Darunavir

Darunavir Brand Name– Prezista

What is Darunavir

Darunavir is an anti-retroviral protease inhibitor.

It was granted accelerated approval by the FDA based on evidence from two randomized, controlled studies comparing the safety and efficacy of a darunavir (boosted with ritonavir) treatment regimen with other ritonavir-boosted protease inhibitor (PI) treatment regimens; treatment regimens included usual antiretroviral combinations, with or without enfuvirtide.

Darunavir-treated patients experienced higher rates of reduction of their HIV viral load than patients on other ritonavir-boosted PI combinations.

At 24 weeks, 69% to 77% of the darunavir-treated patients achieved a viral load reduction of at least 1 log₁₀ copies/mL from baseline compared with 25% in the control groups (p less than 0.001); 43% to 53% of the darunavir-treated patients achieved viral load less than 50 copies/mL compared with 18% in the control group (p less than 0.001).

HIV strains in patients who have previously received and developed resistance to other PIs are responsive to darunavir.

Darunavir must be used in combination with an individualized antiretroviral regimen, be administered with a pharmacokinetic enhancer (i.e., cobicistat or low dose ritonavir), and be given with food in order to attain appropriate concentrations.

Indications

1. human immunodeficiency virus (HIV)
2. human immunodeficiency virus (HIV) infection
3. human immunodeficiency virus (HIV) prophylaxis

Side Effects

1. abdominal pain
2. acute generalized exanthematous pustulosis (AGEP)
3. angioedema
4. anorexia
5. asthenia
6. bleeding
7. breast enlargement
8. conjunctivitis
9. Cushingoid features
10. diabetes mellitus
11. diabetic ketoacidosis
12. diarrhea
13. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
14. dyspepsia
15. elevated hepatic enzymes
16. eosinophilia
17. fatigue
18. fever
19. flatulence
20. gynecomastia
21. headache
22. hematoma
23. hepatitis
24. hyperamylasemia
25. hyperbilirubinemia
26. hypercholesterolemia
27. hyperglycemia
28. hyperlipidemia
29. hypertriglyceridemia
30. lipodystrophy
31. malaise
32. myalgia
33. nausea
34. nightmares
35. oral ulceration
36. osteonecrosis
37. pancreatitis
38. pruritus
39. rash
40. rhabdomyolysis
41. Stevens-Johnson syndrome
42. toxic epidermal necrolysis
43. urticaria
44. 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
• bleeding
• breast-feeding
• children
• diabetes mellitus
• diabetic ketoacidosis
• Graves’ disease
• Guillain-Barre syndrome
• hemophilia
• hepatic disease
• hepatitis
• hepatitis B and HIV coinfection
• hepatitis C and HIV coinfection
• human immunodeficiency virus (HIV) infection resistance
• hyperglycemia
• hyperlipidemia
• hypertriglyceridemia
• immune reconstitution syndrome
• infants
• jaundice
• neonates
• pancreatitis
• pregnancy
• pregnancy testing
• serious rash
• sulfonamide hypersensitivity

Interactions

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