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 600mg once daily had severe hypersensitivity reactions compared with patients taking ZIAGEN 300mg 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.
Description of 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 770HIV-1-infected, therapy-naive adults were randomized and received either ZIAGEN 600mg once daily or ZIAGEN 300mg twice daily, both in combination with EPIVIR 300mg once daily and efavirenz 600mg once daily. The double-blind treatment duration was at least 48weeks. Study participants had a mean age of 37years, were: male (81%), Caucasian (54%), black (27%), and American Hispanic (15%). The median baseline CD4+ cell count was 262cells/mm3 (range: 21 to 918cells/mm3) and the median baseline plasma HIV-1 RNA was 4.89log10copies/mL (range: 2.60 to 6.99log10copies/mL).
The outcomes of randomized treatment are provided in Table 3.
Table 3. Outcomes of Randomized Treatment Through Week 48 (CNA30021)
*Patients achieved and maintained confirmed HIV-1 RNA <50copies/mL (<400copies/mL) through Week 48 (Roche AMPLICOR Ultrasensitive HIV-1 MONITOR standard test version 1.0).
Includes viral rebound, failure to achieve confirmed <50copies/mL (<400copies/mL) by Week48, and insufficient viral load response.
Includes consent withdrawn, lost to follow-up, protocol violations, clinical progression, and other.
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%
After 48weeks of therapy, the median CD4+ cell count increases from baseline were 188cells/mm3 in the group receiving ZIAGEN 600mg once daily and 200cells/mm3 in the group receiving ZIAGEN 300mg twice daily. Through Week 48, 6subjects (2%) in the group receiving ZIAGEN 600mg once daily (4CDC classification C events and 2deaths) and 10subjects (3%) in the group receiving ZIAGEN 300mg twice daily (7CDC classification C events and 3deaths) experienced clinical disease progression. None of the deaths were attributed to study medications.