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

Darunavir (Prezista, DRV)

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
Darunavir
(DRV)
Prezista

Note: Must be combined with low- dose RTV or COBI boosting.

(DRV/COBI)
Prezcobix

(DRV/COBI/FTC/TAF)
Symtuza
DRV (Prezista)
Tablet:
  • 75 mg
  • 150 mg
  • 600 mg
  • 800 mg
Oral Suspension:
  • 100 mg/mL
DRV/COBI (Prezcobix):
  • DRV 800 mg plus COBI 150 mg tablet
DRV/COBI/FTC/TAF (Symtuza):
  • DRV 800 mg plus COBI 150 mg plus FTC 200 mg plus TAF 10 mg tablet
Standard Adult Doses

ARV-Naive Patients:
  • DRV 800 mg plus RTV 100 mg once daily with food
  • DRV 800 mg plus COBI 150 mg once daily with food
ARV-Experienced Patients:
If Patient Has No DRV Resistance Mutations:
  • DRV 800 mg plus RTV 100 mg once daily with food
  • DRV 800 mg plus COBI 150 mg once daily with food
If Any DRV Resistance Mutations Are Present:
  • DRV 600 mg plus RTV 100 mg twice daily with food
DRV/COBI (Prezcobix):
  • 1 tablet once daily with food
DRV/COBI/FTC/TAF (Symtuza):
  • 1 tablet once daily with food
Dosing in Pregnancy:
  • The Panel does not recommend once-daily dosing with DRV/r during pregnancy or the use of DRV/c during pregnancy. Twice-daily DRV/r dosing (DRV 600 mg plus RTV 100 mg with food) is recommended for all pregnant women. Increased twice-daily DRV dose (DRV 800 mg plus RTV 100 mg with food) during pregnancy does not result in an increase in darunavir exposure and is not recommended

PK in Pregnancy:
  • Decreased exposure in pregnancy with use of DRV/r.
  • For guidance about use of combination products in pregnancy, please see the specific sections on other components (i.e., COBI,FTC,TAF)
Low placental transfer to fetus.b

No evidence of teratogenicity in mice, rats, or rabbits. No evidence of human teratogenicity.

Must be boosted with low-dose RTV.

The Panel does not recommend once-daily dosing with DRV/r during pregnancy or the use of DRV/c during pregnancy. If a DRV/c regimen is continued during pregnancy, 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

Key to Acronyms: ARV = antiretroviral; COBI = cobicistat; DRV = darunavir; DRV/c = darunavir/cobicistat; DRV/r = darunavir/ritonavir; FDC = fixed-dose combination; FTC = emtricitabine; PK = pharmacokinetic; RTV = ritonavir; TAF = tenofovir alafenamide

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