评估孕产妇病毒载量对围产期和产后HIV传播的影响：一项系统评价和荟萃分析。
Estimating the effect of maternal viral load on perinatal and postnatal HIV transmission: a systematic review and meta-analysis.
作者信息
Dugdale Caitlin M, Ufio Ogochukwu, Giardina John, Shebl Fatma, Coskun Elif, Pletner Eden, Torola Pamela R, Cosar Duru, Shapiro Roger, Kim Maria, Mofenson Lynne, Ciaranello Andrea L
机构信息
Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA; Division of Infectious Diseases, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA, USA.
出版信息
Lancet. 2025 Jul 10. doi: 10.1016/S0140-6736(25)00765-2.
BACKGROUND
Although a growing body of evidence supports zero risk of sexual HIV transmission from a person with sustained virological suppression, known as U=U (undetectable equals untransmittable), data have been insufficient to determine whether this is also true for vertical HIV transmission. We conducted a systematic review and meta-analysis to quantify vertical transmission risk by maternal HIV viral load (mHVL) and to evaluate the applicability of U=U to perinatal and postnatal HIV transmission.
METHODS
In this systematic review and meta-analysis, we searched PubMed, Embase, Web of Science, Cochrane Library, Cumulative Index of Nursing and Allied Health Literature, the WHO Global Health Library, and abstracts from the International AIDS Society Conference and the Conference on Retroviruses and Opportunistic Infections (2016-24) for studies published from Jan 1, 1989, to Dec 31, 2024, reporting the relationship between mHVL near birth (to estimate perinatal transmission risk by 6 weeks) or during breastfeeding (to estimate monthly postnatal transmission risk by mHVL within the past 6 months) and vertical transmission. We pooled risks of perinatal and postnatal transmission across prespecified mHVL categories. We also conducted comparative analyses to determine the adjusted relative risk (aRR) of transmission by mHVL using Poisson meta-regression. The protocol for this analysis is registered on the International Prospective Register of Systematic Reviews (PROSPERO; CRD42019146768).
FINDINGS
147 studies were included in the analysis; 138 studies contributed to perinatal analyses and 13 studies contributed to postnatal analyses. Data on 82 723 mother-child pairs were included across all analyses. Pooled perinatal transmission risks were 0·2% (95% CI 0·2-0·3) with a mHVL of <50 copies per mL, 1·3% (1·0-1·7) with 50-999 copies per mL, and 5·1% (2·6-7·9) with ≥1000 copies per mL. aRRs of perinatal transmission were 6·3 (3·9-10·3) with a mHVL of 50-999 copies per mL and 22·5 (13·9-36·5) with ≥1000 copies per mL versus <50 copies per mL. In subgroup analyses, in five studies reporting on 4675 women receiving pre-conception antiretroviral therapy (ART) with a mHVL of <50 copies per mL near birth, there were zero (0%, 0·0-0·1) perinatal transmissions. Monthly postnatal transmission risks were 0·1% (0·0-0·4) with recent mHVL <50 copies per mL and 0·5% (0·1-1·8) with a mHVL of ≥50 copies per mL.
INTERPRETATION
Perinatal transmission with a mHVL of <50 copies per mL is ≤0·2% overall. Zero transmissions were observed among women receiving ART before pregnancy with a mHVL of <50 copies per mL near birth, supporting U=U in pregnancy and birth. Postnatal transmission was very low-but not zero-among women with a recent mHVL of <50 copies per mL. Current data, largely from studies lacking frequent mHVL monitoring or modern first-line ART regimens, are insufficient to assess U=U during breastfeeding.
FUNDING
National Institutes of Health, WHO, and Massachusetts General Hospital.
背景
尽管越来越多的证据支持，病毒得到持续抑制的人发生性传播艾滋病毒的风险为零，即所谓的“U=U”（检测不到即不具传染性），但尚无足够数据来确定这是否也适用于垂直传播艾滋病毒。我们进行了一项系统评价和荟萃分析，以量化孕产妇艾滋病毒载量（mHVL）导致的垂直传播风险，并评估“U=U”在围产期和产后艾滋病毒传播中的适用性。
方法
在这项系统评价和荟萃分析中，我们检索了PubMed、Embase、Web of Science、Cochrane图书馆、护理及相关健康文献累积索引、世卫组织全球健康图书馆，以及国际艾滋病学会会议和逆转录病毒与机会性感染会议（2016 - 2024年）的摘要，以查找1989年1月1日至2024年12月31日发表的研究，这些研究报告了临近分娩时的mHVL（以估计6周时的围产期传播风险）或母乳喂养期间的mHVL（以估计过去6个月内每月的产后传播风险）与垂直传播之间的关系。我们汇总了预先设定的mHVL类别中的围产期和产后传播风险。我们还进行了比较分析，以使用泊松荟萃回归确定mHVL导致传播的调整相对风险（aRR）。该分析方案已在国际前瞻性系统评价注册库（PROSPERO；CRD42019146768）上注册。
结果
147项研究纳入了分析；138项研究用于围产期分析，13项研究用于产后分析。所有分析共纳入了82723对母婴的数据。mHVL每毫升<50拷贝时，汇总围产期传播风险为0.2%（95%CI 0.2 - 0.3）；每毫升50 - 999拷贝时为1.3%（1.0 - 1.7）；每毫升≥1000拷贝时为5.1%（2.6 - 7.9）。与每毫升<50拷贝相比，mHVL每毫升50 - 999拷贝时围产期传播的aRR为6.3（3.9 - 10.3），每毫升≥1000拷贝时为22.5（13.9 - 36.5）。在亚组分析中，五项研究报告了4675名在临近分娩时mHVL每毫升<50拷贝且接受孕前抗逆转录病毒治疗（ART）的女性，围产期传播为零（0%，0.0 - 0.1）。近期mHVL每毫升<50拷贝时，每月产后传播风险为0.1%（0.0 - 0.4），mHVL每毫升≥50拷贝时为0.5%（0.1 - 1.8）。
解读
mHVL每毫升<50拷贝时，总体围产期传播率≤0.2%。在临近分娩时mHVL每毫升<50拷贝且孕前接受ART的女性中未观察到传播，支持孕期和分娩时的“U=U”。近期mHVL每毫升<50拷贝的女性产后传播率很低，但不为零。目前的数据大多来自缺乏频繁mHVL监测或现代一线ART方案的研究，不足以评估母乳喂养期间的“U=U”。
资助
美国国立卫生研究院、世界卫生组织和马萨诸塞州总医院。
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