Peripheral Neuropathy in Virologically Suppressed People Living with HIV: Evidence from the PIVOT Trial

The aim of this study is to identify the factors associated with peripheral neuropathy and to explore neurofilament light chain (NfL) as a biomarker for peripheral neuropathy (PN) in effectively virologically suppressed adults living with HIV. All protease inhibitor monotherapy versus ongoing triple...

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Vydáno v:	Viruses Ročník 16; číslo 1; s. 2
Hlavní autoři:	Schuldt, Anna L., Bern, Henry, Hart, Melanie, Gompels, Mark, Winston, Alan, Clarke, Amanda, Chen, Fabian, Stöhr, Wolfgang, Heslegrave, Amanda, Paton, Nicholas I., Petzold, Axel, Arenas-Pinto, Alejandro
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	Switzerland MDPI AG 19.12.2023 MDPI
Témata:	Adult Ankle biomarkers blood glucose Blood levels Blood pressure CD4 antigen CD4 lymphocyte count Complications and side effects Diabetes Diagnosis Drug resistance Drug therapy Fasting Female Glucose HIV HIV infection HIV infections HIV Infections - complications HIV Infections - drug therapy Human immunodeficiency virus Humans Male males Metabolic Syndrome monotherapy Neurotoxicity odds ratio Patient outcomes people Peripheral nerve diseases peripheral nervous system diseases Peripheral Nervous System Diseases - complications Peripheral neuropathy Plasma levels Population protease inhibitor Protease Inhibitors - therapeutic use Proteinase inhibitors Regression analysis risk Risk Factors standard deviation Statistical analysis therapeutics Toxicity Triglycerides United Kingdom metabolic syndrome protease inhibitor HIV peripheral neuropathy monotherapy
ISSN:	1999-4915, 1999-4915
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Abstract	The aim of this study is to identify the factors associated with peripheral neuropathy and to explore neurofilament light chain (NfL) as a biomarker for peripheral neuropathy (PN) in effectively virologically suppressed adults living with HIV. All protease inhibitor monotherapy versus ongoing triple therapy in the long-term management of HIV infection (PIVOT) trial participants with data on PN at baseline were included in the study. NfL plasma levels (pNfL) were measured in a sub-set of participants. Multivariable logistic regression was used to examine the associations of PN with potential risk factors (including age, sex, nadir CD4 cell count, history of dideoxynucleoside (d-drugs) exposure, and blood glucose levels) and NfL levels. Of the 585 participants included, 131 (22.4%) reported PN during the study period (median of 44 months). The participants were predominantly male (76.6%), White (68.2%), and virologically suppressed for a median period of 37 months (range of 20–63) before recruitment. The age at baseline was 44.3 years (standard deviation (SD) of 9.2). PN was independently associated with age (adjusted odds ratio (aOR) = 1.35, 95% CI of 1.20–1.52; additional 5 years), history of d-drugs (aOR 1.88, 95% CI of 1.12–3.16), height (aOR 1.19, 95% CI of 1.05–1.35; additional 5 cm), nadir CD4 cell count (aOR 1.10 CI of 1.00–1.20; 50 cells fewer), and metabolic syndrome (aOR 2.31, 95% CI of 1.27 4.20), but not pNfL. The excess risk for PN associated with d-drug use remains after the exposure has stopped for years, suggesting non-reversible toxicity. In people with HIV, metabolic syndrome is independently associated with PN. There was no additional value for pNfL as a screening test for peripheral neuropathy in effectively virologically suppressed adults living with HIV.
