title: Birth outcomes in South African women receiving highly active antiretroviral therapy: a retrospective observational study.
abstract: BACKGROUND
  Use of highly active antiretroviral therapy (HAART), a triple-drug combination, in HIV-infected pregnant women markedly reduces mother to child transmission of HIV and decreases maternal morbidity. However, there remains uncertainty about the effects of in utero exposure to HAART on foetal development.
  
  
  METHODS
  Our objectives were to investigate whether in utero exposure to HAART is associated with low birth weight and/or preterm birth in a population of South African women with advanced HIV disease. A retrospective observational study was performed on women with CD4 counts ≤250 cells/mm3 attending antenatal antiretroviral clinics in Johannesburg between October 2004 and March 2007. Low birth weight (<2.5 kg) and preterm birth rates (<37 weeks) were compared between those exposed and unexposed to HAART during pregnancy. Effects of different HAART regimen and duration were assessed.
  
  
  RESULTS
  Among HAART-unexposed infants, 27% (60/224) were low birth weight compared with 23% (90/388) of early HAART-exposed (exposed <28 weeks gestation) and 19% (76/407) of late HAART-exposed (exposed ≥28 weeks) infants (p = 0.05). In the early HAART group, a higher CD4 cell count was protective against low birth weight (AOR 0.57 per 50 cells/mm3 increase, 95% CI 0.45-0.71, p < 0.001) and preterm birth (AOR 0.68 per 50 cells/mm3 increase, 95% CI 0.55-0.85, p = 0.001). HAART exposure was associated with an increased preterm birth rate (15%, or 138 of 946, versus 5%, or seven of 147, in unexposed infants, p = 0.001), with early nevirapine and efavirenz-based regimens having the strongest associations with preterm birth (AOR 5.4, 95% CI 2.1-13.7, p < 0.001, and AOR 5.6, 95% CI 2.1-15.2, p = 0.001, respectively).
  
  
  CONCLUSIONS
  In this immunocompromised cohort, in utero HAART exposure was not associated with low birth weight. An association between NNRTI-based HAART and preterm birth was detected, but residual confounding is plausible. More advanced immunosuppression was a risk factor for low birth weight and preterm birth, highlighting the importance of earlier HAART initiation in women to optimize maternal health and improve infant outcomes.
authors.affiliation: Empilweni Services and Research Unit, Department of Paediatrics and Child Health, Rahima Moosa Mother and Child Hospital, University of the Witwatersrand Johannesburg, South Africa. vandermerwekj@gmail.com
authors.forename: Karin
authors.initials: K
authors.lastname: van der Merwe
authors.forename: Risa
authors.initials: R
authors.lastname: Hoffman
authors.forename: Vivian
authors.initials: V
authors.lastname: Black
authors.forename: Matthew
authors.initials: M
authors.lastname: Chersich
authors.forename: Ashraf
authors.initials: A
authors.lastname: Coovadia
authors.forename: Helen
authors.initials: H
authors.lastname: Rees
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D036801:Parturition / Q000502:physiology*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D047928:Premature Birth / Q000139:chemically induced; D012189:Retrospective Studies; D013019:South Africa; D016896:Treatment Outcome
chemical_list: D019380:Anti-HIV Agents