Journal
CLINICAL INFECTIOUS DISEASES
Volume 61, Issue 6, Pages 996-1003Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/civ437
Keywords
HIV; infant bone mineral content; tenofovir; intrauterine exposure
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Funding
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- National Institute on Drug Abuse
- National Institute of Allergy and Infectious Diseases
- Office of AIDS Research
- National Institute of Mental Health
- National Institute of Neurological Disorders and Stroke
- National Institute on Deafness and Other Communication Disorders
- National Heart Lung and Blood Institute
- National Institute of Dental and Craniofacial Research
- National Institute on Alcohol Abuse and Alcoholism
- Harvard University School of Public Health [U01 HD052102]
- Tulane University School of Medicine [U01 HD052104]
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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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