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Randomized Controlled Trial
. 2023 Jan 17;23(1):34.
doi: 10.1186/s12884-022-05341-3.

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

Patricia Mandima #  1 , Kristin Baltrusaitis #  2 , Grace Montepiedra  2 , Lisa Aaron  2 , Jyoti Mathad  3 , Carolyne Onyango-Makumbi  4 , Mandisa Nyati  5 , James Ngocho  6 , Gift Chareka  7 , Ponego Ponatshego  8 , Gaerolwe Masheto  8 , Katie McCarthy  9 , Patrick Jean-Philippe  10 , Amita Gupta  11 , Lynda Stranix-Chibanda  7   12 ; IMPAACT P1078 T. B. APPRISE study team
Collaborators, Affiliations
Randomized Controlled Trial

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

Patricia Mandima et al. BMC Pregnancy Childbirth. .

Abstract

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: 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: 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: 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: 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.

Keywords: Depression; Efavirenz; Isoniazid preventive therapy; PHQ-9; Pregnant and Breastfeeding Women.

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Conflict of interest statement

The authors have no financial disclosures to report.

Figures

Fig. 1
Fig. 1
Randomization and analysis sets
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