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Analysis of Six Clinical Trials Finds EPZICOM(R) Effective in Treatment-Naive HIV Patients With Both High and Low Baseline Viral Loads
Date:8/7/2008

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EPZICOM contains abacavir, which is also contained in ZIAGEN(R) (abacavir sulfate) and TRIZIVIR(R) (abacavir sulfate, lamivudine, and zidovudine). Patients taking EPZICOM may have a serious allergic reaction (hypersensitivity reaction) that can cause death.

If you get a symptom from 2 or more of the following groups while taking EPZICOM, stop taking EPZICOM and call your doctor right away:

1. Fever

2. Rash

3. Nausea, vomiting, diarrhea, or abdominal (stomach area) pain

4. Generally ill feeling, extreme tiredness, or achiness

5. Shortness of breath, cough, or sore throat

Carefully read the Warning Card that your pharmacist gives you and carry it with you at all times.

If you stop EPZICOM because of an allergic reaction, NEVER take EPZICOM or any other abacavir-containing medicine (ZIAGEN, TRIZIVIR) again. If you take EPZICOM or any other abacavir-containing medicine again after you have had an allergic reaction, WITHIN HOURS you may get life-threatening symptoms that may include very low blood pressure or death.

If you stop EPZICOM for any other reason, even for a few days, and you are not allergic to EPZICOM, talk with your healthcare professional before taking it again. Taking EPZICOM again can cause a serious or life-threatening reaction, even if you never had an allergic reaction before. If your healthcare professional tells you that you can take EPZICOM again, start taking it when you are around medical help or people who can call a doctor if you need one.

A build up of lactic acid in the blood and an enlarged liver, including fatal cases, have been reported.

Do not take EPZICOM if your liver does not function normally.

Some patients infected with both hepatitis B virus (HBV) and HIV have worsening of hepatitis after stopping lamivudine (a component of EPZICOM). Discuss any change in treatment with your doctor. If you have both HBV and HIV and stop treatment
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SOURCE GlaxoSmithKline
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