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Pregnancy and Neonatal Outcomes Following Prenatal Exposure to Dolutegravir

Vannappagari, Vani MBBS, MPH, PhD1,2; Thorne, Claire MSc, PhD3 for APR* and EPPICC

JAIDS Journal of Acquired Immune Deficiency Syndromes: March 29, 2019 - Volume Publish Ahead of Print - Issue - p
doi: 10.1097/QAI.0000000000002035
Original Article: PDF Only

Background: Birth outcomes data with dolutegravir exposure during pregnancy, particularly in the first trimester, are needed.

Setting: Data were prospectively collected from the Antiretroviral Pregnancy Registry and European Pregnancy and Paediatric HIV Cohort Collaboration.

Methods: We reviewed 2 large, independent antiretroviral pregnancy registries to assess birth outcomes associated with maternal dolutegravir treatment during pregnancy.

Results: Of 265 pregnancies reported to the Antiretroviral Pregnancy Registry, initial exposure to dolutegravir occurred at conception or first trimester in 173 pregnancies and during the second or third trimester in 92 pregnancies. There were 246 (92.8%) live births resulting in 255 neonates (9 twins), 6 (2.3%) induced abortions, 11 (4.2%) spontaneous abortions, and 2 (0.8%) stillbirths. Birth defects occurred in 7 (2.7%) of 255 live-born neonates, 5 (3.1%) of 162 (includes 6 twins) with conception/first-trimester exposure. Of 101 pregnancies reported to the European Pregnancy and Paediatric HIV Cohort Collaboration, outcomes were available for 84 pregnancies (16 continuing to term and 1 lost to follow-up). There were 81 live births (80 with known initial dolutegravir exposure at conception or first, second, and third trimesters in 42, 21, and 17 live births, respectively), 1 stillbirth (second-trimester exposure), 1 induced abortion (first-trimester exposure), and 1 spontaneous abortion (first-trimester exposure), respectively. Birth defects occurred in 4 live births (4.9%; 95% confidence interval, 1.4-12.2), 3 of 42 (7.1%) with exposure at conception or first trimester.

Conclusions: Our findings are reassuring regarding dolutegravir treatment of HIV infection during pregnancy but remain inconclusive due to small sample sizes.

1ViiV Healthcare, Research Triangle Park, NC, USA;

2Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA;

3UCL Great Ormond Street Institute of Child Health, London, UK

Correspondence and reprint requests to: Vani Vannappagari, MBBS, MPH, PhD 5 Moore Drive, Mail Stop 5.3C Research Triangle Park, NC, 27709-3398, USA Telephone: 919-483-7046 E-mail:

Conflicts of Interest and Source of Funding: Vani Vannappagari is an employee of ViiV Healthcare and owns stock in GlaxoSmithKline. Claire Thorne reports grants from ViiV via the PENTA Foundation during the study; personal fees from ViiV, grants from Public Health England, grants from the European Commission, grants from the Medical Research Council, and grants from the PENTA Foundation outside the submitted work.

* A list of other author contributors is provided in the Acknowledgments section.

Meetings in which the data were previously presented: 9th International AIDS Society Conference on HIV Science; July 23-26, 2017; Paris, France.

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