A Randomized, Double-Blind, Placebo-Controlled Trial of Systemically Administered Interferon- , - , or -  in Combination with Cryotherapy for the Treatment of Condyloma Acuminatum

Abstract

One hundred fifty-two patients were enrolled in a study to evaluate 3 interferon (IFN) preparations used in combination with cryotherapy for treatment of anogenital warts. Subjects received subcutaneous injections (2 x 10(6) units/m2) of IFN-alpha n1, -beta, -gamma or placebo 3 times a week for 6 weeks and cryotherapy with liquid nitrogen. Subjects were followed < or = 1 year. Among patients followed > or = 12 weeks, two-thirds had a complete response. No significant differences in rates of complete response (P = .37) or reappearance of a wart at the initial site (P = .20) were noted among the treatment groups. However, patients who received IFN-beta or -gamma developed new warts at a significantly lower frequency (P = .02). IFN administration was associated with side effects but was well tolerated. IFN-beta was the least toxic of the 3 preparations and had the best therapeutic ratio.

Therapy for genital human papillomavirus-related disease

“…However, IFN-␣ has been shown not to affect outcome compared to placebo following CO 2 laser ablation (Condyloma International Study Group, 1993). Similarly, a study comparing IFN-␣, -␤, -␥ or placebo in combination with cryotherapy found no difference in response (Bonnez et al, 1995). Interferon therapy has never really gained a therapeutic niche.…”

Adjuvant treatment of anogenital warts with systemic interferon: a systematic review and meta-analysis

“…Two trials (n=137) investigated adjuvant beta-IFN in a high-dose5 and very high dose2 combined with an ablative therapy. No significant differences between the verum and placebo groups were seen for short-term CC (1 RCT, RR 0.88, 95% CI 0.45 to 1.73, GRADE: low) and intermediate-term CC (1 RCT, RR 1.22, 95% CI 0.95 to 1.56, GRADE: low), both of these referring to a very high dose regimen.…”

“…No significant differences between the verum and placebo groups were seen for short-term CC (1 RCT, RR 0.88, 95% CI 0.45 to 1.73, GRADE: low) and intermediate-term CC (1 RCT, RR 1.22, 95% CI 0.95 to 1.56, GRADE: low), both of these referring to a very high dose regimen. The RR regarding dropout due to AE could not be calculated due to zero events 5. Occurrence of AE showed no significant differences to placebo (see online supplementary material 2.4.2); these data refer to the high-dose regimen.…”

“…Two trials (n=95) evaluated a placebo comparison of high-dose5 or low-dose11 gamma-IFN combined with ablative therapy. No significant differences were detected regarding long-term CC (1 RCT, RR 1.25, 95% CI 0.47 to 3.33, GRADE: moderate), intermediate-term recurrence (1 RCT, RR 1.20, 95% CI 0.54 to 2.67, GRADE: moderate) and long-term recurrence (1 RCT, RR 1.00, 95% CI 0.39 to 2.53, GRADE: moderate); these data refer to the low-dose regimen.…”

“…The study by Bonnez and colleagues5 compared high-dose regimens of adjuvant alpha-, beta- and gamma-IFN, combined with cryotherapy in each of the groups. Results for efficacy outcomes were not extractable, since no absolute data were stated in this study (see online supplementary material 2.3).…”