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Updated HIV treatment guidelines now include three GSK HIV medications for initial antiretroviral treatment regimens


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Toronto, Canada– August 13, 2006 – Updated treatment guidelines issued today by the International AIDS Society-USA (IAS-USA) now include three GlaxoSmithKline HIV medications as part of their recommendations for initial antiretroviral therapy. These guidelines were presented today at the International AIDS Conference (IAC) in Toronto, Canada.

In the guidelines, epzicom™ (abacavir sulfate and lamivudine) and combivir® (lamivudine and zidovudine) are both recommended nucleoside reverse transcriptase inhibitors, and lexiva® (fosamprenavir calcium) boosted with ritonavir is now listed among the recommended options for protease inhibitor-based regimens in the initial treatment of adults with HIV infection.

Additional information in the guidelines recommends the use of epzicom as an initial NRTI backbone. “Abacavir in combination with lamivudine, has comparable antiretroviral activity with the other dual nRTI components listed in the guidelines.” The guidelines also support the use of combivir as a first-line therapy based on the “extensive clinical trial data set and phase 4 experience supporting use.”

The IAS-USA commissions expert panels to issue recommendations and guidelines to provide standard approaches to patient care. The updated guidelines published in the current issue of Journal of the American Medical Association (JAMA) stated that, “[t]he choice of initial drug centers on acceptability; predicted tolerance; pill burden; comorbid conditions; short-term, mid-term and long term adverse event profiles.”

The updated guidelines reflect the international perspectives of the panelists and are designed to serve as a tool for clinicians in countries where resources are sufficient to provide relatively unrestricted choices of drugs.

“We are pleased to see that the guidelines committee has recognized combivir, epzicom, and lexiva as important treatment options for patients with HIV,” said Mark Shaefer, Director, Clinical Development, HIV Infectious Disease Medicine Development Center at GSK.

IMPORTANT INDICATION AND SAFETY INFORMATION FOR COMBIVIR , EPZICOM, AND LEXIVA

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

Combivir

Combivir is a combination tablet containing e pivir ® (lamivudine, 3TC) and retrovir ® (zidovudine, AZT).

INDICATION

Combivir is indicated in combination with other antiretroviral agents for the treatment of HIV infection.

IMPORTANT SAFETY INFORMATION

All HIV drugs have side effects. The most commonly reported side effects by patients who take combivir are: headache (35%), upset stomach (33%), fatigue (27%), and nasal signs and symptoms (20%). Patients should see their doctor regularly because serious side effects can occur, such as muscle damage and a decrease in red and white blood cells. A buildup of lactic acid in the blood and an enlarged liver, including fatal cases, have been seen.

Some patients infected with both hepatitis B virus (HBV) and HIV have worsening of hepatitis after stopping lamivudine (a component of combivir). Patients should discuss any change in treatment with your doctor. Patients who have both HBV and HIV and stop treatment with combivir should be closely monitored by a 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 combivir 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.

For complete prescribing information about combivir, visit http://us.gsk.com/products/assets/us_combivir.pdf.

Epzicom

INDICATION

* Epzicom, in combination with other antiretroviral agents, is indicated for the treatment of HIV infection in adults.
o Epzicom is one of 3 medicines containing abacavir. Before starting epzicom, your healthcare professional will review your medical history in order to avoid the use of abacavir if you have experienced an allergic reaction to abacavir in the past.
o In one study, more patients had a severe hypersensitivity reaction in the abacavir once-daily group than in the abacavir twice-daily group.
o Epzicom should not be used as part of a triple nucleoside regimen.

IMPORTANT SAFETY INFORMATION

Epzicom contains abacavir, which is also contained in ziagen® (abacavir sulfate) and trizivir® (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. 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 full prescribing information please visit www.treathiv.com

# # #

Lexiva

Lexiva is a protease inhibitor that was co-discovered by GlaxoSmithKline and Vertex Pharmaceuticals Incorporated.

INDICATION

* Lexiva is indicated in combination with other antiretroviral agents for the treatment of HIV infection in adults.

o The PI-experienced patient study was not large enough to reach a definitive conclusion that lexiva/ritonavir and lopinavir/ritonavir are clinically equivalent.
o Once-daily administration of lexiva /ritonavir is not recommended for PI-experienced patients. Lexiva does not cure HIV or prevent passing HIV to others.

IMPORTANT SAFETY INFORMATION

* You should not take lexiva if you have had an allergic reaction to lexiva or agenerase® (amprenavir).
* High blood sugar, diabetes or worsening of diabetes, and bleeding in hemophiliacs have occurred in some patients taking protease inhibitors.
* 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. The cause and long-term health effects of these conditions are not known at this time.
* Skin rashes can occur in patients taking lexiva. Rarely, rashes were severe or life threatening.
* Opportunistic infections can develop when you have HIV and your immune system is weak. It is very important that you see your healthcare provider regularly while you are taking lexiva to discuss any side effects or concerns.
* Most common side effects in clinical studies were diarrhea, headache, nausea, rash, and vomiting. In most cases, these side effects did not cause people to stop taking their medicine.

Drug Interactions

* Lexiva should not be taken with: agenerase® (amprenavir), Halcion® (triazolam), ergot medications (Cafergot®, Migranal®, D.H.E. 45®, and others), Propulsid® (cisapride), Versed® (midazolam), Orap® (pimozide), Zocor® (simvastatin), Mevacor® (lovastatin), Rifadin® (rifampin), Rescriptor® (delavirdine mesylate), or St. John’s wort (Hypericum perforatum). If you are taking Norvir® (ritonavir), you should not take Tambocor® (flecainide), or Rythmol® (propafenone hydrochloride).
* Serious and/or life-threatening events could occur between lexiva and other medications, including Cordarone® (amiodarone), lidocaine (intravenous only), Elavil® (amitriptyline HCl) and Tofranil® (imipramine pamoate), tricyclic antidepressants, and Quinaglute® (quinidine).
* Women who use birth control pills should choose a different kind of contraception. Lexiva can affect the safety and effectiveness of birth control pills.
* Patients taking Viagra® (sildenafil citrate) or levitra® (vardenafil HCl) with lexiva may be at an increased risk of side effects.
* This list of drug interactions is not complete. Be sure to tell your healthcare provider about all medicines you are taking or plan to take, including over-the-counter drugs, vitamins, and herbals.

Resistance

* Missing or skipping doses of your medicine may make it easier for the virus to mutate and multiply. Your medicines may not work as well against a mutated virus and you may become cross-resistant to other HIV medicines. It’s important to take your medicine exactly as prescribed.

For full prescribing information please go to www.LEXIVA.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.

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 www.bridgestoaccess.gsk.com or call 1-866-PATIENT.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed to the discovery and development of breakthrough small molecule drugs for serious diseases. The company’s strategy is to commercialize its products both independently and in collaboration with major pharmaceutical companies. Vertex’s product pipeline is principally focused on viral diseases, inflammation, autoimmune diseases and cancer. Vertex co-discovered the HIV protease inhibitor, lexiva, with GlaxoSmithKline.

Vertex’s press releases are available at www.vrtx.com.



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