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Kivexa, One Tablet Once a Day Simplifies Treatment for HIV Patients

MONTREAL, CANADA -- October 26, 2005 -- Kivexa(TM), a new medication for the treatment of HIV (human immunodeficiency virus) infection from GlaxoSmithKline (GSK) and Shire BioChem, is now available to patients in Canada.

Kivexa can simplify treatment for patients with HIV because it combines two medicines in one tablet and is taken just once a day. Kivexa can also be taken with or without food or fluids, unlike many other HIV treatments.

Because antiretroviral medicines for HIV work more effectively together than alone, it has become standard clinical practice to prescribe them in multi-drug regimens. Kivexa combines two widely-used nucleoside reverse transcriptase inhibitors (NRTIs), Ziagen(R) (abacavir sulfate, ABC) and 3TC(R) (lamivudine), into one tablet, and is taken in combination with other antiretroviral drugs, in adults.

"Doctors have extensive experience with the component medications in Kivexa and know them to be well-tolerated and highly effective in treating HIV infection," said Dr. Joss De Wet, clinical assistant professor, Department of Family Practice, University of British Columbia. "Regimens for HIV can be complex and burdensome for patients, so doctors and patients will welcome a new choice that makes it simpler for patients to take their HIV medications as prescribed."

Kivexa is an NRTI "backbone" for combination therapy with other antiretroviral drugs. Kivexa has the flexibility to be combined with other antiretroviral drugs, such as protease inhibitors (PIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs), as there is little potential for interactions with these HIV treatments. Another important treatment goal for clinicians is minimising the risk of HIV resistance to antiretroviral drugs so that future treatment options are preserved. Clinical trials have demonstrated that Kivexa was associated with a low risk of cross-resistance with other NRTIs.¹

Improved patient satisfaction with Kivexa has been demonstrated by results from an ongoing trial involving 260 people with HIV. Patient satisfaction increased when subjects were switched from a multi-drug regimen including Ziagen + 3TC twice-daily, to Kivexa once-daily within the rest of their existing regimen. Patients were asked about considerations such as treatment demands, convenience, flexibility, and the way that treatment fits into their lifestyles.² Studies have shown that patients are more likely to adhere to their antiretroviral medication if the dosing is less frequent, and if there are no food restrictions.^1,3,4

"Because HIV therapy involves combinations of drugs, juggling many different tablets every day can be challenging for patients. Treatment is life-long, and keeping up with a complex regimen has long been an issue for people living with HIV," said Dr. Anita Rachlis, infectious disease consultant, Sunnybrook and Women's College Health Sciences Centre in Toronto. "Kivexa offers treatment flexibility in a single pill without any food or fluid restrictions."

The components of Kivexa are well-established in clinical use. Current experience with the two components includes more than 509,000 patient years' experience with regimens containing Ziagen and 2.6 million patient years' with regimens containing 3TC. Also, more than 5,800 patients have participated in clinical studies that have demonstrated the safety, efficacy and resistance profiles of Kivexa in multi-drug HIV regimens. In an effort to provide maximum value, GlaxoSmithKline and Shire BioChem will sell Kivexa at price parity with the two individual components (Ziagen and 3TC).

"Any advancement that improves adherence to a treatment regimen is beneficial, which will make the lives of people living with HIV easier," said Murray Jose, executive director, Toronto People With AIDS Foundation.

Kivexa safety

The safety profile of Kivexa's components is well-established and there have been no new safety concerns in studies with Kivexa.

Some of the most common side effects with abacavir or lamivudine are gastrointestinal symptoms, malaise, fatigue, and headache.

The most important safety consideration with Kivexa is hypersensitivity reaction (HSR), a serious allergic reaction that occurs in about eight out of 100 patients taking abacavir sulfate (contained in Kivexa, Ziagen and TRIZIVIR(R)). In clinical trials using an abacavir once-daily regimen, the reported rate of HSR remained within the range recorded for abacavir given twice-daily. The hypersensitivity reaction is characterized by fever, rash, gastrointestinal symptoms, such as nausea, vomiting, headaches, 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. Patients experiencing possible symptoms of HSR must contact their doctor immediately to see whether they should stop taking Kivexa.

About HIV⁵

According to the Public Health Agency of Canada, more than 57,000 Canadians tested positive for HIV from 1985 to the end of 2004. There has been a 20 per cent increase in the number of positive HIV test reports in the last five years.

The majority of those reported positive with HIV are adult men between ages of 30 to 39. The overall trends include a slight rise among men who have sex with men, a decrease among injecting drug users and an overall increase, in the number of heterosexual exposure cases.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GSK developed the first combination products to treat HIV infection. COMBIVIR(R) (lamivudine/zidovudine) was approved in Canada in 1998, and TRIZIVIR(R) (abacavir/lamivudine/zidovudine) was approved in 2001. GSK is an industry leader in HIV research and therapies and is engaged in research programs designed to investigate new targets to treat HIV/AIDS. For more information, visit GlaxoSmithKline's Web site at www.gsk.com.

About Shire

Based in Saint-Laurent, Québec, Shire BioChem is a subsidiary of Shire Pharmaceuticals. Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), renal diseases and human genetics. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

For further information on Shire, please visit the Company's website: www.shire.com.

FOR ADDITIONAL INFORMATION, PLEASE CONTACT:

Marie-Christine Beauchemin - GlaxoSmithKline (514) 956-3105
Nila Jacob/Jessica McBay - NATIONAL PharmaCom (416) 586-0180

Kivexaä and Trizivirä are trademarks used under GlaxoSmithKline Shire BioChem.

Combivir(R)and 3TC^â are registered trademarks, used under license by GlaxoSmithKline Shire BioChem.

Ziagenâ is a registered trademark, used under license by GlaxoSmithKline Inc.

REFERENCES:
1. European Medicines Agency (EMEA, 2005). European Public Assessment Report, Kivexa (EMEA H/C/581). http://www.emea.eu.int/humandocs/Humans/EPAR/Kivexa/Kivexa.htm.

2. Stone VE. Strategies for optimizing adherence to highly active antiretroviral therapy: lessons from research and clinical practice. Clin Infect Dis. 2001; 33: 865 – 872.

3. Stone VE. Enhancing adherence to antiretrovirals: Strategies and regimens. Medscape General Medicine 2002; 4(3).http://www.medscape.com/viewarticle/438193.

4. Wood E, Hogg RS, Yip B et al. Effect of medication adherence on survival of HIV-infected adults who start highly active antiretroviral therapy when the CD4+ cell count is 0.200 to 0.350 x 10(9) cells/L. Ann Intern Med. 2003;139(10): 810 – 816.

5. Public Health Agency of Canada. HIV and AIDS in Canada. Surveillance report to December 31, 2004. http://www.phac-aspc.gc.ca/publicat/aids-sida/haic-vsac1204/pdf/april_2005.pdf. Apr 2005.


SOURCE: GlaxoSmithKline and Shire BioChem

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