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: January 17, 2020; Last Reviewed: January 17, 2020

Excerpt from Table 8

Note: When using FDCs, refer to other sections in Appendix B and Table 8 for information about the dosing and safety of individual drug components of the FDC during pregnancy.

Excerpt from Table 8
Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendationsa Use in Pregnancy
Efavirenz
(EFV)
Sustiva

(EFV/FTC/TDF)
Atripla

(EFV/3TC/TDF)
Symfi

(EFV/3TC/TDF)
Symfi Lo

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

EFV/FTC/TDF (Atripla):
  • EFV 600 mg/FTC 200 mg/TDF 300 mg tablet 
EFV/3TC/TDF (Symfi):
  • EFV 600 mg/3TC 300 mg/TDF 300 mg tablet
EFV/3TC/TDF (Symfi Lo):
  • EFV 400 mg/3TC 300 mg/TDF 300 mg tablet
Standard Adult Doses
EFV (Sustiva):
  • EFV 600 mg once daily at or before bedtime
  • Take on an empty stomach to reduce side effects.
EFV/FTC/TDF (Atripla):
  • One tablet once daily at or before bedtime
  • Take on an empty stomach to reduce side effects.
EFV/3TC/TDF (Symfi or Symfi Lo):
  • One tablet once daily on an empty stomach and preferably at bedtime
Pregnancy
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. However, the data on more than 7,900 periconception EFV exposures from Botswana rules out a ≥3-fold increased risk of NTDs. 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 doses may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Guidelines Appendix B, Table 10).
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 product available

Key: 3TC = lamivudine; ARV = antiretroviral; AUC = area under the curve; EFV = efavirenz; FDA = Food and Drug Administration; FDC = fixed-dose combination; FTC = emtricitabine; NTDs = neural tube defects; PK = pharmacokinetic; TDF = tenofovir disoproxil fumarate; WHO = World Health Organization

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