Lower Newborn Bone Mineral Content Associated with Maternal Use of Tenofovir Disoproxil Fumarate during Pregnancy

George K. Siberry, Denise L. Jacobson, Heidi J. Kalkwarf, Julia W. Wu, Linda A. Dimeglio, Ram Yogev, Katherine M. Knapp, Justin J. Wheeler, Laurie Butler, Rohan Hazra, Tracie L Miller, George R. Seage, Russell B. Van Dyke, Emily Barr, Mariam Davtyan, Lynne M. Mofenson, Kenneth C. Rich

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Abstract

Background.Fetal bone effects of maternal tenofovir use have not been well studied. We sought to compare whole-body bone mineral content (BMC) of newborns exposed vs not exposed to tenofovir in utero. Methods.We enrolled participants from April 2011 to June 2013 at 14 US clinical sites. Singleton infants of women with human immunodeficiency virus (HIV) infection who took tenofovir in late pregnancy (tenofovir-exposed) or no tenofovir during pregnancy (tenofovir-unexposed) were enrolled during late pregnancy or within 72 hours of birth. Infants born before 36 weeks gestation or with confirmed HIV infection were excluded. Whole-body BMC was measured in the first month of life and compared with that of the tenofovir-exposed and tenofovir-unexposed newborns, unadjusted and adjusted for covariates. Results.Seventy-four tenofovir-exposed and 69 tenofovir-unexposed infants had evaluable BMC measurements. Tenofovir-exposed mothers were more likely to be married (31% vs 22%; P =. 04) and to use boosted protease inhibitors (84% vs 62%; P =. 004). Tenofovir-exposed newborns did not differ from unexposed newborns on mean gestational age (38.2 vs 38.1 weeks) or mean length (-0.41 vs-0.18) or weight (-0.71 vs-0.48) Z-scores. The mean (standard deviation) BMC of tenofovir-exposed infants was 12% lower than for unexposed infants (56.0 [11.8] vs 63.8 [16.6] g; P =. 002). The adjusted mean bone mineral content was 5.3 g lower (95% confidence interval,-9.5,-1.2; P =. 013) in the tenofovir-exposed infants. Conclusions.Maternal tenofovir use is associated with significantly lower neonatal BMC. The duration and clinical significance of this finding should be evaluated in longitudinal studies.

Original languageEnglish (US)
Pages (from-to)996-1003
Number of pages8
JournalClinical Infectious Diseases
Volume61
Issue number6
DOIs
StatePublished - Jun 8 2015

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Tenofovir
Bone Density
Mothers
Newborn Infant
Pregnancy
Virus Diseases

Keywords

  • HIV
  • infant bone mineral content
  • intrauterine exposure
  • tenofovir

ASJC Scopus subject areas

  • Infectious Diseases
  • Microbiology (medical)

Cite this

Siberry, G. K., Jacobson, D. L., Kalkwarf, H. J., Wu, J. W., Dimeglio, L. A., Yogev, R., ... Rich, K. C. (2015). Lower Newborn Bone Mineral Content Associated with Maternal Use of Tenofovir Disoproxil Fumarate during Pregnancy. Clinical Infectious Diseases, 61(6), 996-1003. https://doi.org/10.1093/cid/civ437

Lower Newborn Bone Mineral Content Associated with Maternal Use of Tenofovir Disoproxil Fumarate during Pregnancy. / Siberry, George K.; Jacobson, Denise L.; Kalkwarf, Heidi J.; Wu, Julia W.; Dimeglio, Linda A.; Yogev, Ram; Knapp, Katherine M.; Wheeler, Justin J.; Butler, Laurie; Hazra, Rohan; Miller, Tracie L; Seage, George R.; Van Dyke, Russell B.; Barr, Emily; Davtyan, Mariam; Mofenson, Lynne M.; Rich, Kenneth C.

In: Clinical Infectious Diseases, Vol. 61, No. 6, 08.06.2015, p. 996-1003.

