Combined therapy trial with interferon alpha-2a and ablative therapy in the treatment of anogenital warts.
OBJECTIVE
To determine whether the combination of systemically administered interferon alpha-2a and ablative surgery for the treatment of genital and/or perianal warts produces a 30% or greater improvement in lasting response rate compared with a control group receiving a combination of placebo and ablative therapy.


METHODS
Randomised, triple-blind, placebo-controlled trial using 1 or 3 MIU of interferon alpha-2a or placebo administered subcutaneously three times weekly for 10 weeks in combination with ablative surgery.


METHODS
International, multicentre study in 10 genitourinary medicine clinics.


METHODS
Two hundred and fifty patients with anogenital warts.


METHODS
Lasting response at week 38.


RESULTS
Standard efficacy analysis at week 38 showed a lasting response in 51% (35/68) of 3 MIU interferon-treated patients, 48% (30/63) of 1 MIU interferon-treated patients and 43% (29/67) of placebo-treated patients.


CONCLUSIONS
With the doses and regime described, treatment with interferon alpha-2a in combination with ablative therapy is not significantly superior in the treatment of anogenital warts than placebo and ablative therapy.
Armstrong
D K
DK
Department of Genitourinary Medicine, Royal Victoria Hospital, Belfast.
Maw
R D
RD
Dinsmore
W W
WW
Blaakaer
J
J
Correa
M A
MA
Falk
L
L
Ferenczy
A S
AS
Fortier
M
M
Frazer
I
I
Law
C
C
Moller
B M
BM
Oyakawa
N
N
D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D001004:Anus Diseases / Q000601:surgery / Q000628:therapy*; D003131:Combined Modality Therapy; D003218:Condylomata Acuminata / Q000601:surgery / Q000628:therapy*; D005260:Female; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D011994:Recombinant Proteins; D016896:Treatment Outcome; D014860:Warts / Q000601:surgery / Q000628:therapy*
D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins