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

Table 2 Summary of neurotoxicity (depression symptoms, cognitive complaint, poor sleep quality, and peripheral neuropathy Grade) by postpartum study visit. Values are presented as N/Total N [% (95% CI)] for dichotomous outcome measures and N/Total N (%) otherwise

Analysis Visit	Depression Symptoms^a				Cognitive Complaint^b	Poor Sleep Quality^c	Peripheral Neuropathy^d
Analysis Visit	Minimal (PHQ-9: 1–4)	Mild (PHQ-9: 5–9)	Moderate (PHQ-9: 10–14)	Moderately severe, severe (PHQ-9: 15–27)	Yes	Yes	Mild (Grade 1)	Moderate (Grade 2)	Severe (Grade 3)
AP Visit	27/78 (35)	11/78 (14)	0/78 (0)	0/78 (0)	5/78 [6 (2, 14)]	11/73 [15 (8, 25)]	102/956 (11)	1/956 (< 0.5)	0/956 (0)
PP Week 4	28/136 (21)	8/136 (6)	0/136 (0)	2/136 (1)	5/135 [4 (1, 8)]	5/121 [4 (1, 9)]	57/879 (6)	0/879 (0)	0/879 (0)
PP Week 12	57/229 (25)	24/229 (10)	4/229 (2)	1/229 (< 0.5)	19/232 [8 (5, 12)]	19/198 [10 (6, 15)]	112/886 (13)	0/886 (0)	1/886 (< 0.5)
PP Week 24	91/378 (24)	29/378 (8)	3/378 (1)	3/378 (1)	22/379 [6 (4, 9)]	25/322 [8 (5, 11)]	108/841 (13)	4/841 (< 0.5)	0/841 (0)
PP Week 36	117/539 (22)	26/539 (5)	9/539 (2)	2/539 (< 0.5)	31/544 [6 (4, 8)]	26/457 [6 (4, 8)]	96/812 (12)	5/812 (1)	0/812 (0)
PP Week 48	127/689 (18)	25/689 (4)	4/689 (1)	1/689 (< 0.5)	29/691 [4 (3, 6)]	32/573 [6 (4, 8)]	71/779 (9)	0/779 (0)	0/779 (0)

CI Clopper-Pearson confidence interval, AP Antepartum, PP Postpartum, PHQ-9 Patient health questionnaire 9, aPSQI Adapted pittsburgh sleep quality Index, BPNS Brief peripheral neuropathy screening
^aDepression symptoms were evaluated using the PHQ-9 questionnaire
^bCognitive complaint was defined as responding “Yes, Definitely” to any of three questions relating to neurocognitive impairment
^cPoor sleep quality was defined as aPSQI score ≥ 4
^dPeripheral neuropathy was evaluated using the BPNS tool

ISSN: 1471-2393