Differential body composition effects of protease inhibitors recommended for initial treatment of HIV infection: A randomized clinical trial
Author
Martinez, Esteban; Gonzalez-Cordon, Ana; Ferrer, Elena; Domingo, Pere; Negredo, Eugenia; Gutierrez, Felix; Portilla, Joaquin; Curran, Adrià; Podzamczer, Daniel; Ribera, Esteban; Murillas, Javier; Bernardino, Jose I.; Santos Gil, Ignacio de los; Carton, Jose A.; Peraire, Joaquim; Pich, Judit; Deulofeu, Ramon; Pérez, Ignacio; Gatell, Jose M.; Arnaiz, Juan A.; Beleta, Helena; Garcia, David; Pejenaute, Andrea; Ramos, Nuria; Arcaina, P.; Giner, L.; Moya, S.; Pampliega, M.; Portilla, J.; Barrera, G.; Podzamczer, Daniel; Rozas, N.; Saumoy, M.; Ferrer, E.; Asensi, V.; Cartón, J. A.; Gatell, J. M.; González-Cordón, A.; Pérez, I.; Martínez, E.; Masiá, M.; Padilla, S.; Ramos, J. R.; Robledano, C.; Gutiérrez, F.; Puig, J.; Negredo, E.; Arribas López, José Ramón; Castro, J. M.; Bernardino, J. I.; Sanz, J.; Santos, I.; Cairó, M.; Velli, P.; Dalmau, D.; Lamas, A.; Martí-Belda, P.; Dronda, F.; Blanco, J. R.; Gutierrez, M.; Mateo, M. G.; Domingo, P.; Losada, E.; Prieto, A.; Antela, A.; Murillas, J.; Aguilar, A.; Peraire, J.; Vargas, M.; Viladés, C.; Vidal, F.; Crespo, M.; Curran, A.; Ribera, Esteban; Arnaiz, J. A.; Beleta, H.; Garcia, D.; Pejenaute, Andrea; Ramos, Nuria; Pich, J.Entity
UAM. Departamento de MedicinaPublisher
Oxford University PressDate
2015-01-01Citation
10.1093/cid/ciu898
Clinical Infectious Diseases 60.5 (2015): 811-820
ISSN
1058-4838 (print); 1537-6591 (on line)DOI
10.1093/cid/ciu898Funded by
This is an Investigator Sponsored Research study. It was supported in part by research grants from Bristol‐Myers Squibb and Janssen‐Cilag; Instituto de Salud Carlos III (PI12/01217) and Red Temática Cooperativa de Investigación en SIDA G03/173 (RIS‐EST11), Ministerio de Ciencia e Innovación, Spain. (Registration number: NCT01274780; registry name: ATADAR; EUDRACT; 2010‐021002‐38).Project
Gobierno de España. NCT01274780Editor's Version
http://dx.doi.org/10.1093/cid/ciu898Subjects
Antiretroviral therapy; MedicinaNote
This article has been accepted for publication in Clinical Infectious Diseases ©2014 The Authors .Published by Oxford University Press on Clinical Infectious Disease 60.5. DOI: 10.1093/cid/ciu898Rights
© The Author 2014Abstract
Background. It is unclear whether metabolic or body composition effects may differ between protease inhibitor-based regimens recommended for initial treatment of HIV infection.
Methods. ATADAR is a phase IV, open-label, multicenter randomized clinical trial. Stable antiretroviral-naive HIV-infected adults were randomly assigned to atazanavir/ritonavir 300/100 mg or darunavir/ritonavir 800/100 mg in combination with tenofovir/emtricitabine daily. Pre-defined end-points were treatment or virological failure, drug discontinuation due to adverse effects, and laboratory and body composition changes at 96 weeks.
Results. At 96 weeks, 56 (62%) atazanavir/ritonavir and 62 (71%) darunavir/ritonavir patients remained free of treatment failure (estimated difference 8.2%; 95%CI -0.6 to 21.6); and 71 (79%) atazanavir/ritonavir and 75 (85%) darunavir/ritonavir patients remained free of virological failure (estimated difference 6.3%; 95%CI -0.5 to 17.6). Seven vs. five patients discontinued atazanavir/ritonavir or darunavir/ritonavir due to adverse effects. Total and HDL cholesterol similarly increased in both arms, but triglycerides increased more in atazanavir/ritonavir arm. At 96 weeks, body fat (estimated difference 2862.2 gr; 95%CI 726.7 to 4997.7; P=0.0090), limb fat (estimated difference 1403.3 gr; 95%CI 388.4 to 2418.2; P=0.0071), and subcutaneous abdominal adipose tissue (estimated difference 28.4 cm2; 95%CI 1.9 to 55.0; P=0.0362) increased more in atazanavir/ritonavir than in darunavir/ritonavir arm. Body fat changes in atazanavir/ritonavir arm were associated with higher insulin resistance.
Conclusions. We found no major differences between atazanavir/ritonavir and darunavir/ritonavir in efficacy, clinically-relevant side effects, or plasma cholesterol fractions. However, atazanavir/ritonavir led to higher triglycerides and total and subcutaneous fat than darunavir/ritonavir and fat gains with atazanavir/ritonavir were associated with insulin resistance
Files in this item
Google Scholar:Martinez, Esteban
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Gonzalez-Cordon, Ana
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Ferrer, Elena
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Domingo, Pere
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Negredo, Eugenia
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Gutierrez, Felix
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Portilla, Joaquin
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Curran, Adrià
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Podzamczer, Daniel
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Ribera, Esteban
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Murillas, Javier
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Bernardino, Jose I.
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Santos Gil, Ignacio de los
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Carton, Jose A.
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Peraire, Joaquim
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Pich, Judit
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Deulofeu, Ramon
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Pérez, Ignacio
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Gatell, Jose M.
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Arnaiz, Juan A.
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Beleta, Helena
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Garcia, David
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Pejenaute, Andrea
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Ramos, Nuria
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Arcaina, P.
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Giner, L.
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Moya, S.
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Pampliega, M.
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Portilla, J.
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Barrera, G.
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Podzamczer, Daniel
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Rozas, N.
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Saumoy, M.
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Ferrer, E.
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Asensi, V.
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Cartón, J. A.
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Gatell, J. M.
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González-Cordón, A.
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Pérez, I.
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Martínez, E.
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Masiá, M.
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Padilla, S.
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Ramos, J. R.
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Robledano, C.
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Gutiérrez, F.
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Puig, J.
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Negredo, E.
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Arribas López, José Ramón
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Castro, J. M.
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Bernardino, J. I.
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Sanz, J.
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Santos, I.
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Cairó, M.
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Velli, P.
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Dalmau, D.
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Lamas, A.
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Martí-Belda, P.
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Dronda, F.
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Blanco, J. R.
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Gutierrez, M.
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Mateo, M. G.
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Domingo, P.
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Losada, E.
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Prieto, A.
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Antela, A.
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Murillas, J.
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Aguilar, A.
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Peraire, J.
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Vargas, M.
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Viladés, C.
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Vidal, F.
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Crespo, M.
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Curran, A.
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Ribera, Esteban
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Arnaiz, J. A.
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Beleta, H.
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Garcia, D.
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Pejenaute, Andrea
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Ramos, Nuria
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Pich, J.
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