Changes in Cognitive Function Over 96 weeks in Naïve Patients Randomised to Darunavir-ritonavir plus either Raltegravir or Tenofovir-Emtricitabine: a substudy of the NEAT001/ANRS143 trial.

Alan Winston, Wolfgang Stöhr, Andrea Antinori, Helene Amieva, Philippe Perré, Stephane de Wit, Jacques Reynes, Mark Gompels, Antonella D’Arminio Monforte, Jose Maria Gatell, Jesper Grarup, Anton Pozniak, Abdel Babiker, François Raffi, Laura Richert, the NEAT 001ANRS 143 Study Group

Research output: Contribution to journalArticle

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Abstract

BACKGROUND:: Improvements in cognitive function are described after initiation of combination antiretroviral therapy (cART), with sparse data on differences between cART strategies. METHODS:: We assessed changes in cognition, over 96 weeks, in therapy naïve HIV-positive adults randomised to darunavir/ritonavir (800/100mg once daily) with either raltegravir (400mg twice daily, Arm1) or tenofovir/emtricitabine (245/200mg once daily, Arm2). Seven cognitive tests were administered at baseline and week 96. Changes from baseline in individual cognitive test scores and composite score (NPZ) were assessed. Comparisons between treatment arms were by intention-to-treat and associations with immunological and virological parameters by regression models. FINDINGS:: Of 343 subjects enrolled, 208 completed the week 96 cognitive assessment. Baseline median (IQR) CD4+ count and plasma HIV RNA was 348(282-398) cells/uL and 4.7(4.2-5.1) log10 copies/mL, respectively. At week 96, numbers with plasma HIV RNA undetectable and remaining on randomised cART were 85(92%) and 110(96%), and 84(90%) and 107(93%) in Arm1 and Arm2, respectively. Overall, performance significantly improved by week 96 in 5 of 7 individual tests and in NPZ. Mean change in NPZ was 0.28 versus 0.21 for Arm1 and 2, respectively (p=0.37). No statistically significant differences between study treatment arms were observed in individual cognitive domains apart from attention (greater improvement in Arm1, p=0.0499). At week 96, NPZ-score increase was associated with increase in CD4+ (p=0.001) but not HIV RNA area-under-curve (p=0.60). INTERPRETATION:: Subsequent to the initiation of cART, immunological recovery rather than type of antiretroviral therapy is the major driver of changes in cognitive function.

Original languageEnglish
JournalJournal of Acquired Immune Deficiency Syndromes
DOIs
Publication statusAccepted/In press - Oct 3 2016

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Tenofovir
Ritonavir
Cognition
HIV
RNA
Therapeutics
Raltegravir Potassium
Darunavir
Emtricitabine
CD4 Lymphocyte Count

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Infectious Diseases

Cite this

Changes in Cognitive Function Over 96 weeks in Naïve Patients Randomised to Darunavir-ritonavir plus either Raltegravir or Tenofovir-Emtricitabine : a substudy of the NEAT001/ANRS143 trial. / Winston, Alan; Stöhr, Wolfgang; Antinori, Andrea; Amieva, Helene; Perré, Philippe; de Wit, Stephane; Reynes, Jacques; Gompels, Mark; Monforte, Antonella D’Arminio; Gatell, Jose Maria; Grarup, Jesper; Pozniak, Anton; Babiker, Abdel; Raffi, François; Richert, Laura; the NEAT 001ANRS 143 Study Group.

In: Journal of Acquired Immune Deficiency Syndromes, 03.10.2016.

