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.
OBJECTIVE
The primary objective was to determine if six weeks treatment with subcutaneous interferon alpha-2a (IFN) and podophyllin 25% W/V 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.


METHODS
Randomised, double-blind parallel group study.


METHODS
Multicentre study in six genitourinary clinics within the U.K.


METHODS
One hundred and twenty-four patients with primary anogenital warts.


METHODS
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% (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 the complete response in 57% (8/14 patients) of the IFN-treated group and 80% (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 regime 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.
Armstrong
D K
DK
Department of Genitourinary Medicine, Royal Victoria Hospital, Belfast, Northern Ireland.
Maw
R D
RD
Dinsmore
W W
WW
Morrison
G D
GD
Pattman
R S
RS
Watson
P G
PG
Nathan
P M
PM
Moss
T
T
Nayagam
A
A
Wade
A
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D001004:Anus Diseases / Q000628:therapy* / Q000821:virology; D003218:Condylomata Acuminata / Q000628:therapy* / Q000821:virology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005831:Genital Diseases, Female / Q000628:therapy* / Q000821:virology; D005832:Genital Diseases, Male / Q000628:therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011033:Podophyllin / Q000627:therapeutic use*; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome
D016898:Interferon-alpha; D011033:Podophyllin