title: Cognitive and language outcomes in HIV-uninfected infants exposed to combined antiretroviral therapy in utero and through extended breast-feeding.
abstract: OBJECTIVE
  To determine whether there is a higher risk for cognitive or language delay among HIV-exposed uninfected (HEU) children exposed to cART (zidovudine/lamivudine/lopinavir/ritonavir) in utero and through 1 year of breast-feeding (World health Organization Option B+), compared with the control children born to HIV-uninfected mothers.
  
  
  METHODS
  This is a double cohort study from Lusaka, Zambia.
  
  
  METHODS
  HEU (n = 97) and control (n = 103) children aged 15-36 months were assessed on their early nonverbal problem-solving and language skills using the standardized Capute Scales. A score of less than 85 on the Capute Full-Scale Developmental Quotient (FSDQ) was considered indicative of developmental delay and was the primary outcome of interest.
  
  
  RESULTS
  An FSDQ of less than 85 was found in eight (8.3%) of HEU participants and 15 (14.6%) of controls. In univariate logistic regressions, lower income [odds ratio (OR) = 0.93, P = 0.02], older infant age (OR = 1.08, P = 0.03), lower birth weight (OR = 0.16, P < 0.001), and less maternal education (OR = 0.41, P = 0.047) were associated with the probability of FSDQ less than 85, whereas Group (control/HEU) was not (OR = 1.88, P = 0.16). In the multivariable analysis, only lower birth weight (OR = 0.15, P < 0.001) remained associated with FSDQ less than 85.
  
  
  CONCLUSIONS
  Our study did not support the presence of an adverse effect on cognitive and language development with prolonged antepartum and postpartum cART e/xposure. Larger studies and studies of older HEU children will be required to confirm these reassuring findings.
authors.affiliation: aUniversity of Zambia School of Medicine bDepartment of Pediatrics, University Teaching Hospital, Lusaka, Zambia cUniversity of Toronto, Toronto dUniversity of British Columbia eWomen's Health Research Institute fCentre for Blood Research, Vancouver gThe Hospital for Sick Children, Toronto hPublic Health Agency of Canada, Ottawa iWestern University, London, Canada.
authors.forename: Mary S
authors.initials: MS
authors.lastname: Ngoma
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Hunter
authors.forename: Jessica A
authors.initials: JA
authors.lastname: Harper
authors.forename: Paige T
authors.initials: PT
authors.lastname: Church
authors.forename: Scholastica
authors.initials: S
authors.lastname: Mumba
authors.forename: Mulapati
authors.initials: M
authors.lastname: Chandwe
authors.forename: Hélène C F
authors.initials: HC
authors.lastname: Côté
authors.forename: Arianne Y K
authors.initials: AY
authors.lastname: Albert
authors.forename: Mary-Lou
authors.initials: ML
authors.lastname: Smith
authors.forename: Chisomo
authors.initials: C
authors.lastname: Selemani
authors.forename: Paul A
authors.initials: PA
authors.lastname: Sandstrom
authors.forename: Lucas
authors.initials: L
authors.lastname: Bandenduck
authors.forename: Utsile
authors.initials: U
authors.lastname: Ndlovu
authors.forename: Sara
authors.initials: S
authors.lastname: Khan
authors.forename: Lina
authors.initials: L
authors.lastname: Roa
authors.forename: Michael S
authors.initials: MS
authors.lastname: Silverman
mesh_terms: D000293:Adolescent; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects* / Q000379:methods*; D001942:Breast Feeding; D002657:Child Development / Q000187:drug effects*; D002675:Child, Preschool; D003071:Cognition / Q000187:drug effects*; D015331:Cohort Studies; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008603:Mental Health; D011247:Pregnancy; D055815:Young Adult; D015024:Zambia