Objective: To evaluate the efficacy of surgical-cidofovir (SCT), surgical (ST) and cidofovir (CT) treatment of genital warts in HIV-infected patients.
Design: Open randomized prospective pilot study.
Setting: Outpatients attending the sexually transmitted disease service of the II Dept of Infectious Diseases, L Sacco Hospital, Milan-Italy.
Patients: Consenting HIV-positive patients with anal-genital warts recruited from January 2000 to March 2001.
Interventions: Three treatment arms: surgical excision by electrocautery, topical 1% cidofovir-gel (5 days per week, maximum 6 weeks) and electrocautery-cidofovir treatment with 1% cidofovir-gel applied within 1 month of surgical treatment (5 days per week for 2 weeks).
Main outcome measures: Rate of wart clearance and time and rate of relapses within a 6-month follow-up period.
Results: Complete response was achieved in 93.1% of 29 patients treated by ST, 76.2% of 26 treated by CT and in 100% of 19 patients treated by SCT (P = 0.0033). The relapse rate in 49 patients followed-up was 73.68% in ST, 35.29% in CT and 27.27% in SCT patients (P = 0.018). Median time to relapses in ST patients was 66 days (Kaplan-Meyer, P = 0.0012). Human papillomavirus DNA was cleared in 52.63% of 19 patients evaluated. The rate of clearance of high risk and low risk genotypes was 0% and 57.14% 25% and 50% 100% and 71.42% in ST, CT and SCT patients, respectively.
Conclusions: A combination of surgical and medical treatment was most effective in clearing lesions completely and in reducing the relapse rate. Human papillomavirus DNA clearance can be attributed to the antiviral effect of cidofovir and could explain the low relapse rate observed. Larger studies are required to determine the most appropriate medical treatment for viral eradication after surgery.