Research output: Contribution to journalArticle

Siberry, GK, Jacobson, DL, Kalkwarf, HJ, Wu, JW, Dimeglio, LA, Yogev, R, Knapp, KM, Wheeler, JJ, Butler, L, Hazra, R, Miller, TL, Seage, GR, Van Dyke, RB, Barr, E, Davtyan, M, Mofenson, LM & Rich, KC 2015, 'Lower Newborn Bone Mineral Content Associated with Maternal Use of Tenofovir Disoproxil Fumarate during Pregnancy', Clinical Infectious Diseases, vol. 61, no. 6, pp. 996-1003. https://doi.org/10.1093/cid/civ437
Siberry, George K. ; Jacobson, Denise L. ; Kalkwarf, Heidi J. ; Wu, Julia W. ; Dimeglio, Linda A. ; Yogev, Ram ; Knapp, Katherine M. ; Wheeler, Justin J. ; Butler, Laurie ; Hazra, Rohan ; Miller, Tracie L ; Seage, George R. ; Van Dyke, Russell B. ; Barr, Emily ; Davtyan, Mariam ; Mofenson, Lynne M. ; Rich, Kenneth C. / Lower Newborn Bone Mineral Content Associated with Maternal Use of Tenofovir Disoproxil Fumarate during Pregnancy. In: Clinical Infectious Diseases. 2015 ; Vol. 61, No. 6. pp. 996-1003.
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abstract = "Background.Fetal bone effects of maternal tenofovir use have not been well studied. We sought to compare whole-body bone mineral content (BMC) of newborns exposed vs not exposed to tenofovir in utero. Methods.We enrolled participants from April 2011 to June 2013 at 14 US clinical sites. Singleton infants of women with human immunodeficiency virus (HIV) infection who took tenofovir in late pregnancy (tenofovir-exposed) or no tenofovir during pregnancy (tenofovir-unexposed) were enrolled during late pregnancy or within 72 hours of birth. Infants born before 36 weeks gestation or with confirmed HIV infection were excluded. Whole-body BMC was measured in the first month of life and compared with that of the tenofovir-exposed and tenofovir-unexposed newborns, unadjusted and adjusted for covariates. Results.Seventy-four tenofovir-exposed and 69 tenofovir-unexposed infants had evaluable BMC measurements. Tenofovir-exposed mothers were more likely to be married (31{\%} vs 22{\%}; P =. 04) and to use boosted protease inhibitors (84{\%} vs 62{\%}; P =. 004). Tenofovir-exposed newborns did not differ from unexposed newborns on mean gestational age (38.2 vs 38.1 weeks) or mean length (-0.41 vs-0.18) or weight (-0.71 vs-0.48) Z-scores. The mean (standard deviation) BMC of tenofovir-exposed infants was 12{\%} lower than for unexposed infants (56.0 [11.8] vs 63.8 [16.6] g; P =. 002). The adjusted mean bone mineral content was 5.3 g lower (95{\%} confidence interval,-9.5,-1.2; P =. 013) in the tenofovir-exposed infants. Conclusions.Maternal tenofovir use is associated with significantly lower neonatal BMC. The duration and clinical significance of this finding should be evaluated in longitudinal studies.",
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author = "Siberry, {George K.} and Jacobson, {Denise L.} and Kalkwarf, {Heidi J.} and Wu, {Julia W.} and Dimeglio, {Linda A.} and Ram Yogev and Knapp, {Katherine M.} and Wheeler, {Justin J.} and Laurie Butler and Rohan Hazra and Miller, {Tracie L} and Seage, {George R.} and {Van Dyke}, {Russell B.} and Emily Barr and Mariam Davtyan and Mofenson, {Lynne M.} and Rich, {Kenneth C.}",
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AU - Siberry, George K.

AU - Jacobson, Denise L.

AU - Kalkwarf, Heidi J.

AU - Wu, Julia W.

AU - Dimeglio, Linda A.

AU - Yogev, Ram

AU - Knapp, Katherine M.

