Last reviewed: March 2019
Last updated: December  2018
18 Dec 2018

Dolutegravir should not be used during the first trimester of pregnancy

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.

See Management: approach

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • increased risk of maternal HIV infection
  • increased risk of perinatal HIV transmission

Other diagnostic factors

  • oral candidiasis
  • increasing dyspnea
  • weight loss
  • fever
  • malaise
  • lymphadenopathy
  • maculopapular blanching rash

Risk factors

  • needle-sharing with injection drug use
  • receptive penile-vaginal intercourse
  • unprotected receptive anal intercourse
  • percutaneous needle stick
  • sexually transmitted infections (STIs) and bacterial vaginosis
  • high maternal viral load (perinatal transmission)
  • absence of prenatal maternal antiretroviral therapy (perinatal transmission)
  • breast-feeding (perinatal transmission)
  • violence against women and girls
  • receptive oral intercourse
  • insertive oral intercourse
  • multiple sexual partners
  • low maternal CD4 count (perinatal transmission)

Diagnostic investigations

1st investigations to order

  • maternal HIV-1/HIV-2 antigen/antibody enzyme-linked immunosorbent assay (ELISA)
  • maternal HIV-1/HIV-2 antibody differentiation immunoassay
  • neonatal HIV DNA or RNA polymerase chain reaction (PCR)
Full details

Investigations to consider

  • HIV-1 western blot
  • HIV-1 indirect immunofluorescence assay (IFA)
  • HIV-1 nucleic acid test (NAT)
  • CD4 count
  • plasma viral load
  • renal function tests
  • liver function tests (LFTs)
  • tests for coinfections
  • drug resistance test (genotyping)
  • complete blood count
  • glucose screening
  • fetal ultrasound
Full details

Treatment algorithm

Contributors

Authors VIEW ALL

Assistant 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

Disclosures

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.

Peer reviewers VIEW ALL

Assistant Professor of Medicine

Associate Residency Program Director

University of Chicago

Chicago

IL

Disclosures

AS declares that she has no competing interests.

Reader in Communicable Diseases

Faculty of Medicine

Imperial College

London

UK

Disclosures

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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