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 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
Atazanavir
(ATV)
Reyataz

Note: Generic 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 plus COBI 150 mg tablet
Standard Adult Doses
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.
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
ARV-Experienced Patients:
  • ATV 300 mg plus RTV 100 mg once daily with food
  • Do not use with PPIs or EFV
If Combined with an H2-Receptor Antagonist:
  • ATV 300 mg plus RTV 100 mg once daily with food
If Combined with 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/COBI (Evotaz):
  • 1 tablet once daily with food
PK in Pregnancy
ATV (Reyataz):
  • ATV concentrations reduced during pregnancy; further reduced when given concomitantly with TDF or H2-receptor antagonist.
ATV/COBI (Evotaz):
  • No PK studies in human pregnancy.
For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., COBI).

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 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 on 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/COBI (Evotaz):
  • Insufficient data to make dosing recommendation in pregnancy (see Cobicistat section).
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 as low-dose RTV-boosted regimen in pregnancy.

Effect of in utero ATV exposure on infant indirect bilirubin levels is unclear. Nonpathologic elevations of neonatal hyperbilirubinemia 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.

ATV/COBI is not recommended for use in pregnancy. For women who become pregnant while taking ATV/COBI, consider switching to a more effective, recommended regimen. If an ATV/COBI regimen is continued, doses should be administered with food; viral load should be monitored frequently.
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
d Generic formulation available

Key to Acronyms: ARV = antiretroviral; ATV = atazanavir; COBI = cobicistat; EFV = efavirenz; FDC = fixed-dose combination; PK = pharmacokinetic; PPI = proton pump inhibitor; RTV = ritonavir; TDF = tenofovir disoproxil fumarate

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