PDF(Pubmed)
Abstract：
UNASSIGNED: The World Health Organization (WHO) recommends tenofovir disoproxil fumarate (TDF)-based oral pre-exposure prophylaxis (PrEP), the dapivirine vaginal ring, and long-acting intramuscular injectable cabotegravir (CAB-LA) for HIV prevention in populations at substantial risk of HIV infection. Pregnancy is a period of elevated risk of maternal HIV infection and transmission to the infant. This systematic review and meta-analysis assessed the risk of adverse perinatal outcomes among HIV-negative pregnant women with exposure to any PrEP modality.
UNASSIGNED: We conducted a systematic review by searching Medline, EMBASE, CINAHL, Global Health, the Cochrane Library, WHO ICTR, ISRCTN, PACTR, and ClinicalTrials.gov for studies published between 1 January 2000 and 29 August 2023. We included studies reporting on the association of antenatal exposure to any PrEP modality with 13 perinatal outcomes: preterm birth (PTB), very PTB, spontaneous PTB, spontaneous very PTB, low birthweight (LBW), very LBW, term LBW, preterm LBW, small for gestational age (SGA), very SGA, miscarriage, stillbirth, or neonatal death (NND). Quality assessments of included studies were performed. Fixed-effect meta-analyses were conducted to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs). The protocol is registered with PROSPERO, CRD42022339825.
UNASSIGNED: Of 18,598 citations identified, 13 studies (eight randomised controlled trials (RCTs) and five cohort studies), assessing 8712 pregnant women in Africa, were included. Oral PrEP, compared to no PrEP, was not associated with PTB in meta-analyses of six RCTs (OR 0.73, 95% CI 0.43-1.26; I2 = 0.0%) or five unadjusted cohort studies (OR 0.84, 95% CI 0.69-1.03; I2 = 0.0%), but was associated with a reduced risk of PTB in three adjusted cohort studies (aOR 0.67; 95% CI 0.52-0.88, I2 = 0.0%). There was no association of oral PrEP with LBW, vLBW, SGA, or NND, compared to no PrEP. There was no association with PTB when oral TDF/emtricitabine (FTC) PrEP, oral TDF PrEP, and tenofovir vaginal gel were compared to each other. There was no association of the dapivirine vaginal ring with PTB or NND, compared to placebo or oral TDF/FTC PrEP. We found no data on CAB-LA.
UNASSIGNED: We found no evidence of adverse perinatal outcomes associated with PrEP exposure during pregnancy. Our findings support the WHO recommendation to provide oral PrEP to women of reproductive age and pregnant women. More data is needed to assess the safety of all PrEP modalities in pregnancy.
UNASSIGNED: None.
UNASSIGNED: We conducted a systematic review by searching Medline, EMBASE, CINAHL, Global Health, the Cochrane Library, WHO ICTR, ISRCTN, PACTR, and ClinicalTrials.gov for studies published between 1 January 2000 and 29 August 2023. We included studies reporting on the association of antenatal exposure to any PrEP modality with 13 perinatal outcomes: preterm birth (PTB), very PTB, spontaneous PTB, spontaneous very PTB, low birthweight (LBW), very LBW, term LBW, preterm LBW, small for gestational age (SGA), very SGA, miscarriage, stillbirth, or neonatal death (NND). Quality assessments of included studies were performed. Fixed-effect meta-analyses were conducted to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs). The protocol is registered with PROSPERO, CRD42022339825.
UNASSIGNED: Of 18,598 citations identified, 13 studies (eight randomised controlled trials (RCTs) and five cohort studies), assessing 8712 pregnant women in Africa, were included. Oral PrEP, compared to no PrEP, was not associated with PTB in meta-analyses of six RCTs (OR 0.73, 95% CI 0.43-1.26; I2 = 0.0%) or five unadjusted cohort studies (OR 0.84, 95% CI 0.69-1.03; I2 = 0.0%), but was associated with a reduced risk of PTB in three adjusted cohort studies (aOR 0.67; 95% CI 0.52-0.88, I2 = 0.0%). There was no association of oral PrEP with LBW, vLBW, SGA, or NND, compared to no PrEP. There was no association with PTB when oral TDF/emtricitabine (FTC) PrEP, oral TDF PrEP, and tenofovir vaginal gel were compared to each other. There was no association of the dapivirine vaginal ring with PTB or NND, compared to placebo or oral TDF/FTC PrEP. We found no data on CAB-LA.
UNASSIGNED: We found no evidence of adverse perinatal outcomes associated with PrEP exposure during pregnancy. Our findings support the WHO recommendation to provide oral PrEP to women of reproductive age and pregnant women. More data is needed to assess the safety of all PrEP modalities in pregnancy.
