What's New in the Guidelines

Updated Reviewed

June 12, 2025

The U.S. Department of Health and Human Services Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission (the Panel) has reviewed and updated guidelines sections to address new data and publications where relevant. Key updates are summarized below. Three sections developed in collaboration with the Panel on Antiretroviral Therapy and Medical Management of Children Living With HIV were published on December 19, 2024. All revisions are highlighted in yellow in the PDF version of the guidelines.

Pregnancy and Postpartum HIV Testing and Identification of Perinatal and Postnatal HIV Exposure

  • When determining the timing of repeat HIV testing in the third trimester of pregnancy, some clinicians conduct testing at or around 28 weeks of gestation in conjunction with the recommended timing of syphilis testing. This approach limits the number of blood draws and allows adequate time for syphilis treatment and congenital syphilis prophylaxis. Some clinicians also conduct a third test for HIV at the time of delivery hospitalization admission.

Prepregnancy Counseling and Care

  • The Panel has added a bulleted recommendation about the care for partners in the setting of childbearing potential with HIV. Assess knowledge about partner HIV status and the need to screen partner(s) for HIV and sexually transmitted infections; provide testing or refer for services as needed. Discuss whether HIV status has been disclosed to sexual partner(s); discuss options for pre-exposure prophylaxis (PrEP) when indicated.

Lack of Experience With Antiretroviral Drugs During Pregnancy and Prior to Pregnancy (Antiretroviral-Naive)

  • Bictegravir (BIC) plus tenofovir alafenamide (TAF) plus emtricitabine (FTC) (available as the fixed-dose combination [FDC] BIC/TAF/FTC) is now recommended as a Preferred antiretroviral therapy (ART) regimen for HIV during pregnancy. BIC/TAF/FTC is also now recommended as a Preferred regimen when trying to conceive if ART and long-acting cabotegravir (CAB-LA) as PrEP have never been previously used. BIC/TAF/FTC was previously recommended as an Alternative ART regimen.
  • Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy When Antiretroviral Therapy Has Never Been Received has been revised to reflect updated Panel recommendations for people who are antiretroviral (ARV) naive and list the advantages and disadvantages of ARV combinations and regimens.

Table 7. Situation-Specific Recommendations for Use of Antiretroviral Drugs During Pregnancy and When Trying to Conceive

  • BIC, which is available in the FDC BIC/TAF/FTC, is now recommended as a Preferred ARV for use in pregnancy and when trying to conceive based on available data that suggest sufficient pharmacokinetics, efficacy, and safety in pregnancy.
  • Abacavir (ABC) is now recommended as an Alternative rather than a Preferred ARV for use in pregnancy and when trying to conceive due to the need for HLA-B*5701 testing prior to initiating therapy and concerns over cardiac safety with ABC.
  • Appendix C: Antiretroviral Counseling Guide for Health Care Providers has been updated to incorporate changes in the tables and text sections that address recommendations regarding the use of specific ARV drugs in pregnancy.

Antiretroviral Drug Regimens and Pregnancy Outcomes

  • The Panel has updated bulleted recommendations and revised the section text to streamline content and focus on recent, relevant data.
  • The Panel recommends that ART should not be avoided or withheld before conception or in early pregnancy for the purpose of preventing preterm birth.
  • ART should not be avoided or withheld to prevent hypertensive disorders of pregnancy (HDP) or stopped if HDP develops.
  • Enhanced antenatal surveillance of fetal growth in the third trimester may be considered, especially if ART with boosted protease inhibitors is prescribed during pregnancy, due to the increased risk for low birth weight or small-for-gestational-age infants.

HIV-2 Infection and Pregnancy

Early (Acute and Recent) HIV Infection

  • The Panel has revised bulleted recommendations about ARV resistance testing and ART for early (acute or recent) HIV to reflect updated Panel recommendations about Preferred ART in pregnancy and to align with the Early (Acute and Recent) HIV Infection section of the Adult and Adolescent Antiretroviral Guidelines.
  • Preferred ART regimens recommended for treating early (acute or recent) HIV infection when ART and CAB-LA as PrEP have not previously been used now include BIC plus TAF plus FTC or dolutegravir (DTG) plus (TAF or tenofovir disoproxil fumarate [TDF]) plus (FTC or 3TC).
  • For instances of early (acute and recent) HIV infection and a history of CAB-LA use as PrEP, a regimen of ritonavir-boosted darunavir with (TAF or TDF) plus (FTC or 3TC) is recommended for initial ART.
    • Use of an empiric integrase strand transfer inhibitor (INSTI)–containing regimen is not recommended unless genotype testing shows no evidence of INSTI resistance. This is because INSTI resistance may be present in those who acquire HIV during and possibly after the use of CAB-LA as PrEP.
    • If baseline drug-resistance tests show no evidence of INSTI resistance, a switch to one of the Preferred INSTI-based regimens with DTG or BIC (listed above) should be considered.
  • When early HIV infection is diagnosed during the postpartum period, decisions on HIV drug-resistance testing and ARV regimens should be guided by recommendations outlined in the Early (Acute and Recent) HIV Infection section of the Adult and Adolescent Antiretroviral Guidelines.

