Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States

This counseling guide summarizes recommendations from the U.S. Department of Health and Human Services Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission regarding the use of antiretroviral (ARV) drugs during pregnancy or when trying to conceive. Its purpose is to support informed, shared decision-making for individuals living with HIV and their clinicians. Effective antiretroviral therapy (ART) with sustained viral suppression is the cornerstone of maternal health and prevention of perinatal HIV transmission. When ART is initiated prior to conception and viral suppression is maintained throughout pregnancy, the risk of mother-to-child transmission can be reduced to 1% or less. Counseling should therefore address reproductive intentions, potential risks and benefits of specific ARVs, and contraceptive options for those wishing to avoid unintended pregnancy. Discussions should include dosing requirements, side effects, tolerability, potential risks such as birth defects or preterm birth, and the limited safety data for some newer ARVs in pregnancy. Clinicians are encouraged to report exposures to the Antiretroviral Pregnancy Registry (APR), which monitors teratogenicity trends. Current evidence indicates that dolutegravir (DTG) is not associated with increased neural tube defects, and that bictegravir (BIC) has not shown elevated risk in available data. The Panel generally recommends continuing a patient’s current suppressive regimen during pregnancy, while providing additional monitoring if drugs with limited pregnancy data (e.g., cabotegravir, doravirine, cobicistat-boosted regimens) are used. Preferred regimens include DTG or BIC combined with two nucleoside reverse transcriptase inhibitors (NRTIs) such as tenofovir alafenamide (TAF) or tenofovir disoproxil fumarate (TDF) plus emtricitabine (FTC) or lamivudine (3TC). Alternative options include raltegravir, boosted protease inhibitors, and rilpivirine. The guidance underscores that regimen changes during pregnancy may increase viral load and risk of transmission, and therefore must be carefully weighed. Frequent viral load monitoring (every 1–2 months when non-preferred agents are used) is advised. Ultimately, the recommendations aim to balance efficacy, safety, tolerability, and prevention of transmission while supporting reproductive autonomy and optimizing outcomes for both mother and infant.