Research output: Contribution to journalArticle

Winston, A, Stöhr, W, Antinori, A, Amieva, H, Perré, P, de Wit, S, Reynes, J, Gompels, M, Monforte, ADA, Gatell, JM, Grarup, J, Pozniak, A, Babiker, A, Raffi, F, Richert, L & the NEAT 001ANRS 143 Study Group 2016, 'Changes in Cognitive Function Over 96 weeks in Naïve Patients Randomised to Darunavir-ritonavir plus either Raltegravir or Tenofovir-Emtricitabine: a substudy of the NEAT001/ANRS143 trial.', Journal of Acquired Immune Deficiency Syndromes. https://doi.org/10.1097/QAI.0000000000001189
Winston, Alan ; Stöhr, Wolfgang ; Antinori, Andrea ; Amieva, Helene ; Perré, Philippe ; de Wit, Stephane ; Reynes, Jacques ; Gompels, Mark ; Monforte, Antonella D’Arminio ; Gatell, Jose Maria ; Grarup, Jesper ; Pozniak, Anton ; Babiker, Abdel ; Raffi, François ; Richert, Laura ; the NEAT 001ANRS 143 Study Group. / Changes in Cognitive Function Over 96 weeks in Naïve Patients Randomised to Darunavir-ritonavir plus either Raltegravir or Tenofovir-Emtricitabine : a substudy of the NEAT001/ANRS143 trial. In: Journal of Acquired Immune Deficiency Syndromes. 2016.
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abstract = "BACKGROUND:: Improvements in cognitive function are described after initiation of combination antiretroviral therapy (cART), with sparse data on differences between cART strategies. METHODS:: We assessed changes in cognition, over 96 weeks, in therapy na{\"i}ve HIV-positive adults randomised to darunavir/ritonavir (800/100mg once daily) with either raltegravir (400mg twice daily, Arm1) or tenofovir/emtricitabine (245/200mg once daily, Arm2). Seven cognitive tests were administered at baseline and week 96. Changes from baseline in individual cognitive test scores and composite score (NPZ) were assessed. Comparisons between treatment arms were by intention-to-treat and associations with immunological and virological parameters by regression models. FINDINGS:: Of 343 subjects enrolled, 208 completed the week 96 cognitive assessment. Baseline median (IQR) CD4+ count and plasma HIV RNA was 348(282-398) cells/uL and 4.7(4.2-5.1) log10 copies/mL, respectively. At week 96, numbers with plasma HIV RNA undetectable and remaining on randomised cART were 85(92{\%}) and 110(96{\%}), and 84(90{\%}) and 107(93{\%}) in Arm1 and Arm2, respectively. Overall, performance significantly improved by week 96 in 5 of 7 individual tests and in NPZ. Mean change in NPZ was 0.28 versus 0.21 for Arm1 and 2, respectively (p=0.37). No statistically significant differences between study treatment arms were observed in individual cognitive domains apart from attention (greater improvement in Arm1, p=0.0499). At week 96, NPZ-score increase was associated with increase in CD4+ (p=0.001) but not HIV RNA area-under-curve (p=0.60). INTERPRETATION:: Subsequent to the initiation of cART, immunological recovery rather than type of antiretroviral therapy is the major driver of changes in cognitive function.",
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T2 - a substudy of the NEAT001/ANRS143 trial.

AU - Winston, Alan

AU - Stöhr, Wolfgang

AU - Antinori, Andrea

AU - Amieva, Helene

AU - Perré, Philippe

AU - de Wit, Stephane

AU - Reynes, Jacques

AU - Gompels, Mark

AU - Monforte, Antonella D’Arminio

AU - Gatell, Jose Maria

AU - Grarup, Jesper

AU - Pozniak, Anton

AU - Babiker, Abdel

AU - Raffi, François

AU - Richert, Laura

AU - the NEAT 001ANRS 143 Study Group

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N2 - BACKGROUND:: Improvements in cognitive function are described after initiation of combination antiretroviral therapy (cART), with sparse data on differences between cART strategies. METHODS:: We assessed changes in cognition, over 96 weeks, in therapy naïve HIV-positive adults randomised to darunavir/ritonavir (800/100mg once daily) with either raltegravir (400mg twice daily, Arm1) or tenofovir/emtricitabine (245/200mg once daily, Arm2). Seven cognitive tests were administered at baseline and week 96. Changes from baseline in individual cognitive test scores and composite score (NPZ) were assessed. Comparisons between treatment arms were by intention-to-treat and associations with immunological and virological parameters by regression models. FINDINGS:: Of 343 subjects enrolled, 208 completed the week 96 cognitive assessment. Baseline median (IQR) CD4+ count and plasma HIV RNA was 348(282-398) cells/uL and 4.7(4.2-5.1) log10 copies/mL, respectively. At week 96, numbers with plasma HIV RNA undetectable and remaining on randomised cART were 85(92%) and 110(96%), and 84(90%) and 107(93%) in Arm1 and Arm2, respectively. Overall, performance significantly improved by week 96 in 5 of 7 individual tests and in NPZ. Mean change in NPZ was 0.28 versus 0.21 for Arm1 and 2, respectively (p=0.37). No statistically significant differences between study treatment arms were observed in individual cognitive domains apart from attention (greater improvement in Arm1, p=0.0499). At week 96, NPZ-score increase was associated with increase in CD4+ (p=0.001) but not HIV RNA area-under-curve (p=0.60). INTERPRETATION:: Subsequent to the initiation of cART, immunological recovery rather than type of antiretroviral therapy is the major driver of changes in cognitive function.

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