Polyphenon E®: a new treatment for external anogenital warts

Authors


  • Conflicts of interest
    S.T., E.S. and K.R.B. have served as clinical trial investigators (contracted research) for MediGene AG, Martinsried, Germany. H.T., P.W., U.E. and A.M. are employees of MediGene AG, and they receive a salary from and own stock in the company. E.S. and K.R.B are study investigators, consultants, congress speakers and members of the Advisory Committee for MediGene AG. The study was supported by Medigene AG, Martinsried, Germany.

Silvio Tatti.
E-mail:siltatti@fibertel.com.ar

Summary

Background  External genital warts (EGWs, condylomata acuminata) are a common, highly contagious disease caused by human papillomavirus (HPV), predominantly HPV 6 and HPV 11. Green tea catechins have been identified for their immunostimulatory, antiproliferative and antitumour properties. Two phase III trials evaluated treatment of EGWs with ointment containing a mixture of green tea catechins (Polyphenon E®, U.S. adopted name: sinecatechins).

Objectives  To obtain additional data on the efficacy and safety of Polyphenon E® ointment in the treatment of EGWs from two randomized, double-blind, vehicle-controlled trials.

Methods  Men and women aged ≥ 18 years (n = 1005), with two to 30 EGWs (12–600 mm2 total area) applied vehicle (GVeh; n = 207), Polyphenon E® ointment 10% (G10%; n = 401) or Polyphenon E® ointment 15% (G15%; = 397) three times daily until complete clearance of all EGWs (baseline + new EGWs) or for a maximum of 16 weeks.

Results  A total of 1004 patients were evaluable for safety and 986 for efficacy; 838 completed treatment after 16 weeks. Complete clearance of all EGWs was obtained in 53·6% (G10%) and 54·9% (G15%) of patients with Polyphenon E® vs. vehicle (35·4%) (< 0·001). Statistically significant differences in clearance rates appeared after 6 weeks of active treatment. Odds ratios vs. GVeh for G10% [2·10; 95% confidence interval (CI) 1·49–2·98] and G15% (2·22; 95% CI 1·57–3·14) indicated about a twofold higher chance of complete clearance under active treatment. Time to complete clearance was shorter with active treatment (hazard ratios 1·57 and 1·87, respectively, for G10% and G15% vs. GVeh groups; < 0·001). Recurrence rates during follow-up were low and similar across groups: 5·8%, 6·8% and 6·5% (GVeh, G10% and G15% groups, respectively). Adverse events were evenly distributed across groups (∼ 30% of patients). Severe local signs were more frequent but moderate in the active treatment groups (1·5%, 9·2% and 13·5% for GVeh, G10% and G15% groups, respectively).

Conclusions  Polyphenon E® ointment is effective and well tolerated in the treatment of EGWs.

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