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Table 4 Baseline risk factors of neurotoxicity (probable depression, cognitive complaint, poor sleep quality, and peripheral neuropathy). Values are presented as adjusted OR (95% CI)

From: 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

Risk Factor

Adjusteda OR (95% CI)

Probable Depressionb,c

Cognitive Complaintb,d

Poor Sleep Qualityb,e

Peripheral Neuropathyf,g

Entry Cotrimoxazole Use

9.45 (1.32, 413.68)

1.95 (0.89, 4.26)

-

0.24 (0.16, 0.35)

Positive Entry Hepatitis C serology

-

-

-

5.83 (1.32, 25.75)

CD4 Count < 350h

-

0.33 (0.09, 1.20)

-

-

350—< 500h

-

1.09 (0.47, 2.57)

-

-

500—< 650h

-

0.60 (0.20, 1.76)

-

-

HBsAg + at Entry

-

-

-

1.61 (0.70, 3.72)

CD4 Count (cells/mm3)i

-

-

-

0.97 (0.94, 1.01)

Age (years)

-

-

-

1.03 (1.00, 1.06)

BMI (kg/m2)

-

-

-

1.06 (1.03, 1.10)

  1. OR Odds ratio, CI Confidence interval, EFV Efavirenz, HBsAg Hepatitis B surface antigen, BMI Body mass index
  2. aMultivariate model includes gestational age stratum and all covariates with p < 0.15 in simple models that were adjusted for gestational age stratum. Simple models included study arm, EFV-regimen, Hepatitis B surface antigen (HBsAg) status, Hepatitis C serology status, Country, CD4 count, HIV viral load, age, Body Mass Index (BMI), INH acetylation status, EFV metabolism status and Cotrimoxazole use. “– “ indicates that the covariate was not included in multivariate model
  3. bOutcome measure at postpartum Week 36
  4. cProbable depression was defined as PHQ-9 score ≥ 10
  5. dCognitive complaint was defined as “Yes, Definitely” to any of three questions relating to neurocognitive impairment
  6. ePoor sleep quality was defined as aPSQI score ≥ 4 
  7. fPeripheral neuropathy was defined as BPNS Grade ≥ 1
  8. gOutcome measure at any study visit
  9. hReference group was CD4 Count ≥ 650
  10. iPer 50 cells/mm3 increase