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
Por:
Gatell, JM, Assoumou, L, Stellbrink, HJ, Esser, S, Gras, J, Pozniak, AL, Vandekerckhove, L, Caluwe, E, De Wit, S, Necsoi, C, Florence, E, Van Frankenhuijsen, M, Raffi, F, Allavena, C, Reliquet, V, Cavellec, M, Rodallec, A, Le Tourneau, T, Connault, J, Molina, JM, Ferret, S, Previlon, M, Yazdanpanah, Y, Landman, R, Joly, V, Martinez, AP, Katlama, C, Caby, F, Ktorza, N, Schneider, L, Stephan, C, Wolf, T, Schuttfort, G, Rockstroh, J, Wasmuth, JC, Schwarze-Zander, C, Boesecke, C, Stellbrink, HJ, Hoffmann, C, Sabranski, M, Esser, S, Jablonka, R, Wiehler, H, Behrens, G, Stoll, M, Ahrenstorf, G, Guaraldi, G, Nardini, G, Beghetto, B, Montforte, AD, Bini, T, Cogliandro, V, Di Pietro, M, Fusco, FM, Galli, M, Rusconi, S, Giacomelli, A, Meraviglia, P, Martinez, E, Gonzalez-Cordon, A, Torres, B, Domingo, P, Mateo, G, Gutierrez, M, Portillo, J, Merino, E, Reus, S, Boix, V, Masia, M, Gutierrez, F, Padilla, S, Clotet, B, Negredo, E, Bonjoch, A, Casado, JL, Banon-Escandell, S, Saban, J, Duque, A, Podzamczer, D, Saumoy, M, Acerete, L, Gonzalez-Garcia, J, Bernardino, JI, Arribas, JR, Hontanon, V, Moyle, G, Pagani, N, Bracchi, M, Vera, J, Clarke, A, Adams, T, Richardson, C, Winston, A, Mora-Peris, B, Mullaney, S, Waters, L, de Esteban, N, Milinkovic, A, Pett, S, Fox, J, Tiraboschi, JM, Johnson, M, Youle, M, Orkin, C, Rackstraw, S, Hand, J, Gompels, M, Jennings, L, Nicholls, J, Johnston, S, European Network AIDS Treatment
Publicada:
15 feb 2019
Resumen:
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.
Filiaciones:
Gatell, JM:
Univ Barcelona, Hosp Clin, Inst Invest Biomed August Pi & Suner, Barcelona, Spain
ViiV Healthcare, Tres Cantos, Spain
Assoumou, L:
Sorbonne Univ, INSERM, Inst Pierre Louis Epidemiol & Sante Publ, Unite Med Rech Sci 1136, Paris, France
Stellbrink, HJ:
Infekt Med Study Ctr, Hamburg, Germany
Esser, S:
Univ Klinikum, Essen, Germany
Gras, J:
Hop St Louis, Paris, France
Pozniak, AL:
Chelsea & Westminster Hosp, London, England
St Stephens AIDS Trust, London, England
De Wit, S:
Univ Libre Bruxelles, St Pierre Hosp, Brussels, Belgium
Florence, E:
Inst Trop Med, Antwerp, Belgium
Raffi, F:
Univ Hosp, Infect Dis, Nantes, France
Ctr Hop Univ Nantes, Ctr Invest Clin, Unite Invest Clin INSERM 1413, Nantes, France
Katlama, C:
Hop La Pitie Salpetriere, Paris, France
Stephan, C:
Klinikum Goethe Univ, Frankfurt, Germany
Rockstroh, J:
Med Klin & Poliklin, Bonn, Germany
Esser, S:
Univ Klinikum, Essen, Germany
Guaraldi, G:
Univ Modena & Reggio Emilia, Modena, Italy
Giacomelli, A:
Hosp Luigi Sacco, Milan, Italy
Martinez, E:
Univ Barcelona, Hosp Clin, Inst Invest Biomed August Pi & Suner, Barcelona, Spain
ViiV Healthcare, Tres Cantos, Spain
Domingo, P:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Masia, M:
Hosp Elche, Alicante, Spain
Saumoy, M:
Hosp Bellvitge Princeps Espanya, Barcelona, Spain
Bernardino, JI:
Hosp La Paz, Madrid, Spain
Moyle, G:
Chelsea & Westminster Hosp, London, England
St Stephens AIDS Trust, London, England
Vera, J:
Brighton & Sussex Med Sch, Global Hlth & Infect, Brighton, E Sussex, England
Winston, A:
St Marys Hosp, London, England
Waters, L:
Mortimer Market Ctr, London, England
Fox, J:
Guys & St Thomas Hosp, London, England
Johnson, M:
Royal Free Hosp, London, England
Gompels, M:
Southmead Hosp, Bristol, Avon, England
Green Accepted
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