Magazine article Drug Topics

Glaxo Wellcome Drug Combines Antiretrovirals

Magazine article Drug Topics

Glaxo Wellcome Drug Combines Antiretrovirals

Article excerpt

Glaxo Wellcome has secured approval from the Food & Drug Administration for Combivir, which combines two of the most common antiretroviral medications in a single tablet indicated for the treatment of HIV infection. The company believes the combination drug will simplify the complicated dosing regimens often associated with HIV treatment.

Each Combivir tablet contains Epivir (lamivudine 150 mg, 3TC) and Retrovir (zidovudine 300 mg, AZT), equaling half of the antiretrovirals` daily dose as typically prescribed. Patients take one tablet of Combivir twice daily. In contrast, patients taking lamivudine and zidovudine separately may need to take up to eight pills daily to receive the same dosage levels.

Glaxo Wellcome is stressing the simplicity of the new combination formulation, which can be taken with or without food. Because many HIV patients follow multiple drug regimens to treat both the virus and opportunistic infections, the company believes Combivir's ease of use will increase patient compliance by reducing the chances of confusion or frustration over dosing complexity.

Although Combivir has not been tested in clinical trials, Glaxo Wellcome is relying on studies of Epivir and Retrovir in combination therapy to describe the new formulation's efficacy. Clinical trials combining the two antiretrovirals indicated that headaches, nausea, and fatigue were the most common side effects, but that, overall, the combination treatment was generally well tolerated. Because Combivir is a fixeddose tablet, it is not an appropriate choice for patients who require dose adjustments of either lamivudine or zidovudine, such as those suffering from renal insufficiency or pediatric patients less than 12 years old. …

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