Abstract

AIDS: Forvade, a cidofovir gel used topically for treatment of acyclovir-resistant herpes lesions, has recently been turned down for marketing by the Food and Drug Administration (FDA) due to insufficient test data. Published data of the test revealed the effectiveness of Forvade over placebo in all measurements used: lesion healing, viral cultures, and pain relief. In an interview with AIDS Treatment News, Dr. Jay Lalezari, one of the most experienced physicians in the country in treating acyclovir-resistant herpes, offers his insights on Forvade's importance as a herpes lesion treatment, why he believes the FDA made this decision to deny marketing rights, and what the fate of the drug is now likely to be. Dr. Lalezari argues that the FDA's position is weak, that the drug works, and that the needs of the patients were sacrificed in favor of speculative concerns.