RECOMBINANT HUMAN INTERFERON-BETA FOR CONDYLOMATA ACUMINATA - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF INTRALESIONAL THERAPY

To assess the efficacy of a novel glycosylated mammalian cell derived recombinant human interferon-beta (r-hIFN-beta-1a) in the intralesiona l treatment of genital condylomata acuminata. The study was randomized , double-blind and placebo-controlled. Patients (n = 60) with up to 8 distinct condylomata acuminata were randomized to receive either one m illion international units (IU) of r-hIFN-beta-1a or placebo intralesi onally into each lesion, 3 times a week, fora total of 9 occasions. Bi opsies were taken from each patient before enrolment to allow human pa pillomavirus (HPV) testing, and patients were tested for the developme nt of anti-IFN-beta antibodies. Efficacy was assessed by measuring the complete response rate 3 months after treatment. The complete respons e rate was not significantly better with r-hIFN-beta-1a than with plac ebo. However, after 3 months, 73.3% of patients treated with r-hIFN-be ta-1a had experienced at least a partial response to treatment, compar ed with 33.3% of placebo-treated patients. At 19 days and 6 weeks, r-h IFN-beta-1a produced a significantly larger reduction in the area of c ondylomata. Lesions with detectable HPV6 or 11 showed a trend towards a better response rate to treatment with r-hIFN-beta-1a than lesions w here no HPV DNA was detected. The treatment was well tolerated. In the 5 patients who developed non-neutralizing anti-IFN-beta antibodies, t herapeutic efficacy was not compromised. Intralesional r-hIFN-beta-1a was effective in the reduction of the size of genital condylomata acum inata.