- When choosing an antiretroviral (ARV) drug regimen for a pregnant woman, providers and patients should consider multiple factors, including adverse effects, drug interactions, pharmacokinetics (PKs), convenience of the individual drugs and drug combinations in the regimen, available pregnancy safety and outcome data, and the patient’s resistance test results and comorbidities (AIII).
- The same regimens that are recommended for the treatment of nonpregnant adults should be used in pregnant women when sufficient data suggest that appropriate drug exposure is achieved during pregnancy; clinicians should weigh the risks of adverse effects for women, fetuses, or infants against the benefits of these regimens and recognize that there are often incomplete data on the safety of ARV drugs in pregnancy (AII). For more information, see Tables 4 and 5.
- In most cases, women who present for obstetric care on fully suppressive ARV regimens should continue their current regimens (AIII).
- PK changes in pregnancy may lead to lower plasma levels of drugs and necessitate increased doses, more frequent dosing, boosting, or more frequent viral load monitoring (AII).
Updated Panel Recommendations Regarding the Use of Dolutegravir in Pregnancy:
- Dolutegravir (DTG) exposure around the time of conception has been associated with a small but significant increase in the risk of infant neural tube defects (NTDs) in Botswana (0.3%). 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 Preconception Counseling and Care for Women of Childbearing Age Living with HIV, Teratogenicity, Appendix D: Dolutegravir Counseling Guide for Health Care Providers, and Tables 4 and 5.
- When DTG use is continued after delivery, clinicians should discuss reproductive desires, the risks and benefits of conceiving on DTG, and contraceptive options (AIII). See Preconception Counseling and Care and Postpartum Care for more information.
- 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.