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Tenofovir: Very Effective, Few Toxicities, Little Resistance

KEY POINT

An FDA advisory committee has unanimously recommended approval of tenofovir disoproxil fumarate (Viread—Gilead Sciences) for use in treatment-experienced adult patients with HIV infection. The agent appears to cause fewer adverse effects and to induce less viral resistance than other HIV drugs. The company is seeking an indication for use of tenofovir in both treatment-experienced and -naive patients even though data were available only in previously treated patients. The majority of committee members voted that the new medication should only be used in treatmentexperienced patients, although FDA will make the final determination. Tenofovir is given as one tablet once daily, making it convenient and simple for patients.

SOURCES

FDA briefing document: Viread (tenofovir DF). Accessed October 4, 2001, at www.fda.gov/ohrms/dockets/ac/01/briefing/3792b1_01_gilead.pdf.