Prevalence of neurotoxicity symptoms among postpartum women on isoniazid preventive therapy and efavirenz-based treatment for HIV: an exploratory objective of the IMPAACT P1078 randomized trial.
Depression
Efavirenz
Isoniazid preventive therapy
PHQ-9
Pregnant and Breastfeeding Women
Journal
BMC pregnancy and childbirth
ISSN: 1471-2393
Titre abrégé: BMC Pregnancy Childbirth
Pays: England
ID NLM: 100967799
Informations de publication
Date de publication:
17 Jan 2023
17 Jan 2023
Historique:
received:
21
06
2022
accepted:
30
12
2022
entrez:
17
1
2023
pubmed:
18
1
2023
medline:
20
1
2023
Statut:
epublish
Résumé
This exploratory analysis investigates the prevalence and risk factors of neurocognitive toxicity in postpartum women on HIV treatment in response to a concern of an Isoniazid Preventive Therapy (IPT)/Efavirenz interaction. Pregnant women on HIV treatment from countries with high TB prevalence were randomized in IMPAACT P1078 to 28 weeks of IPT started either during pregnancy or at 12 weeks postpartum. Partway through study implementation, the Patient Health Questionnaire 9, the cognitive complaint questionnaire, and the Pittsburg Sleep Quality Index were added to evaluate depression, cognitive function, and sleep quality at postpartum weeks. Screening for peripheral neuropathy was conducted throughout the study. We summarized percentages of women with depression symptoms, cognitive dysfunction, poor sleep quality and peripheral neuropathy and assessed the association of 11 baseline risk factors of neurotoxicity using logistic regression, adjusted for gestational age stratum. Of 956 women enrolled, 749 (78%) had at least one neurocognitive evaluation. During the postpartum period, the percentage of women reporting at least mild depression symptoms, cognitive complaint and poor sleep quality peaked at 13%, 8% and 10%, respectively, at 12 weeks, and the percentage of women reporting peripheral neuropathy peaked at 13% at 24 weeks. There was no evidence of study arm differences in odds of all four neurotoxic symptoms. Timing of IPT initiation and EFV use were not associated with symptoms of neurotoxicity. Further study is advised to formally assess risk factors of neurotoxicity.
Sections du résumé
BACKGROUND
BACKGROUND
This exploratory analysis investigates the prevalence and risk factors of neurocognitive toxicity in postpartum women on HIV treatment in response to a concern of an Isoniazid Preventive Therapy (IPT)/Efavirenz interaction.
TRIAL DESIGN
METHODS
Pregnant women on HIV treatment from countries with high TB prevalence were randomized in IMPAACT P1078 to 28 weeks of IPT started either during pregnancy or at 12 weeks postpartum. Partway through study implementation, the Patient Health Questionnaire 9, the cognitive complaint questionnaire, and the Pittsburg Sleep Quality Index were added to evaluate depression, cognitive function, and sleep quality at postpartum weeks. Screening for peripheral neuropathy was conducted throughout the study.
METHODS
METHODS
We summarized percentages of women with depression symptoms, cognitive dysfunction, poor sleep quality and peripheral neuropathy and assessed the association of 11 baseline risk factors of neurotoxicity using logistic regression, adjusted for gestational age stratum.
RESULTS
RESULTS
Of 956 women enrolled, 749 (78%) had at least one neurocognitive evaluation. During the postpartum period, the percentage of women reporting at least mild depression symptoms, cognitive complaint and poor sleep quality peaked at 13%, 8% and 10%, respectively, at 12 weeks, and the percentage of women reporting peripheral neuropathy peaked at 13% at 24 weeks. There was no evidence of study arm differences in odds of all four neurotoxic symptoms.
CONCLUSIONS
CONCLUSIONS
Timing of IPT initiation and EFV use were not associated with symptoms of neurotoxicity. Further study is advised to formally assess risk factors of neurotoxicity.
