Gilead Applies for FDA Approval of Nucleotide Analogue Tenofovir
May 20, 2001
Gilead Sciences has submitted an application for approval to the FDA for the anti-HIV nucleotide analogue reverse transcriptase inhibitor tenofovir. [For more on tenofovir, see Early Access Program Opened for Nucleotide Analogue Tenofovir.] This unexpected announcement means that tenofovir could be approved and available for prescription as early as November of this year. Gilead has also announced that it will relax the criteria for the tenofovir expanded access program. Originally, entrance was restricted to people with CD4 counts less than 100 and viral loads over 10,000. Due to low enrollment, there are now no official CD4 or viral load cut offs, but people must still have documented treatment failure with at least two protease inhibitors (PI) or one PI and one non-nucleoside reverse transcriptase inhibitor (NNRTI). To obtain more information directly from Gilead, call 1-800-Gilead-5.
This article was provided by Seattle Treatment Education Project. It is a part of the publication STEP Ezine.