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| |  Combivir Approved In Canada For HIV Treatment LAVAL, QC and MISSISSAUGA, ON -- Dec. 4, 1998 -- The Health Protection Branch of Health Canada has approved Glaxo Wellcome Inc.'s and BioChem Pharma’s Combivir(R). The drug is the first and only existing HIV compact formulation to offer proven safety and efficacy and which could improve treatment adherence for HIV/AIDS patients requiring potent nucleoside analogue therapy. Combivir is a unique fixed dose formulation combining two well-established anti-HIV drugs, 3TC(R) (lamivudine) and Retrovir(R) (AZT(TM)/zidovudine), into one tablet. Taken twice daily, Combivir offers the advantage of reducing the number of tablets by up to six tablets per day or 2,190 tablets per year compared to the use of the two other drugs as individual compounds. Combivir is easy to take and, unlike many other HIV drugs, can be taken with or without food. "The approval of Combivir represents a welcome solution to addressing treatment adherence issues. Its very simple dosing schedule, without food or fluid restrictions, combined with its safety and tolerability profile are likely to help increase adherence to often complex, multi-drug treatment regimens which many HIV patients are currently receiving,'' said Dr. Chris Tsoukas, director of the Immune Deficiency Treatment Centre, Montreal General Hospital, McGill University. "Adherence to treatment is a major issue in the fight against HIV. Forgetting to keep to these strict treatment regimens can reduce the effectiveness of the treatment, leading to the emergence of drug resistant viruses and ultimately to treatment failure." Combination treatment, involving three or more different drugs, is currently regarded as the optimal treatment regimen for the suppression of HIV. However, these treatment regimens can be difficult to adhere to, involving between 10-20 pills a day which have to be taken at different times of the day and depending on the drugs involved, either with or without food and drink. Combivir is indicated for the treatment of HIV infection, when therapy is warranted and can be used either at initiation of treatment or can replace 3TC and Retrovir taken separately. Combivir can also be used in patients requiring treatment modification. Each tablet contains 150 mg 3TC and 300 mg Retrovir. Data presented at the 12th World AIDS Conference in Geneva in July, 1998 showed that as part of triple combination therapy, taking the fixed dose combination, Combivir, is at least as effective as taking 3TC and Retrovir separately. More than 30,000 patients have been using Combivir since its introduction in the United States in October, 1997. The most frequently reported adverse events related to Combivir are headache or dizziness and nausea, although all reported events were mild in intensity.
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