"Trizivir" Approved: Three Existing Drugs in One

On November 15 the FDA approved Trizivir®, a product that combines adult doses of three previously approved Glaxo-Wellcome drugs -- AZT, 3TC, and abacavir -- into a single tablet. The rationale is that taking only one tablet twice a day without regard to food may improve adherence in some patients. Some activists are concerned that this treatment might be chosen for institutional convenience (for example when treating prisoners) even when it is not the best medical option for the individual.

The following writeup was released November 15 by the AIDS Treatment Information Service, an agency which provides AIDS treatment information for the U.S. government:

November 15, 2000: The Food and Drug Administration (FDA) today approved Trizivir for the treatment of HIV in adults and adolescents. Each dose of Trizivir is a fixed-dose combination of Ziagen (abacavir/ABC), Retrovir (zidovudine/AZT), and Epivir (lamivudine/3TC), three nucleoside reverse transcriptase inhibitors (NRTIs) already approved by FDA. Trizivir is not recommended for treatment in adults or adolescents who weigh less than 40 kilograms because it is a fixed-dose tablet.

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Because Trizivir combines a single dose of three drugs into one pill, it may be easier for some patients to comply with their medication regimen. Each component of Trizivir is also available separately. This combination product should only be used by those whose treatment regimens would otherwise include these doses of these three nucleoside analogues. It may be used alone or in combination with other antiretroviral agents for the treatment of HIV infection, but should not be administered concomitantly with abacavir, lamivudine, or zidovudine, which are already contained in Trizivir. The recommended dose is one tablet twice a day.

For more information, contact our ATIS Health Information Specialists at 1-800-448-0440 or at atis@hivatis.org. You can find the complete FDA press release at http://www.hivatis.org/atisnew.html

ISSN # 1052-4207

Copyright 2000 by John S. James. Permission granted for noncommercial reproduction, provided that our address and phone number are included if more than short quotations are used.

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