@article{3182262,
    title = "Patient-Reported Outcomes in First-Line Antiretroviral Therapy: Results
From NEAT001/ANRS143 Trial Comparing Darunavir/Ritonavir in Combination
With Tenofovir/Emtricitabine or Raltegravir",
    author = "George, Elizabeth C. and Bucciardini, Raffaella and Richert, Laura and and Dedes, Nikos and Fragola, Vincenzo and Nieuwkerk, Pythia and Spire, and Bruno and Volny-Anne, Alain and West, Brian and Molina, Jean-Michel and and Horban, Andrzej and Fox, Julie and Pozniak, Anton and Vella, Stefano and and Termote, Monique and Raffi, Francois and Chene, Genevieve and Allavena, and Clotilde and Autran, Brigitte and Antinori, Andrea and Arribas, Jose and and Babiker, Abdel G. and Boffito, Marta and Pillay, Deenan and Franquet, and Xavier and Schwarze, Siegfried and Grarup, Jesper and Fischer, Aurelie and and Wallet, Cedrick and Diallo, Alpha and Saillard, Juliette and and Moecklinghoff, Christiane and Stellbrink, Hans-Jurgen and Van Leeuwen, and Remko and Gatell, Jose and Sandstrom, Eric and Flepp, Markus and and Babiker, Abdel G. and Ewings, Fiona and Hudson, Fleur and Pearce, and Gillian and Quercia, Romina and Rogatto, Felipe and Leavitt, Randi and and Nguyen, Bach-Yen and Allavena, Clotilde and Arnault, Fabien and Fischer, and Aurelie and Paniego, Virginie and Schwimmer, Christine and Touzeau, and Guillaume and Wallet, Cedrick and Boucherie, Celine and Jean, Delphine and and Paraina, Felasoa and Rouch, Elodie and Soussi, Malika and Taieb, and Audrey and Babiker, Abdel G. and Ewings, Fiona and Dodds, Wendy and and Hudson, Fleur and Cursley, Adam and Hoppe, Anne and Kummeling, Ischa and and Pacciarini, Filippo and Paton, Nick and Russell, Charlotte and Taylor, and Kay and Ward, Denise and Gey, Daniela and Jansson, Per O. and Jensen, and Karoline and Pearson, Mary and Nielsen, Birgit Riis and Aagaard, Bitten and and Eid, Marius and Jensen, Birgitte Gram and Jakobsen, Marie-Louise and and Joensen, Zillah Maria and Larsen, Ellen Moseholm and Pahl, Christiane and and Reilev, Soren Stentoft and Lathouwers, Desiree and Manting, Corry and and Van Leeuwen, Remko and Christ, Ilse and Diallo, Alpha and Mendy, and Bienvenu Yves and Metro, Annie and Saillard, Juliette and and Couffin-Cadiergues, Sandrine and Palmisiano, Lucia and Knellwolf, and Anne-Laure and Aznar, Esther and Barea, Cristina and Cotarelo, Manuel and and Esteban, Herminia and Girbau, Iciar and Moyano, Beatriz and Ramirez, and Miriam and Saiz, Carmen and Sanchez, Isabel and Yllescas, Maria and and Binelli, Andrea and Colasanti, Valentina and Massella, Maurizio and and Palmisiano, Lucia and Anagnostou, Olga and Gioukari, Vicky and Touloumi, and Giota and Schmied, Brigitte and Rieger, Armin and Vetter, Norbert and De and Wit, Stephane and Florence, Eric and Vandekerckhove, Linos and Gerstoft, and Jan and Mathiesen, Lars and Katlama, Christine and Cabie, Andre and and Cheret, Antoine and Dupon, Michel and Ghosn, Jade and Girard, and Pierre-Marie and Goujard, Cecile and Levy, Yves and Morlat, J. -M. M. and Philippe and Neau, Didier and Obadia, Martine and Perre, Philippe and and Piroth, Lionel and Reynes, Jacques and Tattevin, Pierre and Ragnaud, and Jean Marie and Weiss, Laurence and Yazdanpanah, Yazdan and Yeni, Patrick and and Zucman, David and Behrens, Georg and Esser, Stefan and Fatkenheuer, and Gerd and Hoffmann, Christian and Jessen, Heiko and Rockstroh, Jurgen and and Schmidt, Reinhold and Stephan, Christoph and Unger, Stefan and Hatzakis, and Angelos and Daikos, George L. and Papadopoulos, Antonios and Skoutelis, and Athamasios and Banhegyi, Denes and Mallon, Paddy and Mulcahy, Fiona and and Antinori, Andrea and Andreoni, Massimo and Bonora, Stefano and Castelli, and Francesco and D'Arminio, Antonella Monforte and Di Perri, Giovanni and and Galli, Massimo and Lazzarin, Adriano and Mazzotta, Francesco and Carlo, and Torti and Vullo, Vincenzo and Prins, Jan and Richter, Clemens and and Verhagen, Dominique and Van Eeden, Arne and Doroana, Manuela and and Antunes, Francisco and Maltez, Fernando and Sarmento-Castro, Rui and and Garcia, Juan Gonzalez and Aldeguer, Jose Lopez and Clotet, Bonaventura and and Domingo, Pere and Gatell, Jose M. and Knobel, Hernando and Marquez, and Manuel and Pilar, Martin Miralles and Portilla, Joaquin and Soriano, and Vicente and Tellez, Maria-Jesus and Thalme, Anders and Blaxhult, Anders and and Gisslen, Magnus and Winston, Alan and Fox, Julie and Gompels, Mark and and Herieka, Elbushra and Johnson, Margaret and Leen, Clifford and and Teague, Alastair and Williams, Ian and Lauriola, Marco and Murri, Rita and and NEAT 001 ANRS 143 Study Grp and TDT and TSC and TMT",
    journal = "JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES",
    year = "2018",
    volume = "79",
    number = "4",
    pages = "519-526",
    publisher = "Lippincott, Williams & Wilkins",
    doi = "10.1097/QAI.0000000000001844",
    keywords = "quality of life; raltegravir; treatment satisfaction; EQ-5D;
ritonavir-boosted darunavir; health improvement",
    abstract = "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."
}