Acyclovir-Resistant Herpes: Expanded Access Available for Cidofovir Gel (FORVADE(TM))

Certain patients with herpes lesions which do not respond to acyclovir are eligible for expanded access to topical cidofovir gel. Cidofovir -- formerly called HPMPC -- is active against many viruses and is currently approved for injection use in treating CMV retinitis in persons with AIDS(under the name VISTIDE(R), or cidofovir for injection). InJanuary 1997 Gilead Sciences applied to the FDA for approval to market a gel formulation, under the name FORVADE(TM), and announced a pre-approval expanded access program for this formulation.

To be eligible for this program, patients must have mucocutaneous herpes simplex infection unresponsive to at least a ten-day course of treatment with acyclovir. They must be over 13 years of age, and must not concomitantly use drugs with anti-herpes activity, or use other topical medications for the lesion. There are some other inclusion/exclusion criteria.

For more information about this program, patients should have their physician call Gilead Sciences Medical Information,800-GILEAD-5 (press 3), from 8:30 a.m. to 5:00 p.m. Pacific time.