The Effects on the Growth of HIV-exposed Uninfected Infants of Initiating Dolutegravir-based Versus Efavirenz-based cART in Late Pregnancy (DolPHIN-2).
Lisa Hagens, Lisanne A H Bevers, Thokozile R Malaba, Sylvia Cornelia Nassiwa, Megan Mrubata, Helene Theunissen, Helen Reynolds, Nengjie He, Jim Read, David M Burger, Mohammed Lamorde, Landon Myer, Duolao Wang, Saye Khoo, Catriona Waitt, Angela Colbers
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引用次数: 0
Abstract
Background: In 2019, the World Health Organization (WHO) changed its recommendations for pregnant women living with HIV from efavirenz-based to dolutegravir-based therapy due to its superior efficacy, tolerability and resistance profile. Perinatal exposure to antiretrovirals may influence infant growth, but limited data exist on the effects of specific regimens over time.
Aim: This study aimed to compare growth trajectories over the first 72 weeks of life among infants exposed to dolutegravir-based versus efavirenz-based therapy during late pregnancy.
Methods: The DolPHIN-2 trial was a randomized, open-label trial conducted in South Africa and Uganda, researching the efficacy of dolutegravir-based versus efavirenz-based therapy in pregnant women living with HIV, initiating treatment in the third trimester. In this secondary analysis, we compared growth trajectories until 72 weeks postpartum between HIV-exposed uninfected infants perinatally exposed to dolutegravir-based versus efavirenz-based therapy. Measures of infant weight, length and head circumference were converted to WHO-defined weight-for-age, weight-for-length, length-for-age and head circumference-for-age Z-scores. Subsequently, Z-scores were compared across treatment arms, using linear mixed-effect models.
Results: After exclusions, 232 infants remained (dolutegravir: n = 116; efavirenz: n = 116). In both crude models and models adjusted for study site and maternal height, length-for-age Z-scores were 0.277 units higher in the dolutegravir arm. No statistically significant impact of treatment was observed for other outcomes. In both study arms, a decline in mean length-for-age Z-scores occurred over the first 72 weeks, while mean weight-for-age Z-scores declined between weeks 48 and 72.
Conclusion: Our data support the WHO in recommending dolutegravir-based therapy over efavirenz-based therapy in pregnant women living with HIV.
背景：2019年，世界卫生组织（WHO）改变了对感染艾滋病毒的孕妇的建议，从以依非韦伦为基础的治疗改为以曲地韦为基础的治疗，因为它具有优越的疗效、耐受性和耐药性。围产期接触抗逆转录病毒药物可能会影响婴儿的生长，但关于特定治疗方案长期影响的数据有限。目的：本研究旨在比较妊娠后期暴露于以盐酸孕酮为基础的治疗和以依非韦伦为基础的治疗的婴儿在出生后72周内的生长轨迹。方法：DolPHIN-2试验是在南非和乌干达进行的一项随机、开放标签试验，研究以多曲地韦为基础的治疗与以依非韦伦为基础的治疗对妊娠晚期感染艾滋病毒的孕妇的疗效。在这一次要分析中，我们比较了艾滋病毒暴露的未感染婴儿在产后72周之前的生长轨迹，围产期暴露于以头孢维韦为基础的治疗和以依非韦伦为基础的治疗。将婴儿体重、身长和头围的测量值转换为世卫组织定义的年龄体重、身高体重、年龄身高和头围年龄z分数。随后，使用线性混合效应模型比较各治疗组的z分数。结果：排除后，仍有232名婴儿存活(dolutegravir: n = 116；Efavirenz: n = 116)。在原始模型和根据研究地点和母亲身高调整的模型中，偏重力组的身高年龄比z分数高0.277个单位。没有观察到治疗对其他结果有统计学意义的影响。在两个研究组中，平均年龄长度z分数在前72周内下降，而平均年龄体重z分数在48周至72周之间下降。结论：我们的数据支持世卫组织推荐对感染艾滋病毒的孕妇进行以曲地韦为基础的治疗，而不是以依非韦伦为基础的治疗。
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The Pediatric Infectious Disease Journal® (PIDJ) is a complete, up-to-the-minute resource on infectious diseases in children. Through a mix of original studies, informative review articles, and unique case reports, PIDJ delivers the latest insights on combating disease in children — from state-of-the-art diagnostic techniques to the most effective drug therapies and other treatment protocols. It is a resource that can improve patient care and stimulate your personal research.
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