title: Maternal Highly Active Antiretroviral Therapy and Child HIV-Free Survival in Malawi, 2004-2009.
abstract: OBJECTIVE
  Highly active antiretroviral therapy (HAART) provision to eligible HIV-infected pregnant and post-partum women is critical for optimizing maternal health. We assessed the impact of maternal HAART on HIV-free survival of breastfed infants in Malawi.
  
  
  METHODS
  The post-exposure prophylaxis of infants-Malawi trial (2004-2009) enrolled mothers/infants during labor or immediately post-partum to evaluate 14-week extended infant antiretroviral prophylaxis for preventing HIV transmission through breastfeeding. Mothers meeting national HAART guidelines were referred for therapy. Child HIV-free survival-survival without HIV infection-was compared by maternal HAART status.
  
  
  RESULTS
  Overall, 3022 mother-infant pairs contributed 4214 infant/person-years (PY) at-risk for HIV infection or death, with 532 events (incidence 12.6/100 PY, 95 % confidence interval [CI] 11.6-13.7). During follow-up, 349 mothers were HAART initiated; 581 remained HAART naïve with CD4 cell counts <250 cells/mm(3), and 2092 were never HAART-eligible. By 3 months, 11 % of infants with HAART naïve mothers (CD4 < 250) were infected with HIV or died versus 7 % of infants of HAART-initiated mothers and 4 % of infants of HAART-ineligible mothers. Maternal HAART was associated with a 46 % reduction in infant HIV infection or death as compared to infants with HAART naïve mothers (CD4 < 250) (adjusted hazards ratio 0.54, 95 % CI 0.36-0.81). Among HIV-exposed, uninfected infants, breastfeeding, but not HAART, was significantly associated with decreased child mortality.
  
  
  CONCLUSIONS
  HIV infection and mortality are high during the first 3 months post-partum in infants of mothers with advanced HIV, and rapid maternal HAART initiation can significantly improve HIV-related infant outcomes. Clinical Trials Registration This study is registered at http://clinicaltrials.gov/ under trial number NCT00115648.
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, E7139, Baltimore, MD, 21205, USA. sschwartz@jhu.edu.
authors.forename: Sheree R
authors.initials: SR
authors.lastname: Schwartz
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, E7139, Baltimore, MD, 21205, USA.
authors.forename: Newton
authors.initials: N
authors.lastname: Kumwenda
authors.affiliation: Department of Medicine, College of Medicine, University of Malawi, Blantyre, Malawi.
authors.forename: Johnstone
authors.initials: J
authors.lastname: Kumwenda
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, E7139, Baltimore, MD, 21205, USA.
authors.forename: Shu
authors.initials: S
authors.lastname: Chen
authors.affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA.
authors.forename: Lynne M
authors.initials: LM
authors.lastname: Mofenson
authors.affiliation: Epidemiology Branch, Division of HIV/AIDS Prevention, National Center for HIV, Viral Hepatitis, STD and TB Prevention, Centers for Disease Control and Prevention, Atlanta, GA, USA.
authors.forename: Allan W
authors.initials: AW
authors.lastname: Taylor
authors.affiliation: Department of Pathology, Johns Hopkins Medical School, Baltimore, MD, USA.
authors.forename: Mary Glenn
authors.initials: MG
authors.lastname: Fowler
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, E7139, Baltimore, MD, 21205, USA. ttaha1@jhu.edu.
authors.forename: Taha E
authors.initials: TE
authors.lastname: Taha
mesh_terms: D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D001942:Breast Feeding; D018791:CD4 Lymphocyte Count; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000208:ethnology / Q000401:mortality; D006801:Humans; D007223:Infant; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008295:Malawi / Q000453:epidemiology; D009035:Mothers / Q000706:statistics & numerical data; D049590:Postpartum Period; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000821:virology; D011256:Pregnancy Outcome; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Breastfeeding; Child survival; HIV-1; Highly active antiretroviral therapy; Prevention of mother-to-child transmission