Perinatal Antiretroviral Intensification to Prevent Intrapartum HIV Transmission When Antenatal Antiretroviral Therapy Is Initiated Less Than 8 Weeks Before Delivery.
Perinatal Antiretroviral Intensification to Prevent Intrapartum HIV Transmission When Antenatal Antiretroviral Therapy Is Initiated Less Than 8 Weeks Before Delivery.
复制标题
DOI：
10.1097/qai.0000000000002350
复制
发表时间：
2020-07-01
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
感染艾滋病毒的妇女在怀孕后期开始联合抗逆转录病毒治疗（cART）所生的婴儿在分娩时感染的风险很高。母亲/婴儿围产期抗逆转录病毒强化可大大降低这一风险。在这项单臂贝叶斯试验中，在泰国接受抗逆转录病毒预防标准治疗的艾滋病孕妇（孕妇产前基于洛匹那韦的cART;非母乳喂养的婴儿（出生后4周的齐多夫定）提供“抗逆转录病毒强化”（分娩期单剂量奈韦拉平+婴儿齐多夫定-拉米夫定-奈韦拉平2周，随后齐多夫定-拉米夫定2周）如果他们在分娩前≤8周开始产前cART。出生时HIV-DNA聚合酶链反应（PCR）阴性，随后经确认PCR阳性，定义为产时传播。在研究开始之前，我们使用我们之前在泰国进行的试验中招募的3738对母亲/婴儿对的数据，使用logistic模型，以围产期母亲/婴儿抗逆转录病毒方案和分娩时预测的病毒载量作为主要协变量，对分娩时传播概率进行建模。使用的妇女谁注册接受强化治疗的特点，以前的产时传播概率（可信区间）与/不强化进行了估计。在包括当前研究中观察到的传输数据后，推导出相应的贝叶斯后验传输概率。在接受强化治疗的88对母婴中，未观察到分娩期间艾滋病毒传播。估计分娩期传播概率为22%（95%可信区间0.5-6.1），无强化，强化为0.3%（0.0-1.6）。强化治疗优于标准治疗的概率为94.4%。抗逆转录病毒强化治疗似乎是安全的。在产前接受≤8周cART的孕妇中，母婴抗逆转录病毒强化治疗可有效预防分娩期HIV传播。
Infants born to women living with HIV initiating combination antiretroviral therapy (cART) late in pregnancy are at high risk of intrapartum infection. Mother/infant perinatal antiretroviral intensification may substantially reduce this risk. In this single-arm Bayesian trial, pregnant women with HIV receiving standard of care antiretroviral prophylaxis in Thailand (maternal antenatal lopinavir-based cART; nonbreastfed infants 4 weeks’ postnatal zidovudine) were offered “antiretroviral intensification” (labor single-dose nevirapine plus infant zidovudine-lamivudine-nevirapine for 2 weeks followed by zidovudine-lamivudine for 2 weeks) if their antenatal cART was initiated ≤8 weeks before delivery. A negative birth HIV-DNA polymerase chain reaction (PCR) followed by a confirmed positive PCR defined intrapartum transmission. Before study initiation, we modeled intrapartum transmission probabilities using data from 3738 mother/infant pairs enrolled in our previous trials in Thailand using a logistic model, with perinatal maternal/infant antiretroviral regimen and predicted viral load at delivery as main covariates. Using the characteristics of the women enrolled who received intensification, prior intrapartum transmission probabilities (credibility intervals) with/without intensification were estimated. After including the transmission data observed in the current study, the corresponding Bayesian posterior transmission probability was derived. No intrapartum transmission of HIV was observed among the 88 mother/infant pairs receiving intensification. The estimated intrapartum transmission probability was 22% (95% credibility interval 0.5–6.1) without intensification versus 0.3% (0.0–1.6) with intensification. The probability of superiority of intensification over standard of care was 94.4%. Antiretroviral intensification appeared safe. Mother/infant antiretroviral intensification was effective in preventing intrapartum transmission of HIV in pregnant women receiving ≤8 weeks antepartum cART.