title: Levels of bone markers in a population of infants exposed in utero and during breastfeeding to tenofovir within an Option B+ programme in Malawi.
abstract: No data are available on bone metabolism in infants exposed to tenofovir during breastfeeding. We investigated bone metabolism markers in the first year of life in infants from mothers who received tenofovir, lamivudine and efavirenz during pregnancy and 12 months of breastfeeding in a national Option B+ programme in Malawi.
  
  
  
  Serum samples collected at 6 and 12 months in tenofovir-exposed infants and in a small sample of tenofovir-unexposed infants from the same clinical centre were analysed in batches for levels of bone-specific alkaline phosphatase (BAP; marker of bone formation) and of C-terminal telopeptide of type I collagen (CTX; marker of bone resorption).
  
  
  
  Overall, 136 tenofovir-exposed infants were evaluated. No infant had at either timepoint CTX values above the upper normal limit, while most of them had at 6 and 12 months levels of BAP above the upper normal limit for the age range. Levels of bone markers showed no differences by gender and no association with growth parameters. Tenofovir-unexposed and -exposed children had similar mean levels of bone markers at 6 months (CTX: 0.62 versus 0.55 ng/mL, P = 0.122; BAP: 384 versus 362 U/L, P = 0.631).
  
  
  
  No significant association between treatment with tenofovir and CTX or BAP levels was found. The high levels of BAP, coupled to the normal levels observed for CTX, might reflect primarily skeletal growth. Potential negative effects of prolonged exposure to tenofovir through breastfeeding cannot however be excluded and longitudinal studies that evaluate bone mineralization status in children enrolled in Option B+ programmes are warranted.
authors: Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Rome, Italy marco.floridia@iss.it.
authors: Marco
authors: M
authors: Floridia
authors: Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.
authors: Giuseppe
authors: G
authors: Liotta
authors: Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Rome, Italy.
authors: Mauro
authors: M
authors: Andreotti
authors: Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Rome, Italy.
authors: Clementina M
authors: CM
authors: Galluzzo
authors: Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Rome, Italy.
authors: Roberta
authors: R
authors: Amici
authors: DREAM Programme, Community of S. Egidio, Blantyre, Malawi.
authors: Haswell
authors: H
authors: Jere
authors: DREAM Programme, Community of S. Egidio, Blantyre, Malawi.
authors: Jean-Baptiste
authors: JB
authors: Sagno
authors: LUMSA University, Rome, Italy.
authors: Maria C
authors: MC
authors: Marazzi
authors: Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.
authors: Ersilia
authors: E
authors: Buonomo
authors: Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.
authors: Paola
authors: P
authors: Scarcella
authors: Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.
authors: Sandro
authors: S
authors: Mancinelli
authors: Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Rome, Italy.
authors: Stefano
authors: S
authors: Vella
authors: Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità, Rome, Italy.
authors: Marina
authors: M
authors: Giuliano
authors: Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy.
authors: Leonardo
authors: L
authors: Palombi
mesh_terms: D000328:Adult; D000469:Alkaline Phosphatase / Q000097:blood; D000480:Alkynes; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D048588:Benzoxazines / Q000008:administration & dosage; D015415:Biomarkers / Q000097:blood; D001862:Bone Resorption / Q000139:chemically induced*; D001942:Breast Feeding; D024042:Collagen Type I / Q000097:blood; D003521:Cyclopropanes; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D019259:Lamivudine / Q000008:administration & dosage; D008295:Malawi; D008297:Male; D010455:Peptides / Q000097:blood; D011247:Pregnancy; D000068698:Tenofovir / Q000008:administration & dosage / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D000480:Alkynes; D019380:Anti-HIV Agents; D048588:Benzoxazines; D015415:Biomarkers; D024042:Collagen Type I; D003521:Cyclopropanes; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D019259:Lamivudine; D000068698:Tenofovir; D000469:Alkaline Phosphatase; C098320:efavirenz