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J Acquir Immune Defic Syndr. 2019 Apr 19. doi: 10.1097/QAI.0000000000002065. [Epub ahead of print]

Is there a safety signal for dolutegravir and integrase inhibitors during pregnancy?

Chouchana L1,2,3, Beeker N2,4,3, Treluyer JM1,2,4.

Author information

1
Assistance Publique-Hopitaux de Paris, Hopitaux Universitaires Paris Centre, Centre Régional de Pharmacovigilance. 27 rue du Faubourg Saint-Jacques, 75014 Paris, France.
2
Sorbonne Paris Cité, Université Paris Descartes, EA7323 «Evaluation thérapeutique et pharmacologie périnatale et pédiatrique ». 27 rue du Faubourg Saint-Jacques, 75014 Paris, France.
3
These authors contribute equally to this work.
4
Assistance Publique-Hopitaux de Paris, Hopitaux Universitaires Paris Centre, Unité de Recherche clinique. 27 rue du Faubourg Saint-Jacques, 75014 Paris, France.

Abstract

BACKGROUND:

Dolutegravir, an integrase strand transfer inhibitor (InSTI) is a major antiretroviral agent for HIV infection. Its use is promising, especially in low and middle-income countries, because of a high resistance barrier and a good safety profile. Very recently, a WHO safety signal has been raised regarding neural tube defects after first trimester exposure. Furthermore to date, the experience is limited regarding the use of the others InSTI drugs (raltegravir and elvitegravir) during pregnancy. Our objective is to analyze the safety of InSTI drugs in pregnant women.

SETTING:

Nation-wide database cohort analysis METHODS:: We evaluated the risk of major birth defects according to EUROCAT classification in pregnant women which had had a first-trimester exposure to dolutegravir, raltegravir or elvitegravir.

RESULTS:

We found a major birth defect rate of 1.8% in the general population between 2012 and 2016. As InSTI drugs are not used as first line therapy in pregnant women, we found a very low exposure in this population. Among 49, 240, and 70 pregnancy outcomes exposed to dolutegravir, raltegravir and elvitegravir, respectively, during the first trimester, there were 2, 3 and 1 major birth defects, respectively. There was no case of neural tube defect.

CONCLUSIONS:

Drug exposure to InSTI is limited in our nation-wide database. Nevertheless, our data do not support a pharmacovigilance signal on neural tube defects in women exposed to dolutegravir during pregnancy, as well as for raltegravir or elvitegravir. Due to a small number of pregnancy outcomes, these results need to be confirmed with further studies.

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