf, Gerrit IR - Ahrenstorf G FIR - Guaraldi, Giovanni IR - Guaraldi G FIR - Nardini, Giulia IR - Nardini G FIR - Beghetto, Barbara IR - Beghetto B FIR - Montforte, Antonella D'Arminio IR - Montforte AD FIR - Bini, Teresa IR - Bini T FIR - Cogliandro, Viola IR - Cogliandro V FIR - Di Pietro, Massimo IR - Di Pietro M FIR - Fusco, Francesco Maria IR - Fusco FM FIR - Galli, Massimo IR - Galli M FIR - Rusconi, Stefano IR - Rusconi S FIR - Giacomelli, Andrea IR - Giacomelli A FIR - Meraviglia, Paola IR - Meraviglia P FIR - Martinez, Esteban IR - Martinez E FIR - Gonzalez-Cordon, Ana IR - Gonzalez-Cordon A FIR - Torres, Berta IR - Torres B FIR - Domingo, Pere IR - Domingo P FIR - Mateo, Gracia IR - Mateo G FIR - Gutierrez, Mar IR - Gutierrez M FIR - Portillo, Joaquin IR - Portillo J FIR - Merino, Esperanza IR - Merino E FIR - Reus, Sergio IR - Reus S FIR - Boix, Vicente IR - Boix V FIR - Masia, Mar IR - Masia M FIR - Gutierrez, Felix IR - Gutierrez F FIR - Padilla, Sergio IR - Padilla S FIR - Clotet, Bonaventura IR - Clotet B FIR - Negredo, Eugenia IR - Negredo E FIR - Bonjoch, Anna IR - Bonjoch A FIR - Casado, Jose L IR - Casado JL FIR - Banon-Escandell, Sara IR - Banon-Escandell S FIR - Saban, Jose IR - Saban J FIR - Duque, Africa IR - Duque A FIR - Podzamczer, Daniel IR - Podzamczer D FIR - Saumoy, Maria IR - Saumoy M FIR - Acerete, Laura IR - Acerete L FIR - Gonzalez-Garcia, Juan IR - Gonzalez-Garcia J FIR - Bernardino, Jose Ignacio IR - Bernardino JI FIR - Arribas, Jose Ramon IR - Arribas JR FIR - Hontanon, Victor IR - Hontanon V FIR - Moyle, Graeme IR - Moyle G FIR - Pagani, Nicole IR - Pagani N FIR - Bracchi, Margherita IR - Bracchi M FIR - Vera, Jaime IR - Vera J FIR - Clarke, Amanda IR - Clarke A FIR - Adams, Tanya IR - Adams T FIR - Richardson, Celia IR - Richardson C FIR - Winston, Alan IR - Winston A FIR - Mora-Peris, Borja IR - Mora-Peris B FIR - Mullaney, Scott IR - Mullaney S FIR - Waters, Laura IR - Waters L FIR - de Esteban, Nahum IR - de Esteban N FIR - Milinkovic, Ana IR - Milinkovic A FIR - Pett, Sarah IR - Pett S FIR - Fox, Julie IR - Fox J FIR - Tiraboschi, Juan Manuel IR - Tiraboschi JM FIR - Johnson, Margaret IR - Johnson M FIR - Youle, Mike IR - Youle M FIR - Orkin, Chloe IR - Orkin C FIR - Rackstraw, Simon IR - Rackstraw S FIR - Hand, James IR - Hand J FIR - Gompels, Mark IR - Gompels M FIR - Jennings, Louise IR - Jennings L FIR - Nicholls, Jane IR - Nicholls J FIR - Johnston, Sarah IR - Johnston S EDAT- 2018/06/19 06:00 MHDA- 2020/03/18 06:00 CRDT- 2018/06/19 06:00 PHST- 2018/04/08 00:00 [received] PHST- 2018/06/12 00:00 [accepted] PHST- 2018/06/19 06:00 [pubmed] PHST- 2020/03/18 06:00 [medline] PHST- 2018/06/19 06:00 [entrez] AID - 5038116 [pii] AID - 10.1093/cid/ciy505 [doi] PST - ppublish SO - Clin Infect Dis. 2019 Feb 1;68(4):597-606. doi: 10.1093/cid/ciy505.