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  • 1. Trizivir® Jason Cavolina BS, MS, PharmD Candidate Arnold & Marie Schwartz College of Pharmacy and Health Sciences Long Island University Drug Information Clerkship P & T Presentation
  • 2. Trizivir Identity
    • Trade Name and Manufacturer:
      • Trizivir, GlaxoSmithKline
    • Generic Name:
      • Abacavir sulfate, Lamivudine (3TC), Zidovudine (AZT)
  • 3. Therapeutic Category
    • Abacavir (Ziagen®):
      • carbocyclic nucleoside reverse transcriptase inhibitor
    • Lamivudine (Epivir®) (3TC):
      • dideoxynucleoside reverse transcriptase inhibitor
    • Zidovudine (Retrovir®) (AZT):
      • dideoxynucleoside reverse transcriptase inhibitor
  • 4. Indication
    • Treatment of HIV-1 infection
    • Alone
    • In Combination
  • 5. Pharmacology
    • Abacavir  CBV-TP ↓ native dGTP & chain terminates vDNA
    • Lamivudine & Zidovudine  base-TP  ↓ reverse transcriptase via chain termination
  • 6. Pharmacokinetics
    • 1 Trizivir tablet = 1 300 mg Ziagen tablet + 1 150 mg Epivir tablet + 1 300 mg Retrovir tablet
    • Well absorbed PO
    • Large volume of distribution
    • Low protein binding
    • Variable/minor metabolism
    • Renal clearance
  • 7. Black Box Warning
    • Hypersensitivity Reactions
      • Abacavir: potentially fatal hypersensitivity
        • Fever
        • Rash
        • Gastrointestinal (N/V/D/Ab pain)
        • Constitutional
        • Respiratory (dyspnea, cough, or pharyngitis)
  • 8. Black Box Warning
    • Hematological Toxicity
      • Zidovudine associated with
        • neutropenia
        • severe anemia
        • patients advanced HIV
        • Prolonged  symptomatic myopathy
  • 9. Black Box Warning
    • Lactic Acidosis and Severe Hepatomegaly
      • Possible fatal
      • Reported with nucleoside analogues alone or in combination
    • Exacerbations of Hepatitis B
      • Pt HBV + HIV
      • D/C Lamivudine
      • Monitor LFTs/ LETs
  • 10. Dose & Dosage
    • Each tablet contains:
      • Abacavir 300 mg
      • Lamivudine 150 mg
      • Zidovudine 300 mg
    • Dosage 1 tablet twice daily
  • 11. VA Acquisition Cost 3,027.36 252.28 Viread ® 300mg 1,902.00 158.50 Emtriva ® 200mg 4,929.36 410.78 Truveda® 2,674.80 222.90 Retrovir® 300mg 2,254.92 187.91 Epivir® 150mg 4,929.72 410.60 Combivir® 2,674.80 222.90 Retrovir® 300mg 2,254.92 187.91 Epivir® 150mg 3,058.68 254.89 Ziagen® 300mg 7,868.40 665.42 Trizivir® Yearly Acquisition Cost per Patient (dollars) 30 Day supply per Patient (dollars)
  • 12. Trizivir versus Combivir Abacavir
    • Randomized, open-label, parallel-group, multicenter, formulation switch, non-inferiority trial
      • 195 HIV-1 infected patients
      • Trizivir Vs. Combivir + abacavir (ABC)
    • Results :
      • Similar rate of virologic success (83% and 77%)
      • Fewer HIV-1 copies/ml (99% and 93%)
      • Mean adherence did not differ
    • Conclusion :
      • Trizivir clinically equivalent to Combivir-ABC
    • Fischl M, et al Pharmacotherapy 2003;23(11):1432–144
  • 13. Switching from Successful HAART to Trizivir®
    • Randomized, open-label, multi-center study
      • History of undetectable plasma HIV-1 RNA
      • Plasma viral load <50 HIV RNA copies/mL
      • Patients were randomized 1:1 into original treatment or switched to Trizivir®
    • Results:
      • Trizivir® non-inferior to the continued therapy
      • Adverse events similar
      • ↓ cholesterol and plasma triglycerides
    • Conclusions:
      • Switching to Trizivir® is effective and offers a simplified regimen
      • Trizivir ↓ lipid abnormalities that may arise from other treatment regimens
      • C Katlama et al. HIV Medicine 2003; 4;79-86
  • 14. Recommendation
    • Add Trizivir® to VA formulary:
      • Bioequivalent to other regimens
      • Offers simple regimen
      • Low pill burden
      • Very good adherence
      • Cost effective
      • Positive lipid effects