General Principles Regarding Use of Antiretroviral Drugs during Pregnancy
Last Updated: December 12, 2019; Last Reviewed: December 12, 2019
Panel's Recommendations Regarding Teratogenicity
- All cases of antiretroviral (ARV) drug exposure during pregnancy should be reported to the Antiretroviral Pregnancy Registry (AIII).
- Based on multiple studies indicating no difference in rates of total birth defects for first-trimester exposure compared with later ARV drug exposures, women can be counseled that ARV drugs during pregnancy generally do not increase the risk of birth defects (BIII); a possible exception is a small increased risk of neural tube defects (NTDs) with dolutegravir (DTG) use during the periconception period. Providers should be aware that data on the risks of birth defects for many ARV drugs are limited.
Updated Panel Recommendations Regarding the Use of Dolutegravir at the Time of Conception and During Pregnancy:
- DTG exposure around the time of conception has been associated with a small but significant increase in the risk of infant NTDs in Botswana (0.3%), where food is not routinely fortified with folate. Although this risk was higher than the risk for NTDs in infants born to women who were receiving efavirenz (0.05%) and women without HIV (0.08%), there are not enough data to determine the risk of NTDs with preconception use of all Preferred and Alternative regimens, including DTG, in the United States. Based on the available evidence, the Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission (the Panel) recommends DTG as a Preferred drug for pregnant women, irrespective of trimester (AII), and an Alternative drug for women who are trying to conceive (AIII).
- The Panel emphasizes the importance of counseling and informed decision-making regarding all ARV regimens for people with HIV (AIII). For additional information, see Appendix D: Dolutegravir Counseling Guide for Health Care Providers.
- Clinicians should discuss future reproductive plans and timing as well as the risks and benefits of conceiving on specific ARV medications and use of appropriate contraceptive options to prevent unintended pregnancy (AIII).
- Folic acid is known to prevent NTDs in the general population. All pregnant women and women who might conceive should take at least 400 mcg of folic acid daily (AI). There is no established link between the use of DTG and impaired folate metabolism, nor is there evidence that folate supplementation prevents DTG-associated NTDs.
- For additional information, see Updated Guidance about the Use of Dolutegravir in Pregnancy in Recommendations for Use of Antiretroviral Drugs During Pregnancy, Preconception Counseling and Care for Women of Childbearing Age Living with HIV, Pregnant Women Living with HIV Who Are Currently Receiving Antiretroviral Therapy, and Dolutegravir.