Relationship of genital wart burden to therapeutic response to fluorouracil/epinephrine injectable gel

The efficacy of a single cycle of a new therapy for genital warts, intradermal fluorouracil/epinephrine (5-FU/epi) injectable gel, has been evaluated in 2 large pivotal trials; the objective of this study was to evaluate a second cycle of treatment. Twenty-two patients with total wart areas of 5-447 mm2 were treated with up to 2 cycles of < or =6 treatments of 5-FU/epi gel. After the first cycle of treatments, patients with warts showing a partial response or no response or new warts were continued into a second cycle. Seventy-three per cent (16/22) of patients had complete responses. Patients with total wart areas < or = 100 mm2 tended to respond completely in the first cycle of treatment (average 4.7 treatments). Patients with numerous warts or large total wart areas (>100 mm2) required an average of 7.5 treatments to achieve a complete response. Thus, a second treatment cycle may be appropriate for difficult-to-treat patients with numerous warts or large total wart areas.