Intrapartum HIV Care

  • When HIV RNA is >1,000 copies/mL or is unknown near the time of birth, scheduled cesarean birth at 38 weeks of gestation is recommended to minimize perinatal HIV transmission. However, given the potential for rapid decreases in viral load with current ART options, individualized birth plans to extend these pregnancies beyond 38 weeks to avoid the need for a cesarean birth can be considered with expert consultation and shared decision-making. Expert guidance from the National Perinatal HIV/AIDS Clinical Consultation Center (1-888-448-8765) may be helpful when choosing to develop an individualized birth plan.
  • Fetal scalp electrodes should be avoided when virologic suppression is achieved during pregnancy and should not be used when virologic suppression (≥50 copies/mL) is not achieved during pregnancy.

Initial Postnatal Management of the Neonate Exposed to HIV

Appendix B: Safety and Toxicity of Individual Antiretroviral Agents in Pregnancy

December 19, 2024

Preventing HIV Transmission During Infant Feeding

  • Bulleted recommendations now include information from the text on counseling about the infant feeding options of formula feeding, use of banked donor milk, or breastfeeding. Recommendations also address clinical management if viremia is identified.
    • In the case of a detectable viral load during breastfeeding, the Panels recommend breastfeeding be stopped temporarily or discontinued and replacement feeding initiated while the viral load is rechecked; causes for the viremia are assessed, and, when applicable, adherence counseling is reinforced (AII). Most experts recommend permanent discontinuation of breastfeeding when HIV RNA is ≥200 copies/mL (CIII).
    • Depending on the level and persistence of viremia during breastfeeding, next steps may include initiating or modifying infant antiretroviral (ARV) prophylaxis, permanently stopping breastfeeding, and considering the need for additional infant HIV testing.
    • If the repeat viral load is undetectable, a joint decision should be made by the parent and providers about whether breastfeeding may resume (AIII).

Diagnosis of HIV Infection in Infants and Children

Antiretroviral Management of Infants With In Utero, Intrapartum or Breastfeeding Exposure or HIV Infection

  • This section has been extensively revised and the title has been updated to reflect changes in recommendations, associated content about infant ARV management according to risk from in utero and intrapartum HIV exposure, and guidance for infant ARV prophylaxis during breastfeeding.
  • The Panels have added Table 10. Transmission Risk Assessment by HIV RNA Levels and Antenatal Time Period, which summarizes risk of transmission from exposure during three antenatal time periods. Because robust data are not available to define thresholds of risk across pregnancy, the Panels have selected time points balancing available data with implications for clinical management. Transmission risk categories inform ARV choice and management of prophylaxis and presumptive HIV therapy for infants with HIV exposure.
  • Revised criteria for infant risk of HIV infection from in utero or intrapartum exposure and recommended ARV management are summarized in Figure 1. Antiretroviral Management Algorithm for Infants With In Utero or Intrapartum HIV Exposure by Risk of Transmission and Table 11. Antiretroviral Management for Infants With In Utero or Intrapartum Exposure to HIV. The Panels recommend the following:
    • Infants at high risk of HIV infection from in utero or intrapartum exposure, defined as being perinatally exposed to viremia (HIV RNA ≥50 copies/mL) in the 4 weeks prior to delivery, should be provided a three-drug ARV regimen, administered from birth for 2 to 6 weeks, that serves as presumptive HIV therapy or enhanced prophylaxis. If the duration of the three-drug regimen is shorter than 6 weeks, zidovudine (ZDV) should be continued alone to complete a total of 6 weeks of prophylaxis (AII).
    • Infants at low risk of in utero and intrapartum HIV acquisition, defined as being perinatally exposed to HIV RNA levels <50 copies/mL from 20 weeks of gestation through delivery, should receive ZDV alone for a duration of 2 weeks (AII).
    • Infants not meeting the criteria for high or low risk should have ARV regimens and durations based on case-specific factors related to the level and timing of viremia during the pregnancy (AII).
  • The section now includes updated recommendations and expanded content about ARV prophylaxis for infants who are being breastfed. Recommendations of the Panels are summarized in a new table, Table 12. Antiretroviral Management of Infants With Exposure to HIV During Breastfeeding.
    • For infants with low risk of HIV acquisition during breastfeeding, some Panel members do not recommend extended ARV prophylaxis; however, other Panel members do recommend extended ARV prophylaxis with either nevirapine or lamivudine (CIII). The Panels did not reach consensus.
    • Infants are considered at low risk of transmission during breastfeeding when (1) maternal antiretroviral therapy is being used while breastfeeding and sustained maternal virologic suppression (HIV RNA <50 copies/mL) was achieved for at least 3 months prior to delivery and (2) the provider and patient are confident that maternal ART adherence will be maintained during breastfeeding (AII).
  • Bulleted recommendations and associated content have been added to provide guidance about infant ARV prophylaxis or use of presumptive HIV therapy when new maternal viremia occurs while breastfeeding or there are concerns about future risk of viremia.
  • Table 12.1. Antiretroviral Prophylaxis Dosing for Infants Who Are Breastfed has been revised to provide updated dosing information and to address infant ARV management for scenarios when maternal viremia develops or  maternal HIV is diagnosed during breastfeeding.

Download Guidelines

Related Content