Dolutegravir is a highly effective antiretroviral therapy (ART) allowing a fast viral load decrease, which is promising in low-income and middle-income countries. However, according to preliminary results from a nationwide birth surveillance programme in Botswana, it has been associated with the development of neural tube defects in newborn babies. Incidence of neural tube defects in the newborn babies of women who were taking dolutegravir at the time of conception was estimated to be 0·94% (95% CI 0·37–2·4). Updated results from this cohort still showed a slightly increased incidence of neural tube defects of 0·3% (0·13–0·69) among newborn babies of women given dolutegravir at conception, compared with 0·10% (0·06–0·17) among those given any non-dolutegravir ART. These additional data were highly awaited since the communication in May, 2018, of the preliminary results led to a worldwide safety signal on dolutegravir. Since then, studies done in several other cohorts have not confirmed this signal. Nonetheless, these studies, done in high-income countries (eg, Canada, Germany, France, and the UK) included few exposed pregnancies. A review of neural tube defect cases has also been done on pharmacovigilance databases; however, this review lacks data on dolutegravir exposure in pregnant women necessary to make any conclusion.

中文翻译：

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Dolutegravir和神经管缺陷：新见解。

Dolutegravir是一种高效的抗逆转录病毒疗法（ART），可快速降低病毒载量，这在低收入和中等收入国家很有希望。但是，根据博茨瓦纳全国出生监测计划的初步结果，这与新生儿神经管缺陷的发生有关。受孕时服用多洛格韦的新生儿婴儿的神经管缺陷发生率估计为0·94％（95％CI 0·37-2·4）。该队列的最新结果仍然显示，在接受孕产妇多洛格韦治疗的新生儿中，神经管缺损的发生率略有增加，为0·3％（0·13–0·69），而0％至10％（0·06– 0·17）接受非多洛韦韦ART治疗的患者中。自2018年5月通信以来，我们一直期待着这些额外的数据，初步结果表明，dolutegravir在全球范围内均具有安全性。从那以后，在其他几个队列中进行的研究尚未证实这一信号。但是，这些研究是在高收入国家（例如加拿大，德国，法国和英国）进行的）包括很少的暴露妊娠。在药物警戒数据库中也对神经管缺陷病例进行了回顾。但是，该评价缺乏得出任何结论所必需的孕妇服用多洛格韦的数据。