Update to the Perinatal HIV Clinical Guideline

Cross-posted from: clinicalinfo.hiv.gov

The Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission has updated the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States guidelines sections to address new data and publications where relevant. Key updates are summarized below. All revisions are highlighted in yellow in the PDF version of the guidelines.

Pre-exposure Prophylaxis (PrEP) to Prevent HIV During Periconception, Antepartum, and Postpartum Periods

• There are now several U.S. Food and Drug Administration (FDA)–approved oral and long-acting injectable pre-exposure prophylaxis (PrEP) options for preventing HIV transmission from receptive vaginal sex, including during pregnancy and breastfeeding. Health care professionals should discuss potential options with patients and engage in shared decision-making to assist in choosing the best HIV prevention option for the individual patient.

Initial Use of Antiretroviral Therapy During Pregnancy

• Dolutegravir (DTG)/lamivudine (3TC) is now classified as an Alternative antiretroviral therapy (ART) regimen for use in pregnancy when used in individuals without prior long-acting cabotegravir PrEP exposure, with HIV RNA ≤500,000 copies/mL, with no evidence of hepatitis B virus (HBV) coinfection, and with confirmed 3TC susceptibility on HIV resistance testing.
• Table 6. What to Start: Initial Antiretroviral Regimens During Pregnancy has been revised to reflect updated Panel recommendations for initial use of ART during pregnancy.

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

• DTG/3TC is now classified as an Alternative ART regimen for use when initiating ART in pregnancy when antiretroviral (ARV) drugs have never been previously used, starting or restarting ART during pregnancy when ARV drugs have been used in the past, or starting ART when trying to conceive as long as HIV RNA is ≤500,000 copies/mL, there is no evidence of HBV coinfection, and there is confirmed 3TC susceptibility on current or historical HIV resistance testing.

Hepatitis B Virus/HIV Coinfection

• The Panel recommends that everyone should be tested for hepatitis B surface antigen (HBsAg) in every pregnancy. Triple panel (HBsAg, hepatitis B core antibody [HBcAb], and hepatitis B surface antibody [HBsAb]) screening is recommended for pregnant women who do not have a documented triple screen after age 18 years that indicates vaccine-induced immunity (HBsAb ≥10 mIU/mL with negative HBsAg and HBcAb) or presence of HBV infection (i.e., HBsAg positive).

Hepatitis C Virus/HIV Coinfection

• Updated information about ongoing studies of direct-acting antivirals in pregnancy has been included.

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

• Lenacapavir is now FDA approved for HIV PrEP in addition to treatment for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection whose current ARV regimen is failing due to resistance, intolerance, or safety considerations. Pharmacokinetic and safety data are available in pregnancy and lactation and detailed in the Lenacapavir drug section.

Clinicalinfo welcomes your feedback on the latest revisions to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States. Please send your comments with the subject line “Perinatal HIV Clinical Guidelines” to HIVinfo@NIH.gov by April 21, 2026.