Gilead Provides Expanded Access Program for Tenofovir

Gilead Sciences, the developers of a new nucleotide analogue, tenofovir (PMPA), started a small expanded access program in January.

The most important use of this drug, for now, will probably be in people who have developed resistance to several of the NRTI drugs, like d4T (Zerit) and AZT (Retrovir), and need something new to shore up their combination therapy. It is less clear whether the drug will compensate for protease inhibitor failure. The initial program will begin small and expand during 2001 as drug supplies increase.

To qualify, people must have all of the following:

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• Over 10,000 copies HIV RNA and CD4+ cell counts below 100 or CD4+ cell counts below 200 and an opportunistic infection within the past three months;

• Intolerance to and/or viral load increases to at least two protease inhibitors or one protease inhibitor and one NNRTI (for a list of the names and types of anti-HIV drugs, call Project Inform's Hotline); and

• Unable to construct a viable drug combination without tenofovir.

To register patients in the program, physicians should call 800-GILEAD-5 (800-445-3235).

As more drug supplies become available, the criteria to qualify will change.

Back to the Project Inform Perspective March 2001 contents page.