Paper # 926 
Exposure during Gestation to HAART, including Tenofovir, Does Not Impair Bone Status and Metabolism in HIV- Children Born to HIV+ Mothers
Alessandra Vigano*1, G V Zuccotti1, S Stucchi1, C Cerini1, F Marinacci1, F Salvini2, C Gabiano3, M Cellini4, E Tamburrini5, and S Mora6
1Luigi Sacco Hosp, Univ of Milan, Italy; 2San Paolo Hosp, Univ of Milan, Italy; 3R Margherita Hosp, Univ of Turin, Italy; 4Univ of Modena and Reggio Emilia, Italy; 5Catholic Univ of Rome, Italy; and 6San Raffaele Sci Inst, Milan, Italy
Background: Recent works demonstrated the
applicability of Quantitative Ultrasound (QUS) in newborn, children and
adolescents. Bone toxicity due to fetal exposure to TDF has been shown in
animal models. Fetal risks associated to the use of TDF during pregnancy in
HIV-infected women became an urgent priority. The aim of the study was to
assess bone status and metabolism in seroreverter (SR) children in-uterus
exposed to TDF.
Methods: This is a multicenter observational
prospective cross-sectional study. We enrolled 51 seroreverter children,
in-uterus exposed to a Protease Inhibitor (PI)- based HAART regimen, including
TDF in 27 cases (TDF+) and not including TDF in 24 cases (TDF‑).
Since bone formation occurs mostly in the middle and late pregnancy, a TDF exposure
at least in the third trimester of pregnancy was the main inclusion criteria.
Neonatal parameters and duration of HAART exposure were recorded; at enrollment
anthropometric measurements, tibial speed of sound (SOS) by QUS, serum level of
bone alkaline phosphatase (BAP) and C-terminal telopeptide of type I collagen
(CTx) were assessed. SOS data were expressed as absolute values and z-scores.
Comparisons between TDF+ and TDF‑ cases were made
by Wilcoxon tests.
Results: TDF+ and TDF‑
cases were similar for mean gestational age (36.6 vs 37.2 weeks), mean birth
weight (2694 vs 2701 g), mean birth length (46.7 vs 46.2 cm) and duration
of HAART-exposure (mean exposure 27.1 vs 30.8; median exposure; range 25 [6 to 38]
vs 34 [20 to 38] weeks). At enrollment, they were also comparable for age (mean
age 29.7 vs 36.5 months; median age 23.2 (range 13 to 16.2) vs 35.4 (17.5 to
77.9), mean weight (12.7 vs 13.9 kg), mean height (88.9 vs 92.8 cm). Although
absolute tibial SOS values were lower in TDF+ than in TDF‑
cases (3471 vs 3558 m/s; P =0.038), tibial SOS z-scores were
similar in the 2 groups (0.6 vs 0.9; P =0.45). Similarly, no
differences between groups were detected in serum concentration of BAP (mean
value 145.8 vs 139.1 U/L) and type I collagen (mean value 1.41 vs 1.57 ng/mL).
Conclusions: Our study showed that exposure to TDF
during the second and third trimesters of gestation, when bone formation
occurs, does not impair bone mass and bone metabolism in seroreverter children
born to HIV-infected women.
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