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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Protease Inhibitors

Atazanavir (Reyataz, ATV)

Last Updated: December 24, 2019; Last Reviewed: December 24, 2019

Excerpt from Table 8

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

Excerpt from Table 8
Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendationsa Use in Pregnancy
Atazanavir
(ATV)
Reyataz

Note: Generic products are available for some formulations.

Note: ATV must be combined with low-dose RTV boosting in pregnancy.

(ATV/COBI)
Evotaz
ATV (Reyataz)
Capsules:
  • 100 mg (generic product only)
  • 150 mgd
  • 200 mgd
  • 300 mgd
Oral Powder:
  • 50 mg packet
ATV/COBI (Evotaz):
  • ATV 300 mg/COBI 150 mg tablet
Standard Adult Doses
In ARV-Naive Patients without RTV Boosting:
  • ATV 400 mg once daily with food; ATV without RTV boosting is not recommended when used with TDF, H2-receptor antagonists, PPIs, or during pregnancy.
In ARV-Naive Patients with RTV Boosting:
  • ATV 300 mg plus RTV 100 mg once daily with food
  • When combined with EFV in ARV-naive patients: ATV 400 mg plus RTV 100 mg once daily with food
In ARV-Experienced Patients:
  • ATV 300 mg plus RTV 100 mg once daily with food
  • Do not use with PPIs or EFV
In ARV-Experienced Patients Who Are Receiving an H2-Receptor Antagonist:
  • ATV 300 mg plus RTV 100 mg once daily with food
In ARV-Experienced Patients Who Are Receiving an H2-Receptor Antagonist and TDF:
  • ATV 400 mg plus RTV 100 mg once daily with food
Powder Formulation:
  • Oral powder is taken with RTV once daily with food at the same recommended adult dose as the capsules.
ATV/c (Evotaz):
  • One tablet once daily with food

Pregnancy
PKs in Pregnancy
ATV (Reyataz):
  • ATV concentrations are reduced during pregnancy, and they are further reduced when ATV is given concomitantly with TDF or an H2-receptor antagonist.
ATV/c (Evotaz):
  • Use of ATV/c is not recommended during pregnancy, because ATV trough concentrations are 80% to 85% lower than the ATV concentrations seen in nonpregnant adults.
Dosing in Pregnancy ATV (Reyataz):
  • Use of unboosted ATV is not recommended during pregnancy.
  • Use of ATV is not recommended for ARV-experienced pregnant women who are taking TDF and an H2-receptor antagonist.
  • Use of an increased dose (ATV 400 mg plus RTV 100 mg once daily with food) during the second and third trimesters results in plasma ATV concentrations equivalent to those seen in nonpregnant adults receiving standard dosing. Although some experts recommend increased ATV dosing in all women during the second and third trimesters, the package insert recommends increased ATV dosing only for ARV-experienced pregnant women in the second and third trimesters who are also receiving either TDF or an H2-receptor antagonist.
ATV/c (Evotaz):
  • Insufficient data to make dosing recommendation in pregnancy (see COBI).
For guidance about the use of combination products in pregnancy, please see the specific sections on other components (i.e., COBI).
Low placental transfer to fetus.b

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

Must be given with RTV boosting in pregnancy.

Effect of in utero ATV exposure on infant indirect bilirubin levels is unclear. Nonpathologic elevations of neonatal bilirub have been observed in some, but not all, clinical trials to date.

Oral powder (but not capsules) contains phenylalanine, which can be harmful to patients with phenylketonuria.

Use of ATV/c is not recommended during pregnancy. See Recommendations for Use of Antiretroviral Drugs During Pregnancy, Table 4, and Table 5 for discussions about avoiding the use of ATV/c during pregnancy.
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: ARV = antiretroviral; ATV = atazanavir; ATV/c = atazanavir/cobicistat; COBI = cobicistat; EFV = efavirenz; FDC = fixed-dose combination; PK = pharmacokinetic; PPI = proton pump inhibitor; RTV = ritonavir; TDF = tenofovir disoproxil fumarate

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