title: In utero exposure to tenofovir disoproxil fumarate does not impair growth and bone health in HIV-uninfected children born to HIV-infected mothers.
abstract: BACKGROUND
  Growth impairment and bone toxicity due to tenofovir disoproxil fumarate (TDF) fetal exposure has been described mainly in animals. We evaluated growth pattern and bone health in TDF-exposed HIV-uninfected children born to HIV-infected mothers, defined as seroreverters (SR).
  
  
  METHODS
  This was a multicentre observational cross-sectional cohort study enrolling 68 SR who were in utero exposed to an antiretroviral regimen including (TDF+) or not including (TDF-) tenofovir. Neonatal data and duration of antiretroviral exposure were recorded. At enrolment, anthropometric measures, tibial speed of sound (SOS) by quantitative ultrasound and several parameters of bone metabolism were assessed.
  
  
  RESULTS
  Gestational age and median in utero antiretroviral exposure were similar in subjects exposed to TDF (n=33) and those non-exposed (n =35). Age at enrolment was comparable in the two groups (TDF-exposed range 11.8-76.2 months and TDF non-exposed range 11.8-77.9 months). The incidence of low weight and length measurements (<10th percentiles) at birth was similar in TDF-exposed and TDF non-exposed. Normal growth development was found in both groups of subjects at enrolment. The median (0.6; range -2.4-2.6) SOS z-score of TDF-exposed was similar to the median (0.8; range -2.2-4.4) SOS z-score of TDF non-exposed (Student's t=0.84; P=0.40). Parameters of bone metabolism were similar in the two groups.
  
  
  CONCLUSIONS
  Exposure to TDF during pregnancy does not impair growth patterns, bone health and markers of bone metabolism in SR infants and young children born to HIV-infected women.
authors.affiliation: Department of Paediatrics, L Sacco Hospital, University of Milan, Milan, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Viganò
authors.forename: Stefano
authors.initials: S
authors.lastname: Mora
authors.forename: Vania
authors.initials: V
authors.lastname: Giacomet
authors.forename: Sara
authors.initials: S
authors.lastname: Stucchi
authors.forename: Valeria
authors.initials: V
authors.lastname: Manfredini
authors.forename: Clara
authors.initials: C
authors.lastname: Gabiano
authors.forename: Filippo
authors.initials: F
authors.lastname: Salvini
authors.forename: Monica
authors.initials: M
authors.lastname: Cellini
authors.forename: Enrica
authors.initials: E
authors.lastname: Tamburrini
authors.forename: Maria
authors.initials: M
authors.lastname: Puzzovio
authors.forename: Gian Vincenzo
authors.initials: GV
authors.lastname: Zuccotti
mesh_terms: D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use; D023241:Antiretroviral Therapy, Highly Active; D001842:Bone and Bones / Q000187:drug effects* / Q000502:physiology; D002648:Child; D002675:Child, Preschool; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D005260:Female; D005333:Fetus / Q000187:drug effects* / Q000502:physiology; D006678:HIV / Q000187:drug effects* / Q000502:physiology; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006679:HIV Seropositivity; D006801:Humans; D007223:Infant; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D007558:Italy; D008297:Male; D019370:Observation; D063065:Organophosphonates / Q000008:administration & dosage* / Q000627:therapeutic use; D011247:Pregnancy; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use; D000068698:Tenofovir
chemical_list: D019380:Anti-HIV Agents; D063065:Organophosphonates; D018894:Reverse Transcriptase Inhibitors; D000068698:Tenofovir; D000225:Adenine