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EPIVIR and ZIAGEN have no known pharmacokinetic interactions with protease inhibitors (PIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs). EPZICOM can be combined with PIs or NNRTIs.

There are more than 509,000 patient years experience with regimens containing ZIAGEN and 2.64 million patients years with regimens containing EPIVIR, according to Dr. Manion.

EPZICOM Tablets, in combination with other antiretroviral agents, are indicated for the treatment of HIV-1 infection. EPZICOM is one of multiple products containing abacavir. Before starting EPZICOM, healthcare professionals should review the patient's 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.

GSK developed the first two combination products to treat HIV infection. COMBIVIR(R) (lamivudine/zidovudine) was approved in 1997, and TRIZIVIR(R) (abacavir sulfate, lamivudine and zidovudine) was approved in 2000. The medications contained in EPZICOM have been well studied in BID (twice a day) and QD dosing regimens and in multiple combinations with other classes of antiretroviral drugs. Multiple clinical trials have studied the use of EPIVIR and ZIAGEN in more than 5,800 patients as a dual-NRTI backbone of multi-drug regimens.

Pivotal studies submitted for FDA approval of EPZICOM include:
• CAL10001, which established the bioequivalence of EPZICOM with the medicines EPIVIR and ZIAGEN dosed separately.
• CNA30021, which demonstrated comparable efficacy between 300mg ZIAGEN dosed BID and 600mg dosed QD when given in combination with EPIVIR 300mg QD and efavirenz 600mg QD.

Product Information
HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to others.
EPIVIR and ZIAGEN in COMBINATION = EPZICOM.
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Contact: Annie Noland
anoland@pcipr.com
Public Communications Inc.
2-Aug-2004