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在 FACTS-001 试验中,孕妇和非孕妇中的 HIV 发病率:对 HIV 预防,特别是 PrEP 使用的影响。

HIV Incidence Among Pregnant and Nonpregnant Women in the FACTS-001 Trial: Implications for HIV Prevention, Especially PrEP Use.

机构信息

Wits Reproductive Health and HIV Institute (Wits RHI), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.

Aurum Institute, Johannesburg, South Africa.

出版信息

J Acquir Immune Defic Syndr. 2021 Dec 1;88(4):376-383. doi: 10.1097/QAI.0000000000002785.

DOI:10.1097/QAI.0000000000002785
PMID:34710071
Abstract

BACKGROUND

During pregnancy and postpartum period, the sexual behaviors of women and their partners change in ways that may either increase or reduce HIV risks. Pregnant women are a priority population for reducing both horizontal and vertical HIV transmission.

SETTING

Nine sites in 4 South African provinces.

METHODS

Women aged 18-30 years were randomized to receive pericoital tenofovir 1% gel or placebo gel and required to use reliable modern contraception. We compared HIV incidence in women before, during, and after pregnancy and used multivariate Cox Proportional hazards models to compare HIV incidence by pregnancy status.

RESULTS

Rates of pregnancy were 7.1 per 100 woman-years (95% confidence interval [CI]: 6.3 to 8.1) and highest in those who reported oral contraceptive use (25.1 per 100 woman-years; adjusted hazard ratio 22.97 higher than other women; 95% CI: 5.0 to 105.4) or had 2 children. Birth outcomes were similar between trial arms, with 59.8% having full-term live births. No difference was detected in incident HIV during pregnancy compared with nonpregnant women (2.1 versus 4.3%; hazard ratio = 0.56, 95% CI: 0.14 to 2.26). Sexual activity was low in pregnancy and the early postpartum period, as was consistent condom use.

CONCLUSIONS

Pregnancy incidence was high despite trial participation being contingent on contraceptive use. We found no evidence that rates of HIV acquisition were elevated in pregnancy when compared with those in nonpregnant women. Risks from reductions in condom use may be offset by reduced sexual activity. Nevertheless, high HIV incidence in both pregnant and nonpregnant women supports consideration of introducing antiretroviral-containing pre-exposure prophylaxis for pregnant and nonpregnant women in high HIV prevalence settings.

摘要

背景

在妊娠和产后期间,女性及其伴侣的性行为会发生变化,这些变化可能会增加或降低 HIV 风险。孕妇是减少水平和垂直 HIV 传播的优先人群。

地点

南非 4 个省份的 9 个地点。

方法

18-30 岁的女性被随机分配接受 pericoital 替诺福韦 1%凝胶或安慰剂凝胶,并需要使用可靠的现代避孕方法。我们比较了女性在妊娠前、妊娠中和产后的 HIV 发病率,并使用多变量 Cox 比例风险模型比较了妊娠状态对 HIV 发病率的影响。

结果

妊娠率为 7.1/100 名女性年(95%置信区间 [CI]:6.3 至 8.1),报告使用口服避孕药的女性妊娠率最高(25.1/100 名女性年;调整后的危险比为 22.97,高于其他女性;95%CI:5.0 至 105.4)或有 2 个孩子。试验组的分娩结局相似,足月活产率为 59.8%。与非妊娠女性相比,妊娠期间新发 HIV 无差异(2.1 对 4.3%;危险比=0.56,95%CI:0.14 至 2.26)。妊娠和产后早期的性活动较少,避孕套的使用也不一致。

结论

尽管参与试验取决于避孕措施的使用,但妊娠发生率仍然很高。我们没有发现与非妊娠女性相比,妊娠期间 HIV 感染率升高的证据。避孕套使用减少带来的风险可能会被性活动减少所抵消。然而,妊娠和非妊娠女性的 HIV 发病率均较高,支持在高 HIV 流行地区考虑为孕妇和非孕妇提供包含抗逆转录病毒药物的暴露前预防。

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