Identifiants
pubmed: 36650479
doi: 10.1186/s12884-022-05341-3
pii: 10.1186/s12884-022-05341-3
pmc: PMC9847058
doi:
Substances chimiques
Isoniazid
V83O1VOZ8L
Antitubercular Agents
0
efavirenz
JE6H2O27P8
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
34Subventions
Organisme : NIAID NIH HHS
ID : UM1 AI069456
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068632
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069453
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI068616
Pays : United States
Organisme : NIAID NIH HHS
ID : UM1 AI069436
Pays : United States
Organisme : NIAID NIH HHS
ID : U01 AI069436
Pays : United States
Investigateurs
Haroon Saloojee
(H)
Wafaa El-Sadr
(W)
David Harrington
(D)
Jonathan B Levine
(JB)
Mary Faith Marshall
(MF)
Lucky Mokgatlhe
(L)
Paula Munderi
(P)
Andrew Nunn
(A)
Jerome Amir Singh
(JA)
Betty Kwagala
(B)
Alwyn Mwinga
(A)
Papa Salif Sow
(PS)
Catherine Hill
(C)
Jerrold J Ellner
(JJ)
Grace John-Stewart
(G)
Steven Joffe
(S)
Barbara E Murray
(BE)
Merlin L Robb
(ML)
Enid Kabugho
(E)
Deo Wabwire
(D)
Hellen Kaganzi
(H)
Joel Maena
(J)
Hajira Kataike
(H)
Emmie Marote
(E)
Mercy Mutambanengwe
(M)
Teacler Nematadzira
(T)
Suzen Maonera
(S)
Vongai Chanaiwa
(V)
Tapiwa Mbengeranwa
(T)
Sukunena Maturure
(S)
Tsungai Mhembere
(T)
Nasreen Abrahams
(N)
Haseena Cassim
(H)
Ruth Mathiba
(R)
Joan Coetzee
(J)
Jeanne Louw
(J)
Marlize Smuts
(M)
Lindie Rossouw
(L)
Magdel Rossouw
(M)
Celeste de Vaal
(C)
Sharon Mbaba
(S)
Karen du Preez
(K)
Frieda Verheye-Dua
(F)
Aisa Shao
(A)
Boniface Njau
(B)
Philoteus Sakasaka
(P)
Seleman Semvua
(S)
Tebogo J Kakhu
(TJ)
Thuto Ralegoreng
(T)
Ayotunde Omoz-Oarhe
(A)
Unoda Chakalisa
(U)
Nishi Suryavanshi
(N)
Sandesh Patil
(S)
Neetal Nevrekar
(N)
Renu Bharadwaj
(R)
Vandana Kulkarni
(V)
Fuanglada Tongprasert
(F)
Tavitiya Sudjaritruk
(T)
Chintana Khamrong
(C)
Prapaporn Janjing
(P)
Marie Flore Pierre
(MF)
Maria Linda Aristhomene
(ML)
Dominique Lespinasse
(D)
Emelyne Dumont
(E)
Rebecca LeBlanc
(R)
Amy James Loftis
(AJ)
Soyeon Kim
(S)
David Shapiro
(D)
Camlin Tierney
(C)
Vivian Rexroad
(V)
Renee Browning
(R)
Informations de copyright
© 2023. The Author(s).
Références
Eval Health Prof. 2018 Mar;41(1):67-81
pubmed: 27899687
Psychiatry Res. 1989 May;28(2):193-213
pubmed: 2748771
PLoS One. 2013;8(2):e56916
pubmed: 23451110
Antimicrob Agents Chemother. 2014 Jul;58(7):4145-52
pubmed: 24820076
Clin Pharmacol Ther. 2021 Apr;109(4):1034-1044
pubmed: 32909316
Antimicrob Agents Chemother. 2016 Dec 27;61(1):
pubmed: 27799216
CNS Drugs. 2010 Aug;24(8):655-67
pubmed: 20658798
BMC Psychiatry. 2019 Oct 30;19(1):330
pubmed: 31666033
Front Psychol. 2019 Jan 09;9:2666
pubmed: 30687151
N Engl J Med. 2019 Oct 3;381(14):1333-1346
pubmed: 31577875
J Affect Disord. 2017 Feb;209:195-200
pubmed: 27930912
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941
AIDS Care. 2013;25(10):1245-52
pubmed: 23398282
J Infect Dis. 2015 Jan 15;211(2):197-205
pubmed: 25081933
Top Antivir Med. 2011 Nov;19(4):137-42
pubmed: 22156215
Horm Behav. 2016 Jan;77:153-66
pubmed: 26319224
PLoS One. 2019 Oct 31;14(10):e0224515
pubmed: 31671160
Sleep. 2012 Jan 01;35(1):131-7
pubmed: 22215927
Am J Trop Med Hyg. 2010 Sep;83(3):565-70
pubmed: 20810821
CMAJ. 2012 Feb 21;184(3):E191-6
pubmed: 22184363
J Neurol Neurosurg Psychiatry. 2003 Sep;74(9):1267-71
pubmed: 12933932
BMC Pregnancy Childbirth. 2020 Apr 6;20(1):197
pubmed: 32252675
Br J Clin Pharmacol. 2018 Aug;84(8):1641-1658
pubmed: 29624706
AIDS. 2010 Jun 1;24(9):1243-50
pubmed: 19996937
J Clin Psychiatry. 2015 Oct;76(10):1385-96
pubmed: 26528645
World J Hepatol. 2015 May 8;7(7):922-5
pubmed: 25954475
Pharmacol Rev. 2018 Jul;70(3):684-711
pubmed: 29945900
Open Forum Infect Dis. 2020 Nov 18;8(1):ofaa561
pubmed: 33447632
BMC Psychiatry. 2016 Jun 10;16:196
pubmed: 27287387