Viganò Alessandra, Mora Stefano, Giacomet Vania, Stucchi Sara, Manfredini Valeria, Gabiano Clara, Salvini Filippo, Cellini Monica, Tamburrini Enrica, Puzzovio Maria, Zuccotti Gian Vincenzo
Department of Paediatrics, L Sacco Hospital, University of Milan, Milan, Italy.
Antivir Ther. 2011;16(8):1259-66. doi: 10.3851/IMP1909.
Growth impairment and bone toxicity due to tenofovir disoproxil fumarate (TDF) fetal exposure has been described mainly in animals. We evaluated growth pattern and bone health in TDF-exposed HIV-uninfected children born to HIV-infected mothers, defined as seroreverters (SR).
This was a multicentre observational cross-sectional cohort study enrolling 68 SR who were in utero exposed to an antiretroviral regimen including (TDF+) or not including (TDF-) tenofovir. Neonatal data and duration of antiretroviral exposure were recorded. At enrolment, anthropometric measures, tibial speed of sound (SOS) by quantitative ultrasound and several parameters of bone metabolism were assessed.
Gestational age and median in utero antiretroviral exposure were similar in subjects exposed to TDF (n=33) and those non-exposed (n =35). Age at enrolment was comparable in the two groups (TDF-exposed range 11.8-76.2 months and TDF non-exposed range 11.8-77.9 months). The incidence of low weight and length measurements (<10th percentiles) at birth was similar in TDF-exposed and TDF non-exposed. Normal growth development was found in both groups of subjects at enrolment. The median (0.6; range -2.4-2.6) SOS z-score of TDF-exposed was similar to the median (0.8; range -2.2-4.4) SOS z-score of TDF non-exposed (Student's t=0.84; P=0.40). Parameters of bone metabolism were similar in the two groups.
Exposure to TDF during pregnancy does not impair growth patterns, bone health and markers of bone metabolism in SR infants and young children born to HIV-infected women.
富马酸替诺福韦二吡呋酯（TDF）胎儿暴露导致的生长发育受损和骨毒性主要在动物中有所描述。我们评估了感染HIV的母亲所生未感染HIV的儿童（定义为血清学转换者，SR）在胎儿期暴露于TDF后的生长模式和骨骼健康状况。
这是一项多中心观察性横断面队列研究，纳入了68名血清学转换者，他们在子宫内暴露于含（TDF+）或不含（TDF-）替诺福韦的抗逆转录病毒治疗方案。记录了新生儿数据和抗逆转录病毒治疗暴露时间。在入组时，评估了人体测量指标、定量超声测量的胫骨声速（SOS）以及几个骨代谢参数。
暴露于TDF的受试者（n=33）和未暴露的受试者（n =35）的胎龄和子宫内抗逆转录病毒治疗的中位暴露时间相似。两组入组时的年龄相当（暴露于TDF组范围为11.8 - 76.2个月，未暴露于TDF组范围为11.8 - 77.9个月）。暴露于TDF组和未暴露于TDF组出生时低体重和低身长测量值（<第10百分位数）的发生率相似。两组受试者在入组时生长发育均正常。暴露于TDF组的SOS z评分中位数（0.6；范围-2.4 - 2.6）与未暴露于TDF组的SOS z评分中位数（0.8；范围-2.2 - 4.4）相似（学生t检验t=0.84；P=0.40）。两组的骨代谢参数相似。
孕期暴露于TDF不会损害感染HIV的妇女所生血清学转换婴儿和幼儿的生长模式、骨骼健康及骨代谢标志物。
