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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Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors

Tenofovir Disoproxil Fumarate (Viread, TDF)

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
Tenofovir Disoproxil Fumarate
(TDF)
Viread

(TDF/EFV/FTC)
Atripla

(TDF/3TC)
Cimduo

(TDF/FTC/RPV)
Complera

(TDF/DOR/3TC)
Delstrigo

(TDF/EVG/COBI /FTC)
Stribild

(TDF/EFV/3TC)
Symfi

(TDF/EFV/3TC)
Symfi Lo

(TDF/3TC)
Temixys

(TDF/FTC)
Truvada

Note: Generic available for some formulations
TDF (Viread)
Tablet:d
  • 300 mg
Powder:
  • 40 mg/1 g oral powder
TDF/EFV/FTC (Atripla):
  • TDF 300 mg plus EFV 600 mg plus FTC 200 mg tablet
TDF/3TC (Cimduo):
  • TDF 300 mg plus 3TC 300 mg tablet
TDF/FTC/RPV (Complera):
  • TDF 300 mg plus FTC 200 mg plus RPV 25 mg tablet
TDF/DOR/3TC (Delstrigo):
  • TDF 300 mg plus DOR 100 mg plus 3TC 300 mg tablet
TDF/EVG/COBI /FTC (Stribild):
  • TDF 300 mg plus EVG 150 mg plus COBI 150 mg plus FTC 200 mg tablet
TDF/EFV/3TC (Symfi):
  • TDF 300 mg plus EFV 600 mg plus 3TC 300 mg tablet
TDF/EFV/3TC (Symfi Lo):
  • TDF 300 mg plus EFV 400 mg plus 3TC 300 mg tablet
TDF/3TC (Temixys):
  • TDF 300 mg plus 3TC 300 mg tablet
TDF/FTC (Truvada):
  • TDF 300 mg plus FTC 200 mg tablet
Standard Adult Doses
TDF (Viread)
Tablet:
  • TDF 300 mg once daily without regard to food
Powder:
  • TDF 8 mg/kg (up to a maximum of TDF 300 mg). Take with food.
TDF/EFV/FTC (Atripla):
  • 1 tablet once daily at or before bedtime. Take on an empty stomach to reduce side effects.
TDF/3TC (Cimduo):
  • 1 tablet once daily without regard to food
TDF/FTC/RPV (Complera):
  • 1 tablet once daily with food
TDF/DOR/3TC (Delstrigo):
  • 1 tablet once daily without regard to food.
TDF/EVG/COBI/FTC (Stribild):
  • 1 tablet once daily with food
TDF/EFV/3TC (Symfi or Symfi Lo):
  • 1 tablet once daily on an empty stomach and preferably at bedtime
TDF/3TC (Temixys):
  • 1 tablet once daily without regard to food
TDF/FTC (Truvada):
  • 1 tablet once daily without regard to food
PK in Pregnancy:
  • AUC is lower in third trimester than postpartum, but trough levels are adequate.
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, COBI, DOR, EFV, EVG, FTC, RPV)
High placental transfer to fetus.b

No evidence of human teratogenicity (can rule out 1.5-fold increase in overall birth defects).

Studies in monkeys (at doses approximately 2-fold higher than those for human therapeutic use) show decreased fetal growth and reduction in fetal bone porosity within 2 months of starting maternal therapy. Human studies demonstrate no consistent link to low birth weight, but data are conflicting about potential effects on growth outcomes later in infancy.

If patient is HBV coinfected, it is possible that an HBV flare may occur if TDF is stopped; see HIV/Hepatitis B Virus Coinfection.

Renal function should be monitored because of potential for renal toxicity.
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 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

Key to Acronyms: : AUC = area under the curve; 3TC = lamivudine; COBI = cobicistat; DOR = doravirine; EFV = efavirenz; EVG = elvitegravir; FDC = fixed-dose combination; FTC = emtricitabine; HBV = hepatitis B virus; PK = pharmacokinetic; RPV = rilpivirine; TDF = tenofovir disoproxil fumarate

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