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[Editorial] Dolutegravir for HIV: a lesson in pregnancy safety research

Preliminary results prompted WHO, the European Medicines Agency, and the US Food and Drug Administration to issue warnings on May 18 about the use of dolutegravir, a first-line antiretroviral drug, by women at the time of conception. In an unplanned preliminary analysis of an ongoing 4-year observational study in Botswana, 0·9% (4/426) of babies whose mothers became pregnant while taking dolutegravir had a neural tube defect compared with 0·1% (14/11 173) of babies whose mothers took other HIV medicines.

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