Increased Risk of Preterm Delivery Among HIV-Infected Women Randomized to Protease Versus Nucleoside Reverse Transcriptase Inhibitor-Based HAART During Pregnancy
Increased Risk of Preterm Delivery Among HIV-Infected Women Randomized to Protease Versus Nucleoside Reverse Transcriptase Inhibitor-Based HAART During Pregnancy
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DOI：
10.1093/infdis/jir307
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发表时间：
2011-08-15
影响因子：
6.4
通讯作者：
Shapiro, Roger L.
中科院分区：
文献类型：
--
作者：
Powis, Kathleen M.;Kitch, Douglas;Shapiro, Roger L.
背景资料。在一些观察性研究中，妊娠期间使用基于蛋白酶抑制剂(PI)的高效抗逆转录病毒疗法(HAART)与早产有关。在一项预防母婴传播的临床试验中，HIV感染、HAART幼稚、CD4+细胞计数=200个/mm(3)的孕妇被随机分配到怀孕26至34周的洛匹那韦/利托那韦/齐多夫定/拉米夫定(PI组)或阿巴卡韦/齐多夫定/拉米夫定(NRTI组)。用Logistic回归分析活体婴儿早产(37周)的危险因素和差异。PI组的267名妇女早产率高于NRTI组的263名妇女(21.4%比11.8%，P=0.003)。以PI为基础的HAART是早产最显著的危险因素[优势比=2.03，95%可信区间1.26-3.27，P=0.004]。在HAART开始后1个月，PI组孕妇体重指数(BMI)的平均变化较低(P<；.001)；然而，这与早产并不显著相关。6个月的婴儿住院率和死亡率均不受母体方案的影响。在临床试验中，基于PI的HAART与早产增加有关，但与婴儿住院或死亡率增加无关。孕晚期使用PI与BMI较低增加之间的关系值得进一步研究。
Background. Protease inhibitor (PI)-based highly active antiretroviral therapy (HAART) use in pregnancy has been associated with preterm deliveries in some observational studies.Methods. HIV-infected, HAART-naive pregnant women with CD4+ counts >= 200 cells/mm(3) were randomized between 26 and 34 weeks gestation to lopinavir/ritonavir/zidovudine/lamivudine (PI group) or abacavir/zidovudine/lamivudine (NRTI group) in a clinical trial to prevent mother-to-child HIV transmission. Risk factors for preterm delivery (< 37 weeks) and differences by randomization arm were evaluated for live infants by logistic regression.Results. Preterm delivery rates were higher among 267 women in the PI group than 263 women in the NRTI group (21.4% vs 11.8%, P = .003). PI-based HAART was the most significant risk factor for preterm delivery [odds ratio = 2.03, 95% confidence interval 1.26-3.27, P = .004]. Mean change in maternal body mass index (BMI) 1 month after HAART initiation was lower in the PI group (P < .001); however, this was not significantly associated with preterm delivery. Neither infant hospitalizations nor mortality through 6 months of life differed by maternal regimen.Conclusions. PI-based HAART was associated with increased preterm delivery but not increased infant hospitalizations or mortality in a clinical trial setting. The association between PI use and lower increase in BMI in late pregnancy warrants further study.