Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Center of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
J Int AIDS Soc. 2020 Oct;23(10):e25624. doi: 10.1002/jia2.25624.
Tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) is used for HIV pre-exposure prophylaxis (PrEP). TDF may affect bone mineral density (BMD), particularly in youth who are at a stage of peak bone mass accrual. The objective of this study was to evaluate the effect of vitamin D and calcium supplementation on BMD among Thai youth receiving daily oral PrEP.
This open-label randomized trial was conducted in male youth aged between 15 and 24 years. Participants were randomized to Arm A who received once-daily TDF/FTC plus vitamin D3 and calcium supplementation with meals twice daily (400 units of vitamin D3 and 1200 mg of elemental calcium/day) or Arm B who received once-daily TDF/FTC only. PrEP users were defined as taking at least two tablets/week (tenofovir-diphosphate level of >350 fmol/punch). Adherence to vitamin D/calcium supplementation was defined as self-reported adherence of >50%. Lumbar spine (L2-L4) BMD (LSBMD) was evaluated by dual-energy X-ray absorptiometry scan zero and six months after PrEP initiation.
From March 2019 to March 2020, 100 youth were enrolled. Baseline characteristics between the two arms were similar. Median (IQR) age was 18 (17 to 20) years. At entry, median (IQR) LSBMD z-score was -0.8 (-1.5 to -0.3), 17% had low LSBMD (Z-score < -2). The median amount of calcium intake from nutritional three-day recall was 167 (IQR 94 to 272) mg/day, 39% of participants had vitamin D deficiency, defined as 25(OH)D levels <20 IU/mL. At six months, 79 participants were evaluated. Of these, 42 (52%) were PrEP takers and 25 of 38 (66%) of arm A participants had good adherence to vitamin D/calcium supplementation. Significantly higher proportions of youth in arm A compared to arm B had >3% increase in LSBMD at month 6 compared to baseline (67.6% vs. 42.9% respectively; p = 0.03). There were significantly higher increases in LSBMD among youth with vitamin D deficiency who were supplemented; arm A + 0.05 (0 to 0.05) compared to arm B + 0.03 (-0.1 to 0.03), p = 0.04.
Increases in LSBMD over six months among youth using PrEP who received vitamin D/calcium supplementation was greater than those not supplemented. Long-term follow-up should be considered to explore long-term outcomes.
富马酸替诺福韦二吡呋酯和恩曲他滨（TDF/FTC）用于 HIV 暴露前预防（PrEP）。TDF 可能会影响骨矿物质密度（BMD），尤其是在处于骨量峰值积累阶段的年轻人中。本研究的目的是评估维生素 D 和钙补充剂对接受每日口服 PrEP 的泰国年轻人 BMD 的影响。
这是一项开放标签随机试验，纳入了年龄在 15 至 24 岁之间的男性青年。参与者被随机分配到 A 组，每天服用 TDF/FTC 加维生素 D3 和钙补充剂，每天两次随餐服用（400 单位维生素 D3 和 1200 毫克元素钙/天），或 B 组，每天仅服用 TDF/FTC。PrEP 用户定义为每周至少服用两片（替诺福韦二磷酸水平>350 fmol/冲）。维生素 D/钙补充剂的依从性定义为自我报告的依从性>50%。腰椎（L2-L4）骨矿物质密度（LSBMD）在 PrEP 开始后零个月和六个月时通过双能 X 射线吸收法扫描评估。
从 2019 年 3 月至 2020 年 3 月，共纳入了 100 名年轻人。两组之间的基线特征相似。中位（IQR）年龄为 18（17 至 20）岁。入组时，LSBMD z 评分的中位数（IQR）为-0.8（-1.5 至-0.3），17%的人 LSBMD 较低（Z 评分<−2）。通过三天的营养回忆，钙的中位摄入量为 167（IQR 94 至 272）mg/天，39%的参与者维生素 D 缺乏，定义为 25（OH）D 水平<20 IU/mL。在六个月时，对 79 名参与者进行了评估。其中，42 名（52%）为 PrEP 使用者，38 名参与者中有 25 名（66%）A 组参与者对维生素 D/钙补充剂的依从性良好。与 B 组相比，A 组在六个月时 LSBMD 增加>3%的年轻人比例更高（分别为 67.6%和 42.9%；p=0.03）。在接受维生素 D 补充的年轻人中，LSBMD 有显著更高的增加，A 组+0.05（0 至 0.05）与 B 组+0.03（-0.1 至 0.03）相比，p=0.04。
在接受维生素 D/钙补充剂的接受 PrEP 的年轻人中，LSBMD 在六个月内的增加大于未接受补充剂的年轻人。应考虑进行长期随访以探索长期结局。
