Patient satisfaction with once-daily dosing of HIV fixed-dose combination tablet Epzicom

(I-Newswire) August 1, 2005 - 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. In one controlled study (CNA30021), more patients taking ZIAGEN 600mg once daily had severe hypersensitivity reactions compared to patients taking ZIAGEN 300mg twice daily. As part of a triple drug regimen, EPZICOM is recommended for use with antiretroviral drugs from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs).

"These results underscore GlaxoSmithKline's ongoing commitment to provide antiretroviral options that offer convenience for patients," said Mark Shaefer, Pharm. D., acting vice president, HIV, Infectious Disease Medicine Development Center at GSK. "EPZICOM provides patients and treaters with an NRTI backbone that combines two NRTIs that have been widely used in antiretroviral therapy for years."

The data presented at IAS are from ESS30008, a multicenter study that enrolled 260 patients with viral suppression on a regimen containing EPIVIR and ZIAGEN and randomized them to receive EPZICOM QD or EPIVIR and ZIAGEN dosed separately BID. Patients in both study groups also took a protease inhibitor (PI) or non-nucleoside reverse transcriptase inhibitor (NNRTI). Patient satisfaction was measured by a standardized questionnaire. Results at week 48 of treatment included:

* Trends toward greater improvement in satisfaction with treatment convenience and flexibility among patients who received EPZICOM QD compared to those who received EPIVIR and ZIAGEN BID.

* Patient satisfaction was determined in part by dosing symmetry. Compared with patients on a regimen containing both BID and QD antiretrovirals, those on a pure QD regimen reported significantly greater satisfaction on six of ten items included in the questionnaire. These six items assessed:

1. satisfaction with current treatment
2. treatment demands
3. treatment convenience
4. treatment flexibility
5. treatment/lifestyle fit
6. satisfaction with continuing treatment

There are more than 509,000 patient years experience with regimens containing ZIAGENand 2.64 million patients years with regimens containing EPIVIR.

GSK developed the first two combination products to treat HIV infection, as well as its most recently approved combination product, EPZICOM. The medications contained in EPZICOM have been well studied 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 Safety Information

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

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.

EPZICOM is not for use in patients with hepatic impairment. EPZICOM is not intended for use in pediatric patients.

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® (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.

The most common side effects seen with EPZICOM in combination with efavirenz were allergic reaction, trouble sleeping, depression, headache, tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain, abnormal dreams and anxiety.

GlaxoSmithKline

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 treathiv.com

GSK's Bridges to Access program can help provide qualified individuals with access to GSK's antiretroviral medications, as well as help identify insurance or other support for medications. Patients may be eligible for this program if they are not eligible for prescription drug benefits through any other private or public insurer, payer or program. In 2004, GlaxoSmithKline donated more than $372.5 million worth of prescription drugs to 475,000 patients. For more information, visit bridgestoaccess.gsk.com or call 1-866-PATIENT.

At a Glance

* Patients taking an HIV regimen containing the fixed dose combination EPZICOM (abacavir and lamivudine) dosed once daily (QD) tended to be more satisfied with the convenience of their HIV regimens than those taking ZIAGEN (abacavir sulfate) + EPIVIR (lamivudine) separately twice daily.

* Several aspects of treatment satisfaction were greater when HIV medications in the regimen were dosed all QD or all BID, than when regimens included both QD and BID components.

* EPZICOM may help simplify combination regimens for some patients with HIV.

* Abacavir and lamivudine are well-established drugs, with more than 509,000 patient years experience with regimens containing ZIAGEN and 2.64 million patients years with regimens containing lamivudine.

Media Contact:
Mary Faye Dark
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