INDICATIONS AND USAGE
EPZICOM Tablets, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection.
Additional important information on the use of EPZICOM for treatment of HIV-1 infection:
- EPZICOM is one of multiple products containing abacavir. Before starting EPZICOM, 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.
- In one controlled study (CNA30021), more patients taking ZIAGEN 600 mg once daily had severe hypersensitivity reactions compared to patients taking ZIAGEN 300 mg twice daily.
- As part of a triple-drug regimen, EPZICOM Tablets are recommended for use with antiretroviral agents from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors.
See WARNINGS, ADVERSE REACTIONS, and Description of Clinical Studies.
Clinical Studies
EPZICOM
There have been no clinical trials conducted with EPZICOM (see CLINICAL PHARMACOLOGY for information about bioequivalence of EPZICOM). One EPZICOM Tablet given once daily is an alternative regimen to EPIVIR Tablets 300 mg once daily plus ZIAGEN Tablets 2 x 300 mg once daily as a component of antiretroviral therapy.
The following study was conducted with the individual components of EPZICOM.
Therapy-Naive Adults
CNA30021 was an international, multi-center, double-blind, controlled study in which 770 HIV-infected, therapy-naive adults were randomized and received either ZIAGEN 600 mg once daily or ZIAGEN 300 mg twice daily, both in combination with EPIVIR 300 mg once daily and efavirenz 600 mg once daily. The double-blind treatment duration was at least 48 weeks. Study participants had a mean age of 37 years, were: male (81%), Caucasian (54%), black (27%), and American Hispanic (15%). The median baseline CD4+ cell count was 262 cells/mm3 (range 21 to 918 cells/mm3) and the median baseline plasma HIV-1 RNA was 4.89 log10 copies/mL (range: 2.60 to 6.99 log10 copies/mL).
The outcomes of randomized treatment are provided in Table 3.
Table 3. Outcomes of Randomized Treatment Through Week 48 (CNA30021) |
Outcome
|
ZIAGEN 600 mg q.d. plus EPIVIR plus Efavirenz
(n = 384)
|
ZIAGEN 300 mg b.i.d. plus EPIVIR plus Efavirenz
(n = 386)
|
|
Responder*
|
64% (71%)
|
65% (72%)
|
|
Virologic failure†
|
11% (5%)
|
11% (5%)
|
|
Discontinued due to adverse reactions
|
13%
|
11%
|
|
Discontinued due to other reasons‡
|
11%
|
13%
|
* Patients achieved and maintained confirmed HIV-1 RNA <50 copies/mL (<400 copies/mL) through Week 48 (Roche AMPLICOR Ultrasensitive HIV-1 MONITOR® standard test version 1.0).
† Includes viral rebound, failure to achieve confirmed <50 copies/mL (<400 copies/mL) by Week 48, and insufficient viral load response.
‡ Includes consent withdrawn, lost to follow up, protocol violations, clinical progression, and other.
After 48 weeks of therapy, the median CD4+ cell count increases from baseline were 188 cells/mm3 in the group receiving ZIAGEN 600 mg once daily and 200 cells/mm3 in the group receiving ZIAGEN 300 mg twice daily. Through Week 48, 6 subjects (2%) in the group receiving ZIAGEN 600 mg once daily (4 CDC classification C events and 2 deaths) and 10 subjects (3%) in the group receiving ZIAGEN 300 mg twice daily (7 CDC classification C events and 3 deaths) experienced clinical disease progression. None of the deaths were attributed to study medications.
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