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 24, 2019; Last Reviewed: December 24, 2019

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
Tenofovir Disoproxil Fumarate
(TDF)
Viread

(TDF/EFV/FTC)
Atripla

(TDF/3TC)
Cimduo

(TDF/FTC/RPV)
Complera

(TDF/DOR/3TC)
Delstrigo

(TDF/EVG/c/FTC)
Stribild

(TDF/EFV/3TC)
Symfi

(TDF/EFV/3TC)
Symfi Lo

(TDF/3TC)
Temixys

(TDF/FTC)
Truvada

Note: Generic products are available for some formulations.
TDF (Viread)
Tablet:d
  • 300 mg
Powder:
  • 40 mg/1 g oral powder
TDF/EFV/FTC (Atripla):
  • TDF 300 mg/EFV 600 mg/FTC 200 mg tablet
TDF/3TC (Cimduo):
  • TDF 300 mg/3TC 300 mg tablet
TDF/FTC/RPV (Complera):
  • TDF 300 mg/FTC 200 mg/RPV 25 mg tablet
TDF/DOR/3TC (Delstrigo):
  • TDF 300 mg/DOR 100 mg/3TC 300 mg tablet
TDF/EVG/c/FTC (Stribild):
  • TDF 300 mg/EVG 150 mg/COBI 150 mg/FTC 200 mg tablet
TDF/EFV/3TC (Symfi):
  • TDF 300 mg/EFV 600 mg/3TC 300 mg tablet
TDF/EFV/3TC (Symfi Lo):
  • TDF 300 mg/EFV 400 mg/3TC 300 mg tablet
TDF/3TC (Temixys):
  • TDF 300 mg/3TC 300 mg tablet
TDF/FTC (Truvada):
  • TDF 300 mg/FTC 200 mg tablet
Standard Adult Doses
TDF (Viread)
Tablet:
  • TDF 300 mg once daily without regard to food
Powder:
  • TDF 8 mg/kg daily (up to a maximum of TDF 300 mg). Take with food.
TDF/EFV/FTC (Atripla):
  • One tablet once daily at or before bedtime. Take on an empty stomach to reduce side effects.
TDF/3TC (Cimduo):
  • One tablet once daily without regard to food
TDF/FTC/RPV (Complera):
  • One tablet once daily with food
TDF/DOR/3TC (Delstrigo):
  • One tablet once daily without regard to food
TDF/EVG/c/FTC (Stribild):
  • One tablet once daily with food
TDF/EFV/3TC (Symfi or Symfi Lo):
  • One tablet once daily on an empty stomach and preferably at bedtime
TDF/3TC (Temixys):
  • One tablet once daily without regard to food
TDF/FTC (Truvada):
  • One tablet once daily without regard to food
Pregnancy
PKs 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 the 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 has HBV/HIV coinfection, it is possible that an HBV flare may occur if TDF is stopped; see Hepatitis B Virus/HIV 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 Antiretroviral 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 is available.

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

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