A randomised, double-blind, parallel group study to compare subcutaneous interferon alpha-2a plus podophyllin with placebo plus podophyllin in the treatment of primary condylomata acuminata

Abstract

Objectives-The primary objective was to determine if six weeks treatment with subcutaneous interferon alpha-2a (IFN) and podophyllin 25% WIV administered twice per week, preceded by IFN alpha-2a three times weekly for one week showed a greater complete response rate in patients with primary condylomata acuminata when assessed at week 10 than treatment with podophyllin and placebo injections in the same schedule. The secondary objective was to compare recurrence rates in complete responders at six months in the two treatment groups. Design: Randomised, double-blind parallel group study. Setting: Multicentre study in six genitourinary clinics within the U.K. Patients-One hundred and twenty-four patients with primary anogenital warts. Main Outcome Measures-Complete response rate at week 10, and recurrence rate at week 26 in complete responders. Results: At week 10 analysis of the efficacy population showed complete response in 36% (15142 patients) of IFNtreated group and 26% (11143 patients) in the placebo group (no significant difference). Analysis ofthe safety population at week 26 showed persistence of the complete response in 57% (8114 patients) of the IFN-treated group and 80%/o (12/15 patients) of the placebo group (no significant difference). Adverse effects were more common in IFN-treated patients, involved particularly application site reaction and malaise but were generally mild. Conclusions-At the dose and with the reime described treatment with IFN alpha-2a in combination with podophyllin is no more effective in the treatment of primary anogenital warts than podophyllin alone and is associated with more adverse events.