title: Safety of tenofovir use during pregnancy:  early growth outcomes in HIV-exposed uninfected infants.
abstract: OBJECTIVE
  To evaluate the association of tenofovir disoproxil fumarate (TDF) use during pregnancy with early growth parameters in HIV-exposed, uninfected (HEU) infants.
  
  
  METHODS
  US-based prospective cohort study of HEU children to examine potential adverse effects of prenatal TDF exposure.
  
  
  METHODS
  We evaluated the association of maternal TDF use during pregnancy with small for gestational age (SGA); low birth weight (LBW, <2.5 kg); weight-for-age z-scores (WAZ), length-for-age z-scores (LAZ), and head circumference-for-age (HCAZ) z-scores at newborn visit; and LAZ, HCAZ, and WAZ at age 1 year. Logistic regression models for LBW and SGA were fit, adjusting for maternal and sociodemographic factors. Adjusted linear regression models were used to evaluate LAZ, WAZ, and HCAZ by TDF exposure.
  
  
  RESULTS
  Of 2029 enrolled children with maternal antiretroviral information, TDF was used by 449 (21%) HIV-infected mothers, increasing from 14% in 2003 to 43% in 2010. There was no difference between those exposed to combination regimens with vs. without TDF for SGA, LBW, and newborn LAZ and HCAZ. However, at age 1 year, infants exposed to combination regimens with TDF had significantly lower adjusted mean LAZ and HCAZ than those without TDF (LAZ: -0.17 vs. -0.03, P=0.04; HCAZ: 0.17 vs. 0.42, P=0.02).
  
  
  CONCLUSIONS
  TDF use during pregnancy was not associated with increased risk for LBW or SGA. The slightly lower mean LAZ and HCAZ observed at age 1 year in TDF-exposed infants are of uncertain significance but underscore the need for additional studies of growth outcomes after TDF use during pregnancy.
authors.affiliation: Pediatric Adolescent Maternal AIDS Branch, Eunice Kennedy Shriver National Institutes of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland 20892, USA. siberryg@mail.nih.gov
authors.forename: George K
authors.initials: GK
authors.lastname: Siberry
authors.forename: Paige L
authors.initials: PL
authors.lastname: Williams
authors.forename: Hermann
authors.initials: H
authors.lastname: Mendez
authors.forename: George R
authors.initials: GR
authors.lastname: Seage
authors.forename: Denise L
authors.initials: DL
authors.lastname: Jacobson
authors.forename: Rohan
authors.initials: R
authors.lastname: Hazra
authors.forename: Kenneth C
authors.initials: KC
authors.lastname: Rich
authors.forename: Raymond
authors.initials: R
authors.lastname: Griner
authors.forename: Katherine
authors.initials: K
authors.lastname: Tassiopoulos
authors.forename: Deborah
authors.initials: D
authors.lastname: Kacanek
authors.forename: Lynne M
authors.initials: LM
authors.lastname: Mofenson
authors.forename: Tracie
authors.initials: T
authors.lastname: Miller
authors.forename: Linda A
authors.initials: LA
authors.lastname: DiMeglio
authors.forename: D Heather
authors.initials: DH
authors.lastname: Watts
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives*; D019380:Anti-HIV Agents / Q000009:adverse effects*; D049628:Body Size / Q000187:drug effects*; D002657:Child Development; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn / Q000254:growth & development*; D007236:Infant, Small for Gestational Age; D008297:Male; D063065:Organophosphonates / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D011446:Prospective Studies; D012307:Risk Factors; D000068698:Tenofovir
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine