OBJECTIVES: Human Genital warts (GW) are common and increasing in sexually active people. Ninety percent of GW are due to Human Papillomavirus (HPV) types 6 and 11. Current treatments can be long, painful, sometimes fail, and relapses are frequent. The objective of this study was to assess treatment patterns and costs associated with the treatment of GW in Italy. Such estimation is important to assess the cost-effectiveness of Gardasil®, the quadrivalent HPV vaccine (types 6, 11, 16 & 18). METHODS: A national retrospective observational study was designed to involve 40 investigators in public gynaecological, dermatological, and sexually transmitted disease centres, enrolling 360 patients aged 14-64 years, with newly diagnosed or recurrent GW. Investigators documented medical resource utilisation and absence from work for the treatment of GW and related complications in 2005 (physician visits, diagnostic tests, medications, office-based treatments, hospitalisations, days off work). Annual direct medical costs per patient were estimated along with productivity losses from the societal perspective. RESULTS: A total of 28 investigators enrolled 341 patients (189 men and 152 women); 8 patients were admitted directly to day-hospital and 333 (97.7%) had at least one investigator visit (on average 3.4 visits); 267 outpatient cases (80.2%) underwent at least one office-based procedure. 124 patients (36.4%) were prescribed a self-applied therapy. 39 cases (11.4%) were admitted to day-hospital. 47 patients (13.8%) reported a medical complication related to GW treatment. Mean annual direct medical costs per patient were €242 for men and €332 for women. Mean costs per patient including productivity losses were €325 and €464 for men and women, respectively. CONCLUSION: This study is the first to identify therapeutic patterns and costs of GW in Italy. Treatment costs are in line with recent European estimates, whereas a wider use of office-based procedures instead of self-applied therapies was found.