Darunavir for use in pregnant women with HIV

Expert Rev Clin Pharmacol. 2017 Dec;10(12):1317-1327. doi: 10.1080/17512433.2017.1390428. Epub 2017 Nov 14.


Combination antiretroviral therapy is recommended during pregnancy to decrease the rate of HIV transmission to the baby and reduce morbidity in the mother. More than 50% of women are prescribed a protease inhibitor-based regimen during pregnancy. Darunavir was recently reclassified as a first-line protease inhibitor for use in pregnancy in the US Department of Health and Human Services Perinatal Guidelines. Areas covered: This is a brief review of the use of protease inhibitor therapy during pregnancy, and a discussion of darunavir's utility in this area. Clinical pharmacology and trial data are reviewed, and the safety, efficacy and dosing of darunavir during pregnancy is discussed. Expert commentary: Darunavir has become an important option in the management of HIV during pregnancy. Both once-daily dosing and twice-daily dosing regimens have shown efficacy in clinical studies. Although a significant reduction in total (protein bound and unbound) plasma concentrations of darunavir has been noted during pregnancy, antiviral activity appears to be maintained with standard dosing. This is likely due to diminished changes in unbound drug concentrations. Preterm delivery and low birth weight have been noted for pregnancies of women on darunavir-containg regimens, but a causal relationship has not yet been demonstrated.

Keywords: Darunavir; human immunodeficiency virus; once-daily; pharmacokinetics; pregnancy; protease inhibitors; twice-daily.

Publication types

  • Review

MeSH terms

  • Animals
  • Darunavir / administration & dosage*
  • Darunavir / adverse effects
  • Darunavir / therapeutic use
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Female
  • HIV Infections / drug therapy*
  • HIV Infections / virology
  • HIV Protease Inhibitors / administration & dosage
  • HIV Protease Inhibitors / adverse effects
  • HIV Protease Inhibitors / therapeutic use
  • Humans
  • Infectious Disease Transmission, Vertical / prevention & control
  • Practice Guidelines as Topic
  • Pregnancy
  • Pregnancy Complications, Infectious / drug therapy*
  • Pregnancy Complications, Infectious / virology


  • HIV Protease Inhibitors
  • Darunavir