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Bone Age and Mineral Density Assessments Using Plain Roentgenograms in Tenofovir-exposed Infants in Malawi and Brazil
Luiz Eduardo Osorio1, Maria Ines Boechat, Mark Mirochnick
1From the *Department of Pediatrics, David Geffen UCLA School of Medicine, Los Angeles, California; †Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts; ‡Department of Medicine, Malawi College of Medicine, Blantyre, Malawi; §Department of Obstetrics and Gynecology, Santa Casa de Misericordia, Porto Alegre, Brazil; ¶SCHARP Fred Hutchinson Cancer Research Center, Seattle, Washington; ‖Department of Pediatrics, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil; **Department of Infectious Diseases, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; ††Department of Infectious Diseases, Hospital Conceicao, Porto Alegre, Brazil; ‡‡Family Health International, Durham, North Carolina; §§National Institute of Allergy and Infectious Diseases, and ¶¶Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.
Insights
Bone abnormalities were observed in HIV-exposed infants, but Tenofovir disoproxil fumarate (TDF) exposure was unlikely the cause. Maternal HIV and nutritional status may impact fetal bone development, warranting further research.
Area of Science:
- Pediatric Bone Health
- Antiretroviral Therapy Safety
- HIV Perinatal Transmission
Background:
- Increasing use of Tenofovir disoproxil fumarate (TDF) during pregnancy raises concerns about infant bone toxicity.
- Previous studies have suggested a link between TDF exposure and bone abnormalities.
Purpose of the Study:
- To evaluate bone abnormalities in infants exposed to Tenofovir disoproxil fumarate (TDF) during pregnancy.
- To assess the potential association between TDF exposure and bone development in newborns.
Main Methods:
- Radiographs of hand/wrist and spine were taken at 3 days and 12 weeks of age in infants born to HIV-infected mothers.
- Infants were part of a pharmacokinetic study involving three TDF dosing cohorts for mothers and/or infants.
- Radiographic assessments were performed on 89 infants at one time point and 85 at both.
Main Results:
- Metaphyseal lucency was identified in 3 infants (1 in Brazil, 2 in Malawi).
- Bone age discrepancies were noted in 15% of infants in Brazil and 9% in Malawi.
- Additional bone abnormalities, including wrist and spine osteopenia, were observed more frequently in Malawi.
Conclusions:
- Bone abnormalities were relatively common in HIV-exposed infants.
- Limited TDF exposure at birth makes it unlikely to be the primary cause of observed bone findings.
- Maternal HIV disease and nutritional status are potential contributing factors to fetal bone development that require further investigation.
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.
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