MEXICO CITY, Aug. 7 /EMWNews/ -- GlaxoSmithKline (NYSE:

GSK) today announced that 96-week data from the HEAT study show that

once-daily EPZICOM (abacavir + lamivudine) provides comparable efficacy to

once-daily Truvada(R) (tenofovir DF + emtricitabine) as a first-line option

for the treatment of HIV. The data were presented today at the 17th

International AIDS Conference in Mexico City, Mexico.



    HEAT is the first large, prospective, long-term, head-to-head trial to

evaluate the safety and efficacy of EPZICOM and Truvada both combined with

a boosted protease inhibitor (Kaletra) administered once-daily in adults

who had no previous exposure to HIV medicines. The study involved 688 HIV

therapy-naive patients: 343 randomized to treatment with EPZICOM and 345

randomized to treatment with Truvada.



    Results of the study found that through 96 weeks efficacy endpoints for

EPZICOM were comparable to Truvada, regardless of baseline viral load. At

96 weeks 60% of subjects receiving EPZICOM versus 58% of subjects receiving

Truvada achieved a viral load     EPZICOM should not be used as part of a triple-nucleoside regimen.

    EPZICOM does not cure HIV infection/AIDS or prevent passing HIV to others.

    Important Safety Information



    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 buildup 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 with EPZICOM, you should be closely monitored by

your doctor for at least several months.



    Worsening of liver disease (sometimes resulting in death) has occurred

in patients infected with both HIV and hepatitis C virus who are taking

anti-HIV medicines and are also being treated for hepatitis C with

interferon with or without ribavirin. If you are taking EPZICOM as well as

interferon with or without ribavirin and you experience side effects, be

sure to tell your doctor.



    When you start taking HIV medicines, your immune system may get

stronger and could begin to fight infections that have been hidden in your

body, such as pneumonia, herpes virus, or tuberculosis. If you have new

symptoms after starting your HIV medicines, be sure to tell your doctor.



    Changes in body fat may occur in some patients taking antiretroviral

therapy. These changes may include an increased amount of fat in the upper

back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat

from the legs, arms, and face may also occur. The cause and long-term

health effects of these conditions are not known at this time.



    The most common side effects seen with the drugs in EPZICOM dosed

once-daily were allergic reaction, trouble sleeping, depression, headache,

tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain, abnormal

dreams, and anxiety. Most of the side effects do not cause people to stop

taking EPZICOM.



    For additional important information about EPZICOM please visit

http://www.epzicom.com.

    About 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 information on

GSK's HIV medications, please visit http://www.treatHIV.com.



    Cautionary statement regarding forward-looking statements



    Under the safe harbor provisions of the U.S. Private Securities

Litigation Reform Act of 1995, GSK cautions investors that any

forward-looking statements or projections made by GSK, including those made

in this announcement, are subject to risks and uncertainties that may cause

actual results to differ materially from those projected. Factors that may

affect GSK' s operations are described under 'Risk Factors' in the

'Business Review' in the company' s Annual Report on Form 20-F for 2007.






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