Trizivir® Jason Cavolina BS, MS, PharmD Candidate Arnold & Marie Schwartz College of Pharmacy and Health Sciences Long Isl...
Trizivir Identity  <ul><li>Trade Name and Manufacturer: </li></ul><ul><ul><li>Trizivir, GlaxoSmithKline </li></ul></ul><ul...
Therapeutic Category <ul><li>Abacavir (Ziagen®): </li></ul><ul><ul><li>carbocyclic nucleoside reverse transcriptase inhibi...
Indication <ul><li>Treatment of HIV-1 infection  </li></ul><ul><li>Alone  </li></ul><ul><li>In Combination </li></ul>
Pharmacology   <ul><li>Abacavir    CBV-TP  ↓ native  dGTP & chain terminates vDNA </li></ul><ul><li>Lamivudine & Zidovudi...
Pharmacokinetics   <ul><li>1 Trizivir tablet = 1 300 mg Ziagen tablet + 1 150 mg Epivir tablet + 1 300 mg Retrovir tablet ...
Black Box Warning   <ul><li>Hypersensitivity Reactions </li></ul><ul><ul><li>Abacavir: potentially fatal hypersensitivity ...
Black Box Warning   <ul><li>Hematological Toxicity  </li></ul><ul><ul><li>Zidovudine associated with </li></ul></ul><ul><u...
Black Box Warning   <ul><li>Lactic Acidosis and Severe Hepatomegaly </li></ul><ul><ul><li>Possible fatal </li></ul></ul><u...
Dose & Dosage <ul><li>Each tablet contains: </li></ul><ul><ul><li>Abacavir 300 mg  </li></ul></ul><ul><ul><li>Lamivudine 1...
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...
Trizivir versus Combivir Abacavir <ul><li>Randomized, open-label, parallel-group, multicenter,   formulation switch, non-i...
Switching from Successful HAART to Trizivir®   <ul><li>Randomized, open-label, multi-center study </li></ul><ul><ul><li>Hi...
Recommendation <ul><li>Add Trizivir® to VA formulary: </li></ul><ul><ul><li>Bioequivalent to other regimens </li></ul></ul...
Upcoming SlideShare
Loading in...5
×

Trizivir P&T

386

Published on

Published in: Health & Medicine, Technology
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
386
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
4
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Trizivir P&T

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

    Clipping is a handy way to collect important slides you want to go back to later.

×