title: Infant growth outcomes after maternal tenofovir disoproxil fumarate use during pregnancy.
abstract: OBJECTIVE
  To determine whether maternal use of tenofovir disoproxil fumarate for treatment of HIV in pregnancy predicts fetal and infant growth.
  
  
  METHODS
  The study population included HIV-uninfected live-born singleton infants of mothers enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group protocol P1025 (born 2002-2011) in the United States and exposed in utero to a combined (triple or more) antiretroviral regimen. Infant weight at birth and 6 months was compared between infants exposed and unexposed to tenofovir in utero using 2-sample t test, χ test, and multivariable linear and logistic regression models, including demographic and maternal characteristics.
  
  
  RESULTS
  Among 2025 infants with measured birth weight, there was no difference between those exposed (N = 630, 31%) versus unexposed to tenofovir in mean birth weight (2.75 vs. 2.77 kg, P = 0.64) or mean gestational age- and sex-adjusted birth weight z-score (WASZ) (0.14 vs. 0.14, P = 0.90). Among 1496 infants followed for 6 months, there was no difference in mean weight at 6 months between tenofovir-exposed (N = 457, 31%) and tenofovir-unexposed infants (7.64 vs. 7.59 kg, P = 0.52) or in mean WASZ (0.29 vs. 0.26, P = 0.61). Tenofovir exposure during the second/third trimester, relative to no exposure, significantly predicted underweight (WASZ < 5%) at age 6 months [odds ratio (95% confidence interval): 2.06 (1.01 to 3.95), P = 0.04]. Duration of tenofovir exposure did not predict neonatal or infant growth.
  
  
  CONCLUSIONS
  By most measures, in utero exposure to tenofovir did not significantly predict infant birth weight or growth through 6 months of age.
authors.affiliation: *Department of Obstetrics and Gynecology, Vanderbilt University, Nashville, TN; †Center for Biostatistics in AIDS Research and ‡Department of Epidemiology, Harvard School of Public Health, Boston, MA; §Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL; ‖Maternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institutes of Child Health and Human Development, National Institutes of Health, Bethesda, MD; and ¶Department of Obstetrics and Gynecology, Duke University Medical School, Durham, NC.
authors.forename: Carla E
authors.initials: CE
authors.lastname: Ransom
authors.forename: Yanling
authors.initials: Y
authors.lastname: Huo
authors.forename: Kunjal
authors.initials: K
authors.lastname: Patel
authors.forename: Gwendolyn B
authors.initials: GB
authors.lastname: Scott
authors.forename: Heather D
authors.initials: HD
authors.lastname: Watts
authors.forename: Paige
authors.initials: P
authors.lastname: Williams
authors.forename: George K
authors.initials: GK
authors.lastname: Siberry
authors.forename: Elizabeth G
authors.initials: EG
authors.lastname: Livingston
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002657:Child Development / Q000187:drug effects*; D005260:Female; D006801:Humans; D007223:Infant; D063065:Organophosphonates / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy; D000068698:Tenofovir; D015430:Weight Gain
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine