A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO COMPARE SUBCUTANEOUS INTERFERON ALPHA-2A PLUS PODOPHYLLIN WITH PLACEBO PLUS PODOPHYLLININ THE TREATMENT OF PRIMARY CONDYLOMATA ACUMINATA

Objectives-The primary objective was to determine if six weeks treatme nt with subcutaneous interferon alpha-2a (IFN) and podophyllin 25% W/V administered twice per week, preceded by IFN alpha-2a three times wee kly for one week showed a greater complete response rate in patients w ith primary condylomata acuminata when assessed at week 10 than treatm ent with podophyllin and placebo injections in the same schedule. The secondary objective was to compare recurrence rates in complete respon ders at six months in the two treatment groups. Design-Randomised, dou ble-blind parallel group study. Setting-Multicentre study in six genit ourinary 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 sho wed complete response in 36% (15/42 patients) of IFN-treated group and 26% (11/43 patients) in the placebo group (no significant difference) . Analysis of the safety population at week 26 showed persistence of t he complete response in 57% (8/14 patients) of the IFN-treated group a nd 80% (12/15 patients) of the placebo group (no significant differenc e). 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 regime described treatment with IFN alpha-2a in combination with podophyllin is no more effectiv e in the treatment of primary anogenital warts than podophyllin alone and is associated with more adverse events.