Guidelines recommend long-acting injectable PrEP and a two-drug ART alternative initial regimen as options during pregnancy and breastfeeding
The US Department of Health and Human Services Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission has updated its guidelines to recommend long-acting injectable pre-exposure prophylaxis (PrEP) options during pregnancy and breastfeeding.
Three PrEP options are now available for women during pregnancy and breastfeeding:
Tenofovir disoproxil/emtricitabine - taken orally every day
Lenacapavir - injected subcutaneously every 6 months
Cabotegravir - injected intramuscularly every 2 months
These options are approved by the Food and Drug Administration (FDA) for preventing HIV transmission from receptive vaginal sex, including during pregnancy and breastfeeding.
All options are highly effective at preventing HIV transmission; however, oral tenofovir disoproxil/emtricitabine has the most robust published safety data on use during pregnancy and breastfeeding, while data for cabotegravir are still considered emerging.
Healthcare professionals are advised to discuss potential options with patients and participate in a shared decision-making process to assist the choice of the best option for an individual patient.
The updated guidelines also recommend a two-drug antiretroviral therapy (ART) regimen as a potential initial treatment option in certain patients. Typically, a three-drug ART regimen is recommended.
Dolutegravir/lamivudine may be considered for use in treatment-naive pregnant women who are starting ART for the first time. However, it is classified as an alternative option and may only be used in women who have not used long-acting cabotegravir as PrEP previously, provided they meet the following criteria:
HIV RNA ≤500,000 copies/mL
No evidence of hepatitis B virus coinfection
HIV resistance testing shows susceptibility to lamivudine
There is very limited data about the use of two-drug regimens in pregnancy. Data for this regimen are limited to a small, single-center study in Brazil in which 20 women received this regimen; all women achieved viral suppression before birth with no safety concerns, and no cases of perinatal transmission were detected.
Summary
Definition
History and exam
Key diagnostic factors
- increased risk of maternal HIV acquisition
- increased risk of perinatal HIV transmission
Other diagnostic factors
- oral candidiasis
- increasing dyspnea
- weight loss
- fever
- malaise
- lymphadenopathy
- maculopapular blanching rash
Risk factors
- people who inject drugs
- unprotected penile-vaginal intercourse
- unprotected anal intercourse
- percutaneous needle stick injury
- coinfection with other sexually transmitted infections (STIs) or bacterial vaginosis
- high maternal viral load (perinatal transmission)
- absence of prenatal maternal antiretroviral therapy (perinatal transmission)
- breastfeeding in mothers without viral suppression (perinatal transmission)
- violence against women and girls
- receptive oral intercourse
- insertive oral intercourse
- multiple sexual partners
- low maternal CD4 count (perinatal transmission)
- cosmetic injection procedures
Diagnostic tests
1st tests to order
- maternal HIV-1/HIV-2 antigen/antibody enzyme-linked immunosorbent assay (ELISA)
- maternal HIV-1/HIV-2 antibody differentiation immunoassay
- infant HIV DNA or RNA polymerase chain reaction (PCR)
Tests to consider
- HIV-1 western blot
- HIV-1 indirect immunofluorescence assay (IFA)
- HIV-1 nucleic acid test (NAT)
- CD4 count
- plasma HIV RNA levels (viral load)
- renal function tests
- liver function tests (LFTs)
- drug resistance tests
- complete blood count
- glucose screening
- fetal ultrasound
- tests for coinfections
Treatment algorithm
pregnant women: <38 weeks not in labor (regardless of HIV RNA level)
pregnant women with HIV RNA levels >1000 copies/mL: at 38 weeks or in labor
pregnant women with HIV RNA levels ≤1000 copies/mL: at 38 weeks or in labor
infant with in utero or intrapartum HIV exposure
Contributors
Authors
Anna Powell, MD
Associate Professor
Johns Hopkins University School of Medicine
Gynecology and Obstetrics
Baltimore, MD
Disclosures
AP declares that she has been paid for consultancy work with Cepheid, Juno Bio, and Evvy and receives royalties for authorship from UpToDate.
Acknowledgements
Dr Anna Powell would like to gratefully acknowledge Dr Rachel K. Scott, Dr Isaac Delke, Dr Christina Bailey, and Dr Mettassebia Kano, the previous contributors to this topic.
Disclosures
RKS declares that she has participated in an advisory meeting for ViiV Healthcare and has received research funding from ViiV, managed by MedStar Health Institute. ID, CB, and MK declare that they have no competing interests.
Peer reviewers
Aisha Sethi, MD
Assistant Professor of Medicine
Associate Residency Program Director
University of Chicago
Chicago, IL
Disclosures
AS declares that she has no competing interests.
Graham P. Taylor, MBChB, FRCP, FHEA
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.
Peer reviewer acknowledgements
BMJ Best Practice topics are updated on a rolling basis in line with developments in evidence and guidance. The peer reviewers listed here have reviewed the content at least once during the history of the topic.
Disclosures
Peer reviewer affiliations and disclosures pertain to the time of the review.
References
Key articles
Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. Jun 2026 [internet publication].Full text
Reference articles
A full list of sources referenced in this topic is available to users with access to all of BMJ Best Practice.
Differentials
- Infectious mononucleosis
- Toxoplasmosis
- Viral hepatitis
More DifferentialsGuidelines
- Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States
- CDC Yellow Book: health information for international travel - travelers with HIV
More GuidelinesPatient information
HIV infection in pregnancy
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