The United States Department of Health and Human Services (DHHS) guideline, Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States, was recently updated. Multiple sections throughout the guideline received updates this year, updating recommendations on topics including formula supplementation, PrEP to prevent HIV during pregnancy and breastfeeding, HIV drug-resistance testing, and more.
Today, we are comparing the latest update to the January 2024 version of the guideline.
Guidelines Referenced:
- Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States
- Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States
- United States Department of Health and Human Services (DHHS)
- Publication: January 2024
- Full Text
Major Changes and Key Takeaways (2024-2026)
In 2026, DHHS released an updated version of its guideline, Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. The update included numerous recommendation updates, some of which are outlined below, along with other changes including tables being reworked for clarity . Notably, all mentions of non-subtype B HIV-1 have been removed from the guideline, as it is no longer a diagnostic concern.
The following table compares a portion of the new guidance added in the 2026 update to the previous 2024 version. To view the complete guidelines, including all of the other recommendations, view the full-text versions using the links featured above.
| Topic | 2024 | 2026 |
|---|---|---|
| Formula Supplementation | In the context of parental ART and viral suppression, it is not known whether formula supplementation increases the risk of HIV acquisition in the breastfed infant. | There is no evidence that formula supplementation increases the risk of HIV acquisition in the breastfed infant in the context of parental ART and viral suppression. |
| Mastitis | In the case of mastitis or bleeding nipples, pump and either flash heat or discard milk from the affected breast while continuing to feed or pump from the unaffected breast. | Women with HIV with mastitis or other unilateral breast pathology stop breastfeeding on the affected breast and feed on the contralateral breast; once symptoms resolve, women can again feed from both breasts. |
| Three-Drug Presumptive Treatment for Infants | Newborns who are at a high risk for HIV acquisition should receive the ZDV component of the three-drug presumptive HIV therapy regimen for 6 weeks. The other two ARVs (3TC and NVP or 3TC plus RAL) may be administered for 2 to 6 weeks | Three-drug presumptive treatment for infants with high risk of HIV acquisition now consists of ZDV/3TC plus nevirapine (NVP) or DTG. |
| PrEP to Prevent HIV During Pregnancy/Breastfeeding | The preferred PrEP option for HIV prevention in people who have receptive vaginal sex during pregnancy and breastfeeding is tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). TDF/FTC is currently the only U.S. Food and Drug Administration (FDA)–approved PrEP option with known safety and efficacy data during pregnancy and breastfeeding. People who become pregnant while using TDF/FTC as PrEP can continue PrEP throughout pregnancy and breastfeeding. Risk for HIV acquisition should be reassessed, and people should be counseled regarding the benefits and risks of PrEP use in pregnancy and during breastfeeding. | Tenofovir disoproxil fumarate plus emtricitabine is recommended for PrEP during pregnancy and breastfeeding as a daily oral product with robust safety and pharmacokinetic data during pregnancy and postpartum/breastfeeding. Lenacapavir is recommended for PrEP during pregnancy and breastfeeding as an injectable product given subcutaneously every 6 months that is highly effective for vaginal exposure to HIV and for which there is evidence for efficacy and safety during pregnancy and breastfeeding. Cabotegravir (CAB) can be considered for PrEP during pregnancy and breastfeeding as an injectable PrEP product given intramuscularly every 2 months that is highly effective for vaginal exposure to HIV, with emerging data to suggest that CAB is effective and safe during pregnancy and breastfeeding. |
| HIV Drug-Resistance Testing | Testing should be conducted before: Modifying ARV regimens for people with HIV who become pregnant while receiving ARV drugs or people who have suboptimal virologic response to ARV drugs that were started during pregnancy | Testing should be conducted before: Modifying ARV regimens in pregnancy when virologic failure or suboptimal viral load reduction have occurred (AII); testing will assist with selecting active drugs. |
| Test Results Reviewing | Not addressed. | All prior and current drug-resistance test results, when available, should be reviewed and considered when considering a new regimen. |
| Testing with No History of Prior ART Use | Not addressed. | In most cases, perform genotypic rather than phenotypic testing when there is no history of prior ART use. |
| Integrase Strand Transfer Inhibitor | If the use of an integrase strand transfer inhibitor (INSTI) is being considered and INSTI resistance is a concern, providers should supplement standard resistance testing with a specific INSTI genotypic resistance assay (AIII). INSTI resistance may be a concern if: A patient received prior treatment or pre-exposure prophylaxis that included an INSTI. A patient has had a sexual partner on INSTI therapy who was not virologically suppressed or with unknown viral load. | In most cases, perform standard genotype testing (for reverse transcriptase and protease mutations rather than integrase strand transfer inhibitor [INSTI] mutations). Important exceptions include when: Transmitted INSTI resistance is suspected. There was previous use of long-acting cabotegravir (CAB-LA) as pre-exposure prophylaxis. There was previous use of an INSTI-based regimen for post-exposure prophylaxis or for treatment of HIV without sustained viral suppression. |
| Optimal Timing of Drug-Resistance Testing | Not addressed. | The optimal time to perform drug-resistance testing depends on the clinical scenario: When a non–long-acting ARV regimen is being taken, drug-resistance testing in the setting of virologic failure should be performed while the ARV regimen is still being taken, or, if that is not possible, within 4 weeks after discontinuation of the ARV regimen (AII). If more than 4 weeks have elapsed since the non–long-acting agents have been discontinued, resistance testing may still provide useful information to guide therapy; however, it is important to recognize that previously selected resistance mutations can be missed because of lack of drug-selective pressure. In the context of previous CAB-LA–based ART use (e.g., cabotegravir with rilpivirine or lenacapavir) and virologic failure, resistance testing (including INSTI genotypic testing) should be performed regardless of the time since the last dose of long-acting ARV. |
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