Ερευνητικό υλικό ΕΚΠΑ

Patient-Reported Outcomes in First-Line Antiretroviral Therapy: Results
From NEAT001/ANRS143 Trial Comparing Darunavir/Ritonavir in Combination
With Tenofovir/Emtricitabine or Raltegravir

Αγγλικά

Background: There are few data comparing patient-reported outcomes
(PROs) in randomized trials of initial antiretroviral therapy. We
present results from a substudy of the NEAT001/ ANRS143 trial.
Methods: The randomized trial compared first-line DRV/r 800/100 mg once
daily plus RAL 400 mg twice daily and DRV/r plus TDF/ FTC 245/200 mg
once daily. Changes in PROs were assessed with 3 questionnaires: EuroQoL
5 domains (EQ-5D), Center for Epidemiologic Studies Depression (CES-D)
scale, and HIV Treatment Satisfaction Questionnaire. Major depressive
disorder (MDD) was defined as CES-D $ 16. General estimating equations
were used to model change over 96 weeks in PROs from baseline.
Results: Of the 805 participants, 797 (99%) contributed to the
substudy. Baseline PRO data were similar for the 2 randomized groups.
Health status improved over time with a mean increase in EQ-5D visual
analogue scale (VAS) of 8.0 by W96 [95% confidence interval (CI): 6.5
to 9.4; P, 0.001], and no statistically significant differences between
groups (difference of 0.3 on VAS score (95% CI: 21.7 to 2.3); P = 0.7,
global P value $ 0.05 for all domains over follow-up). There was no
significant difference between groups on CES-D [difference of 20.1
(95% CI: 21.3 to 1.1); P = 0.9], or MDD during follow-up, adjusted for
baseline MDD (odds ratio = 0.98, 95% CI: 0.82 to 1.18; P = 0.9). RAL +
DRV/r group had lower level of convenience (P = 0.03) and fitted less
well into patients’ lifestyle (P = 0.007) than the TDF/FTC + DRV/r
regimen, and was associated with lower treatment satisfaction [median
score: 53 RAL + DRV/r vs 55 TDF/FTC + DRV/r (P = 0.001)].
Conclusion: PROs improved after starting antiretroviral therapy, with no
statistically significant difference between groups. The lower
satisfaction with RAL + DRV/r may be explained by twicedaily
administration.

