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Prevalence of depression among postpartum women on Isoniazid-Preventive Therapy and Efavirenz-based treatment for HIV'an exploratory objective of the IMPAACT P1078 randomized trial

Title
Prevalence of depression among postpartum women on Isoniazid-Preventive Therapy and Efavirenz-based treatment for HIV'an exploratory objective of the IMPAACT P1078 randomized trial
Presenter
Kristin Baltrusaitis
Authors
K. Baltrusaitis * (1), L. Stranix-Chibanda (2), G. Montepiedra (1), L. Aaron (1), J. Mathad (3), C. Onyango-Makumbi (4), P. Mandima (2), M. Nyati (5), J. Ngocho (6), G. Chareka (2), P. Ponatshego (7), G. Masheto (7), K. McCarthy (8), P. Jean-Phillippe (9), A. Gupta (10).
Institutions
(1) Harvard T.H. Chan School of Public Health, Biostatistics, Boston, United States, (2) University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe, (3) Weill Cornell Medical College, New York, United States, (4) Makerere University - JHU Research Collaboration, Kampala, Uganda, (5) Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa, (6) Kilimanjaro Clinical Research Institute, Moshi, Tanzania, United Republic of, (7) Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana, (8) FHI 360, Durham, United States, (9) Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, United States, (10) Center for Clinical Global Health Education, Johns Hopkins University, Baltimore, United States

BACKGROUND: In response to a concern for Isoniazid-Preventive Therapy (IPT)/efavirenz (EFV) interaction, we conducted an exploratory analysis of IMPAACT P1078 to investigate possible neurocognitive toxicity in postpartum women on HIV treatment.
METHODS: Pregnant women on HIV treatment from 8 high-incidence tuberculosis countries were randomized in IMPAACT P1078 to 28 weeks of IPT started during pregnancy or 12 weeks postpartum and followed monthly until 48 weeks postpartum. Partway through study implementation, the Patient Health Questionnaire 9 (PHQ-9) was added to systematically evaluate depression symptoms at entry, quarterly antepartum, and postpartum weeks 4, 12, 24, 36, and 48. We summarized percentages of women with depression symptoms at postpartum visits and assessed the association of 11 risk factors of probable depression (PHQ-9 '¥10) at 36 weeks postpartum using exact logistic regression, adjusted for gestational age stratum. Week 36 was selected post-hoc because it had a high prevalence. Study arm effect modification by EFV use was also evaluated.
RESULTS: Of 956 women enrolled, 749 (78%) women had '¥1 PHQ-9 evaluation(s). At study entry, 691/749 (92%) women were Black African/Black of African origin, with median (Q1, Q3) age of 29 years (24, 33) and gestational age of 26 weeks (22, 30). Most women were at WHO Clinical Stage I (88%), on an EFV-containing regimen (85%), and had undetectable HIV RNA levels (63%), with median CD4 count of 499 cells/mm3 (355, 689). Across postpartum visits, probable depression was reported in 0.7-2.2% of women (Table). Cotrimoxazole use was associated with increased odds of probable depression at Week 36 [adjusted odds ratio (95% confidence interval): 3.1 (1.1, 20.3)]. There was no evidence of study arm differences in odds of probable depression, nor treatment effect modification by EFV use.

Postpartum Study Visit WeekNumber of Women EvaluatedDepression SymptomsProbable Depression (PHQ-9 '¥ 10)
Minimal
(PHQ-9: 1-4)		Mild
(PHQ-9: 5-9)		Moderate
(PHQ-9: 10-14)		Moderately severe, severe
(PHQ-9: 15-27) 		IPT initiated in pregnancy
(Immediate)		IPT initiated postpartum
(Deferred)
413628 (20.6%)8 (5.9%)0 (0%)2 (0.7%)0/64 (0%)2/72 (2.8%)
1222957 (24.9%)24 (10.5%)4 (1.7%)1 (0.4%)2/111 (1.8%)3/118 (2.5%)
2437891 (24.1%)29 (7.7%)3 (0.8%)3 (0.8%)3/186 (1.6%)3/192 (1.6%)
36539117 (21.7%)26 (4.8%)9 (1.7%)2 (0.4%)7/270 (2.6%)4/269 (1.5%)
48689127 (18.4%)25 (3.6%)4 (0.6%)1 (0.1%)3/342 (0.9%)2/347 (0.6%)

CONCLUSIONS: Timing of IPT initiation was not associated with probable depression. Further study is advised to formally assess associations of risk factors with probable depression.