AbstractList	The aim of this study is to identify the factors associated with peripheral neuropathy and to explore neurofilament light chain (NfL) as a biomarker for peripheral neuropathy (PN) in effectively virologically suppressed adults living with HIV. All protease inhibitor monotherapy versus ongoing triple therapy in the long-term management of HIV infection (PIVOT) trial participants with data on PN at baseline were included in the study. NfL plasma levels (pNfL) were measured in a sub-set of participants. Multivariable logistic regression was used to examine the associations of PN with potential risk factors (including age, sex, nadir CD4 cell count, history of dideoxynucleoside (d-drugs) exposure, and blood glucose levels) and NfL levels. Of the 585 participants included, 131 (22.4%) reported PN during the study period (median of 44 months). The participants were predominantly male (76.6%), White (68.2%), and virologically suppressed for a median period of 37 months (range of 20-63) before recruitment. The age at baseline was 44.3 years (standard deviation (SD) of 9.2). PN was independently associated with age (adjusted odds ratio (aOR) = 1.35, 95% CI of 1.20-1.52; additional 5 years), history of d-drugs (aOR 1.88, 95% CI of 1.12-3.16), height (aOR 1.19, 95% CI of 1.05-1.35; additional 5 cm), nadir CD4 cell count (aOR 1.10 CI of 1.00-1.20; 50 cells fewer), and metabolic syndrome (aOR 2.31, 95% CI of 1.27 4.20), but not pNfL. The excess risk for PN associated with d-drug use remains after the exposure has stopped for years, suggesting non-reversible toxicity. In people with HIV, metabolic syndrome is independently associated with PN. There was no additional value for pNfL as a screening test for peripheral neuropathy in effectively virologically suppressed adults living with HIV.The aim of this study is to identify the factors associated with peripheral neuropathy and to explore neurofilament light chain (NfL) as a biomarker for peripheral neuropathy (PN) in effectively virologically suppressed adults living with HIV. All protease inhibitor monotherapy versus ongoing triple therapy in the long-term management of HIV infection (PIVOT) trial participants with data on PN at baseline were included in the study. NfL plasma levels (pNfL) were measured in a sub-set of participants. Multivariable logistic regression was used to examine the associations of PN with potential risk factors (including age, sex, nadir CD4 cell count, history of dideoxynucleoside (d-drugs) exposure, and blood glucose levels) and NfL levels. Of the 585 participants included, 131 (22.4%) reported PN during the study period (median of 44 months). The participants were predominantly male (76.6%), White (68.2%), and virologically suppressed for a median period of 37 months (range of 20-63) before recruitment. The age at baseline was 44.3 years (standard deviation (SD) of 9.2). PN was independently associated with age (adjusted odds ratio (aOR) = 1.35, 95% CI of 1.20-1.52; additional 5 years), history of d-drugs (aOR 1.88, 95% CI of 1.12-3.16), height (aOR 1.19, 95% CI of 1.05-1.35; additional 5 cm), nadir CD4 cell count (aOR 1.10 CI of 1.00-1.20; 50 cells fewer), and metabolic syndrome (aOR 2.31, 95% CI of 1.27 4.20), but not pNfL. The excess risk for PN associated with d-drug use remains after the exposure has stopped for years, suggesting non-reversible toxicity. In people with HIV, metabolic syndrome is independently associated with PN. There was no additional value for pNfL as a screening test for peripheral neuropathy in effectively virologically suppressed adults living with HIV. The aim of this study is to identify the factors associated with peripheral neuropathy and to explore neurofilament light chain (NfL) as a biomarker for peripheral neuropathy (PN) in effectively virologically suppressed adults living with HIV. All protease inhibitor monotherapy versus ongoing triple therapy in the long-term management of HIV infection (PIVOT) trial participants with data on PN at baseline were included in the study. NfL plasma levels (pNfL) were measured in a sub-set of participants. Multivariable logistic regression was used to examine the associations of PN with potential risk factors (including age, sex, nadir CD4 cell count, history of dideoxynucleoside (d-drugs) exposure, and blood glucose levels) and NfL levels. Of the 585 participants included, 131 (22.4%) reported PN during the study period (median of 44 months). The participants were predominantly male (76.6%), White (68.2%), and virologically suppressed for a median period of 37 months (range of 20–63) before recruitment. The age at baseline was 44.3 years (standard deviation (SD) of 9.2). PN was independently associated with age (adjusted odds ratio (aOR) = 1.35, 95% CI of 1.20–1.52; additional 5 years), history of d-drugs (aOR 1.88, 95% CI of 1.12–3.16), height (aOR 1.19, 95% CI of 1.05–1.35; additional 5 cm), nadir CD4 cell count (aOR 1.10 CI of 1.00–1.20; 50 cells fewer), and metabolic syndrome (aOR 2.31, 95% CI of 1.27 4.20), but not pNfL. The excess risk for PN associated with d-drug use remains after the exposure has stopped for years, suggesting non-reversible toxicity. In people with HIV, metabolic syndrome is independently associated with PN. There was no additional value for pNfL as a screening test for peripheral neuropathy in effectively virologically suppressed adults living with HIV.
