Elizabeth C George1, Raffaella Bucciardini2, Laura Richert3, Nikos Dedes4, Vincenzo Fragola2, Pythia Nieuwkerk5, Bruno Spire6, Alain Volny-Anne4, Brian West4, Jean-Michel Molina7,8, Andrzej Horban9, Julie Fox10, Anton Pozniak11, Stefano Vella2, Monique Termote3, François Raffi12. 1. MRC CTU at UCL, Institute of Clinical Trials and Methodology, UCL, London, United Kingdom. 2. National Center for Global Health, Istituto Superiore di Sanità (The National Institute of Health), Rome, Italy. 3. INSERM, Bordeaux Population Health Research Center, University of Bordeaux, Bordeaux, France. 4. European AIDS Treatment Group, Brussels, Belgium. 5. Department of Medical Psychology, Academic Medical Center, Amsterdam School of Public Health, Amsterdam, the Netherlands. 6. INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Fac médecine Timone, Aix Marseille Univ, Marseille Cedex, France. 7. Department of Infectious Diseases, Saint-Louis hospital, Paris, France. 8. Assistance Publique Hopitaux de Paris, University of Paris Diderot, Paris, France. 9. Warsaw Medical University and Hospital for Infectious Diseases, Warsaw, Poland. 10. Guys and St Thomas' NHS trust, London, United Kingdom. 11. Chelsea and Westminster Hospital NHS Foundation Trust, London, United Kingdom. 12. Infectious Diseases Department and INSERM CIC 1413, University hospital of Nantes, Nantes, France.
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: -1.7 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 -0.1 (95% CI: -1.3 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 twice-daily administration.
RCT Entities:
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: -1.7 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 -0.1 (95% CI: -1.3 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 twice-daily administration.
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