Trizivir P&T
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Trizivir P&T

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    Trizivir P&T Trizivir P&T Presentation Transcript

    • 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
    • Trizivir Identity
      • Trade Name and Manufacturer:
        • Trizivir, GlaxoSmithKline
      • Generic Name:
        • Abacavir sulfate, Lamivudine (3TC), Zidovudine (AZT)
    • Therapeutic Category
      • Abacavir (Ziagen®):
        • carbocyclic nucleoside reverse transcriptase inhibitor
      • Lamivudine (Epivir®) (3TC):
        • dideoxynucleoside reverse transcriptase inhibitor
      • Zidovudine (Retrovir®) (AZT):
        • dideoxynucleoside reverse transcriptase inhibitor
    • Indication
      • Treatment of HIV-1 infection
      • Alone
      • In Combination
    • Pharmacology
      • Abacavir  CBV-TP ↓ native dGTP & chain terminates vDNA
      • Lamivudine & Zidovudine  base-TP  ↓ reverse transcriptase via chain termination
    • 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
    • Black Box Warning
      • Hypersensitivity Reactions
        • Abacavir: potentially fatal hypersensitivity
          • Fever
          • Rash
          • Gastrointestinal (N/V/D/Ab pain)
          • Constitutional
          • Respiratory (dyspnea, cough, or pharyngitis)
    • Black Box Warning
      • Hematological Toxicity
        • Zidovudine associated with
          • neutropenia
          • severe anemia
          • patients advanced HIV
          • Prolonged  symptomatic myopathy
    • 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
    • Dose & Dosage
      • Each tablet contains:
        • Abacavir 300 mg
        • Lamivudine 150 mg
        • Zidovudine 300 mg
      • Dosage 1 tablet twice daily
    • 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)
    • 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
    • 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
    • Recommendation
      • Add Trizivir® to VA formulary:
        • Bioequivalent to other regimens
        • Offers simple regimen
        • Low pill burden
        • Very good adherence
        • Cost effective
        • Positive lipid effects