Updated guidelines on the use of antiretroviral drugs in pregnant women with HIV infection have been published by the US Department of Health and Human Services.
The panel now recommends considering intrapartum intravenous zidovudine for women with HIV RNA levels between 50 and 999 copies/mL. Previously, intrapartum zidovudine was only recommended in women with HIV RNA levels >1000 copies/mL or unknown viral load near delivery.
There are inadequate data to determine whether reducing this threshold provides additional protection against perinatal transmission; however, some experts administer zidovudine in this setting as the perinatal transmission risk is slightly higher in these patients compared with women with HIV RNA levels <50 copies/mL.
Intravenous zidovudine is not recommended in women with HIV RNA levels <50 copies/mL.
See Management: approach See Management: treatment algorithmThe US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both issued alerts after preliminary results from an ongoing study reported an increased risk of serious neural tube defects in women who became pregnant while taking dolutegravir-based regimens. The risk appears to be highest in women taking the drug at the time of becoming pregnant or early in the first trimester.
It is recommended that women of childbearing age with HIV currently taking dolutegravir are counseled about this new potential risk. Pregnant women currently taking dolutegravir should not stop their treatment but should discuss the possible risks with their healthcare provider.
Women of childbearing age with HIV who are trying to become pregnant should discuss alternative antiretroviral therapy regimens with their healthcare provider. Women of childbearing age with HIV who are not planning to become pregnant may be on dolutegravir-based regimens provided their pregnancy test before starting therapy is negative and they consistently use a reliable method of contraception during treatment.
Both the FDA and the EMA said they would continue to monitor results from the ongoing study and would issue further advice as additional data become available.
See Management: approach See Management: treatment algorithmAssistant Professor of Obstetrics and Gynecology
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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