Association of tenofovir disoproxil fumarate with neonatal growth
Background: The use of Tenofovir Disoproxil Fumarate (TDF) for the treatment of HIV in pregnancy is increasing. The effects of exposure to TDF in utero on fetal and infant growth are unclear. Methods: The study population included live born singleton infants of mothers enrolled in the International Maternal Pediatric Adolescent AIDS Clinical Trials Group protocol P1025 born between 2002 and 2011 in the United States and exposed to a combined (triple or more) antiretroviral (ARV) regimen in utero. Infants who were HIV-infected, born at or before 23 weeks gestation or part of a multiple gestation were excluded. Infant weight at birth and 6 months was compared between infants exposed to TDF in utero and infants not exposed to TDF using two-sample t-tests and one-way ANOVA tests, as appropriate. Results: Among 1496 infants followed for 6 months, 457 (31%) were exposed to TDF in utero. Among the 2025 infants with birth weight, there was no difference between those exposed versus unexposed to TDF in mean birth weight (Table 1: 3.0 vs. 3.0 kg, p=0.47), or mean age and sex-adjusted birth weight z-score (-0.3 vs. -0.3, p=0.91). No difference was found in mean weight at 6 months in TDF-exposed and TDF-unexposed infants (Table 2: 7.8 vs. 7.7 kg, p= 0.51), or in mean age- and sex-adjusted weight z-score (0.3 vs. 0.2, p= 0.58). Duration of TDF exposure had no effect on neonatal or infant growth. Women on TDF during pregnancy had lower CD4 counts at delivery compared to women not on TDF (median: 428 vs. 507, P< 0.001) and were older at delivery (mean age: 28.8 vs. 27.6 years, p< 0.001). Conclusions: Among infants of women receiving combination ARV regimens during pregnancy, in utero exposure to TDF does not appear to be associated with infant birth weight or infant growth.
Ransom, C; Huo, Y; Patel, K; Scott, G; Watts, H; Williams, P; Siberry, G; Livingston, E; P1025 Team of the International Maternal Pediatric Adolescent AIDS Clinical Trials Group,
19th International Aids Conference, Washington, Dc
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