2018

George, Elizabeth C.
Bucciardini, Raffaella
Richert, Laura and
Dedes, Nikos
Fragola, Vincenzo
Nieuwkerk, Pythia
Spire,
Bruno
Volny-Anne, Alain
West, Brian
Molina, Jean-Michel and
Horban, Andrzej
Fox, Julie
Pozniak, Anton
Vella, Stefano and
Termote, Monique
Raffi, Francois
Chene, Genevieve
Allavena,
Clotilde
Autran, Brigitte
Antinori, Andrea
Arribas, Jose and
Babiker, Abdel G.
Boffito, Marta
Pillay, Deenan
Franquet,
Xavier
Schwarze, Siegfried
Grarup, Jesper
Fischer, Aurelie
and Wallet, Cedrick
Diallo, Alpha
Saillard, Juliette and
Moecklinghoff, Christiane
Stellbrink, Hans-Jurgen
Van Leeuwen,
Remko
Gatell, Jose
Sandstrom, Eric
Flepp, Markus and
Babiker, Abdel G.
Ewings, Fiona
Hudson, Fleur
Pearce,
Gillian
Quercia, Romina
Rogatto, Felipe
Leavitt, Randi and
Nguyen, Bach-Yen
Allavena, Clotilde
Arnault, Fabien
Fischer,
Aurelie
Paniego, Virginie
Schwimmer, Christine
Touzeau,
Guillaume
Wallet, Cedrick
Boucherie, Celine
Jean, Delphine
and Paraina, Felasoa
Rouch, Elodie
Soussi, Malika
Taieb,
Audrey
Babiker, Abdel G.
Ewings, Fiona
Dodds, Wendy and
Hudson, Fleur
Cursley, Adam
Hoppe, Anne
Kummeling, Ischa and
Pacciarini, Filippo
Paton, Nick
Russell, Charlotte
Taylor,
Kay
Ward, Denise
Gey, Daniela
Jansson, Per O.
Jensen,
Karoline
Pearson, Mary
Nielsen, Birgit Riis
Aagaard, Bitten
and Eid, Marius
Jensen, Birgitte Gram
Jakobsen, Marie-Louise and
Joensen, Zillah Maria
Larsen, Ellen Moseholm
Pahl, Christiane
and Reilev, Soren Stentoft
Lathouwers, Desiree
Manting, Corry
and Van Leeuwen, Remko
Christ, Ilse
Diallo, Alpha
Mendy,
Bienvenu Yves
Metro, Annie
Saillard, Juliette and
Couffin-Cadiergues, Sandrine
Palmisiano, Lucia
Knellwolf,
Anne-Laure
Aznar, Esther
Barea, Cristina
Cotarelo, Manuel
and Esteban, Herminia
Girbau, Iciar
Moyano, Beatriz
Ramirez,
Miriam
Saiz, Carmen
Sanchez, Isabel
Yllescas, Maria and
Binelli, Andrea
Colasanti, Valentina
Massella, Maurizio and
Palmisiano, Lucia
Anagnostou, Olga
Gioukari, Vicky
Touloumi,
Giota
Schmied, Brigitte
Rieger, Armin
Vetter, Norbert
De
Wit, Stephane
Florence, Eric
Vandekerckhove, Linos
Gerstoft,
Jan
Mathiesen, Lars
Katlama, Christine
Cabie, Andre and
Cheret, Antoine
Dupon, Michel
Ghosn, Jade
Girard,
Pierre-Marie
Goujard, Cecile
Levy, Yves
Morlat, J. -M. M.
Philippe
Neau, Didier
Obadia, Martine
Perre, Philippe and
Piroth, Lionel
Reynes, Jacques
Tattevin, Pierre
Ragnaud,
Jean Marie
Weiss, Laurence
Yazdanpanah, Yazdan
Yeni, Patrick
and Zucman, David
Behrens, Georg
Esser, Stefan
Fatkenheuer,
Gerd
Hoffmann, Christian
Jessen, Heiko
Rockstroh, Jurgen and
Schmidt, Reinhold
Stephan, Christoph
Unger, Stefan
Hatzakis,
Angelos
Daikos, George L.
Papadopoulos, Antonios
Skoutelis,
Athamasios
Banhegyi, Denes
Mallon, Paddy
Mulcahy, Fiona and
Antinori, Andrea
Andreoni, Massimo
Bonora, Stefano
Castelli,
Francesco
D'Arminio, Antonella Monforte
Di Perri, Giovanni and
Galli, Massimo
Lazzarin, Adriano
Mazzotta, Francesco
Carlo,
Torti
Vullo, Vincenzo
Prins, Jan
Richter, Clemens and
Verhagen, Dominique
Van Eeden, Arne
Doroana, Manuela and
Antunes, Francisco
Maltez, Fernando
Sarmento-Castro, Rui and
Garcia, Juan Gonzalez
Aldeguer, Jose Lopez
Clotet, Bonaventura
and Domingo, Pere
Gatell, Jose M.
Knobel, Hernando
Marquez,
Manuel
Pilar, Martin Miralles
Portilla, Joaquin
Soriano,
Vicente
Tellez, Maria-Jesus
Thalme, Anders
Blaxhult, Anders
and Gisslen, Magnus
Winston, Alan
Fox, Julie
Gompels, Mark
and Herieka, Elbushra
Johnson, Margaret
Leen, Clifford and
Teague, Alastair
Williams, Ian
Lauriola, Marco
Murri, Rita
and NEAT 001 ANRS 143 Study Grp
TDT
TSC
TMT

JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Lippincott, Williams & Wilkins

79

4

519-526

quality of life; raltegravir; treatment satisfaction; EQ-5D;
ritonavir-boosted darunavir; health improvement

https://doi.org/10.1097/QAI.0000000000001844

10.1097/QAI.0000000000001844

https://pergamos.lib.uoa.gr/uoa/dl/object/3182262