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.

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Non-Nucleoside Reverse Transcriptase Inhibitors

Efavirenz (Sustiva, EFV)

Last Updated: December 7, 2018; Last Reviewed: December 7, 2018

Excerpt from Table 10a

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.

Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendations Use in Pregnancy
Efavirenz
(EFV)
Sustiva

(EFV/FTC/TDF)
Atripla

(EFV/3TC/TDF)
Symfi

(EFV/3TC/TDF)
Symfi Lo

Note: Generic available for some formulations.
EFV (Sustiva)d
Capsules:
  • 50 mg
  • 200 mg
Tablet:
  • 600 mg

EFV/FTC/TDF (Atripla):
  • EFV 600 mg plus FTC 200 mg tablet TDF 300 mg plus
EFV/3TC/TDF (Symfi):
  • EFV 600 mg plus 3TC 300 mg plus TDF 300 mg tablet
EFV/3TC/TDF (Symfi Lo):
  • EFV 400 mg plus 3TC 300 mg plus TDF 300 mg tablet
Standard Adult Doses
EFV (Sustiva):
  • EFV 600 mg once daily at or before bedtime, on an empty stomach to reduce side effects
EFV/FTC/TDF (Atripla):
  • 1 tablet once daily at or before bedtime, on an empty stomach to reduce side effects
EFV/3TC/TDF (Symfi or Symfi Lo):
  • 1 tablet once daily on an empty stomach and preferably at bedtime

PK in Pregnancy:
  • AUC is decreased during the third trimester compared with postpartum, but nearly all third-trimester participants exceeded target exposure.

Dosing in Pregnancy:
  • No change in dose is indicated.
  • For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., 3TC, FTC, TDF)
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:
          High: >0.6
          Moderate: 0.3–0.6
          Low: <0.3
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

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