Audience	Academic
Author	Clarke, Amanda Schuldt, Anna L. Petzold, Axel Gompels, Mark Stöhr, Wolfgang Hart, Melanie Bern, Henry Winston, Alan Chen, Fabian Heslegrave, Amanda Arenas-Pinto, Alejandro Paton, Nicholas I.
AuthorAffiliation	8 Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117597, Singapore 1 Institute for Global Health, University College London, London WC1E 6JB, UK 4 Service of Immunology, Southmead Hospital, Bristol BS10 5NB, UK 3 Queen Square Institute of Neurology, University College London, London WC1N 3BG, UK; melanie.hart@ucl.ac.uk (M.H.); a.heslegrave@ucl.ac.uk (A.H.); a.petzold@ucl.ac.uk (A.P.) 5 Faculty of Medicine, Imperial College London, London SW7 2BX, UK; a.winston@imperial.ac.uk 7 Florey Unit Clinic for Sexual Health, Royal Berkshire Hospital, Reading RG1 5AN, UK; fabian.chen@royalberkshire.nhs.uk 6 Department of HIV, Sexual Health and Contraception, Brighton and Sussex University Hospitals NHS Trust, Brighton BN11 2DH, UK; amanda.clarke16@nhs.net 2 MRC Clinical Trials Unit at UCL, University College London, London WC1V 6LJ, UK w.stohr@ucl.ac.uk (W.S.)
AuthorAffiliation_xml	– name: 5 Faculty of Medicine, Imperial College London, London SW7 2BX, UK; a.winston@imperial.ac.uk – name: 4 Service of Immunology, Southmead Hospital, Bristol BS10 5NB, UK – name: 6 Department of HIV, Sexual Health and Contraception, Brighton and Sussex University Hospitals NHS Trust, Brighton BN11 2DH, UK; amanda.clarke16@nhs.net – name: 2 MRC Clinical Trials Unit at UCL, University College London, London WC1V 6LJ, UK w.stohr@ucl.ac.uk (W.S.) – name: 8 Yong Loo Lin School of Medicine, National University of Singapore, Singapore 117597, Singapore – name: 3 Queen Square Institute of Neurology, University College London, London WC1N 3BG, UK; melanie.hart@ucl.ac.uk (M.H.); a.heslegrave@ucl.ac.uk (A.H.); a.petzold@ucl.ac.uk (A.P.) – name: 1 Institute for Global Health, University College London, London WC1E 6JB, UK – name: 7 Florey Unit Clinic for Sexual Health, Royal Berkshire Hospital, Reading RG1 5AN, UK; fabian.chen@royalberkshire.nhs.uk
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SubjectTerms	Adult Ankle biomarkers blood glucose Blood levels Blood pressure CD4 antigen CD4 lymphocyte count Complications and side effects Diabetes Diagnosis Drug resistance Drug therapy Fasting Female Glucose HIV HIV infection HIV infections HIV Infections - complications HIV Infections - drug therapy Human immunodeficiency virus Humans Male males Metabolic Syndrome monotherapy Neurotoxicity odds ratio Patient outcomes people Peripheral nerve diseases peripheral nervous system diseases Peripheral Nervous System Diseases - complications Peripheral neuropathy Plasma levels Population protease inhibitor Protease Inhibitors - therapeutic use Proteinase inhibitors Regression analysis risk Risk Factors standard deviation Statistical analysis therapeutics Toxicity Triglycerides
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Title	Peripheral Neuropathy in Virologically Suppressed People Living with HIV: Evidence from the PIVOT Trial
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