Emulating a target trial of antiretroviral therapy regimens started before conception and risk of adverse birth outcomes.
Emulating a target trial of antiretroviral therapy regimens started before conception and risk of adverse birth outcomes.
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DOI：
10.1097/qad.0000000000001673
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发表时间：
2018-01-02
期刊：
影响因子：
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通讯作者：
Shapiro RL
中科院分区：
文献类型：
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作者：
Caniglia EC;Zash R;Jacobson DL;Diseko M;Mayondi G;Lockman S;Chen JY;Mmalane M;Makhema J;Hernán MA;Shapiro RL
比较妊娠前开始使用齐多夫定、拉米夫定、奈韦拉平（ZDV/3 TC/NVP）与替诺福韦、恩曲他滨、依法韦仑（TDF/FTC/EFV）对不良出生结局的影响。在基于CD 4的抗逆转录病毒治疗（ART）开始的时代，使用博茨瓦纳出生监测研究模拟一项假设（目标）试验。在HIV诊断后3年内开始ART治疗、ART治疗后0.5-5年怀孕、妊娠≥24周分娩的妇女中，我们估计了死产、早产的风险比，（<37周），极早产（<32周）、小于胎龄儿（SGA）（<10%瓦片）、非常小于胎龄儿（<3%瓦片）以及一线ZDV/3 TC/NVP与TDF/FTC/EFV的任何不良或严重分娩结局。我们对2012-2015年开始TDF/FTC/EFV和2004-2011年开始ZDV/3 TC/NVP的女性进行了历史比较，并在2009-2013年重叠使用的时代进行了同期比较。在历史比较中，1108名女性开始TDF/FTC/EFV，637名开始ZDV/3 TC/NVP。在同期比较中，1052例启动了TDF/FTC/EFV，298例启动了ZDV/3 TC/NVP。在两项比较中，TDF/FTC/EFV启动者比ZDV/3 TC/NVP启动者更年轻，更可能未经产。在历史比较中，比较ZDV/3 TC/NVP与TDF/FTC/EFV的校正风险比（95% CI）为2.95（1.76，4.96）死产，1.40（1.17，1.67）早产，2.58（1.70，3.91）对于极早产，1.96（1.64，2.34）对于SGA，2.32（1.73，3.09）对于非常SGA，1.54（1.38，1.72），任何严重的出生结果为2.20（1.76，2.75），在同期比较中相似。与TDF/FTC/EFV相比，妊娠前开始使用ZDV/3 TC/NVP可能会增加不良出生结局的风险。
To compare the effect of pre-conception initiation of zidovudine, lamivudine, nevirapine (ZDV/3TC/NVP) versus tenofovir, emtricitabine, efavirenz (TDF/FTC/EFV) on adverse birth outcomes. Emulation of a hypothetical (target) trial using a birth surveillance study in Botswana during an era of CD4-based antiretroviral therapy (ART) initiation. In women who initiated ART <3 years from HIV diagnosis, conceived 0.5–5 years after ART initiation, and delivered ≥24 weeks gestation, we estimated risk ratios for stillbirth, preterm delivery (<37 weeks), very preterm delivery (<32 weeks), small-for-gestational-age (SGA) (<10%tile), very SGA (<3%tile), and any adverse or severe birth outcome for first-line ZDV/3TC/NVP vs. TDF/FTC/EFV. We conducted a historical comparison in women who initiated TDF/FTC/EFV in 2012–2015 and ZDV/3TC/NVP in 2004–2011, and a contemporaneous comparison in an era of overlapping use from 2009–2013. In the historical comparison, 1108 women initiated TDF/FTC/EFV and 637 initiated ZDV/3TC/NVP. In the contemporaneous comparison, 1052 initiated TDF/FTC/EFV and 298 initiated ZDV/3TC/NVP. TDF/FTC/EFV initiators were younger and more likely to be nulliparous than ZDV/3TC/NVP initiators in both comparisons. In the historical comparison, the adjusted risk ratios (95% CI) comparing ZDV/3TC/NVP with TDF/FTC/EFV were 2.95 (1.76, 4.96) for stillbirth, 1.40 (1.17, 1.67) for preterm delivery, 2.58 (1.70, 3.91) for very preterm delivery, 1.96 (1.64, 2.34) for SGA, 2.32 (1.73, 3.09) for very SGA, 1.54 (1.38, 1.72) for any adverse birth outcome, and 2.20 (1.76, 2.75) for any severe birth outcome, and were similar in the contemporaneous comparison. Pre-conception initiation of ZDV/3TC/NVP compared with TDF/FTC/EFV may increase the risk of adverse birth outcomes.