The US Department of Health and Human Services has updated its guidance on the management of pregnant women living with HIV infection. The guideline has been revised to include interim recommendations regarding the use of dolutegravir in pregnancy and at the time of conception due to concerns about a possible increased risk of neural tube defects in the fetus.
Recommendations
Do not use dolutegravir during the first trimester of pregnancy, in nonpregnant women who want to become pregnant or who are trying to conceive, or in women who cannot consistently use effective contraception.
Perform a pregnancy test before starting treatment with dolutegravir.
Discuss the risk of fetal neural tube defects with women of childbearing potential who are currently taking dolutegravir or who wish to be started on it.
Provide counseling to pregnant women who present to care during the first trimester and who are taking dolutegravir about the risks and benefits of continuing dolutegravir (or switching to another regimen).
These recommendations are based on data from an observational surveillance study of birth outcomes in pregnant women who are on antiretroviral therapy in Botswana. A preliminary unscheduled analysis reported an increased risk of serious fetal neural tube defects in women who became pregnant while taking dolutegravir-based regimens (0.9% compared with 0.1% in women not taking dolutegravir). The risk appears to be highest in women taking the drug at the time of becoming pregnant or early in the first trimester. According to current available data, it is safe to use dolutegravir after the first trimester.
The Food and Drug Administration and the European Medicines Agency both issued alerts about this risk in May 2018. These recommendations will be revised, if necessary, as additional data becomes available in 2019.
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Georgetown University School of Medicine
Scientific Director of Women’s Health Research
MedStar Health Research Institute
Director
MedStar WHC Women's Center for Positive Living
MedStar Washington Hospital Center Department of Women’s and Infants’ Services
Washington
DC
RKS declares that she has no competing interests.
Dr Rachel K. Scott would like to gratefully acknowledge Dr Isaac Delke, Dr Christina Bailey, and Dr Mettassebia Kano, the previous contributors to this monograph. ID, CB, and MK declare that they have no competing interests.
Assistant Professor of Medicine
Associate Residency Program Director
University of Chicago
Chicago
IL
AS declares that she has no competing interests.
Reader in Communicable Diseases
Faculty of Medicine
Imperial College
London
UK
GPT has been reimbursed by various pharmaceutical companies for attending conferences, lecturing, and consulting, and has been chief investigator of investigator-initiated industry-funded research on HIV and pregnancy.
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