TY - JOUR
T1 - Bone age and mineral density assessments using plain roentgenograms in tenofovir-exposed infants in Malawi and Brazil enrolled in HIV prevention trials network 057
AU - the HIV Prevention Trials Network (HPTN) 057 Protocol Team
AU - Osorio, Luiz Eduardo
AU - Boechat, Maria Ines
AU - Mirochnick, Mark
AU - Kumwenda, Newton
AU - Kreitchmann, Regis
AU - Emel, Lynda
AU - Pinto, Jorge
AU - Joao, Esau
AU - Santos, Breno
AU - Swenson, Molly
AU - George, Kathleen
AU - Sato, Paul
AU - Mofenson, Lynne
AU - Nielsen-Saines, Karin
N1 - Publisher Copyright:
© 2016 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2017
Y1 - 2017
N2 - Background: Tenofovir disoproxil fumarate (TDF) use during pregnancy has been increasing, and studies linking bone toxicity with exposure to TDF have raised concern for its use in infants. Methods: Hand/wrist and spine radiographs were obtained at 3 days and 12 weeks of age in infants born to HIV-infected pregnant women enrolled in the HIV Prevention Trials Network 057 pharmacokinetic study of TDF conducted in Malawi and Brazil assigned to 3 TDF dosing cohorts. In cohort 1, mothers received 600 mg of TDF during labor. In cohort 2, infants received 4 mg/kg dose on days 0, 3 and 5. In cohort 3, a 900 mg maternal dose was given during labor, followed by a 6 mg/kg infant dose on days 0, 3 and 5 of life. Results: Across all 3 cohorts, 89 infants had radiographs performed at either time point, and 85 had radiographs performed at both time points. Metaphyseal lucency was present in 1 case in Brazil and 2 in Malawi. Fifteen percent of infants from Brazil and 9% of infants from Malawi presented bone age discrepancies. No other abnormalities were identified in Brazil, whereas in Malawi, there were 7 more cases of wrist osteopenia, 2 of spine osteopenia and 3 other abnormalities. Conclusion: Bone abnormalities were not uncommon in the overall cohort of HIV-exposed infants. Because of very limited study drug exposure at the time of birth, it is unlikely that TDF was associated with these findings. Untreated maternal HIV disease and/or maternal nutritional status could potentially be related to fetal bone development. This association should be explored in future cohort studies.
AB - Background: Tenofovir disoproxil fumarate (TDF) use during pregnancy has been increasing, and studies linking bone toxicity with exposure to TDF have raised concern for its use in infants. Methods: Hand/wrist and spine radiographs were obtained at 3 days and 12 weeks of age in infants born to HIV-infected pregnant women enrolled in the HIV Prevention Trials Network 057 pharmacokinetic study of TDF conducted in Malawi and Brazil assigned to 3 TDF dosing cohorts. In cohort 1, mothers received 600 mg of TDF during labor. In cohort 2, infants received 4 mg/kg dose on days 0, 3 and 5. In cohort 3, a 900 mg maternal dose was given during labor, followed by a 6 mg/kg infant dose on days 0, 3 and 5 of life. Results: Across all 3 cohorts, 89 infants had radiographs performed at either time point, and 85 had radiographs performed at both time points. Metaphyseal lucency was present in 1 case in Brazil and 2 in Malawi. Fifteen percent of infants from Brazil and 9% of infants from Malawi presented bone age discrepancies. No other abnormalities were identified in Brazil, whereas in Malawi, there were 7 more cases of wrist osteopenia, 2 of spine osteopenia and 3 other abnormalities. Conclusion: Bone abnormalities were not uncommon in the overall cohort of HIV-exposed infants. Because of very limited study drug exposure at the time of birth, it is unlikely that TDF was associated with these findings. Untreated maternal HIV disease and/or maternal nutritional status could potentially be related to fetal bone development. This association should be explored in future cohort studies.
KW - Bone
KW - HIV Prevention Trials Network 057
KW - HIV-exposed infants
KW - Tenofovir
UR - http://www.scopus.com/inward/record.url?scp=84992731456&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84992731456&partnerID=8YFLogxK
U2 - 10.1097/INF.0000000000001386
DO - 10.1097/INF.0000000000001386
M3 - Article
C2 - 27798550
AN - SCOPUS:84992731456
SN - 0891-3668
VL - 36
SP - 184
EP - 188
JO - Pediatric Infectious Disease Journal
JF - Pediatric Infectious Disease Journal
IS - 2
ER -