August 20, 2003

Janet Woodcock
Director, Center for Drug Evaluation and Research
Food and Drug Administration
Building WOC2, Room 6027
MAILSTOP HFD001
Rockville MD 20852

Dear Dr. Woodcock:

The AIDS Treatment Activist Coalition (ATAC) is a national coalition of AIDS activists, many living with HIV/AIDS, working together to end the AIDS epidemic by advancing research on HIV/AIDS and broadening access to treatment.

A letter written to you by Michael Weinstein, of the AIDS Healthcare Foundation (AHF), has come to our attention. The letter requests the removal of Trizivir from the market on the basis of the interim analysis released last March from ACTG 5095. The letter states that it is written on behalf of AHF and ". . . the hundreds of thousands of people in the United States with HIV/AIDS. . . ." As members of this large community, we wish to communicate our position inasmuch as AHF does not speak for the entire affected community.

Members of ATAC have been following recent data on Trizivir, such as that from ACTG 5095, with concern. We feel that this issue warrants further investigation of its efficacy as a "complete regimen." We have communicated our concerns to GlaxoSmithKline directly, but we feel that the FDA should request the appropriate follow-up studies to answer the recent questions that have arisen concerning the efficacy of Trizivir as a sole regimen.

However, we do not think that Trizivir should be removed from the market because its reduced pill burden offers a significant benefit to patients taking antiretroviral therapy. We do feel that until more answers are provided about Trizivir's potency as a single regimen, Trizivir should not be advertised directly and openly as a complete regimen. Clinicians must decide how to best use Trizivir in the meantime, based on patient needs and characteristics.

We are asking the FDA to work with GlaxoSmithKline to resolve these outstanding potency questions about Trizivir as a complete regimen so that physicians may prescribe Trizivir effectively. We also ask the FDA to make any appropriate revisions to Trizivir's labeling to ensure the ethical treatment of patients using Trizivir.

Very truly yours,

ATAC
Drug Development Committee