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Excerpt
Class: Antiretroviral nucleoside analogue
Formulation: 300 mg abacavir, 300 mg zidovudine, and 150 mg lamivudine in each film-coated tablet.
Price: $960.40 per 60 tablets (AWP for a 1-month supply)
Patient assistance program: 1-(800)-722-9294
Product information: 1-(800)-334-0089
Dosage: 300 mg abacavir, 300 mg zidovudine, and 150 mg lamivudine (1 tablet) twice a day with or without food in patients with normal renal and hepatic function.
Pharmacology: Trizivir demonstrated similar pharmacokinetic properties compared with simultaneous administration of abacavir, zidovudine, and lamivudine tablets.
Drug interactions: None
Adverse reaction: GI intolerance, malaise, fatigue, headache (in up to 35%), nausea, vomiting, diarrhea, abdominal pain, anorexia, and insomnia. Bone marrow suppression (anemia and neutropenia seen more commonly with late-stage AIDS), myalgia, myopathy, transaminase elevation, fingernail discoloration. Hypersensitivity reaction with abacavir component-fever, rash, fatigue, malaise, GI symptoms, and arthralgias (noted in 2%–3% of patients), usually in the first 6 weeks. Mandatory discontinuation with hypersensitivity reaction. Do not rechallenge (two deaths reported upon abacavir rechallenge); rare cases of lactic acidosis and severe hepatomegaly with steatosis.
Pregnancy: FDA category C
Clinical trials: The first major comparative trial was CNA 3003 (ABC/AZT/3TC vs. AZT/3TC) in 173 treatment naïve patients with CD4 >100/mm3. At 24 weeks, 70% of those in the three drug arm had VL <400 c/mL, and the average increase in CD4 count was 86/mm3. This was significantly better than results in the AZT/3TC arm. The response at 48 weeks was sustained; however, a subset analysis of participants with baseline viral loads of >100,000/mL demonstrated that only 33% achieved undetectable virus (Fischl M, et al. 6th Conference on Retroviruses and Opportunistic Infections [abstract 16]; 1999; Chicago).
CNA 3005 compared the triple NRTI regimen (ABC/AZT/3TC) with indinavir/AZT/3TC in 562 treatment naïve patients. At 48 weeks, 51% in both groups had achieved VL <400 c/mL by intent-to-treat analysis. Only 31% receiving the ABC regimen with a baseline VL >100,000 c/mL had reduction to <400 c/mL compared with 45% in the IDV arm (Staszewski S. ICAAC [abstract 505]; 1999 Sep). There was comparable immune restoration in the two groups with median CD4 count increases of approximately 140/mm3. Genotypic resistance analysis of HIV strains from failures usually showed wild-type virus or the RT codon 184 mutation (7th CROI, abstract 331, 2000, San Francisco).
The Swiss Cohort study examined patients who responded to PI-containing regimens and were then randomized to continue the PI regimen or switch to a triple NRTI regimen with ABC/AZT/3TC. At 48 weeks, VL and CD4 count responses were comparable in both groups, and blood lipid profiles were better in the triple NRTI group (7th CROI, abstract 457, 2000, San Francisco).
