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| |  Canada Approves Trizivir (Lamivudine/Zidovudine/AZT/Abacavir) For Human Immunodeficiency Virus MONTREAL, QC -- November 6, 2001 -- GlaxoSmithKline Inc. and Shire BioChem Inc. announced today that the Therapeutic Products Directorate (TPD) of Health Canada has approved Trizivir™, the first and only human immunodeficiency virus (HIV) triple combination antiretroviral therapy in a single tablet, in Canada. Trizivir combines the three active ingredients of the widely used HIV medications 3TC® (lamivudine), Retrovir® (zidovudine/AZT™) and Ziagen® (abacavir sulfate). Recently released data from a 48-week study demonstrated Trizivir's significant improvement in patient adherence and tolerability with an equivalent efficacy compared to a protease inhibitor (PI)-based regimen. Moreover, data up to 104 weeks shows that Trizivir provides long-term suppression of HIV. Taken as a single tablet two times a day, Trizivir provides a more manageable treatment option for people living with HIV/AIDS requiring highly active antiretroviral therapy (HAART). Trizivir is now available across Canada by prescription only. "Improving patient adherence to complex drug regimens such as those for HIV/AIDS is an important clinical advance," said Dr. Sharon Walmsley, Associate Professor of Medicine, University of Toronto and Assistant Director, Immunodeficiency Clinic, Toronto General Hospital. "In this regard, Trizivir is a meaningful step towards simplifying antiretroviral therapy regimens for people living with HIV," she added. Trizivir can be taken alone or in combination with other antiretroviral agents for the treatment of HIV infection. The individual components of Trizivir will continue to be available. 3TC and Retrovir are also already available in a dual combination product called Combivir®. On average, people being treated for HIV take as many as 12 tablets or capsules per day just to treat their HIV. This does not include vitamins or medications for other conditions. Some of the HIV medications people are required to take may have food and fluid restrictions or requirements, or require complicated multiple dosings throughout the day. Trizivir does not have any food or fluid restrictions, and does reduce overall pill burden. "Many of us who live with HIV have become frustrated with managing complex treatment regimens. As long as they are tailored to individual needs, new options that are simpler and easier to manage would be most welcome," said Ron Rosenes, Honourary Director, AIDS Committee of Toronto. "The introduction of Trizivir is an important advance in the treatment of HIV/AIDS," said Dr. Anne Phillips, Vice President of Research and Development, GlaxoSmithKline Inc. "With no food or fluid restrictions or requirements, and a smaller pill burden, Trizivir will help many HIV/AIDS patients to simplify their often difficult and complex HIV therapy and should be considered as a potent option for people recently diagnosed." "This regimen is intended to simplify treatment through less pills," said Joseph Rus, President and Chief Executive Officer of Shire BioChem. "Reducing pill burden -- a key challenge in managing the treatment of HIV infection -- may thereby improve adherence." In 48-week study data released at the recent First International AIDS Society Conference on HIV Pathogenesis and Treatment, 72 percent of patients taking a combination of Ziagen + Combivir, the active ingredients in Trizivir, showed greater than 95 percent adherence, compared to 45 percent of those taking a regimen of the combination indinavir + Combivir (p<0.001). Ziagen + Combivir has demonstrated fewer drug-related adverse events than the combination of Combivir/indinavir (65 percent and 87 percent respectively; p<0.001). Moreover, the study found the Ziagen + Combivir arm to be statistically superior (p=0.002), with 66 percent of patients achieving a level of virus under 400 copies/ml, compared to only 50 percent of patients taking the PI-based regimen. In another study, Trizivir was found to be generally well tolerated even after two years of therapy. Additionally, a further study revealed that at 48 weeks of treatment, total cholesterol increase was significantly lower with Trizivir and fewer manifestations of lipid abnormalities were observed when compared to a PI-based regimen. A hypersensitivity reaction has been associated with abacavir. This hypersensitivity reaction can be life threatening. Patients experiencing symptoms of this reaction should stop taking Trizivir or Ziagen and contact their physician immediately. During the clinical trial program, hypersensitivity reaction has been observed in approximately four percent of patients. Patients who have previously experienced a hypersensitivity reaction to abacavir must never use a product containing abacavir again, including Ziagen and Trizivir. SOURCE: GlaxoSmithKline & Shire BioChem
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