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坦桑尼亚达累斯萨拉姆为预防母婴传播艾滋病毒在孕期开始接受B+方案治疗的女性的长期病毒学结果:一项队列研究。

Long-term virological outcomes in women who started option B+ care during pregnancy for prevention of mother-to-child transmission of HIV in Dar es Salaam, Tanzania: a cohort study.

作者信息

Lyatuu Goodluck W, Mwashemele Shally Z, Urrio Roseline, Naburi Helga, Kashmir Nassir, Machumi Lameck, Kibao Ayoub, Sellah Ziada, Ulenga Nzovu, Orsini Nicola, Biberfeld Gunnel, Kilewo Charles, Ekström Anna Mia

机构信息

Management and Development for Health, Dar es Salaam, Tanzania; Department of Obstetrics and Gynaecology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania; Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.

Management and Development for Health, Dar es Salaam, Tanzania.

出版信息

Lancet HIV. 2021 May;8(5):e256-e265. doi: 10.1016/S2352-3018(20)30308-8. Epub 2021 Feb 11.

Abstract

BACKGROUND

Option B+ marked a milestone in prevention of mother-to-child transmission (PMTCT) of HIV by recommending lifelong antiretroviral therapy (ART) for all pregnant women with HIV. Nevertheless, concerns remain regarding long-term outcomes in settings with a high HIV burden. We analysed long-term virological outcomes in women enrolled on option B+ in Tanzania.

METHODS

In this prospective cohort study, we extracted data for pregnant women with HIV starting PMTCT care between Oct 1, 2014, and Sept 30, 2016, in routine health-care settings in Dar es Salaam, Tanzania, from national HIV and district health information system databases. We then excluded women who exited study sites before 6 months of ART follow-up and women who did not have a viral load test. Women were followed up until March 8, 2019. We used Poisson generalised estimating equations to examine trends in HIV viral suppression (<400 copies per mL) and virological failure (≥400 copies per mL), reporting relative risks (RRs) and 95% CIs adjusted for maternal age, gestational age, and several clinical characteristics.

FINDINGS

We identified 15 586 pregnant women with HIV, of whom 10 161 were eligible for follow-up. Women were followed up for a median of 37 months (IQR 31-45) and a maximum of 53 months. The median age at PMTCT initiation was 31 years (IQR 27-35). At PMTCT enrolment, 1245 (17·0%) of 7318 women with available data were in their third trimester, 4901 (48·2%) of 10 161 women started ART at least 1 month before PMTCT enrolment, and 3380 (33·4%) of 10 131 women with available data had advanced HIV. Overall, a viral suppression rate of 88·2% (95% CI 87·8-88·7) was observed over the entire follow-up period, ranging from 85·1% (84·3-85·9) in viral load tests done at 0-11 months to 90·6% (89·7-91·4) at 36 months or longer since PMTCT enrolment. In a complete-case analysis (ie, including patients with <30% missing data; n=7306), the risk of virological failure among women who remained in HIV care decreased over time (adjusted RR 0·87 [95% CI 0·80-0·95] at 12-23 months since PMTCT enrolment; 0·65 [0·59-0·72] at 24-35 months; and 0·63 [0·55-0·71] at ≥36 months vs at 0-11 months). Younger women (aged <20 years: 1·76 [1·40-2·23] vs aged 30-39 years) and those starting PMTCT late in pregnancy (third trimester: 1·28 [1·10-1·50] vs first trimester) or with advanced HIV (1·33 [1·16-1·51] vs without advanced HIV) had increased risk of virological failure. Women who attended an antenatal care facility where more than 50% of attendees received couples HIV testing had a decreased risk of virological failure (adjusted RR 0·81 [0·65-0·99] vs <50% having couples testing).

INTERPRETATION

High rates of viral suppression among women starting option B+ who remain in HIV care are sustainable, and might increase, at least up to 53 months. This rate might be further improved by addressing challenges of adolescent mothers, late presenters, and couples HIV testing at antenatal care.

FUNDING

Swedish International Development Agency.

摘要

背景

“B+方案”通过建议对所有感染艾滋病毒的孕妇进行终身抗逆转录病毒治疗(ART),在预防艾滋病毒母婴传播(PMTCT)方面具有里程碑意义。然而,在艾滋病毒负担较高的地区,对其长期效果仍存在担忧。我们分析了在坦桑尼亚参加“B+方案”的女性的长期病毒学结果。

方法

在这项前瞻性队列研究中,我们从坦桑尼亚达累斯萨拉姆的常规医疗保健机构的国家艾滋病毒和地区卫生信息系统数据库中,提取了2014年10月1日至2016年9月30日期间开始接受PMTCT治疗的感染艾滋病毒的孕妇的数据。然后,我们排除了在ART随访6个月前退出研究地点的女性以及未进行病毒载量检测的女性。对女性进行随访至2019年3月8日。我们使用泊松广义估计方程来研究艾滋病毒病毒抑制(<400拷贝/毫升)和病毒学失败(≥400拷贝/毫升)的趋势,报告根据产妇年龄、孕周和一些临床特征调整后的相对风险(RRs)和95%置信区间(CIs)。

结果

我们确定了15586名感染艾滋病毒的孕妇,其中10161名符合随访条件。女性的中位随访时间为37个月(四分位间距31 - 45个月),最长随访53个月。开始PMTCT时的中位年龄为31岁(四分位间距27 - 35岁)。在进行PMTCT登记时,有可用数据的7318名女性中,1245名(17.0%)处于孕晚期,10161名女性中有4901名(48.2%)在PMTCT登记前至少1个月开始接受ART治疗,有可用数据的10131名女性中有3380名(33.4%)患有晚期艾滋病毒。总体而言,在整个随访期间观察到病毒抑制率为88.2%(95% CI 87.8 - 88.7),从PMTCT登记后0 - 11个月进行的病毒载量检测中的85.1%(84.3 - 85.9)到36个月或更长时间后的90.6%(89.7 - 91.4)。在一个完整病例分析中(即包括缺失数据<30%的患者;n = 7306),留在艾滋病毒护理中的女性病毒学失败风险随时间降低(PMTCT登记后12 - 23个月调整后的RR为0.87 [95% CI 0.80 - 0.95];24 - 35个月为0.65 [0.59 - 0.72];≥36个月为0.63 [0.55 - 0.71],与0 - 11个月相比)。年轻女性(年龄<20岁:1.76 [1.40 - 2.23] 对比30 - 39岁)、在妊娠晚期开始PMTCT的女性(孕晚期:1.28 [1.10 - 1.50] 对比孕早期)或患有晚期艾滋病毒的女性(1.33 [1.16 - 1.51] 对比未患有晚期艾滋病毒)病毒学失败风险增加。在超过50%的就诊者接受夫妻艾滋病毒检测的产前护理机构就诊的女性病毒学失败风险降低(调整后的RR为0.81 [0.65 - 0.99] 对比<50%进行夫妻检测)。

解读

开始“B+方案”且留在艾滋病毒护理中的女性的高病毒抑制率是可持续的,并且可能会增加,至少持续到53个月。通过应对青少年母亲、就诊较晚者以及产前护理中夫妻艾滋病毒检测等挑战,这一比率可能会进一步提高。

资助

瑞典国际开发署

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