AU - Wheeler, Justin J.

AU - Butler, Laurie

AU - Hazra, Rohan

AU - Miller, Tracie L

AU - Seage, George R.

AU - Van Dyke, Russell B.

AU - Barr, Emily

AU - Davtyan, Mariam

AU - Mofenson, Lynne M.

AU - Rich, Kenneth C.

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N2 - Background.Fetal bone effects of maternal tenofovir use have not been well studied. We sought to compare whole-body bone mineral content (BMC) of newborns exposed vs not exposed to tenofovir in utero. Methods.We enrolled participants from April 2011 to June 2013 at 14 US clinical sites. Singleton infants of women with human immunodeficiency virus (HIV) infection who took tenofovir in late pregnancy (tenofovir-exposed) or no tenofovir during pregnancy (tenofovir-unexposed) were enrolled during late pregnancy or within 72 hours of birth. Infants born before 36 weeks gestation or with confirmed HIV infection were excluded. Whole-body BMC was measured in the first month of life and compared with that of the tenofovir-exposed and tenofovir-unexposed newborns, unadjusted and adjusted for covariates. Results.Seventy-four tenofovir-exposed and 69 tenofovir-unexposed infants had evaluable BMC measurements. Tenofovir-exposed mothers were more likely to be married (31% vs 22%; P =. 04) and to use boosted protease inhibitors (84% vs 62%; P =. 004). Tenofovir-exposed newborns did not differ from unexposed newborns on mean gestational age (38.2 vs 38.1 weeks) or mean length (-0.41 vs-0.18) or weight (-0.71 vs-0.48) Z-scores. The mean (standard deviation) BMC of tenofovir-exposed infants was 12% lower than for unexposed infants (56.0 [11.8] vs 63.8 [16.6] g; P =. 002). The adjusted mean bone mineral content was 5.3 g lower (95% confidence interval,-9.5,-1.2; P =. 013) in the tenofovir-exposed infants. Conclusions.Maternal tenofovir use is associated with significantly lower neonatal BMC. The duration and clinical significance of this finding should be evaluated in longitudinal studies.

AB - Background.Fetal bone effects of maternal tenofovir use have not been well studied. We sought to compare whole-body bone mineral content (BMC) of newborns exposed vs not exposed to tenofovir in utero. Methods.We enrolled participants from April 2011 to June 2013 at 14 US clinical sites. Singleton infants of women with human immunodeficiency virus (HIV) infection who took tenofovir in late pregnancy (tenofovir-exposed) or no tenofovir during pregnancy (tenofovir-unexposed) were enrolled during late pregnancy or within 72 hours of birth. Infants born before 36 weeks gestation or with confirmed HIV infection were excluded. Whole-body BMC was measured in the first month of life and compared with that of the tenofovir-exposed and tenofovir-unexposed newborns, unadjusted and adjusted for covariates. Results.Seventy-four tenofovir-exposed and 69 tenofovir-unexposed infants had evaluable BMC measurements. Tenofovir-exposed mothers were more likely to be married (31% vs 22%; P =. 04) and to use boosted protease inhibitors (84% vs 62%; P =. 004). Tenofovir-exposed newborns did not differ from unexposed newborns on mean gestational age (38.2 vs 38.1 weeks) or mean length (-0.41 vs-0.18) or weight (-0.71 vs-0.48) Z-scores. The mean (standard deviation) BMC of tenofovir-exposed infants was 12% lower than for unexposed infants (56.0 [11.8] vs 63.8 [16.6] g; P =. 002). The adjusted mean bone mineral content was 5.3 g lower (95% confidence interval,-9.5,-1.2; P =. 013) in the tenofovir-exposed infants. Conclusions.Maternal tenofovir use is associated with significantly lower neonatal BMC. The duration and clinical significance of this finding should be evaluated in longitudinal studies.

KW - HIV

KW - infant bone mineral content

KW - intrauterine exposure

KW - tenofovir

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