Bone Mineral Density Changes Among Young, Healthy African Women Receiving Oral Tenofovir for HIV Preexposure Prophylaxis
Bone Mineral Density Changes Among Young, Healthy African Women Receiving Oral Tenofovir for HIV Preexposure Prophylaxis
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DOI：
10.1097/qai.0000000000000858
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发表时间：
2016-03-01
影响因子：
3.6
通讯作者：
Marrazzo, Jeanne M.
中科院分区：
文献类型：
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作者：
Mirembe, Brenda G.;Kelly, Clifton W.;Marrazzo, Jeanne M.
背景：关于富马酸替诺福韦二氧吡酯（TDF）用于hiv阴性妇女暴露前预防（PrEP）对骨密度（BMD）的影响的数据有限。我们在HIV-1 PrEP试验中评估了每日口服TDF和恩曲他滨/TDF与安慰剂对BMD的影响。方法：乌干达和津巴布韦未感染艾滋病毒的妇女在基线和每24周用双能x线骨密度仪测量腰椎（LS）和全髋关节（TH），接受48周积极治疗和停止研究药物治疗后48周。在前48周，每12周评估一次血浆替诺福韦水平。结果：入组的518名女性中，432名在基线和第48周有双能x线吸收测量结果。在初步分析中，没有观察到手臂之间髋部或脊柱骨密度变化百分比的显著差异，可能是因为产品依从性较低。在75%-100%的血浆样本中检测到替诺福韦的亚组中，TDF或恩曲他滨/TDF受体从基线到第48周的平均骨密度变化百分比比安慰剂组低1.4% (P = 0.002)， TH骨密度降低0.9% （P = 0.018）。与安慰剂组相比，从积极治疗结束到48周，积极组参与者的骨密度变化显著大于安慰剂组参与者，LS组的净差异约为+0.9% (P = 0.007)， TH组的净差异约为+0.7% （P = 0.003）。结论：含tdf的口服PrEP导致非洲年轻女性髋部和脊柱骨密度小但显著可逆的下降。
Background:Limited data exist on effect of tenofovir disoproxil fumarate (TDF) when used for preexposure prophylaxis (PrEP) on bone mineral density (BMD) in HIV-negative women. We evaluated the effect of daily oral TDF and emtricitabine/TDF compared with placebo on BMD among women enrolled in an HIV-1 PrEP trial.Methods:HIV-uninfected women in Uganda and Zimbabwe had BMD measurements of lumbar spine (LS) and total hip (TH) by dual-energy x-ray absorptiometry at baseline and every 24 weeks for 48 weeks of active treatment and for 48 weeks after discontinuation of study medication. Plasma tenofovir levels were assessed every 12 weeks for the first 48 weeks.Results:Of 518 women enrolled, 432 had dual-energy x-ray absorptiometry results at baseline and week 48. In the primary analysis, no significant differences in percent BMD change in hip or spine between arms observed, likely because of low product adherence. Among the subset with tenofovir detection in 75%-100% of plasma samples, the mean percent BMD change from baseline to week 48 in the LS was 1.4% lower for TDF or emtricitabine/TDF recipients than for placebo (P = 0.002) and TH BMD was 0.9% lower (P = 0.018). BMD changes from end of active treatment to 48 weeks were significantly greater in the active arm participants compared with placebo participants with a net difference of approximately +0.9% at the LS (P = 0.007) and +0.7% (P = 0.003) at the TH.Conclusions:TDF-containing oral PrEP resulted in small but significant reversible decreases in hip and spine BMD among young African women.