INDICATIONS AND USAGE
TRIZIVIR is indicated in combination with other antiretrovirals or alone for the treatment of HIV-1 infection.
Additional important information on the use of TRIZIVIR for treatment of HIV-1 infection:
- TRIZIVIR is one of multiple products containing abacavir. Before starting TRIZIVIR, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir.
- Limited data exist on the use of TRIZIVIR alone in patients with higher baseline viral load levels (>100,000 copies/mL, see Description of Clinical Studies).
Description of Clinical Studies:
TRIZIVIR:
The following study was conducted with the individual components of TRIZIVIR (see CLINICAL PHARMACOLOGY for information about bioequivalence of TRIZIVIR).
CNA3005 was a multicenter, double-blind, controlled study in which 562 HIV-1-infected, therapy-naive adults were randomized to receive either ZIAGEN (300 mg twice daily) plus COMBIVIR® (lamivudine 150 mg/zidovudine 300 mg twice daily), or indinavir (800 mg 3 times a day) plus COMBIVIR twice daily. The study was stratified at randomization by pre-entry plasma HIV-1 RNA 10,000 to 100,000 copies/mL and plasma HIV-1 RNA >100,000 copies/mL. Study participants were male (87%), Caucasian (73%), black (15%), and Hispanic (9%). At baseline the median age was 36 years, the median pretreatment CD4+ cell count was 360 cells/mm3, and median plasma HIV-1 RNA was 4.8 log10 copies/mL. Proportions of patients with plasma HIV-1 RNA <400 copies/mL (using Roche AMPLICOR HIV-1 MONITOR® Test) through 48 weeks of treatment are summarized in Table 3.
Table 3. Outcomes of Randomized Treatment Through Week 48 (CNA3005) | Outcome |
ZIAGEN plus
Lamivudine/Zidovudine
(n = 262)
|
Indinavir plus
Lamivudine/Zidovudine
(n = 265)
|
| Responder* | 49% | 50% |
| Virologic failure† | 31% | 28% |
| Discontinued due to adverse reactions | 10% | 12% |
| Discontinued due to other reasons‡ | 11% | 10% |
| * Patients achieved and maintained confirmed HIV-1 RNA <400 copies/mL. |
| † Includes viral rebound and failure to achieve confirmed <400 copies/mL by Week 48. |
| ‡ Includes consent withdrawn, lost to follow-up, protocol violations, those with missing data, clinical progression, and other. |
Treatment response by plasma HIV-1 RNA strata is shown in Table 4.
Table 4. Proportions of Responders Through Week 48 By Screening Plasma HIV-1 RNA Levels (CNA3005) |
Screening
HIV-1 RNA
(copies/mL)
|
ZIAGEN plus
Lamivudine/Zidovudine
(n = 262)
|
Indinavir plus
Lamivudine/Zidovudine
(n = 265)
|
| <400 copies/mL | n | <400 copies/mL | n |
| ≥10,000 - ≤100,000 | 50% | 166 | 48% | 165 |
| >100,000 | 48% | 96 | 52% | 100 |
In subjects with baseline viral load >100,000 copies/mL, percentages of patients with HIV-1 RNA levels <50 copies/mL were 31% in the group receiving abacavir vs. 45% in the group receiving indinavir.
Through Week 48, an overall mean increase in CD4+ cell count of about 150 cells/mm3 was observed in both treatment arms. Through Week 48, 9 subjects (3.4%) in the group receiving abacavir sulfate (6 CDC classification C events and 3 deaths) and 3 subjects (1.5%) in the group receiving indinavir (2 CDC classification C events and 1 death) experienced clinical disease progression.
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DOSAGE AND ADMINISTRATION
A Medication Guide and Warning Card that provide information about recognition of hypersensitivity reactions should be dispensed with each new prescription and refill. To facilitate reporting of hypersensitivity reactions and collection of information on each case, an Abacavir Hypersensitivity Registry has been established. Physicians should register patients by calling 1-800-270-0425.
The recommended oral dose of TRIZIVIR for adults and adolescents is 1 tablet twice daily. TRIZIVIR is not recommended in adolescents who weigh less than 40 kg because it is a fixed-dose tablet.
Dose Adjustment:
Because it is a fixed-dose tablet, TRIZIVIR should not be prescribed for patients requiring dosage adjustment such as those with creatinine clearance <50 mL/min, patients with hepatic impairment, or patients experiencing dose-limiting adverse events.
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HOW SUPPLIED
TRIZIVIR is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green capsule-shaped, film-coated, and imprinted with GX LL1 on one side with no markings on the reverse side. They are packaged as follows:
Bottles of 60 Tablets (NDC 0173-0691-00).
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) (see USP Controlled Room Temperature).
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