FDA approves EPZICOM

August 02, 2004

Research Triangle Park, NC - August 2, 2004 - EPZICOMTM, a new product combining two HIV medicines into one tablet dosed once a day (QD) with no food or fluid requirements, was cleared for prescription use today by the U.S. Food and Drug Administration (FDA). EPZICOM combines two widely-used nucleoside reverse transcriptase inhibitors (NRTIs), EPIVIR(R) (lamivudine, 3TC) and ZIAGEN(R) (abacavir sulfate, ABC) for use in combination with other antiretroviral drugs. The brand name, EPZICOM, is an acronym for EPIVIR and ZIAGEN in COMbination. EPZICOM Tablets are recommended for use in combination with antiretroviral drugs from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors.

GlaxoSmithKline (GSK), manufacturer of EPZICOM, announced today that it is initiating a voucher program for EPZICOM that will provide a 60 day supply of EPZICOM directly to patients at no cost. These vouchers will be available in limited supply through participating healthcare providers for a limited time. Vouchers can be used to initiate antiretroviral therapy for therapy-naïve patients or for therapy-experienced patients who require a change in regimen.

"EPZICOM marks an important advance in GSK's ongoing commitment to provide new options in antiretroviral therapy for HIV patients," said Doug Manion, vice president for HIV Clinical Research for the Infectious Diseases Medicines Development Center (MDC) for GSK. "The voucher program will be particularly beneficial to people who are not covered by private health care plans or in specific states where the drug is not yet available on all formularies."

Dr. Manion added that EPZICOM provides patients and treaters with a flexible and potent dosing option that combines two NRTIs that have been widely used in antiretroviral therapy for years. "Prescribers are familiar with these medications, which have an established resistance and long-term safety profile reflected in years of clinical experience," Dr. Manion said.

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.Product Information
HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to others.

EPZICOM, in combination with other antiretroviral agents, is indicated for the 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, as well as hypotension as part of a hypersensitivity reaction, compared to patients taking ZIAGEN 300 mg twice daily.

When used as part of a combination regimen, ZIAGEN (one of the two active ingredients in EPZICOM) is a potent nucleoside reverse transcriptase inhibitor. The most serious adverse event associated with ZIAGEN administration is a hypersensitivity reaction that can be life threatening and has been fatal in some cases. The hypersensitivity reaction is characterized by fever, rash, gastrointestinal symptoms, such as nausea, vomiting, diarrhea or abdominal pain, symptoms such as generalized malaise, fatigue or achiness and/or respiratory symptoms such as dyspnea, pharyngitis or cough. Symptoms of this reaction usually occur within the first six weeks of treatment although these reactions can occur at any time during therapy.

To avoid a delay in diagnosis and minimize the risk of a life-threatening hypersensitivity reaction, EPZICOM, ZIAGEN or TRIZIVIR should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (e.g. acute onset respiratory disease, gastroenteritis, or reactions to other medication). Rechallenge is contraindicated after a diagnosis of hypersensitivity. Symptoms of this reaction usually occur within the first six weeks of treatment although these reactions can occur at any time during therapy. The symptoms of this reaction get progressively worse with continued treatment with EPZICOM, ZIAGEN or TRIZIVIR, but generally resolve following permanent discontinuation of EPZICOM, ZIAGEN or TRIZIVIR. Patients experiencing these symptoms should stop taking EPZICOM, ZIAGEN or TRIZIVIR and contact a physician immediately.

Patients experiencing this reaction must not take EPZICOM, ZIAGEN or TRIZIVIR again as restarting the drug after a hypersensitivity reaction has resulted in cases of life-threatening and fatal reactions. When therapy with EPZICOM, ZIAGEN or TRIZIVIR has been discontinued and reinitiation of therapy is under consideration, the reason for discontinuation should be evaluated to ensure that the patient did not have a hypersensitivity reaction. A Medication Guide and Warning Card for EPZICOM, ZIAGEN or TRIZIVIR must be provided by pharmacists to patients with each new and refilled prescription in order to provide further information to the patient on this drug. EPIVIR (a medicine in EPZICOM) in combination with other antiretroviral agents is indicated for the treatment of HIV infection. Patients with HIV or coinfected with HIV and hepatitis B should only receive the recommended HIV dosage of EPIVIR (300mg/day) and not EPIVIR-HBV(R) (100mg/day). EPIVIR has not been adequately studied for treatment of chronic hepatitis B in patients coinfected with hepatitis B and HIV. Clinical and laboratory exacerbations of hepatitis B have occurred after discontinuation of EPIVIR and may be severe in patients with decompensated liver disease.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including ZIAGEN, EPIVIR and other antiretrovirals.

Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy. The causal relationship, mechanism and long-term consequences of these events are currently unknown.

EPZICOM is not for use in patients with hepatic impairment. EPZICOM is not intended for use in pediatric patients. The most common side effects seen with EPZICOM in combination with efavirenz were trouble sleeping, depression, headache, tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain, abnormal dreams and anxiety.
GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and an industry leader in HIV research and therapies. The company is engaged in basic research programs designed to investigate new targets to treat HIV.

For full prescribing information, please see www.treathiv.com

Public Communications Inc.

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