Perinatal outcomes following maternal pre-exposure prophylaxis (PrEP) use during pregnancy: results from a large PrEP implementation program in Kenya
Perinatal outcomes following maternal pre-exposure prophylaxis (PrEP) use during pregnancy: results from a large PrEP implementation program in Kenya
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DOI：
10.1002/jia2.25378
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发表时间：
2019-09-01
影响因子：
6
通讯作者：
John-Stewart, Grace
中科院分区：
文献类型：
--
作者：
Dettinger, Julia C.;Kinuthia, John;John-Stewart, Grace
简介世界卫生组织在建议艾滋病毒阴性孕妇和产后在艾滋病毒高负担环境中进行暴露前预防(PrEP)的同时，倡导继续对这一人群进行PrEP的安全性评估。方法在肯尼亚西部16个地点，青年妇女和青少年PrEP实施方案(PRIA)向整合在常规妇幼保健诊所(MCH)内的孕妇和产后妇女提供PrEP。在方案评估期间，收集了获得产后服务的妇女的孕前暴露和围产期结局数据。PREP的使用是自行报告的，并与临床记录进行了确认。围产儿结局包括出生时的胎龄、出生体重、先天性畸形和婴儿生长发育结果，从参加六周访问的母婴对的临床记录中提取。使用单变量和多变量Logistic回归和线性回归分析婴儿结局和母体产前PrEP使用之间的关系。结果Priya评估确定了1530对有产前PrEP暴露数据的产后母婴：206对产前使用PrEP，1324对未使用PrEP。两组孕妇的平均年龄均为24岁。PREP使用者(任何报告的PrEP使用)报告艾滋病毒风险因素的可能性明显更大，例如：亲密伴侣暴力、性传播感染以及有一个艾滋病毒阳性或未知的伴侣。大多数母亲在孕中期开始使用PrEP(n=116，57%)，并使用PrEP超过一个月(n=110，58%)。两组新生儿平均出生体重3.3公斤，出生时胎龄38.5周。接触PrEP的婴儿和未接触PrEP的婴儿在早产率和低出生体重率方面没有重大差异。在PrEP暴露组中没有发现先天性畸形，在PrEP非暴露组中有5例报告。在产后六周，两组婴儿的生长情况相似。暴露于PrEP的持续时间、PrEP开始的三个月、15至24岁女性的子集分析或多因素分析均未发现婴儿结局的差异。这一分析表明，在孕妇和产后人群中大规模实施PrEP方案，监测婴儿结局是可行的。结论PrEP暴露对妊娠结局和早期婴儿生长没有影响。
Introduction The World Health Organization, while recommending pre-exposure prophylaxis (PrEP) for HIV-negative pregnant and postpartum women in HIV high-burden settings, advocates for continued safety evaluation of PrEP in this population. Methods The PrEP Implementation in Young Women and Adolescents (PrIYA) program delivered PrEP to pregnant and postpartum women integrated within routine maternal and child health clinics (MCH) at 16 sites in Western Kenya. PrEP exposure and perinatal outcome data were collected among women obtaining postnatal services during programme evaluation. PrEP use was self-reported and confirmed with clinical records. Perinatal outcomes including gestational age at birth, birthweight, congenital malformations and infant growth outcomes were abstracted from clinical records for mother-infant pairs attending the six week visit. Associations between infant outcomes and maternal prenatal PrEP use were assessed using univariate and multivariate logistic and linear regression. Results The PrIYA evaluation identified 1530 postpartum mother-infant pairs with data on prenatal PrEP exposure: 206 with prenatal PrEP use, 1324 without. Median maternal age was 24 years in both groups. PrEP users (any reported PrEP use) were significantly more likely to report HIV risk factors such as: intimate partner violence, sexually transmitted infections and having a partner with positive or unknown HIV status. Most mothers initiated PrEP during the second trimester (n = 116, 57%) and used PrEP for more than one month (n = 110, 58%). The mean birthweight was 3.3 kg and gestational age at birth was 38.5 weeks in both groups. There were no major differences between PrEP exposed and unexposed infants in rates of preterm birth and low birthweight. There were no congenital malformations identified in the PrEP-exposed group and five reported in the PrEP unexposed group. At six weeks postpartum, infants in both groups had similar growth. No differences in infant outcomes were found by duration PrEP exposure, trimester of PrEP initiation, a subset analysis of women 15 to 24 years old or in multivariate analyses. This analysis demonstrates that monitoring of infant outcomes is feasible within large-scale programmatic implementation of PrEP among pregnant and postpartum populations. Conclusions Pregnancy outcomes and early infant growth did not differ by PrEP exposure.