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

Fosamprenavir (Lexiva, FPV)

Last Updated: December 7, 2018; Last Reviewed: December 7, 2018

Excerpt from Table 10a
Generic Name
(Abbreviation)
Trade Name
Formulation Dosing Recommendations Use in Pregnancy
Fosamprenavir
(FPV)
Lexiva (a prodrug of amprenavir)

Note:
Must be combined with low-dose RTV boosting in pregnancy
FPV (Lexiva) 
Tablets:
  • 700 mg
Oral Suspension:
  • 50 mg/mL
Standard Adult Doses
FPV (Lexiva)
ARV-Naive Patients:
  • FPV 1400 mg twice daily without food, or
  • FPV 1400 mg plus RTV 100 or 200 mg once daily without food, or
  • FPV 700 mg plus RTV 100 mg twice daily without food
PI-Experienced Patients:
  • Once-daily dosing is not recommended
  • FPV 700 mg plus RTV 100 mg twice daily without food
Co-Administered with EFV:
  • FPV 700 mg plus RTV 100 mg twice daily without food; or
  • FPV 1400 mg plus RTV 300 mg once daily without food

PK in Pregnancy:
  • With RTV boosting, AUC is reduced during the third trimester. However, exposure is greater during the third trimester with boosting than in non-pregnant adults without boosting, and trough concentrations achieved during the third trimester were adequate for patients without PI resistance mutations.

Dosing in Pregnancy:
  • Use of unboosted FPV or once-daily FPV with RTV boosting is not recommended during pregnancy. No change is indicated in standard boosted twice-daily dose (FPV 700 mg plus RTV 100 mg twice daily without food).

FPV should not be used during pregnancy.

Low placental transfer to fetus.b

Insufficient data to assess for teratogenicity in humans. Increased fetal loss in rabbits but no increase in defects in rats and rabbits.

a Individual ARV drug dosages may need to be adjusted in patients with renal or hepatic insufficiency (for details, see the Adult and Adolescent Guidelines Appendix B, Table 7).
b Placental transfer categories—Mean or median cord blood/maternal delivery plasma drug ratio:
          High: >0.6
          Moderate: 0.3–0.6

Key to Acronyms: ARV= antiretroviral; AUC= area under the curve; EFV = efavirenz; FPV = fosamprenavir; PI = protease inhibitor; PK = pharmacokinetic; RTV = ritonavir

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