本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(23)02464-9

摘要内容如下：

背景

全世界新感染艾滋病毒的儿童人数高得令人无法接受，其中一半以上是通过母乳喂养传播的。我们假设，除了母体抗逆转录病毒治疗（ART）外，在即时检测母体病毒载量的指导下，延长拉米夫定的产后预防，可以减少产后传播。

方法

我们在赞比亚的四家卫生保健机构和布基纳法索的四家卫生保健机构进行了一项3期、开放标签、随机对照试验。携带艾滋病毒的母亲及其母乳喂养的未携带艾滋病毒的婴儿参加了扩大免疫计划（EPI-2；6-8周的婴儿）的第二次访视，并按1:1的比例随机分配到干预组或对照组。在干预组中，在EPI-2和6个月时使用Xpert HIV病毒载量测定测量母体病毒载量，并立即提供结果。母亲病毒载量为每毫升1000拷贝或更高的婴儿开始服用拉米夫定糖浆，每天两次，持续12个月或停止母乳喂养后1个月。对照组遵循预防艾滋病毒产后传播的国家指导方针。通过改良意向治疗评估的主要结果是12个月大时的婴儿HIV感染，以及6个月和12个月时的HIV DNA即时检测。该试验在ClinicalTrials.gov（NCT03870438）上注册。

调查结果

在2019年12月12日至2021年9月30日期间，34054名母亲接受了艾滋病毒筛查。其中，1506名感染HIV的母亲及其未感染HIV的婴儿，包括1342对来自赞比亚的母婴和164对来自布基纳法索的母婴，符合条件，并按1:1随机分配到干预组（n=753）或对照组（n=753）。基线时，母亲的中位年龄为30.6岁（IQR 26.0-34.7），1504人中有1480人（98.4%）正在接受抗逆转录病毒治疗，1466人中有169人（11.5%）的病毒载量≥1000 copies/mL。干预组有1例HIV传播病例，对照组有6例，干预组传播发生率为0.19/100人-年（95%CI 0.005-1.04），对照组传播发生率为1.16/100人-年（95%CI 0.43-2.53），差异无统计学意义（P=0.066）。两组的无HIV存活率和严重不良事件相似。

解释

我们的干预措施始于EPI-2，并基于延长的单一药物产后预防，由护理点母体病毒载量指导，可能是消除儿科HIV的重要策略。

英文原文如下：

Abstracts

BACKGROUND  Transmission through breastfeeding accounts for more than half of the unacceptably high number of new paediatric HIV infections worldwide. We hypothesised that, in addition to maternal antiretroviral therapy (ART), extended postnatal prophylaxis with lamivudine, guided by point-of-care assays for maternal viral load, could reduce postnatal transmission.

METHODS  We did a phase 3, open-label, randomised controlled trial at four health-care facilities in Zambia and four health-care facilities in Burkina Faso. Mothers with HIV and their breastfed infants without HIV attending the second visit of the Expanded Programme of Immunisation (EPI-2; infant age 6-8 weeks) were randomly assigned 1:1 to intervention or control groups. In the intervention group, maternal viral load was measured using Xpert HIV viral load assay at EPI-2 and at 6 months, with results provided immediately. Infants whose mothers had a viral load of 1000 copies per mL or higher were started on lamivudine syrup twice per day for 12 months or 1 month after breastfeeding discontinuation. The control group followed national guidelines for prevention of postnatal transmission of HIV. The primary outcome assessed by modified intention to treat was infant HIV infection at age 12 months, with HIV DNA point-of-care testing at 6 months and at 12 months. This trial is registered with ClinicalTrials.gov (NCT03870438).

FINDINGS  Between Dec 12, 2019 and Sept 30, 2021, 34 054 mothers were screened for HIV. Among them, 1506 mothers with HIV and their infants without HIV, including 1342 mother and infant pairs from Zambia and 164 from Burkina Faso, were eligible and randomly assigned 1:1 to the intervention (n=753) or control group (n=753). At baseline, the median age of the mothers was 30·6 years (IQR 26·0-34·7), 1480 (98·4%) of 1504 were receiving ART, and 169 (11·5%) of 1466 had a viral load ≥1000 copies/mL. There was one case of HIV transmission in the intervention group and six in the control group, resulting in a transmission incidence of 0·19 per 100 person-years (95% CI 0·005-1·04) in the intervention group and 1·16 per 100 person-years (0·43-2·53) in the control group, which did not reach statistical significance (p=0·066). HIV-free survival and serious adverse events were similar in both groups.

INTERPRETATION  Our intervention, initiated at EPI-2 and based on extended single-drug postnatal prophylaxis guided by point-of-care maternal viral load could be an important strategy for paediatric HIV elimination.

-----------分割线---------

点击链接：https://www.mediecogroup.com/community/user/vip/categories/ ，成为医咖会员，获取12项专属权益。