Fosamprenavir

Fosamprenavir Brand Name– Lexiva

What is Fosamprenavir

Fosamprenavir is a prodrug of amprenavir, a protease inhibitor used to treat infection with the human immunodeficiency virus (HIV-1).

Fosamprenavir has improved solubility over the parent drug, amprenavir, and provides the opportunity for reduced pill burden for current dosing regimens.

In one clinical trial, in antiretroviral-naive patients, treatment with fosamprenavir, abacavir, and lamivudine for 48 weeks achieved viral loads < 400 copies/mL in 66% of patients, compared with 52% of patients who received nelfinavir, abacavir, and lamivudine.

In another clinical trial, in protease inhibitor-experienced patients previously experiencing virologic failure, treatment with fosamprenavir, ‘boosted’ with ritonavir, for 48 weeks achieved viral loads < 400 copies/mL in 58% of patients, compared to 61% of patients treated with lopinavir; ritonavir.

However, this study was not large enough to reach a definitive conclusion that fosamprenavir boosted with ritonavir is clinically equivalent to lopinavir; ritonavir in protease inhibitor-experienced patients.

In antiretroviral-naive adult patients, fosamprenavir can be taken once or twice daily, with or without ritonavir (to ‘boost’ fosamprenavir plasma concentrations). In protease inhibitor-experienced patients, the twice-daily administration regimen with ritonavir is required to assure viral suppression.

Fosamprenavir was approved by the FDA for use in adults and adolescents in October 2003. An oral suspension was approved for use in pediatric patients in June 2007.

In April 2012, the FDA approved use of fosamprenavir in protease inhibitor-naive infants >= 4 weeks and in protease inhibitor-experienced infants >= 6 months.

Indications

  • human immunodeficiency virus (HIV)
  • human immunodeficiency virus (HIV) infection
  • human immunodeficiency virus (HIV) prophylaxis

Side Effects

  1. abdominal pain
  2. angioedema
  3. bleeding
  4. diabetes mellitus
  5. diabetic ketoacidosis
  6. diarrhea
  7. elevated hepatic enzymes
  8. fatigue
  9. headache
  10. hemolytic anemia
  11. hypercholesterolemia
  12. hyperglycemia
  13. hypertriglyceridemia
  14. lipodystrophy
  15. maculopapular rash
  16. myocardial infarction
  17. nausea
  18. nephrolithiasis
  19. neutropenia
  20. paresthesias
  21. pruritus
  22. rash
  23. Stevens-Johnson syndrome
  24. vomiting

Monitoring Parameters

  • blood glucose
  • CBC with differential
  • CD4+ T cell count
  • hepatitis B serology
  • LFTs
  • plasma hepatitis C RNA
  • plasma HIV RNA
  • pregnancy testing
  • serum bilirubin (total and direct)
  • serum cholesterol
  • serum lipid profile
  • urinalysis

Contraindications

  • autoimmune disease
  • breast-feeding
  • diabetes mellitus
  • diabetic ketoacidosis
  • geriatric
  • Graves’ disease
  • Guillain-Barre syndrome
  • hemolytic anemia
  • hemophilia
  • hepatic disease
  • hepatitis
  • hepatitis B and HIV coinfection
  • hepatitis C and HIV coinfection
  • human immunodeficiency virus (HIV) infection resistance
  • hypercholesterolemia
  • hyperglycemia
  • hypertriglyceridemia
  • immune reconstitution syndrome
  • infants
  • myocardial infarction
  • neonates
  • pregnancy
  • premature neonates
  • serious rash
  • sulfonamide hypersensitivity

Interactions

  • Abacavir; Dolutegravir; Lamivudine
  • Abemaciclib
  • Acalabrutinib
  • Acarbose
  • Acetaminophen; Butalbital; Caffeine; Codeine
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