Safety and Effectiveness of Isoniazid Preventive Therapy in Pregnant Women Living with Human Immunodeficiency Virus on Antiretroviral Therapy: An Observational Study Using Linked Population Data.
Safety and Effectiveness of Isoniazid Preventive Therapy in Pregnant Women Living with Human Immunodeficiency Virus on Antiretroviral Therapy: An Observational Study Using Linked Population Data.
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DOI：
10.1093/cid/ciz1224
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发表时间：
2020-11-05
期刊：
影响因子：
--
通讯作者：
Boulle A
中科院分区：
文献类型：
--
作者：
Kalk E;Heekes A;Mehta U;de Waal R;Jacob N;Cohen K;Myer L;Davies MA;Maartens G;Boulle A
异烟肼预防性治疗 (IPT) 广泛用于预防人类免疫缺陷病毒 (HIV) 感染者患结核病 (TB)。关于 IPT 对 HIV 感染孕妇 (PWLHIV) 的安全性和有效性的数据参差不齐。我们使用个人层面的全人群健康数据库来研究产前 IPT 暴露与不良妊娠结局、孕产妇结核病、全因死亡率和妊娠期间至产后 12 个月肝损伤之间的关联。我们使用南非西开普省公共部门生成的关联常规电子健康数据来定义接受抗逆转录病毒治疗的 PWLHIV 队列。使用逻辑回归评估妊娠结局；对于产妇结局，我们应用了具有时间更新的 IPT 暴露的比例风险模型。在 43 971 名 PWLHIV 患者中，16.6% 接受了 IPT。接受 IPT 的女性出现不良妊娠结局的可能性较小（调整后优势比 [aOR]，0.83 [95% 置信区间 {CI}，0.78–0.87]）；与无（aOR, 0.71 [95% CI, .65–.79]）或妊娠早期暴露（aOR, 0.64 [95% CI, .55–.75]）相比，这种关联随着妊娠早期开始的IPT而加强。 IPT 将结核病风险降低约 30%（aHR，0.71 [95% CI，0.63–.81]；绝对风险差异，1518/100 000 名女性）。如果 CD4 计数≤350 个细胞/μL，则效果会因 CD4 细胞计数而改变（aHR，0.51 [95% CI，0.41–0.63]），而 CD4 计数 >350 个细胞/μL 则为 0.93 [95% CI，0.76–1.13]。对程序数据的分析令人放心产前 IPT 的安全性，在 CD4 计数≤350 个细胞/μL 的女性中观察到对结核病的最大益处。对南非超过 43 000 名接受抗逆转录病毒治疗的 HIV 感染孕妇的队列中使用异烟肼预防性治疗预防结核病的安全性和有效性进行了个人层面的全人群数据分析，这令人放心。
Isoniazid preventive therapy (IPT) is widely used to protect against tuberculosis (TB) in people living with human immunodeficiency virus (HIV). Data on the safety and efficacy of IPT in pregnant women living with HIV (PWLHIV) are mixed. We used an individual-level, population-wide health database to examine associations between antenatal IPT exposure and adverse pregnancy outcomes, maternal TB, all-cause mortality, and liver injury during pregnancy through 12 months postpartum. We used linked routine electronic health data generated in the public sector of the Western Cape, South Africa, to define a cohort of PWLHIV on antiretroviral therapy. Pregnancy outcomes were assessed using logistic regression; for maternal outcomes we applied a proportional hazards model with time-updated IPT exposure. Of 43 971 PWLHIV, 16.6% received IPT. Women who received IPT were less likely to experience poor pregnancy outcomes (adjusted odds ratio [aOR], 0.83 [95% confidence interval {CI}, .78–.87]); this association strengthened with IPT started after the first trimester compared with none (aOR, 0.71 [95% CI, .65–.79]) or with first-trimester exposure (aOR, 0.64 [95% CI, .55–.75]). IPT reduced the risk of TB by approximately 30% (aHR, 0.71 [95% CI, .63–.81]; absolute risk difference, 1518/100 000 women). The effect was modified by CD4 cell count with protection conferred if CD4 count was ≤350 cells/μL (aHR, 0.51 [95% CI, .41–.63]) vs 0.93 [95% CI, .76–1.13] for CD4 count >350 cells/µL). This analysis of programmatic data is reassuring regarding the safety of antenatal IPT, with the greatest benefits against TB disease observed in women with CD4 count ≤350 cells/μL. Analysis of individual-level population-wide data is reassuring regarding the safety and efficacy of isoniazid preventive therapy to prevent tuberculosis disease in a cohort of >43 000 pregnant women living with HIV on antiretroviral therapy in South Africa.
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作者：
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