Recommendations for the Use of Antiretroviral Drugs in Pregnant Women with HIV Infection and Interventions to Reduce Perinatal HIV Transmission in the United States
The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.
Non-Nucleoside Reverse Transcriptase Inhibitors
Efavirenz (Sustiva, EFV)
Last Updated: December 7, 2018; Last Reviewed: December 7, 2018
Excerpt from Table 10
Note: When using FDCs, refer to other sections in Appendix B and Table 10 for information about the dosing and safety of individual drug components of the FDC during pregnancy.
|Formulation||Dosing Recommendationsa||Use in Pregnancy|
Note: Generic available for some formulations.
|Standard Adult Doses
PK in Pregnancy:
Dosing in Pregnancy:
|Moderate placental transfer to fetus.b
The FDA advises women to avoid becoming pregnant while taking EFV and advises health care providers to avoid administration during the first trimester of pregnancy, as fetal harm may occur.
Although the limited data on first-trimester EFV exposure cannot rule out a 2-fold or 3-fold increased incidence of a rare outcome such as neural tube defects, the available data from a meta-analysis of >2,000 births suggest that there is no large increase in the risk of neural tube defects with first-trimester exposure (e.g., a 10-fold increase to a rate of 1%). As a result, the current Perinatal Guidelines do not restrict the use of EFV in pregnant women or in women who are planning to become pregnant. This is consistent with both the British HIV Association and WHO guidelines for use of ARV drugs in pregnancy.
EFV should be continued in pregnant women who are on a virologically suppressive, EFV-based regimen, because ARV drug changes during pregnancy may be associated with loss of viral control and an increased risk of perinatal transmission (see Pregnant Women Living with HIV Who are Currently Receiving Antiretroviral Therapy).
a Individual ARV drug dosages may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Guidelines Appendix B, Table 8).
b Placental transfer categories are determined by mean or median cord blood/maternal delivery plasma drug ratio:
d Generic formulation available
Key to Acronyms: 3TC = lamivudine; ARV = antiretroviral; AUC = area under the curve; EFV = efavirenz; FDA = Food and Drug Administration; FDC = fixed-dose combination; FTC = emtricitabine; PK = pharmacokinetic; TDF = tenofovir disoproxil fumarate; WHO = World Health Organization
- AIDSinfo Drug Database
- AIDSinfo Patient Materials: Preventing Mother-to-Child Transmission of HIV
- AIDSinfo Patient Materials: HIV Medicines During Pregnancy and Childbirth
- AIDSinfo Patient Materials: Protecting Baby from HIV
- AETC National HIV Curriculum
- How to Cite These Guidelines
- Perinatal Guidelines Archive