UNASSIGNED: None.
摘要：
■世界卫生组织（WHO）建议富马酸替诺福韦酯（TDF）为基础的口服暴露前预防（PrEP），dapivirine阴道环,和长效肌内注射cabotegravir（CAB-LA）用于在有重大艾滋病毒感染风险的人群中预防艾滋病毒。怀孕是母亲感染艾滋病毒并传播给婴儿的风险升高的时期。这项系统评价和荟萃分析评估了暴露于任何PrEP模式的HIV阴性孕妇中不良围产期结局的风险。
■我们通过搜索Medline进行了系统综述，EMBASE,CINAHL,全球卫生,Cochrane图书馆,世卫组织卢旺达问题国际法庭，ISRCTN,PACTR,和ClinicalTrials.gov在2000年1月1日至2023年8月29日之间发表的研究。我们纳入了关于产前暴露与任何PrEP模式与13个围产期结局的关联的研究：早产（PTB），非常PTB，自发性PTB,自发的非常PTB，低出生体重（LBW），非常LBW,术语LBW，早产LBW,小于胎龄（SGA），非常SGA,流产,死产,或新生儿死亡（NND）。对纳入的研究进行质量评估。进行固定效应荟萃分析以计算比值比（OR）和95％置信区间（95％CIs）。协议注册到PROSPERO,CRD42022339825。
■在确定的18,598个引文中，13项研究（8项随机对照试验（RCT）和5项队列研究），评估非洲8712名孕妇，包括在内。OralPrEP,与没有PrEP相比，在6项RCT(OR0.73,95%CI0.43-1.26;I2=0.0%)或5项未调整队列研究(OR0.84,95%CI0.69-1.03;I2=0.0%)的meta分析中,与PTB无关,但在3项校正队列研究中与PTB风险降低相关(aOR0.67;95%CI0.52~0.88,I2=0.0%).口腔PrEP与LBW没有关联，vLBW,SGA,或NND，与没有PrEP相比。当口服TDF/恩曲他滨（FTC）PrEP时，与PTB没有关联，口服TDFPrEP，与替诺福韦阴道凝胶进行比较。dapivirine阴道环与PTB或NND没有关联，与安慰剂或口服TDF/FTCPrEP相比。我们没有找到关于CAB-LA的数据。
■我们没有发现妊娠期间与PrEP暴露相关的不良围产期结局的证据。我们的发现支持WHO建议为育龄妇女和孕妇提供口头PrEP。需要更多的数据来评估所有PrEP模式在怀孕期间的安全性。
■无。
■我们通过搜索Medline进行了系统综述，EMBASE,CINAHL,全球卫生,Cochrane图书馆,世卫组织卢旺达问题国际法庭，ISRCTN,PACTR,和ClinicalTrials.gov在2000年1月1日至2023年8月29日之间发表的研究。我们纳入了关于产前暴露与任何PrEP模式与13个围产期结局的关联的研究：早产（PTB），非常PTB，自发性PTB,自发的非常PTB，低出生体重（LBW），非常LBW,术语LBW，早产LBW,小于胎龄（SGA），非常SGA,流产,死产,或新生儿死亡（NND）。对纳入的研究进行质量评估。进行固定效应荟萃分析以计算比值比（OR）和95％置信区间（95％CIs）。协议注册到PROSPERO,CRD42022339825。
■在确定的18,598个引文中，13项研究（8项随机对照试验（RCT）和5项队列研究），评估非洲8712名孕妇，包括在内。OralPrEP,与没有PrEP相比，在6项RCT(OR0.73,95%CI0.43-1.26;I2=0.0%)或5项未调整队列研究(OR0.84,95%CI0.69-1.03;I2=0.0%)的meta分析中,与PTB无关,但在3项校正队列研究中与PTB风险降低相关(aOR0.67;95%CI0.52~0.88,I2=0.0%).口腔PrEP与LBW没有关联，vLBW,SGA,或NND，与没有PrEP相比。当口服TDF/恩曲他滨（FTC）PrEP时，与PTB没有关联，口服TDFPrEP，与替诺福韦阴道凝胶进行比较。dapivirine阴道环与PTB或NND没有关联，与安慰剂或口服TDF/FTCPrEP相比。我们没有找到关于CAB-LA的数据。
■我们没有发现妊娠期间与PrEP暴露相关的不良围产期结局的证据。我们的发现支持WHO建议为育龄妇女和孕妇提供口头PrEP。需要更多的数据来评估所有PrEP模式在怀孕期间的安全性。
■无。
