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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Integrase Inhibitors

Raltegravir (Isentress, RAL)

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

Excerpt from Table 8

Excerpt from Table 8
Generic Name
Trade Name
Formulation Dosing Recommendationsa Use in Pregnancy
Isentress HD
RAL (Isentress)
Film-Coated Tablets:
  • 400 mg
Chewable Tablets:
  • 25 mg
  • 100 mg

RAL (Isentress HD)
Film-Coated Tablets:
  • 600 mg
Standard Adult Dose:
In Patients Who Are Not Receiving Rifampin:
  • RAL 400-mg, film-coated tablets twice daily without regard to food
  • Two RAL 600-mg, film-coated tablets (1,200 mg) once daily without regard to food for ARV-naive patients or patients who are already virologically suppressed on an initial regimen of RAL 400 mg twice daily
  • Chewable tablets and oral suspension doses are not interchangeable with either film-coated tablets or each other.
In Patients Who Are Receiving Rifampin:
  • Two RAL 400-mg, film-coated tablets (800 mg) twice daily without regard to food
PK in Pregnancy:
  • Decreased drug concentrations in third trimester are not of sufficient magnitude to warrant a change in dosing.

Dosing in Pregnancy:
  • No change in dose is indicated.
  • Once-daily dosing (i.e., two RAL 600-mg, film-coated tablets) should not be used in pregnant women until more information is available.
High placental transfer to fetus.b

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

There is a case report of markedly elevated liver transaminases with RAL use in late pregnancy. Severe, potentially life-threatening, and fatal skin and HSRs have been reported in nonpregnant adults.

RAL chewable tablets contain phenylalanine.

To maximize RAL absorption, doses should not be administered within 2 hours of ingestion of any preparation containing minerals such as iron or calcium, including prenatal vitamins.

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

Key: ARV = antiretroviral; HD= high dose; BIC = bictegravir; HSR = hypersensitivity reaction; PK = pharmacokinetic; RAL = raltegravir

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